A Treatment 

Improvement 

Protocol

Medication-Assisted Treatment

For Opioid Addiction in 

Opioid Treatment Programs

TIP

43

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Treatment

www.samhsa.gov

MEDICATIONASSISTED

TREATMENT
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Treatment

1 Choke Cherry Road

Rockville, MD 20857

Steven L. Batki, M.D.

Consensus Panel Chair

Janice F. Kauffman, R.N., M.P.H., LADC, CAS

Consensus Panel Co-Chair

Ira Marion, M.A.

Consensus Panel Co-Chair

Mark W. Parrino, M.P.A. 

Consensus Panel Co-Chair

George E. Woody, M.D.

Consensus Panel Co-Chair

A Treatment 

Improvement 

Protocol

TIP

43

Medication-Assisted Treatment

For Opioid Addiction in 

Opioid Treatment Programs
Acknowledgments

Numerous people contributed to the 

development of this Treatment Improvement

Protocol (see pp. xi and xiii as well as

Appendixes E and F). This publication was

produced by Johnson, Bassin & Shaw, Inc.

(JBS), under the Knowledge Application

Program (KAP) contract numbers 270-99-

7072 and 270-04-7049 with the Substance

Abuse and Mental Health Services

Administration (SAMHSA), U.S. Department

of Health and Human Services (DHHS).

Christina Currier served as the Center for

Substance Abuse Treatment (CSAT)

Government Project Officer, and Andrea

Kopstein, Ph.D., M.P.H., served as Deputy

Government Project Officer. Robert Lubran,

M.S., M.P.A., and Alan Trachtenberg, M.D.,

served as CSAT technical experts. Lynne

McArthur, M.A., A.M.L.S., served as 

the JBS KAP Executive Project Co-Director.

Barbara Fink, R.N., M.P.H., served as 

the JBS KAP Managing Project Co-Director.

Other JBS KAP personnel included Dennis

Burke, M.S., M.A., Deputy Director for

Product Development; Wendy Caron,

Editorial Quality Assurance Manager;

Frances Nebesky, M.A., Quality Assurance

Editor; Leah Bogdan, Junior Editor; Emily

Tinkler, Junior Writer; and Pamela Frazier,

Document Production Specialist. Catalina

Vallejos Bartlett, M.A., Margaret Brooks,

J.D., Jonathan Max Gilbert, M.A., Randi

Henderson, and Deborah J. Shuman 

were writers. 

Disclaimer

The opinions expressed herein are the views 

of the consensus panel members and do not

necessarily reflect the official position of CSAT,

SAMHSA, or DHHS. No official support of or

endorsement by CSAT, SAMHSA, or DHHS

for these opinions or for particular instruments,

software, or resources described in this 

document is intended or should be inferred.

The guidelines in this document should not be

considered substitutes for individualized client

care and treatment decisions.

Public Domain Notice

All materials appearing in this volume except

those taken directly from copyrighted sources

are in the public domain and may be reproduced

or copied without permission from SAMHSA/ 

CSAT or the authors. Do not reproduce or 

distribute this publication for a fee without 

specific, written authorization from SAMHSAís

Office of Communications.

Electronic Access and Copies

of Publication

Copies may be obtained free of charge from

SAMHSAís National Clearinghouse for Alcohol

and Drug Information (NCADI), (800) 729-6686

or (301) 468-2600; TDD (for hearing impaired),

(800) 487-4889; or electronically through the

following Internet World Wide Web site:

www.ncadi.samhsa.gov.

Recommended Citation

Center for Substance Abuse Treatment.

Medication-Assisted Treatment for Opioid

Addiction in Opioid Treatment Programs.

Treatment Improvement Protocol (TIP) Series

43. DHHS Publication No. (SMA) 05-4048.

Rockville, MD: Substance Abuse and Mental

Health Services Administration, 2005.

Originating Office

Practice Improvement Branch, Division of

Services Improvement, Center for Substance

Abuse Treatment, Substance Abuse and Mental

Health Services Administration, 1 Choke

Cherry Road, Rockville, MD 20857.

DHHS Publication No. (SMA) 05-4048

Printed 2005
Contents

What Is a TIP? ............................................................................................................ix

Consensus Panel ..........................................................................................................xi

KAP Expert Panel and Federal Government Participants ..................................................xiii

Foreword ...................................................................................................................xv

Executive Summary ...................................................................................................xvii

Chapter 1óIntroduction ...............................................................................................1

Purpose of This TIP .......................................................................................................1

Key Definitions..............................................................................................................2

Audience for This TIP.....................................................................................................2

A Decade of Change........................................................................................................2

Remaining Challenges......................................................................................................6

The Future of MAT .......................................................................................................10

Chapter 2óHistory of Medication-Assisted Treatment for Opioid Addiction...........................11

Emergence of Opioid Addiction as a Significant Problem and the Roots of Controversy .................11

Origins of Opioid Maintenance Therapy .............................................................................17

Regulatory History........................................................................................................21

Chapter 3óPharmacology of Medications Used To Treat Opioid Addiction ...........................25

Pharmacology and Pharmacotherapy ................................................................................28

Dosage Forms ..............................................................................................................31

Efficacy......................................................................................................................32

Side Effects .................................................................................................................33

Interactions With Other Therapeutic Medications.................................................................36

Safety ........................................................................................................................42

Chapter 4óInitial Screening, Admission Procedures, and Assessment Techniques ..................43

Initial Screening ...........................................................................................................43

Admission Procedures and Initial Evaluation ......................................................................46

Medical Assessment .......................................................................................................49

Induction Assessment ....................................................................................................53

Comprehensive Assessment .............................................................................................53

Appendix 4-A. Example of Standard Consent to Opioid Maintenance Treatment ..........................61

iii
iv

Chapter 5óClinical Pharmacotherapy ............................................................................63

Contraindications to Opioid Pharmacotherapy ....................................................................64

Stages of Pharmacotherapy.............................................................................................65

Medically Supervised Withdrawal ....................................................................................78

Take-Home Medications ................................................................................................81

Office-Based Opioid Therapy...........................................................................................85

Chapter 6óPatientñTreatment Matching:

Types of Services and Levels of Care ..........................................................................87

Steps in PatientñTreatment Matching ................................................................................88

Patients With Special Needs ............................................................................................91

Treatment Planning.......................................................................................................95

Chapter 7óPhases of Treatment..................................................................................101

Rationale for a Phased-Treatment Approach and Duration ...................................................101

Phases of MAT ...........................................................................................................102

Transition Between Treatment Phases in MAT....................................................................119

Readmission to the OTP ...............................................................................................120

Chapter 8óApproaches to Providing Comprehensive Care and 

Maximizing Patient Retention .................................................................................121

Core Services .............................................................................................................121

Retaining Patients in MAT.............................................................................................122

Counseling and Case Management, Behavioral Treatments, and Psychotherapy .........................124

Benefits of Family Involvement.......................................................................................133

Integrative Approaches.................................................................................................135

Relapse Prevention......................................................................................................136

Referral to Social Services.............................................................................................138

Involuntary Discharge From MAT...................................................................................138

Patient Advocacy ........................................................................................................142

Chapter 9óDrug Testing as a Tool...............................................................................143

Purposes of Drug Testing in OTPs...................................................................................143

Benefits and Limitations of Drug Tests .............................................................................144

Drug-Testing Components and Methods ............................................................................148

Development of Written Procedures.................................................................................151

Other Considerations in Drug-Testing Procedures ...............................................................154

Interpreting and Using Drug Test Results..........................................................................155

Reliability, Validity, and Accuracy of Drug Test Results........................................................158

Contents
v

Chapter 10óAssociated Medical Problems in Patients Who Are Opioid Addicted .................161

Integrated Versus Referral Services .................................................................................162

Routine Testing and Followup for Medical Problems............................................................163

Acute, Life-Threatening Infections ..................................................................................163

Infectious Diseases.......................................................................................................164

Patients With Disabilities ..............................................................................................173

Pain Management........................................................................................................174

Hospitalization of Patients in MAT ..................................................................................178

General Medical Conditions and MAT ..............................................................................178

Chapter 11óTreatment of Multiple Substance Use..........................................................179

Prevalence of Multiple Substance Use in MAT....................................................................180

Common Drug Combinations Used by Patients in MAT ........................................................181

Effects of Other Substance Use.......................................................................................182

Management of Multiple Substance Use in MAT..................................................................186

Inpatient Detoxification and Short-Term Stabilization..........................................................188

Chapter 12óTreatment of Co-Occurring Disorders ........................................................189

Prevalence of Co-Occurring Disorders..............................................................................190

Motivation for Treatment and Co-Occurring Disorders.........................................................191

Etiology of Co-Occurring Disorders .................................................................................191

Screening for Co-Occurring Disorders..............................................................................192

Making and Confirming a Psychiatric Diagnosis .................................................................194

Prognosis for Patients With Co-Occurring Disorders ...........................................................197

Treatment Issues .........................................................................................................199

Appendix 12-A. Internet Resources for Accessing Psychiatric Instruments ................................209

Chapter 13óMedication-Assisted Treatment for Opioid Addiction During Pregnancy............211

Acceptance of Methadone Maintenance as the Standard of Care .............................................211

Diagnosing Opioid Addiction in Pregnant Patients ..............................................................212

Medical and Obstetrical Concerns and Complications ..........................................................212

Methadone Dosage and Management ................................................................................215

Postpartum Treatment of Mothers in MAT ........................................................................218

Breast-Feeding ...........................................................................................................218

Effects on Neonatal Outcome .........................................................................................218

Use of Buprenorphine During Pregnancy..........................................................................220

Importance of Integrated, Comprehensive Services .............................................................222

Nutrition Assessment, Counseling, and Assistance ...............................................................223

Contents
vi

Chapter 14óAdministrative Considerations ...................................................................225

Staffing.....................................................................................................................225

Medication Diversion Control Plans.................................................................................230

The Community Effort .................................................................................................231

OTPs and National Community Education Initiatives ..........................................................236

Evaluating Program and Staff Performance.......................................................................238

Appendix AóBibliography..........................................................................................241

Appendix BóAbbreviations and Acronyms ....................................................................279

Appendix CóGlossary................................................................................................283

Appendix DóEthical Considerations in MAT..................................................................297

Fundamental Ethical Principles......................................................................................297

Ethics in Practice........................................................................................................298

Ethics: Conclusion.......................................................................................................303

Appendix EóResource Panel......................................................................................305

Appendix FóField Reviewers......................................................................................307

Index ......................................................................................................................317

CSAT TIPs and Publications Based on TIPs...................................................................331

Contents
vii

Exhibits

1-1 NIDA Comprehensive Care-Related Principles of Effective Drug Addiction Treatment.............8

3-1 Pharmacotherapeutic Medications for Opioid Addiction Treatment ...................................26

3-2 Requirements for Physiciansí Waivers To Dispense or Prescribe Buprenorphine and 

Buprenorphine-Naloxone to Patients Who Are Opioid Addicted .....................................27

3-3 Intrinsic Activity of Full Agonist (Methadone), Partial Agonist (Buprenorphine), and 

Antagonist (Naloxone) Therapy ..............................................................................31

3-4 Possible Side Effects of Opioid Agonist and Partial Agonist Therapy..................................34

3-5 Reported Drug Interactions With Methadone ...............................................................37

3-6 Other Inducers and Inhibitors of CYP450 and CYP3A4 ..................................................40

4-1 Suicide Risk Factors...............................................................................................45

4-2 Recommended Responses to Indicators of Suicidality .....................................................45

4-3 Recommended Procedures for Identifying and Addressing Domestic Violence.......................57

5-1 Using Signs and Symptoms To Determine Optimal Methadone Levels .................................68

5-2 Induction SimulationóModerate to High Tolerance .......................................................69

5-3 Heroin Use in Preceding 30 Days

(407 Methadone-Maintained Patients by Current Methadone Dose) .................................73

5-4 Methadone Dose/Mean Plasma Levels .........................................................................74

5-5 Blood Plasma Levels Over 4 and 24 Hours With an Adequate and 

Inadequate Methadone Dose ..................................................................................75

5-6 SMLs After Single and Split Methadone Dosing in a Fast Metabolizer .................................76

5-7 Types of Detoxification From Illicit Opioids .................................................................80

6-1 Case Study: PatientñTreatment Planning in MAT ..........................................................97

7-1 Acute Phase of MAT .............................................................................................104

7-2 Rehabilitative Phase of MAT...................................................................................109

7-3 Supportive-Care Phase of MAT ...............................................................................114

7-4 Medical Maintenance Phase of MAT .........................................................................116

7-5 Tapering Phase of MAT .........................................................................................118

8-1 Resource Materials for Psychoeducational, Skill-Building, and 

Group Counseling Sessions..................................................................................127

8-2 Strategy for Contingency Management in MAT ............................................................129

8-3 Common Strategies for Psychotherapy in MAT............................................................131

8-4 Strategies for Psychoeducation in MAT .....................................................................133

8-5 Patient Goals in Building Relapse Prevention Skills......................................................137

9-1 Typical Testing and Confirmation Cutoff Concentrations and Detection Times for

Various Substances of Abuse ................................................................................145

9-2 Common Immunoassays.........................................................................................150

9-3 Sample OTP Guidelines for Monitoring Urine Drug Test Specimen Collection .....................151

9-4 Examples of Onsite Analytical Methods for Drug Tests ..................................................156

10-1 Classification of TB ..............................................................................................165

10-2 Hepatitis C Evaluation Flowchart ............................................................................169

Contents
viii

10-3 Nonpharmacologic Approaches to Managing Chronic Nonmalignant Pain ..........................177

11-1 Reported Use of Other Substances by Patients Admitted to OTPs ....................................180

11-2 Current Substance Use Disorders in Patients Dependent on Another Substance While

Addicted to Opioids and Admitted to OTPs, 

With and Without Co-Occurring Disorders (N=716) ...................................................181

11-3 Drug Combinations and Common Reasons for Use .......................................................182

12-1 Common Co-Occurring Disorders in Patients Who Are Opioid Addicted............................191

12-2 DSM-IV-TR Classification of Diagnoses Associated With 

Different Classes of Substances .............................................................................196

12-3 Mutual-Help Groups for People With Co-Occurring Disorders ........................................203

12-4 Topics for Psychoeducational Groups for People With Co-Occurring Disorders...................204

12-5 Interactions of Some Medications for Depression and Bipolar Disorder 

With Methadone and Recommended Treatment Response in MAT .................................206

13-1 Common Medical Complications Among Pregnant Women Who Are Opioid Addicted............213

13-2 Laboratory Tests for Pregnant Women Who Are Opioid Addicted....................................214

13-3 Common Obstetrical Complications Among Women Addicted to Opioids ............................215

D-1 Case Example......................................................................................................299

D-2 AATOD Canon of Ethics ........................................................................................303

D-3 Ethical Codes of Selected Treatment-Oriented Organizations and Their Web Sites ...............304

Contents
What Is a TIP?

Treatment Improvement Protocols (TIPs), developed by the Center for

Substance Abuse Treatment (CSAT), part of the Substance Abuse and

Mental Health Services Administration (SAMHSA), within the U.S.

Department of Health and Human Services (DHHS), are best-practice

guidelines for the treatment of substance use disorders. CSAT draws on

the experience and knowledge of clinical, research, and administrative

experts to produce the TIPs, which are distributed to facilities and individuals across the country. The audience for the TIPs is expanding

beyond public and private treatment facilities to include practitioners in

mental health, criminal justice, primary care, and other health care and

social service settings.

CSATís Knowledge Application Program (KAP) expert panel, a distinguished group of experts on substance use disorders and professionals in

such related fields as primary care, mental health, and social services,

works with the State Alcohol and Drug Abuse Directors to generate 

topics for the TIPs. Topics are based on the fieldís current needs for

information and guidance.

After selecting a topic, CSAT invites staff from pertinent Federal 

agencies and national organizations to be members of a resource panel

that recommends specific areas of focus as well as resources that should

be considered in developing the content for the TIP. These recommendations are communicated to a consensus panel composed of experts on the

topic who have been nominated by their peers. This consensus panel

participates in a series of discussions. The information and recommendations on which they reach consensus form the foundation of the TIP.

The members of each consensus panel represent substance abuse treatment programs, hospitals, community health centers, counseling programs, criminal justice and child welfare agencies, and private practitioners. A panel chair (or co-chairs) ensures that the contents of the TIP

mirror the results of the groupís collaboration.

A large and diverse group of experts closely reviews the draft document.

Once the changes recommended by these field reviewers have been

incorporated, the TIP is prepared for publication, in print and on line.

TIPs can be accessed via the Internet at www.kap.samhsa.gov. The 

ix
online TIPs are consistently updated and provide the field with state-of-the-art information.

Although each TIP strives to include an 

evidence base for the practices it recommends,

CSAT recognizes that the field of substance

abuse treatment is evolving, and research 

frequently lags behind the innovations pioneered in the field. A major goal of each TIP is

to convey ìfront-lineî information quickly but

responsibly. For this reason, recommendations

proffered in the TIP are attributed to either

panelistsí clinical experience or the literature.

If research supports a particular approach,

citations are provided.

This TIP, Medication-Assisted Treatment for

Opioid Addiction in Opioid Treatment

Programs, incorporates the many changes in

medication-assisted treatment for opioid 

addiction (MAT) that have occurred over the

most active decade of change since the inception of this treatment modality approximately

40 years ago. The TIP describes the nature and

dimensions of opioid use disorders and their

treatment in the United States, including basic

principles of MAT and historical and regulatory

developments. It presents consensus panel 

recommendations and evidence-based best

practices for treatment of opioid addiction in

opioid treatment programs (OTPs). It also

examines related medical, psychiatric, sociological, and substance use disorders and their

treatment as part of a comprehensive maintenance treatment program. The TIP includes a

discussion of the ethical considerations that

arise in most OTPs, and it provides a useful

summary of areas for emphasis in successfully

administering MAT in OTPs.

x What Is a TIP?
Chair

Steven L. Batki, M.D.

Professor and Director of Research

Department of Psychiatry

SUNY Upstate Medical University

Syracuse, New York

Co-Chairs

Janice F. Kauffman, R.N., M.P.H., 

LADC, CAS

Vice President

Addiction Treatment Services

North Charles Foundation, Inc.

Cambridge, Massachusetts;

Director

Addiction Psychiatry Service

Department of Psychiatry

Brigham and Womenís Hospital

Boston, Massachusetts;

and Assistant Professor of Psychiatry

Harvard Medical School

Boston, Massachusetts

Ira Marion, M.A.

Executive Director

Division of Substance Abuse

Albert Einstein College of Medicine

Bronx, New York

Mark W. Parrino, M.P.A.

President

American Association for the 

Treatment of Opioid Dependence

New York, New York

George E. Woody, M.D.

Treatment Research Institute

University of Pennsylvania/

MIRECC Philadelphia VAMC

Philadelphia, Pennsylvania

Editorial Advisory Board

John D. Crowley

Crowley Associates

Elgin, South Carolina

Herbert D. Kleber, M.D.

Professor of Psychiatry

Columbia University College of Physicians 

& Surgeons

New York, New York

Stewart B. Leavitt, Ph.D.

Leavitt Medical Communications

Glenview, Illinois

Jocelyn Sue Woods, M.A.

President

National Alliance of Methadone Advocates

New York, New York

Joan Zweben, Ph.D.

Executive Director

14th Street Clinic & Medical Group, Inc.

East Bay Community Recovery Project

Berkeley, California

Consensus Panelists

Patrick Abbott, M.D.

Medical Director

Center on Alcoholism, Substance Abuse, 

and Addictions

University of New Mexico

Albuquerque, New Mexico 

Leslie Amass, Ph.D.

Principal Investigator

Friends Research Institute, Inc.

Los Angeles, California

Hector D. Barreto, M.D., M.P.H.

Medical Director

Center for Drug-Free Living

Orlando, Florida 

xi

Consensus Panel
Michael D. Couty

Director

Division of Alcohol and Drug Abuse

Missouri Department of Mental Health

Jefferson City, Missouri

Vashti Jude Forbes, R.N., BC., M.S.N.,

LCDC

Associate Director

Substance Abuse and Specialized Services

Austin Travis County Mental Health and

Mental Retardation Center

Austin, Texas

Ron Jackson, M.S.W.

Executive Director 

Evergreen Treatment Services

Seattle, Washington

Karol A. Kaltenbach, Ph.D.

Director

Maternal Addiction Treatment Education 

and Research

Jefferson Medical College

Thomas Jefferson University

Philadelphia, Pennsylvania

Judith Martin, M.D., FASAM

Medical Director

14th Street Clinic & Medical Group, Inc.

Oakland, California

Violanda T. NuÒez, M.S.W.

Executive Director

Ayudantes, Inc.

Santa Fe, New Mexico

J. Thomas Payte, M.D.

Medical Director

Drug Dependence Associates

San Antonio, Texas

Norma J. Reppucci, R.N.

Director

Operations for Eastern MA and NH 

Community Substance Abuse Centers

Malden, Massachusetts

Yong S. Song, Ph.D.

Assistant Clinical Professor and Program 

Director

Opiate Treatment Outpatient Program

University of California, San Francisco 

San Francisco, California

Jo L. Sotheran, Ph.D.

Associate Research Scientist

Mailman School of Public Health

Columbia University

New York, New York

Trusandra Taylor, M.D.

Physician Advisor

Parkside Recovery Methadone Maintenance

Philadelphia, Pennsylvania

xii Consensus Panel
Barry S. Brown, Ph.D.

Adjunct Professor

University of North Carolina at Wilmington

Carolina Beach, North Carolina

Jacqueline Butler, M.S.W., LISW, LPCC, 

CCDC III, CJS

Professor of Clinical Psychiatry

College of Medicine

University of Cincinnati

Cincinnati, Ohio

Deion Cash

Executive Director

Community Treatment and Correction 

Center, Inc.

Canton, Ohio

Debra A. Claymore, M.Ed.Adm.

Owner/Chief Executive Officer

WC Consulting, LLC

Loveland, Colorado

Carlo C. Di Clemente, Ph.D.

Chair

Department of Psychology

University of Maryland Baltimore County

Baltimore, Maryland

Catherine E. Dube, Ed.D.

Independent Consultant

Brown University

Providence, Rhode Island

Jerry P. Flanzer, D.S.W., LCSW, CAC

Chief, Services 

Division of Clinical and Services Research

National Institute on Drug Abuse

Bethesda, Maryland

Michael Galer, D.B.A., M.B.A., M.F.A.

Chairman of the Graduate School of Business

University of PhoenixóGreater Boston 

Campus

Braintree, Massachusetts

Renata J. Henry, M.Ed.

Director

Division of Alcoholism, Drug Abuse, and

Mental Health

Delaware Department of Health and 

Social Services

New Castle, Delaware

Joel Hochberg, M.A.

President

Asher & Partners

Los Angeles, California

Jack Hollis, Ph.D.

Associate Director

Center for Health Research

Kaiser Permanente

Portland, Oregon 

Mary Beth Johnson, M.S.W.

Director

Addiction Technology Transfer Center

University of MissourióKansas City

Kansas City, Missouri 

Eduardo Lopez

Executive Producer

EVS Communications

Washington, D.C.

Holly A. Massett, Ph.D.

Academy for Educational Development

Washington, D.C.

Diane Miller

Chief

Scientific Communications Branch

National Institute on Alcohol Abuse

and Alcoholism

Bethesda, Maryland

Harry B. Montoya, M.A.

President/Chief Executive Officer

Hands Across Cultures

Espanola, New Mexico

xiii

KAP Expert Panel and Federal

Government Participants
xiv

Richard K. Ries, M.D.

Director/Professor

Outpatient Mental Health Services

Dual Disorder Programs

Seattle, Washington

Gloria M. Rodriguez, D.S.W.

Research Scientist

Division of Addiction Services

New Jersey Department of Health and

Senior Services

Trenton, New Jersey

Everett Rogers, Ph.D.

Center for Communications Programs

Johns Hopkins University

Baltimore, Maryland

Jean R. Slutsky, P.A., M.S.P.H.

Senior Health Policy Analyst

Agency for Healthcare Research 

& Quality

Rockville, Maryland

Nedra Klein Weinreich, M.S.

President

Weinreich Communications

Canoga Park, California

Clarissa Wittenberg

Director

Office of Communications and

Public Liaison

National Institute of Mental Health

Bethesda, Maryland

Consulting Members to the

KAP Expert Panel

Paul Purnell, M.A.

Social Solutions, L.L.C.

Potomac, Maryland

Scott Ratzan, M.D., M.P.A., M.A.

Academy for Educational Development

Washington, D.C.

Thomas W. Valente, Ph.D.

Director, Master of Public Health Program

Department of Preventive Medicine

School of Medicine

University of Southern California

Alhambra, California

Patricia A. Wright, Ed.D.

Independent Consultant

Baltimore, Maryland

KAP Expert Panel and Federal Government Participants
Foreword

The Treatment Improvement Protocol (TIP) series supports SAMHSAís

mission of building resilience and facilitating recovery for people with or

at risk for mental or substance use disorders by providing best-practices

guidance to clinicians, program administrators, and payers to improve

the quality and effectiveness of service delivery and thereby promote

recovery. TIPs are the result of careful consideration of all relevant 

clinical and health services research findings, demonstration experience,

and implementation requirements. A panel of non-Federal clinical

researchers, clinicians, program administrators, and client advocates

debates and discusses its particular areas of expertise until it reaches 

a consensus on best practices. This panelís work is then reviewed and

critiqued by field reviewers.

The talent, dedication, and hard work that TIPs panelists and reviewers

bring to this highly participatory process have helped bridge the gap

between the promise of research and the needs of practicing clinicians

and administrators who serve, in the most current and effective ways,

people who abuse substances. We are grateful to all who have joined

with us to contribute to advances in the substance abuse treatment field.

Charles G. Curie, M.A., A.C.S.W.

Administrator

Substance Abuse and Mental Health Services Administration

H. Westley Clark, M.D., J.D., M.P.H., CAS, FASAM

Director

Center for Substance Abuse Treatment

Substance Abuse and Mental Health Services Administration

xv

Executive Summary

Research supports the perspective that opioid addiction is a medical 

disorder that can be treated effectively with medications when they are

administered under conditions consistent with their pharmacological

efficacy and when treatment includes necessary supportive services 

such as psychosocial counseling, treatment for co-occurring disorders,

medical services, and vocational rehabilitation. Medication-assisted

treatment for opioid addiction (MAT) has been effective in facilitating

recovery from opioid addiction for many patients.

This TIP provides a detailed description of MAT, especially in opioid

treatment programs (OTPs). MAT includes optional approaches such as

comprehensive maintenance treatment, medical maintenance treatment,

detoxification, and medically supervised withdrawal. Some or all of

these approaches can be provided in OTPs or other settings. With the

approval of buprenorphine for physicianís office-based opioid treatment, MAT availability is expected to increase.

Growing understanding and acceptance of opioid addiction as a 

treatable medical disorder have facilitated advances in MAT. The 

effectiveness of MAT advanced significantly with the development of

methadone maintenance treatment in the 1960s and the creation and

expansion of publicly funded treatment programs in the 1970s. The first

official Federal use of the term ìmaintenance treatmentî (referring to

opioid addiction treatment) occurred in the Narcotic Addict Treatment

Act of 1974. Perhaps the most important development in MAT during

the 1990s was publication of recommendations by a National Institutes

of Health consensus panel on Effective Medical Treatment of Opiate

Addiction. The panel concluded that opioid addiction is a treatable medical disorder and explicitly rejected notions that addiction is self-induced

or a failure of willpower. The panel called for a commitment to providing

effective treatment for opioid addiction and for Federal and State efforts

to reduce the stigma attached to MAT and to expand MAT through

increased funding and less restrictive regulation. The implementation of

an accreditation system for OTPs further serves to standardize and

improve MAT.

xvii
Accompanying these improvements in opioid

addiction treatment is an increasing emphasis

on the concomitant treatment of diseases such

as HIV/AIDS, hepatitis, and tuberculosis, all of

which occur at higher rates among people who

inject drugs than in the general population. 

This TIP addresses a variety of issues and

challenges in MAT, including

ï Drug testing for screening and assessmentó

how and when (chapters 4 and 9)

ï Administrative dischargeóissues of safety

and noncompliance (chapter 8)

ï Use of other substances with opioids and

resulting complications for MAT (chapter 11)

ï Co-occurring mental disorders and their 

complications for MAT (chapter 12)

ï Administration of staffs and procedures

(chapter 14).

The following paragraphs summarize chapters

in this TIP.

Chapter 1, Introduction, introduces MAT and

provides important concepts for understanding

this TIP. It describes opioid addiction as a

medical disorder with similarities to other disorders. It outlines the main options for MAT,

such as choices of medication and optional 

services. The chapter concludes by summarizing the greatest challenges facing OTPs and

offering a vision of the future.

Chapter 2, History of Medication-Assisted

Treatment for Opioid Addiction, provides the

historical context for MAT. It details the history of the use of opioids in the United States; the

political, legal, and regulatory responses to opioid abuse; treatment trends (including logistics

and strategies); and development of modern

medications available in MAT.

Chapter 3, Pharmacology of Medications 

Used To Treat Opioid Addiction, reviews the

pharmacology and clinical applications of the

medications used for treating opioid addiction.

It focuses on the metabolic activity, dosage

forms, efficacy, side effects, drug interactions,

safety considerations, and current availability

and restrictions for methadone, levo-alpha

acetyl methadol (LAAM), buprenorphine, 

and naltrexone. The information will enable

treatment providers to compare the benefits

and limitations of available opioid addiction

treatment medications.

Chapter 4, Initial Screening, Admission

Procedures, and Assessment Techniques,

describes screening and assessment procedures

used with applicants for admission to treatment and with patients in MAT. The chapter

describes components of the screening (or

intake) process that provides a foundation 

for treatment and procedures used during 

the admissions process to ensure thorough,

efficient data collection and to gather information for ongoing treatment intervention.

Components of substance use, medical, 

medication induction, and comprehensive 

psychosocial assessments are used to determine

MAT eligibility, individualize treatment plans,

and monitor changes in patient status. The

chapter also provides information on managing emergency situations during admission and

treatment.

Chapter 5, Clinical Pharmacotherapy, explains

opioid pharmacotherapy, focusing on the 

clinical use of methadone, buprenorphine,

LAAM, and naltrexone. It details the discrete

stages of opioid pharmacotherapy, each of

which requires unique clinical considerations.

It discusses factors that may affect individual

responses to treatment medications and key

considerations in determining individual

dosages. For patients who must leave MAT,

either voluntarily or involuntarily, the chapter

explains methods of withdrawal from treatment

medications. It also discusses important considerations in administering take-home medication.

Chapter 6, PatientñTreatment Matching: Types

of Services and Levels of Care, describes a

multidimensional, clinically driven strategy 

for matching patients in MAT with the types 

of treatment services and levels of care that

optimize treatment outcomes, within or in 

xviii Executive Summary
conjunction with OTPs. Patientñtreatment

matching involves individualizing the choice

and application of treatment resources to each

patientís needs, abilities, and preferences. The

chapter describes alternative types of treatment programs and settings for identified types

of patients and recommends elements that

should be included in patientñtreatment matching, including ways to accommodate patients

with special needs. The chapter describes 

elements of a treatment plan and the planning

process, including the roles of counselor and

patient, the importance of cultural and linguistic

competence, motivation for treatment, and the

need for a multidisciplinary team.

Chapter 7, Phases of Treatment, describes

phases of treatment for patients in MAT. These

phases are conceptualized as parts of a dynamic continuum of patient progress toward

intended treatment outcomes. Each patient

progresses according to his or her capacity and

needs. After an orientation to introduce

patients to the program, successive treatment

phases include (1) the acute phase, during

which patients attempt to eliminate illicit-opioid

use and lessen the intensity of other problems

associated with their addiction, (2) the rehabilitative phase, during which patients continue to

address addiction while gaining control of other

major life domains, (3) the supportive-care

phase, during which patients maintain their

abstinence while receiving other interventions

when needed, (4) the medical-maintenance

phase, during which patients are committed to

continuing pharmacotherapy for the foreseeable future but no longer rely on other OTP

services, (5) the tapering and readjustment

phase, an optional phase in which patients

gradually reduce and eliminate opioid treatment medication, and (6) the continuing-care

phase, in which patients who have tapered

from treatment medication continue regular

contact with their treatment program. Phases

of treatment address the therapeutic relationship, motivation, patientsí use of alcohol and

illicit drugs, their mental and medical disorders,

legal problems, and basic needs (including 

housing, education, and vocational training).

Most patients need more frequent, intensive

services in the acute phase, careful monitoring

and diversified services during rehabilitative

and supportive-care phases, and less frequent

services in subsequent phases.

Chapter 8, Approaches to Providing

Comprehensive Care and Maximizing Patient

Retention, describes the core- and extendedcare services essential to MAT effectiveness in

OTPs. It explains how a comprehensive treatment program improves patient retention in

treatment and the likelihood of positive treatment outcomes. Patients who receive regular,

frequent, integrated psychosocial and medical

services along with opioid pharmacotherapy

often realize better outcomes than those who

receive only limited services. Counseling 

services are integral to comprehensive maintenance treatment and can be behavioral,

psychotherapeutic, or family oriented.

Strategies that target relapse prevention also

should be part of any comprehensive treatment

program. The chapter describes ways to

increase patient retention and avoid administrative discharge. Administrative discharge 

usually results in rapid relapse and may lead to

incarceration or death. Clear communication

and awareness on the part of both patients 

and staff members help avoid administrative

discharge.

Chapter 9, Drug Testing as a Tool, presents an

overview of drug testing in OTPs. Drug testing

provides an objective measure of treatment

efficacy and a tool to monitor patient progress,

as well as information for quality assurance,

program planning, and accreditation. OTPs

must ensure the clinical utility of test results

and protect patientsí privacy. Several drugtesting methodologies are available or in development, including tests of urine, oral fluid,

blood, sweat, and hair. The chapter describes

the benefits and limitations of these tests. Most

often, OTPs use urine drug testing by

immunoassay or thin-layer chromatography

because these methods are the least costly and

best validated of all options, but the Center for

Substance Abuse Treatment has indicated that

Executive Summary xix
oral-fluid testing may be an alternative

approach in OTPs. The chapter describes 

criteria that an OTP should use to collect

specimens and how treatment providers

should respond to test results that indicate

possible treatment problems.

Chapter 10, Associated Medical Problems in

Patients Who Are Opioid Addicted, focuses

on diagnosis and treatment of the medical

conditions most commonly seen in MAT

patients. A primary issue in MAT is deciding

which medical services patients should receive

in house versus through referral to outside

providers. Chapter 10 examines the factors

that influence this determination and reviews

the screening services and protocols OTPs

should have in place to evaluate patientsí

acute and chronic medical problems and to

perform periodic reassessments.

Chapter 11, Treatment of Multiple Substance

Use, discusses problems associated with

patientsí continued abuse of other substances,

which is likely to affect patientsí participation

in MAT, proper use of medication, and mental

and physical health. Some substances, such as

alcohol and certain sedatives, have a potentially lethal effect when combined with an 

opioid agonist or partial agonist medication. 

A number of interventions can address the

continued abuse of other substances, including increased drug testing and the use of 

disulfiram, contingency management, dose

adjustments, and counseling.

Chapter 12, Treatment of Co-Occurring

Disorders, addresses issues for patients who

have substance use and co-occurring mental

disorders. These patients often exhibit 

behaviors or experience emotions that interfere with treatment and require special 

interventions. The chapter describes the

prevalence of co-occurring disorders, 

screening and diagnosis of these disorders,

and the effects of such disorders on treatment

outcomes. It discusses general issues, specific

psychiatric diagnoses, and a range of interventions (including psychoeducation, 

psychotherapy, and pharmacotherapy) to

treat co-occurring disorders. The chapter

explores special issues such as acute psychiatric

danger, how to handle emergencies, and the

effect of co-occurring disorders on behaviors

that increase the risk of infectious diseases.

Chapter 13, Medication-Assisted Treatment for

Opioid Addiction During Pregnancy, describes

the complications associated with pregnancy

and opioid addiction and how pregnancy

should be addressed during MAT to reduce the

potential for harm to a pregnant woman in

MAT and her fetus. Among the main concerns

are those related to HIV/AIDS and hepatitis C.

The chapter describes how to adjust methadone

dosage and manage overdose and withdrawal

and addresses the postpartum treatment of

mother and child, including topics such as

breast-feeding and neonatal abstinence syndrome. The chapter focuses on methadone,

which has been accepted for treating opioid

addiction during pregnancy since the late 1970s.

Chapter 14, Administrative Considerations,

covers the challenging administrative aspects 

of managing and staffing the complex and

dynamic environment of an OTP. Successful

treatment outcomes depend on the competence,

values, and attitudes of staff members. To

develop and retain a stable team of treatment

personnel, program administrators must

recruit and hire qualified, capable, culturally

sensitive individuals; offer competitive salaries

and benefit packages; and provide good supervision and ongoing training. Implementing 

community relations and community education

efforts is important for OTPs. Outreach and

educational efforts can dispel misconceptions

about MAT and people in recovery. Finally, the

chapter provides a framework for gathering

and analyzing program performance data.

Program evaluation contributes to improved

treatment services by enabling administrators

to base changes in services on evidence of what

works. Evaluation also serves as a way to 

educate and influence policymakers and public

and private payers.

Appendix D, Ethical Considerations in MAT,

explores ethical issues inherent in MAT and

provides a structure that administrators 

and clinicians can use in considering how to

resolve them.

xx Executive Summary
1 Introduction

1

In This

Chapter...

Purpose of This

TIP

Key Definitions

Audience for This

TIP

A Decade of Change

Remaining

Challenges

The Future of MAT

Opioid addiction is a problem with high costs to individuals, families,

and society. Injection drug use-associated exposure accounts for approximately one-third of all AIDS cases diagnosed in the United States

through 2003 (National Center for HIV, STD and TB Prevention 2005)

and for many cases of hepatitis C (National Institute on Drug Abuse

2000; Thomas 2001). In the criminal justice system, people who use

heroin account for an estimated one-third of the $17 billion spent each

year for legal responses to drug-related crime. Indirect costs from lost

productivity and overdose also are high (Mark et al. 2001), and people

with opioid addictions and their families experience severe reductions in

their quality of life. The increasing abuse of prescription opioids is

another major concern, both for their damaging effects and as gateway

drugs to other substance use (see chapter 2).

Purpose of This TIP

This Treatment Improvement Protocol (TIP) is a guide to medicationassisted treatment for opioid addiction (MAT) in opioid treatment 

programs (OTPs). Compared with MAT in other settings, such as physiciansí offices or detoxification centers, treatment in OTPs provides a

more comprehensive, individually tailored program of medication 

therapy integrated with psychosocial and medical treatment and support

services that address most factors affecting each patient. Treatment in

OTPs also can include detoxification from illicit opioids and medically

supervised withdrawal from maintenance medications.

This TIP combines and updates TIP 1 (State Methadone Treatment

Guidelines, published in 1993), TIP 10 (Assessment and Treatment of

Cocaine-Abusing Methadone-Maintained Patients, published in 1994),

TIP 20 (Matching Treatment to Patient Needs in Opioid Substitution

Therapy, published in 1995), and TIP 22 (LAAM in the Treatment of

Opiate Addiction, published in 1995). It incorporates the many changes

in MAT that have occurred since the publication of TIP 1, primarily as

they are reflected in OTPs, and discusses the challenges that remain.
Key Definitions

The glossary (Appendix C) and list of acronyms

(Appendix B) at the back of the book provide

definitions of key words, terms, acronyms, and

abbreviations. Particularly important distinctions among selected terms and phrases are 

discussed below.

Distinctions between dependence and addiction

vary across treatment fields. This TIP uses the

term ìdependenceî to refer to physiological

effects of substance abuse and ìaddictionî for

physical dependence on and subjective need

and craving for a psychoactive substance either

to experience its positive effects or to avoid

negative effects associated with withdrawal

from that substance.

MAT is any treatment for opioid

addiction that

includes a medication (e.g.,

methadone,

buprenorphine,

levo-alpha acetyl

methadol [LAAM],

naltrexone)

approved by the

U.S. Food and Drug

Administration

(FDA) for opioid

addiction detoxification or maintenance

treatment. MAT

may be provided in

an OTP or an OTP medication unit (e.g., pharmacy, physicianís office) or, for buprenorphine, a physicianís office or other health care

setting. Comprehensive maintenance, medical

maintenance, interim maintenance, detoxification, and medically supervised withdrawal

(defined under ìTreatment Optionsî below and

individually in the glossary) are types of MAT.

An OTP is any treatment program certified 

by the Substance Abuse and Mental Health

Services Administration (SAMHSA) in 

conformance with 42 Code of Federal

Regulations (CFR), Part 8, to provide supervised assessment and medication-assisted 

treatment for patients who are opioid addicted.

An OTP can exist in a number of settings,

including, but not limited to, intensive outpatient, residential, and hospital settings. Types of

treatment can include medical maintenance,

medically supervised withdrawal, and detoxification, either with or without various levels of

medical, psychosocial, and other types of care.

The term ìabstinenceî in this TIP refers to

nonuse of alcohol or illicit drugs (drugs not

approved by FDA), as well as nonabuse of 

prescription drugs. Abstinence does not refer

to withdrawal from legally prescribed maintenance medications for addiction treatment (for

which ìmedically supervised withdrawalî is the

preferred term).

Terminology continues to evolve for describing

the combination of substance use and mental

disorders. In this TIP, ìco-occurringî is the

preferred term, but others use ìcoexisting,î

ìdual diagnosis,î and ìcomorbidî to describe

the combination of current or former substance

use disorders and any other Axis I or any 

Axis II mental disorders recognized by the

Diagnostic and Statistical Manual of Mental

Disorders, Fourth Edition, Text Revision

(American Psychiatric Association 2000). 

(See also TIP 42, Substance Abuse Treatment

for Persons With Co-Occurring Disorders

[CSAT 2005b].)

Audience for This TIP

The intended audience for this TIP is treatment providers and administrators working in

OTPs. Other groups that want to understand

the principles and procedures followed in MAT

also will benefit.

A Decade of Change

Several forces are transforming the MAT field.

The implementation of an accreditation system

(Federal Register 64:39814) is standardizing

and improving opioid addiction treatment (for

2 Chapter 1

The intended

audience for this

TIP is treatment

providers and

administrators

working in OTPs.
details, see 42 CFR, Part 8). Choices of medication, including methadone, buprenorphine,

LAAM, and naltrexone (see chapter 3), now are

available to treat opioid addiction. Each has its

own benefits and limitations. Continued

research on opioid addiction and treatment is

clarifying what works to improve treatment

outcomes, with an emphasis on accelerating the

incorporation of evidence-based methods into

treatment. Changes in the health care system

nationwide (e.g., the growth of managed care

and effects of the Health Insurance Portability

and Accountability Act) are having an effect on

OTPs and other types of health care programs.

Understanding and acceptance of opioid addiction as a medical disorder by patients, health

care providers, the media, and the public have

increased since the publication of TIP 1.

MATóA More Accepted Form

of Treatment

Opioid addiction as a medical

disorder

Discussions about whether addiction is a medical disorder or a moral problem have a long

history. For decades, studies have supported

the view that opioid addiction is a medical disorder that can be treated effectively with medications administered under conditions consistent with their pharmacological efficacy, when

treatment includes comprehensive services,

such as psychosocial counseling, treatment for

co-occurring disorders, medical services, vocational rehabilitation services, and case management services (e.g., Dole and Nyswander 1967;

McLellan et al. 1993). 

Dole (1988, p. 3025) described the medical

basis of methadone maintenance as follows:

The treatment is corrective, normalizing neurological and endocrinologic

processes in patients whose endogenous

ligand-receptor function has been

deranged by long-term use of powerful

narcotic drugs. Why some persons who

are exposed to narcotics are more 

susceptible than others to this derangement and whether long-term addicts

can recover normal function without

maintenance therapy are questions for

the future. At present, the most that

can be said is that there seems to be a

specific neurological basis for the compulsive use of heroin by addicts and

that methadone taken in optimal doses

can correct the disorder.

Similarities to other medical

disorders

McLellan and colleagues (2000) compared basic

aspects of substance addiction with those of

three disordersóasthma, hypertension, and

diabetesówhich universally are considered

ìmedicalî and usually chronic and relapsing

and for which behavioral change is an important part of treatment. They found that genetic, personal-choice, and environmental factors

played comparable roles in the etiology and

course for these disorders and that rates of

relapse and adherence to medication were similar, although substance addiction often was

treated as an acute, not chronic, illness. Their

review of outcome literature showed that, as

with the other disorders, substance addiction

has no reliable cure but that patients who comply with treatment regimens have more favorable outcomes. Fewer than 30 percent of

patients with asthma, hypertension, or diabetes

adhered to their medication regimens, prescribed diets, or other changes to increase their

functional status and reduce their risk of symptom recurrence. As a result, 50 to 70 percent

experienced recurrent symptoms each year to

the point of requiring additional medical care

to reestablish remission.

Another similarity found between opioid 

addiction and these medical disorders was their

outcome predictors (McLellan et al. 2000). For

example, patients who were older and

employed with stable families and marriages

were found to be more likely to comply with

treatment and have positive treatment results

than were younger, unemployed patients with

less stable family support.

Introduction 3
4 Chapter 1

The concept of opioid addiction as a medical

disorder was supported further by other treatment followup studies showing that opioid

addiction has a reasonably predictable course,

similar to such conditions as diabetes, hypertension, and asthma. For example, Woody and

Cacciola (1994) found that the risk of relapse

for a person who was opioid addicted was highest during the first 3 to 6 months after cessation of opioid use. This risk declined for the

first 12 months after cessation and continued to

decrease but at a much slower rate. Results

from other posttreatment studies indicated that

roughly 80 percent of patients who are opioid

addicted but leave MAT resume daily opioid

use within 1 year after leaving treatment (e.g.,

Magura and Rosenblum 2001).

Similar to patients with other chronic disorders,

many who are opioid addicted have been found

to respond best to treatment that combines

pharmacological and behavioral interventions.

As detailed throughout this TIP, treatment of

opioid addiction with maintenance medication,

along with other treatment services for related

problems that affect patientsí motivation and

treatment compliance, increases the likelihood

of cessation of opioid abuse. Conversely, discontinuation of maintenance medication often

results in dropout from other services and a

return to previous levels of opioid abuse, with

its accompanying adverse medical and psychosocial consequences (Ball and Ross 1991). Entry

into comprehensive maintenance treatment provides an opportunity to prevent, screen for, and

treat diseases such as HIV/AIDS, hepatitis B

and C, and tuberculosis (see chapter 10) and to

increase compliance with medical, psychiatric,

and prenatal care (Chaulk et al. 1995;

Umbricht-Schneiter et al. 1994). Recent data on

buprenorphine indicate that treatment with this

medication, like methadone, has similar positive

outcomes (CSAT 2004a; Johnson et al. 2000;

Kakko et al. 2003).

Viewing opioid addiction as a medical disorder

is consistent with the idea that treatment of

even severe cases improves outcomes, just as in

other chronic and relapsing medical disorders,

even before abstinence is achieved. For 

example, Metzger and colleagues (1998) found

that substance abuse treatment was associated

with a significantly lower risk of HIV infection 

than was nontreatment. Treatment also was

associated with a significant reduction, but not

necessarily cessation, of drug use for many

individuals. Similar findings on the positive

health outcomes associated with maintenance

treatment of opioid addiction, regardless of

whether abstinence was attained, were seen in

studies finding that methadone maintenance

decreases overdose death. Data on benefits of

partial responses to maintenance treatment

resemble the benefits of treatment for other

chronic medical disorders in terms of symptom

alleviation. An analogy with MAT would be the

desirability of reducing the risk of HIV infection, overdose, and the many psychosocial

complications of addiction, which is not as

desirable as the benefits of attaining complete

abstinence from opioids but is associated 

with significantly improved patient health and 

well-being. The goal is always reducing or 

eliminating the use of illicit opioids and other

illicit drugs and the problematic use of prescription drugs.

The medical community recognizes that opioid

addiction is a chronic medical disorder that

can be treated effectively with a combination of

medication and psychosocial services. An

important development in MAT during the

1990s was the 1997 publication of recommendations by a National Institutes of Health consensus panel on effective medical treatment of

opiate addiction. After hearing from experts

and the public and examining the literature,

the panel concluded that ì[opioid addiction] is

a medical disorder that can be effectively treated with significant benefits for the patient and

societyî (National Institutes of Health 1997b,

p. 18). That panel explicitly rejected the notion

ìthat [addiction] is self-induced or a failure of

willpower and that efforts to treat it inevitably

failî (p. 18). It called for ìa commitment to

offer effective treatment for [opioid addiction]

to all who need itî (p. 2). The panel also called

for Federal and State efforts to reduce the 

stigma attached to MAT and to expand MAT

through increased funding, less restrictive 
regulation, and efforts to make treatment available in all States (p. 24). The consensus panel

for this TIP further recommends that access to

treatment with methadone and other FDAapproved medications for opioid addiction be

increased for people who are incarcerated, on

parole, or on probation.

The trend toward greater acceptance of MAT

as an effective treatment for opioid addiction

has resulted in fewer State-mandated restrictions for treatment. For example, many States

have removed restrictions on the length of time

that patients may remain in treatment.

More Treatment Programs and

More Patients in Treatment

In 1993, when TIP 1 was published, approximately 750 registered OTPs were treating some

115,000 patients in 40 States, the District of

Columbia, Puerto Rico, and the Virgin Islands

(CSAT 1993b, p. 1). At this writing, more than

1,100 OTPs operating in 44 States, the District

of Columbia, Puerto Rico, and the Virgin

Islands are treating more than 200,000 patients

(Substance Abuse and Mental Health Services

Administration n.d.b; Nicholas Reuter, personal

communication, June 2004). As of this writing,

methadone treatment is not available in six

States: Idaho, Mississippi, Montana, North

Dakota, South Dakota, and Wyoming.

Most expansion in the treatment system in the

past 10 years has occurred in the proprietary

sector. Historically, most OTPs were funded

publicly, whereas proprietary programs were

in the minority. In the 1980s, public funding

for methadone treatment began to be reduced,

along with State, Federal, and local budgets,

and increasingly was replaced by private feefor-service treatment programs in which

patients bore more of the costs (Knight et al.

1996a, 1996b; Magura and Rosenblum 2001).

Choices of Medications

The National Institute on Drug Abuse (NIDA)

has been working to broaden the array of effective treatment medications for chronic opioid

addiction. Just after the publication of TIP 1,

FDA approved the use of LAAM, although its

use has been curtailed

substantially since

then (see chapter 3).

In October 2002, 

FDA approved two

new formulations 

containing buprenorphine for treatment 

of opioid addiction.

Buprenorphine is

used to treat individuals who have been

opioid addicted for

less than 1 year, as

well as patients for

whom buprenorphineís unique properties are beneficial

(CSAT 2004a). The

opioid antagonist naltrexone is available to

treat people who are

opioid addicted and have undergone medically

supervised withdrawal. These medications are

discussed in chapter 3.

Treatment Options

OTPs can provide several treatment options:

ï Maintenance treatment combines pharmacotherapy with a full program of assessment,

psychosocial intervention, and support services; it is the approach with the greatest likelihood of long-term success for many patients.

ï Medical maintenance treatment is provided to

stabilize patients and may include long-term

provision of methadone, buprenorphine,

LAAM, or naltrexone, with a reduction in 

clinic attendance and other services. A

patient can receive medical maintenance 

at an OTP, after he or she is stabilized 

fully. The patient usually must complete a

comprehensive treatment program first. The

decision about whether to provide medical

maintenance must be made by a licensed

practitioner. A designated medication unit

5 Introduction

The medical community recognizes

that opioid addiction is a chronic

medical disorder

that can be treated

effectively...
(e.g., physicianís office, pharmacy, long-term

care facility) affiliated with an OTP can provide some medical maintenance services. To

reduce clinic attendanceóa key feature of

medical maintenanceópatients must qualify,

subject to variations in State regulations

(which may be more stringent than Federal

regulations), to receive 7- to 14-day supplies

of methadone for take-home dosing after 1

year of continuous treatment and 15- to 30-

day supplies after 2 years of continuous

treatment in an OTP (if additional criteria

are satisfied [see chapter 5]) (42 CFR, Part 8

ß 12(h); Federal Register 66:4079).

ï Detoxification from short-acting opioids

involves medication and, perhaps, counseling

or other assistance to stabilize patients who

are opioid addicted by withdrawing them in a

controlled manner from the illicit opioids.

ï Medically supervised withdrawal treatment

involves the controlled tapering of treatment

medication for patients who want to remain

abstinent from opioids without the assistance

of medication.

Based on the framework provided by the Drug

Addiction Treatment Act of 2000 (21 United

States Code 823(g)),

qualified practitioners are authorized to

use SubutexÆand

SuboxoneÆ(see

chapter 3) to treat

chronic opioid

addiction in an

office-based opioid

treatment (OBOT)

or other health care

setting.

These alternatives

are increasing access

to care as OTPs

broaden their range

of treatment options,

more physicians offer OBOT and become better trained in MAT principles and methods,

and individuals with opioid addiction seek new

points of treatment entry. At this writing, the

availability of these options varies, often

because of individual State regulations.

Changes in the Federal

Regulatory System

On May 18, 2001, SAMHSA promulgated a

new accreditation oversight system. Its goal 

is to ìreduce the variability in the quality of

opioid treatment services, and reform the

treatment system to provide for expanded

treatment capacityî (Federal Register

64:39814). As OTPs meet these national 

standards, treatment improvement is expected

to continue along with increased attention to

program evaluation and quality improvement

mechanisms. The consensus panel hopes that

this TIP will contribute to the movement

toward quality-driven treatment standards.

Remaining Challenges

Although important strides have been made,

much remains to be done to improve and

expand treatment and to address the stigma

that affects patients and programs.

Administering Appropriate

Dose Levels

The consensus panel believes that programs

should monitor and adjust patientsí dose levels

of methadone and other opioid treatment medications to ensure that they receive therapeutic

dosages without regard to arbitrary dose-level

ceilings that are unsupported by research evidence. Dosage decisions should be appropriate

and tailored to each patient. Progress has been

made to ensure that patients receive the therapeutic dosage levels they need to remain stabilized; however, the panel finds it troubling that

some OTPs still fail to prescribe medication in

adequate doses (DíAunno and Pollack 2002).

6 Chapter 1

Dosage decisions

should be appropriate and tailored

to each patient. 
Treating Patients Who Have

More Complex Problems

Complex problems can complicate patientsí

diagnosis and treatment. When TIP 1 was 

published, the opioid addiction treatment 

system faced two major challengesóthe spread

of HIV/AIDS and the problem of untreated 

co-occurring disorders. The consensus panel

believes that the provision of psychiatric services at or through OTPs has not kept pace

with best practices. It is critical that OTPs be

prepared to diagnose and treat co-occurring

disorders aggressively, either directly or by

referral. This issue is discussed in chapter 12.

The treatment system is grappling with the

implications of hepatitis C virus (HCV) infection among people who inject drugs, with estimates of HCV infection in this group ranging

from 60 percent on average nationwide

(National Institute on Drug Abuse 2000) to 90

percent in some regions (Thomas 2001). OTPs

face the challenge of how to provide patient

education and HCV testing for people who

inject drugs.

Patterns of opioid abuse have changed in the

past decade. For example, in some areas of the

country, patients are presenting with addiction

to pain management medications as a primary

admission indication (CSAT 2001a; Office of

National Drug Control Policy 2002). OTPs

report that patients addicted to pain management medications require higher therapeutic

methadone levels than other patients. Since the

mid-1990s, the prevalence of lifetime heroin

use has increased for both youth and young

adults. From 1995 to 2002, the rate among

youth ages 12 to 17 increased from 0.1 to 0.4

percent; among young adults ages 18 to 25, the

rate rose from 0.8 to 1.6 percent (Substance

Abuse and Mental Health Services

Administration 2003c).

Promoting Evidence-Based

Treatment Services

Throughout this TIP are many examples of

types of interventionsócomprehensive MAT,

medical maintenance, psychosocial interventions, and moreóand program characteristics

that have been demonstrated to improve retention and outcomes for patients. The consensus

panel recommends that program administrators and treatment providers compare their

practices with these evidence-based practices

and make necessary changes where appropriate. Moreover, OTPs should measure their 

outcomes continuously, using appropriate program evaluation tools, to improve treatment

quality (see chapter 14). Finally, OTPs may

want to partner with the research community

to investigate and adopt new interventions for

improving outcomes.

In addition, SAMHSA has established and

funded the Addiction Technology Transfer

Center (ATTC) Network, which is dedicated to

improving the skills and knowledge of substance abuse treatment providers and increasing their awareness of research findings.

Regional centers in the ATTC Network seek to

accomplish this goal by identifying and advancing opportunities to improve addiction treatment through the dissemination of new information in response to emerging needs and

developments in the treatment field. (For more

information, visit the ATTC Web site at

www.nattc.org.)

Expanding the Treatment

System

Although the number of patients enrolled in

OTPs for addiction treatment has almost doubled since 1993, an estimated 898,000 people

chronically or occasionally use heroin in the

United States (Office of National Drug Control

Policy 2003). Only about 20 percent of people

who use heroin are being treated. For people

who abuse opioid medications normally

obtained by prescription, the percentage in

treatment is even lower. 

Lack of funding for services remains a 

significant barrier to treatment. In many

States, Medicaid does not reimburse MAT 

services; accordingly, patients, many of whom

Introduction 7
have limited financial resources, are compelled

to finance their treatment. 

Making Treatment Available

to Criminal Justice Populations

Criminal justice populations are in critical need

of opioid addiction treatment, yet most do not

have access to MAT (National Center on

Addiction and Substance Abuse 1998; National

Drug Court Institute 2002; U.S. Department of

Justice 1999). Resistance to MAT by many in

the criminal justice system may be rooted in the

traditional view that medical maintenance

treatment is substitution of one drug for 

another (National Center on Addiction and

Substance Abuse 1998). The Rikers Island jail

facility in New York City has been providing

inmates access to methadone treatment since

1987 (National Drug Court Institute 2002).

Rhode Island jail facilities offer a 30-day 

dose-tapering program. The consensus panel

understands that few other correctional institutions have provided MAT services. 

Promoting Comprehensive

Treatment

In its 1999 publication, Principles of Drug

Addiction Treatment: A Research-Based Guide,

NIDA stressed the importance of comprehensive treatment services by devoting 3 of the 13

principles of effective drug addiction treatment

to comprehensive care (see Exhibit 1-1)

(National Institute on Drug Abuse 1999).

The consensus panel believes that it is critical

to emphasize the central importance of comprehensive care as more physicians begin to use

buprenorphine to treat chronic opioid addiction in their private offices. Ideally, a full continuum of care should integrate the services of

primary care physicians who dispense opioid

treatment medications in private offices and

other medication units with the services provided by counselors, case managers, and other

essential staff in OTPs. 

Combating Stigma

For almost a century, the predominant view of

opioid addiction has been that it is a selfinduced or self-inflicted condition resulting

from a character disorder or moral failing and

that this condition is best handled as a criminal

matter (see chapter 2). Use of methadone and

other therapeutic medications has been viewed

traditionally as substitute therapyómerely

replacing one addiction with another and the

treatment of choice for those too weak to overcome temptation. The stigma associated with

8 Chapter 1

ï Effective treatment attends to multiple needs of the individual, not just his or her

drug use. 

ï Counseling (individual and/or group) and other behavioral therapies are 

critical components of effective treatment for addiction.

ï Medications are an important element of treatment for many patients, 

especially when combined with counseling and other behavioral therapies.

Source: National Institute on Drug Abuse 1999.

Exhibit 1-1

NIDA Comprehensive Care-Related Principles of 

Effective Drug Addiction Treatment
MAT has been unique in its permeation of community institutions, affecting the attitudes of

medical and health care professionals; social

services agencies and workers; paraprofessionals; employers, families, and friends of persons

who are opioid addicted; and other people 

who formerly abused substances, as well as

influencing criminal justice policies, creating

political opposition, and limiting funding and

space for OTPs.

Although diversion control is an important part

of MAT, public policy sometimes has seemed to

place greater emphasis on protecting society

from methadone than on the addiction, violence, and infectious diseases that these medications help alleviate (Institute of Medicine

1995; Joseph et al. 2000; Nadelmann and

McNeeley 1996). The cost-effectiveness of MAT

often has been overlooked (see chapter 2).

Stigma affects patients in various ways. It 

discourages them from entering treatment and

prompts them to leave treatment early. It creates a barrier for those trying to access other

parts of the health care system. A striking

example is the failure of many medical practitioners to medicate pain adequately in this

group. In addition, the refusal of some organ

transplant programs to provide liver transplants to patients maintained on methadone

may be a result of stigma, as well as a lack of

convincing data on outcomes for methadone

patients who receive transplants.

Stigma affects programs too. It prevents new

programs from opening when community opposition develops. It can affect a programís internal operations. Staff members who work in

OTPs sometimes absorb societyís antipathy

toward patients in MAT and may deliver program services with a punitive or countertherapeutic demeanor. OTPs must guard against

these attitudes through supervision, education,

and leadership efforts (see chapter 14).

Several factors have made the destructive force

of stigma particularly intractable, including the

isolation of MAT from mainstream medicine,

negative media reports about treatment, and

the public impressions made by poorly run

programs. Fortunately, positive changes are

occurring in each area.

Positive stories about MAT in the media are

sometimes overshadowed by highly charged

negative accounts, for example, stories about

patients loitering outside OTPs or diversion of

take-home doses. SAMHSA, recognizing that

ì[s]ignificant reduction in stigma and changes

in attitudes will require a concerted effort

based on systematic researchî (CSAT 2000b, 

p. 4), has undertaken

a national educational

campaign, titled

Partners for

Recovery. Many OTP

managers and staff

members have isolated themselves from

their communities,

which contributes to

negative stereotypes

and media stories.

Managers and staff

members should

develop effective skills

for working with the

media. The consensus

panel believes that the

patient advocacy

movement also can advance a national educational campaign about MAT.

Strong efforts are needed to eliminate stigma

within OTPs as well. Staff members should

treat patients with respect and pay attention 

to the terms they use. The term ìsubstitution

treatmentî should be avoided because it incorrectly implies that long-acting opioid medications act like heroin and other short-acting 

opioids. Terms such as ìdirtyî and ìcleanî in

reference to drug-test specimens should be

replaced by more clinically useful terms such

as ìpositiveî and ìnegative,î respectively. The

use of criminal justice terms such as ìprobationary treatmentî should be replaced with

clinically appropriate language (see chapter 14).

Finally, programs should become better neighbors. Idle, perhaps intoxicated, patients who

Introduction 9

Managers and

staff members

should develop

effective skills for

working with the

media. 
remain near an OTP can become, by default,

the programís public representatives and easy

targets for complaints from the community.

Frequently, patient loitering is a result of insufficient program management. Patient conduct

in and around OTPs should be considered both

a treatment and a community relations concern.

The Future of MAT

This is an exciting and challenging time for the

MAT field, as positive changes accelerate and

reinforce one another. The consensus panel

hopes that this publication will advance highquality care in OTPs by providing up-to-date

information on science-based, best-treatment

practices and by highlighting sound ethical

principles of treatment. Equipped with this

TIP, the accreditation standards, and a developing alliance with the general medical community, OTPs should be able to improve and

expand effective opioid addiction treatment

throughout the country.

10 Chapter 1
In This

ChapterÖ

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11

2 History of MedicationAssisted Treatment for

Opioid Addiction

In This

ChapterÖ

Emergence of

Opioid Addiction as

a Significant

Problem and the

Roots of

Controversy

Origins of Opioid

Maintenance

Therapy

Regulatory History

This chapter describes the history of opioid use and addiction in the

United States; changes in the population groups affected by opioid

addiction disorders; and this countryís social, political, legal, and 

medical responses. The chapter emphasizes factors affecting the development and course of medication-assisted treatment for opioid addiction

(MAT) in opioid treatment programs (OTPs).

Opioid addiction has affected different population groups and socioeconomic classes in the United States at different times. Societyís

response has changed along with changes in the groups or classes most

affected, shifts in social and political attitudes toward opioid addiction,

and the accumulation of more and better information about its causes

and treatments (Musto 1999). The consensus panel for this TIP believes

that an appreciation for the roots of opioid addiction and treatment is

important because attitudes and beliefs about opioid use and addiction

that are rooted in U.S. history over the past 150 years continue to 

influence policies governing MAT.

Emergence of Opioid Addiction as

a Significant Problem and the

Roots of Controversy

Many of todayís substances of abuse including the opioidsóprimarily

opium, morphine, heroin, and some prescription opioidsógained their

early popularity as curatives provided by physicians, pharmacists, and

others in the healing professions or as ingredients in commercial products ranging from pain elixirs and cough suppressants to beverages.

These products usually delivered the benefits for which they were used,

at least initially, such as pain relief, increased physical and mental energy (or ìrefreshmentî), and reduced anxiety. For example, opioids were

often the best available substances to relieve pain on Civil War battlefields. Unfortunately, the uncontrolled use of opioids either for prescribed and advertised benefits or for nonmedicinal effects leads to
increased tolerance and addiction. Tolerance

increases the need for larger quantities of opioids, more frequent use, or combination with

other substances to

sustain their effects;

it also increases the

severity of withdrawal when addiction is

not satisfied. Recognition of this problem has spurred a

long-running debate

among patients and

people who use 

opioids, their families, physicians,

researchers, community leaders, patient

advocates, and 

government officials.

This debate centers

on two different

views: (1) opioid addiction is a generally incurable disease that requires long-term maintenance with medication; or (2) opioid addiction

stems from weak will, lack of morals, other

psychodynamic factors, or an environmentally

determined predilection that is rectified by

criminalization of uncontrolled use and distribution and measures promoting abstinence.

The Changing Face of Opioid

Addiction

Opioid addiction first emerged as a serious

problem in this country during and after the

Civil War, when opioids were prescribed widely

to alleviate acute and chronic pain, other types

of discomfort, and stress. Although a smaller

pattern of nonmedical opioid use continued as

well, mainly opium smoking among Chinese

immigrants and members of the Caucasian

ìundergroundî (e.g., prostitutes, gamblers,

petty criminals), iatrogenic addiction was much

more common (White 1998). By the late 19th

century, probably two-thirds of those addicted

to opioids (including opium, morphine, and

laudanum) were middle- and upper-class White

women, a fact Brecher and the Editors of

Consumer Reports (1972, p. 17) attribute to

ìthe widespread medical custom of prescribing

opiates for menstrual and menopausal discomfort, and the many proprietary opiates prescribed for ëfemale troubles.í î Civil War veterans who were addicted by medical procedures

composed another group, but their numbers

were dwindling. By 1900, an estimated 300,000

persons were opioid addicted in the United

States (Brecher and Editors 1972; Courtwright

2001; Courtwright et al. 1989).

During the late 19th and early 20th centuries,

U.S. society generally viewed iatrogenic addiction among women and disabled war veterans

sympatheticallyóas an unfortunate medical

conditionóand treated these groups with 

tolerance and empathy, particularly because

neither group presented major social problems

(Courtwright 2001). Doctors usually prescribed

more opioids for these patients, and sanatoriums were established for questionable ìcuresî

of the resulting addictions. The chronic nature

of opioid addiction soon became evident, however, because many people who entered sanatoriums for a cure relapsed to addictive opioid

use after discharge. In Eugene OíNeillís autobiographical drama ìLong Dayís Journey Into

Night,î for example, his father refuses to

return OíNeillís mother, who is addicted, to a

sanatorium because he is aware of the addictive

qualities of morphine and is resigned to the

inevitability of relapse (Courtwright 2001).

By the end of the 19th century, doctors became

more cautious in prescribing morphine and

other opioids, and the prevalence of opioid

addiction decreased. Small groups still practiced opium smoking, but most Americans

regarded it as socially irresponsible and

immoral. It is noteworthy, however, that 

heroin, introduced in 1898 as a cough suppressant, also began to be misused for its euphoric

qualities, gradually attracting new types of

users. This development, along with diffusion

of the hypodermic technique of drug administration, which gained popularity between 1910

and 1920, had a profound effect on opioid use

and addiction in the 20th century and beyond

(Courtwright 2001).

12 Chapter 2

[O]pioids were 

prescribed widely

to alleviate acute

and chronic pain,

other types of discomfort, and

stress.
The size and composition of the U.S. opioidaddicted population began to change in the

early 20th century with the arrival of waves of

European immigrants. Courtwright (2001) 

portrays most users of opioids of this period as

young men in their 20s: ìdown-and-outsî of

recent-immigrant European stock who were

crowded into tenements and ghettos and

acquired their addiction during adolescence or

early adulthood. They often resorted to illegal

means to obtain their opioids, usually from

nonmedical sources and specifically for the

euphoric effects. ìGone was the stereotype of

the addicted matron; in its place stood that of

the street criminalî (Courtwright 2001, p. 1).

The initial treatment response in the early 20th

century continued to involve the prescriptive

administration of short-acting opioids. By the

1920s, morphine was prescribed or dispensed

in numerous municipal treatment programs

(Courtwright et al. 1989).

Addictive use of opium, cocaine, and heroin,

along with drug-related crime, especially in

poor urban communities, increasingly concerned social, religious, and political leaders.

The tolerance and empathy shown toward Civil

War veterans and middle-aged women evaporated; negative attitudes toward and discrimination against new immigrants probably colored views of addiction. Immigrants and others

who trafficked in and abused drugs were

viewed as a threat. As detailed below, societyís

response was to turn from rudimentary forms

of treatment to law enforcement (Brecher and

Editors 1972; Courtwright 2001; Courtwright et

al. 1989). For more on trends in the 1920s and

1930s, see ìEarly treatment effortsî below.

McCoy (n.d.) refers to a forced decline in 

opioid addiction during World War II, brought

about by restrictions on shipping and strict

port security, which produced a marked hiatus

in global opium trafficking and caused the U.S.

opioid-addicted population to drop to a historic

low of about 20,000. Once smuggling resumed

after the war, the population that had used 

opioids resumed the habit.

Another major change in the U.S. opioidaddicted population occurred after World 

War II. As many European immigrants moved

from crowded cities, Hispanics and AfricanAmericans moved into areas with preexisting

opioid abuse problems, and the more susceptible people in these groups acquired the disorder

(Courtwright 2001; Courtwright et al. 1989).

The post-World War II shift in the composition

of opioid-addicted groups coincided with hardening attitudes toward these groups, leading

some researchers to conclude that stigmatization of people with addiction disorders and

their substances of abuse reflected, at least in

part, class and ethnic biases. A portion of U.S.

society appeared to view with disdain and fear

the poor White, Asian, African-American, and

Hispanic people with addiction disorders who

lived in the inner-city ghettos (Courtwright et

al. 1989).

Brecher and the Editors of Consumer Reports

(1972) point out that, by the mid-1960s, the

number of middle-class young White Americans

using heroin was on the rise, as was addictionrelated crime. By the 1970s, U.S. military

involvement in Vietnam also was having an

effect. From one-fourth (Brecher and Editors

1972) to one-half (Courtwright 2001) of

American enlisted men in Vietnam were

believed to have used or become addicted to

heroin; however, White (1998) points out that

the feared epidemic of heroin addiction among

returning veterans did not materialize fully. He

concludes, ìVietnam demonstrated that a pattern of drug use could emerge in response to a

particular environment and that spontaneous

remission could occur when the environment

was changedî (p. 303).

By the 1980s, an estimated 500,000 Americans

used illicit opioids (mainly heroin), mostly poor

young minority men and women in the inner

cities. Although this number represented a 

66-percent increase over the estimated number

of late 19th-century Americans with opioid

addiction, the per capita rate was much less

than in the late 19th century because the 

population had more than doubled

History of Medication-Assisted Treatment for Opioid Addiction 13
(Courtwright et al. 1989). Nevertheless, 

addiction became not only a major medical

problem but also an explosive social issue

(Courtwright 2001; Courtwright et al. 1989).

By the end of the 1990s, an estimated 898,000

people in the United States chronically or occasionally used heroin (Office of National Drug

Control Policy 2003), and the number seeking

treatment was approximately 200,000 (almost

double the number during the 1980s). The

abuse of opioids that normally were obtained

by prescription was a growing concern because

of both their damaging effects and their potential as gateway drugs to other substance use.

Treatment admission rates for addiction to opioid analgesics more than doubled between 1992

and 2001 (Substance Abuse and Mental Health

Services Administration 2004), and visits to

emergency rooms related to opioid analgesic

abuse increased 117 percent between 1994 and

2001 (Substance Abuse and Mental Health

Services Administration 2003b).

Societyís Changing Response

The Harrison Narcotic Act of

1914

The Pure Food and Drug Act of 1906, which

required medicines containing opioids to say so

on their labels, was the first national response

to the changing image of people with addictions

(Brecher and Editors 1972). The Harrison

Narcotic Act of 1914 was the earliest significant

Federal attempt to place strict controls on opioids and other substances (Brecher and Editors

1972). Although U.S. mercantile and trade

interests were also at stake, the widely held

perception that people with addictions generally

were members of a White criminal underclass

or a Chinese minority has been portrayed as 

an underlying motivation for the statute

(Courtwright 2001; Courtwright et al. 1989).

The Harrison Act was conceived not as a prohibition law but as a measure to regulate the

manufacture, distribution, and prescription of

opioids, coca, and their derivatives. Under the

actís provisions, manufacturers, pharmacists,

and physicians had to be licensed, keep records

for inspection, and pay modest fees to the U.S.

Department of the Treasury, referred to hereafter as Treasury. 

The act permitted physicians and dentists to

dispense or distribute opioids ìto a patient . . .

in the course of [the physicianís] professional

practice onlyî (38 Stat. 786 [1914]). Although

this provision permitted physicians to prescribe

or dispense opioids so long as they kept the

required records, Treasury interpreted the act

as a prohibition on physiciansí prescribing opioids to persons with addictions to maintain

their addictions. (Treasury was the agency

responsible for enforcing the Harrison Act as

well as prohibition laws.) Treasuryís position

appeared to be that addiction is not a disease

and the person with an addiction, therefore,

was not a patient. It followed that any physician prescribing or dispensing opioids to such

individuals was not doing so in the ìcourse of

his professional practiceî (White 1998). In

1919, the United States Supreme Court upheld

Treasuryís interpretation. This interpretation

and enforcement of the Harrison Act effectively

ended, until well into the 1960s, any legitimate

role for the general medical profession in 

medication-assisted treatment for Americans

who had drug addictions (White 1998).

Early treatment efforts

Until the 1919 Supreme Court decision upholding Treasuryís interpretation of the Harrison

Act, numerous municipalities with large numbers of residents who were opioid addicted

were operating treatment clinics in which 

morphine was prescribed or dispensed. Some

clinics prescribed heroin and cocaine

(Courtwright et al. 1989). These early OTPs

varied in how they functioned; some provided

detoxification treatment and others adopted a

maintenance policy (Courtwright 2001; Gewirtz

1969). Perhaps the best known of these early

OTPs were the Department of Health program

in New York City, where those with addictions

were detoxified with decreasing doses of heroin

and morphine, and the program established by

Dr. Willis Butler in Shreveport, Louisiana,

14 Chapter 2
which not only detoxified patients but also

maintained some of them on morphine

(Courtwright et al. 1989).

Courtwright and others state that Treasury

regarded these clinics as a threat to its antimaintenance philosophy. By the early 1920s, it

had succeeded in closing them through legal

pressure, critical inspections, and threats. The

last program to be closed was Dr. Butlerís in

Shreveport (Courtwright 2001; Courtwright et

al. 1989).

In the 1920s, an increase in crime related to the

acquisition of illicit opioids was reported in

cities throughout the country. In 1929,

Congress appropriated funds to establish two

new treatment facilities, initially called ìnarcotics farmsî (White 1998), in Fort Worth,

Texas, and Lexington, Kentucky. The

Lexington facility, which opened to patients in

1935, was renamed the U.S. Public Health

Service Narcotics Hospital in 1936. These institutions detoxified patients with opioid addiction who entered voluntarily, and they also

served as hospitals for prison inmates who had

opioid addictions and were legally committed

through a Federal court. The prescribed stay

was about 6 months, although some patients

stayed longer. Prisoners could stay for up to 10

years. These hospitals offered social, medical,

psychological, and psychiatric services in 

addition to detoxification and had a low

patient-to-staff ratio (about 2 to 1), but the

atmosphere was described as prisonlike, especially at the Lexington facility (White 1998).

Two major followup studies showed the program to be a failure. One reported a relapse

rate of 93 percent in 1,881 former patients over

a 1.0- to 4.5-year followup period (Hunt and

Odoroff 1962). The second found a relapse rate

of 97 percent in 453 former patients over followup periods of 6 months to 5 years (Duvall et

al. 1963). The Lexington hospital facility was

turned over to the Bureau of Prisons in 1974

(Courtwright et al. 1989). Despite the failure of

these programs, White credits the research

conducted there with providing ìmuch of the

foundation upon which modern treatment

advances were builtî (White 1998, p. 126).

The increase in heroin addiction in New York

City after World War II led, in 1952, to the

establishment of Riverside Hospital for adolescents with addiction disorders. This program

also proved to be a failure. A followup study in

1956 showed a high posttreatment relapse rate

(e.g., at least 86 percent of patients admitted in

1955), and the Riverside facility was closed in

1961 (Brecher and Editors 1972).

Experiment in civil 

commitment

Civil commitment is portrayed by Brecher and

the Editors of Consumer Reports (1972) and

White (1998) as legislation enabling those with

substance addiction and those ìin imminent

danger of becoming addictedî (White 1998, p.

250) to be confined in rehabilitation centers

without having first committed or been convicted of a crime. Civil commitment was instituted

in California and New

York in the 1960s to

allay fears about

addiction-related

crimes against people

and property in the

inner cities. People

with addictions could

be committed to 

facilities through a

voluntary process 

that included a 

medical examination

to validate the presence of an addiction,

or they could be 

committed for 3 years

when arrested on a

misdemeanor charge, as an alternative to a 

jail sentence. The civil commitment program

instituted in New York in 1966 turned out to be

exceedingly expensive, and the positive results

were minimal (Brecher and Editors 1972;

Inciardi 1988). The great majority of those

admitted, treated, and paroled to aftercare

programs dropped out of these programs, and

they usually could not be located. A review of

Californiaís civil commitment experience in the

History of Medication-Assisted Treatment for Opioid Addiction 15

Treasuryís position appeared to

be that addiction

is not a disease... 

and the personÖ

not a patient.
1960s showed that five of every six patients

committed for addictions and subsequently

placed on aftercare relapsed, were rearrested,

dropped out of treatment, died, or were

removed from the program by writs of habeas

corpus (Joseph 1988; Joseph and Dole 1970).

Although statutes permitting involuntary commitment might remain on the books in some

States, such laws rarely have been used to commit people who abuse substances and who are

not under criminal justice jurisdiction (Anglin

1988). Court decisions after the 1960s generally

have required that an individual be a danger to

himself or herself or others before the legal system can use involuntary commitment (e.g.,

OíConnor v. Donaldson, 422 U.S. 563, 1975).

The search for alternatives

In New York, death rates associated with the

injection of heroin increased from 7.2 to 35.8

per 10,000 deaths between 1950 and 1961

(Frank 2000; Joseph et al. 2000). In the 1960s

and 1970s, more than 150,000 names were

added to the

Narcotics Register

in New York City.

(The Narcotics

Register, active

from 1967 to 1974,

was a list of known

or suspected persons

with addictions.)

By the middle to

late 1960s,

illicitñopioid-related

mortality had

become the leading

cause of death for

young adults from

ages 15 to 35 in New

York City. The

number of serum

hepatitis (now

called hepatitis B)

cases related to contaminated needles

also was increasing.

Record numbers of

people with opioid addictions were arrested for

drug-related crimes (e.g., possession, sales,

robbery, burglary), and overcrowded jails had

no effective method to ease detoxification

(Inciardi 1988; Joseph and Dole 1970). By 1968,

the Manhattan County Jail for Men (also known

as the Tombs) had been wracked by riots

blamed on poor living conditions, severe overcrowding, and lack of medical care for inmates

with drug addictions.

As the incidence of addiction and related criminal activity rose dramatically in urban areas,

concern grew in the legal and medical communities because increased incarceration had

failed to stem the tide. The legal and medical

professions were perturbed by the post-World

War II rise in opioid addiction in the United

States and the ineffectiveness of Federal regulatory policy. In 1958, a joint committee of the

American Bar Association and the American

Medical Association (AMA) issued a report 

recommending that an outpatient facility 

prescribing opioids to treat addiction be established on a controlled experimental basis

(Brecher and Editors 1972).

Other groups voiced support for the concept of

opioid maintenance programs. The New York

Academy of Medicine recommended, in 1955

and again in 1963, that clinics be established in

affiliation with hospitals to dispense opioids in a

controlled manner to patients addicted to illicit

opioids. In 1956, the AMA advocated a

research project to investigate the feasibility of

dispensing opioids in an OTP. In 1963, the

Kennedy administrationís Advisory Commission

on Narcotic and Drug Abuse also recommended

research to determine the effectiveness of outpatient OTPsí dispensing of opioids to people

addicted to opioids (Brecher and Editors 1972).

In the early 1970s, faced with increased opioidrelated drug use and crimes, the Nixon administration greatly increased funding to stem the

supply of illicit opioids, primarily heroin,

entering the United States. It also greatly

increased funding for methadone maintenance,

and the number of patients receiving methadone

increased from 9,000 in 1971 to 73,000 in 1973

(Courtwright 2001). Support for opioid 

16 Chapter 2

Support for opioid

maintenance grew,

especially because

no effective 

psychosocial alternative existed to

treat the large

number of people

with opioid 

addictions.
maintenance grew, especially because no effective psychosocial alternative existed to treat the

large number of people with opioid addictions.

Origins of Opioid

Maintenance Therapy

Development of Medications

To Treat Opioid Addiction

Early rationale for

methadone maintenance

treatment

In 1962, Dr. Vincent P. Dole, a specialist in

metabolism at The Rockefeller University,

became chair of the Narcotics Committee of the

Health Research Council of New York City.

After studying the scientific, public health, and

social ramifications of addiction in the city, he

received a grant to establish a research unit to

investigate the feasibility of opioid maintenance. In preparing for this research, he read

The Drug Addict as a Patient by Dr. Marie E.

Nyswander (Nyswander 1956), a psychiatrist

with extensive experience treating patients who

were addicted to opioids. She was convinced

that these individuals could be treated within

general medical practice. She also believed that

many would have to be maintained on opioids

for extended periods to function because a 

significant number of people who attempted

abstinence without medication relapsed, in

spite of detoxifications, hospitalizations, and

psychotherapy (Brecher and Editors 1972;

Courtwright et al. 1989). Dr. Nyswander joined

Dr. Doleís research staff in 1964. Among others

joining the team was clinical investigator Dr.

Mary Jeanne Kreek.

These researchers realized that morphine,

which is related to heroin, was not a good

choice as an opioid maintenance drug because

patientsí social functioning was impaired by

morphineís sedating effects (White 1998). Also,

the short half-life of morphine required several

injections per day, and, as tolerance developed,

increasing amounts were needed over a short

time for patients to remain stable (Brecher and

Editors 1972). Other short-acting opioids, such

as heroin, codeine, oxycodone, and meperidine

(DemerolÆ), showed similar results (Dole 1980,

1988).

Development of methadone

With short-acting opioids eliminated as options

for maintenance therapy, research focused on

methadone. Methadone appeared to be longer

acting and effective when administered orally.

It also was selected on the basis of observations

of its use in patients withdrawing from heroin

and as an analgesic in the experimental treatment of pain (Dole 1980, 1988). In 1964, technology was not available to measure blood levels

of heroin, morphine, or methadone to assess

duration of action. Proof of the efficacy of

methadone maintenance treatment depended

on observation and recognition by researchers.

In an initial study, methadone was administered to two patients previously maintained on

morphine. Once tolerance for daily doses of 50

to 120 mg was established, patients could function normally without the anxiety associated

with drug craving (White 1998). During this

research, the following important findings

about methadone maintenance were noted, all

supporting its efficacy and benefits (Dole 1980,

1988):

ï Patients did not experience euphoric, tranquilizing, or analgesic effects. Their affect

and consciousness were normal. Therefore,

they could socialize and work normally without the incapacitating effects of short-acting

opioids such as morphine or heroin.

ï A therapeutic, appropriate dose of methadone

reduced or blocked the euphoric and tranquilizing effects of all opioid drugs examined

(e.g., morphine, heroin, meperidine, and

opium), regardless of whether a patient

injected or smoked the drugs.

ï No change usually occurred in tolerance 

levels for methadone over time, unlike for

morphine and other opioids; therefore, a

dose could be held constant for extended

periods (more than 20 years in some cases). 

History of Medication-Assisted Treatment for Opioid Addiction 17
ï Methadone was effective when administered

orally. Because it has a half-life of 24 to 36

hours, patients could take it once a day 

without using a syringe.

ï Methadone relieved the opioid craving or

hunger that patients with addiction described

as a major factor in relapse and continued

illegal use.

ï Methadone, like most opioid-class drugs,

caused what were considered minimal side

effects, and research indicated that

methadone was medically safe and nontoxic.

Expansion of methadone

maintenance from research

project to public health 

program

In 1965, the initial research project on

methadone safety and efficacy was transferred

to Manhattan General Hospital in New York

City (Brecher and Editors 1972). Because Dole

and his colleagues knew that an independent

evaluation of this new treatment would be 

necessary, a team headed by Dr. Frances Rowe

Gearing was formed at Columbia University

School of Public Health to evaluate patient

progress as this treatment expanded. In general,

the team found that patientsí social functioning

improved with time in treatment, as measured

by elimination of illicit-opioid use and better

outcomes in employment, school attendance,

and homemaking. Most patients were stabilized

on methadone doses of 80 to 120 mg/day. Most

patients who remained in treatment subsequently eliminated illicit-opioid use. However,

20 percent or more of these patients also had

entered treatment with alcohol and polysubstance abuse problems, despite intake screening

that attempted to eliminate these patients from

treatment (Gearing and Schweitzer 1974).

Methadone treatment was continued for these

patients, along with attempts to treat their 

alcoholism and polysubstance abuse. Further

evaluation, research, and expansion of the 

program ultimately were recommended (Joseph

and Dole 1970) and instituted. Methadone

maintenance became a major public health 

initiative to treat opioid addiction under the

leadership of Dr. Jerome Jaffe, who headed the

Special Action Office for Drug Abuse

Prevention in the Executive Office of the White

House in the early 1970s. Dr. Jaffeís office

oversaw the creation of a nationwide, publicly

funded system of treatment programs for 

opioid addiction.

Development of LAAM

Like methadone, levo-alpha acetyl methadol

(LAAM) was classified as a U.S. Drug

Enforcement Administration (DEA) schedule II

controlled substance (i.e., having a high potential for abuse but also a currently accepted

medical use) that creates a pharmacologic

cross-tolerance for other opioids and therefore

blocks their euphoric effects while controlling

opioid craving. Whereas methadone suppressed

opioid withdrawal symptoms for 24 hours or

longer, LAAM achieved this effect for 48 to 72

hours or longer.

LAAM was first developed in 1948 by German

chemists as an analgesic (Finn and Wilcock

1997). By the late 1960s, interest arose in

LAAM as an alternative to methadone

(American Association for the Treatment of

Opioid Dependence n.d.). Between 1969 and

1981, 27 separate studies of more than 6,000

patients established LAAMís safety and efficacy

(National Institute on Drug Abuse 1993a). The

U.S. Food and Drug Administration (FDA)

approved LAAM for use in OTPs in July 1993

(National Institute on Drug Abuse 1993a).

Later studies continued to confirm that LAAM

was an effective alternative to methadone and

was preferred by some patients (Glanz et al.

1997). However, in April 2001, based on

reported LAAM-related disturbances in cardiac

function, FDA and Roxane Laboratories, Inc.,

manufacturer of ORLAAMÆ, strengthened the

warnings in LAAM product labeling (Haehl

2001). The American Association for the

Treatment of Opioid Dependence has issued

clinical guidelines for LAAM (American

Association for the Treatment of Opioid

Dependence n.d.). At this writing, only 3 

18 Chapter 2
percent of patients enrolled in maintenance

programs in the United States are receiving

LAAM (Substance Abuse and Mental Health

Services Administration 2002a).

In 2003, Roxane Laboratories announced that

it would stop producing LAAM on January 1,

2004 (Schobelock 2003), making LAAMís continued availability doubtful. This TIP continues to include basic, limited coverage of LAAM

in discussions of opioid medications because of

its clinical significance and relevance in MAT.

Development of 

buprenorphine

Information on the development of the latest

successful maintenance medication, buprenorphine, is in ìDEA classification of buprenorphineî below and TIP 40, Clinical Guidelines

for the Use of Buprenorphine in the Treatment

of Opioid Addiction (CSAT 2004a).

Development of naltrexone

Naltrexone is the only pure opioid antagonist of

the medications described here (see chapter 3).

In the early 1980s, the National Institute on

Drug Abuse (NIDA) completed initial testing of

naltrexone to treat opioid addiction, and FDA

approved naltrexone for this use in 1984. In

1995, naltrexone also received FDA approval

as a preventive treatment for relapse to alcohol

use among patients dependent on alcohol. Some

opioid treatment providers have found that

naltrexone is most useful for highly motivated

patients who have undergone detoxification

from opioids and need additional support 

to avoid relapse or who desire an expedited

detoxification schedule because of external 

circumstances. Naltrexone also may benefit

some patients in the beginning stages of opioid

use and addiction. Other patient groups 

frequently have demonstrated poor compliance

with long-term naltrexone therapy, mainly

because naltrexone neither eases craving for

the effects of illicit opioids when used as directed nor produces withdrawal symptoms when

discontinued (Tai et al. 2001).

Public Policy Studies and

Reports Since 1993

Analyses since the publication of TIP 1 have

shown that maintenance treatment for opioid

addiction is effective in both treatment outcomes and costs.

California Drug and Alcohol

Treatment Assessment

In 1994, the California

Department of Alcohol

and Drug Programs

published the results

of a pioneering largescale study of the

effectiveness, benefits,

and costs of substance

abuse treatment in

California. Using State

databases, provider

records, and followup

interviews with treatment participants, the

study detailed the

effects of treatment on

participant behavior

including drug and

alcohol use, criminal

activity, health, health

care use, and income;

the costs of treatment; and the economic value of

treatment to society (Gerstein et al. 1994). 

Among the California Drug and Alcohol

Treatment Assessmentís findings were the 

following:

ï Treatment was cost beneficial to taxpayers,

with the cost averaging $7 returned for every

dollar invested (Gerstein et al. 1994). ìEach

day of treatment paid for itself (the benefits

to taxpaying citizens equaled or exceeded the

costs) on the day it was received, primarily

through an avoidance of crimeî (Gerstein et

al. 1994, p. iv). ìRegardless of the modality

of care, treatment-related economic savings

outweighed costs by at least 4 to 1î (Gerstein

et al. 1994, p. 90).

History of Medication-Assisted Treatment for Opioid Addiction 19

AnalysesÖhave

shown that maintenance treatment

for opioid addiction is effective in

both treatment

outcomes and

costs.
20 Chapter 2

ï Methadone treatment was among the most

cost-effective treatments, yielding savings of

$3 to $4 for every dollar spent. This was true

for each major methadone treatment modality, but costs were lower in an outpatient OTP

than in a residential or social modality

(Gerstein et al. 1994).

ï Patients in methadone maintenance showed

the greatest reduction in intensity of heroin

use, down by two-thirds, of any type of opioid addiction treatment studied.

ï Patients in methadone maintenance showed

the greatest reductions in criminal activity

and drug selling, down 84 percent and 86

percent, respectively, of any type of opioid

addiction treatment studied.

ï Health care use decreased for all treatment

modalities; participants in methadone maintenance treatment showed the greatest reduction in the number of days of hospitalization,

down 57.6 percent, of any modality.

Institute of Medicine

In 1995, the Institute of Medicine (IOM) produced a study titled Federal Regulation of

Methadone Treatment (Institute of Medicine

1995). This study

concluded that FDA

regulations were

inhibiting physicians

from exercising their

professional judgment; isolating

methadone treatment from mainstream medicine,

thereby depriving

patients of important

ancillary services;

and discouraging

research into new

medications. This

IOM study recommended that the

Federal 

regulatory process

be modified to

ï Encourage programs to provide comprehensive services, such as individual and group

counseling and medical care

ï Emphasize the need for continuing clinical

assessment throughout treatment

ï End arbitrary restrictions on OTP practices.

National Institutes of Health

In 1997, a National Institutes of Health (NIH)

consensus panel called for expansion of

methadone maintenance treatment. It identified

such barriers as the publicís misperception of

persons who are opioid addicted not as individuals with a disease but as ìotherî or ìdifferent,î

the misperception ìthat [addiction] is selfinduced or a failure of willpower and that

efforts to treat it inevitably fail,î and overregulation of methadone treatment that limits the

flexibility and responsiveness of treatment 

programs (National Institutes of Health 1997b).

That panel called for the following:

ï Federal leadership to inform the public that

opioid addiction is a medical disorder that

can be treated effectively, with significant

benefits for the patient and society

ï Access to methadone treatment for persons

under legal supervision (e.g., probation,

parole, incarceration)

ï Increase in funding for methadone maintenance treatment

ï Reduction in unnecessary regulation of MAT,

including

ñ Replacement of FDA regulation and 

oversight of MAT with more effective, less

expensive measures, such as accreditation,

to improve the quality of methadone 

treatment

ñ Revision of DEA regulations to eliminate

the extra level of regulation placed on

methadone compared with other schedule

II opioids, thereby encouraging more

physicians and pharmacies to prescribe

and dispense methadone and making

maintenance treatment available in more

locations

For more than

three decades,

methadoneís use to

treat addiction has

been subjected to

extensive Federal,

State, and local

regulation.
History of Medication-Assisted Treatment for Opioid Addiction 21

ñ Faster approval of new medications for

MAT by FDA and the States

ñ Expansion of the availability of 

maintenance pharmacotherapy to States

and programs where it is currently

unavailable.

Regulatory History

For more than three decades, methadoneís use

to treat addiction has been subjected to extensive

Federal, State, and local regulation. (For a

detailed history of Federal regulation of

methadone treatment, see chapter 5 in the IOM

report [1995] edited by Rettig and Yarmolinsky.)

Laws Related to Controlled

Substances as Addiction

Treatment Medications

Congress has enacted several significant

statutes since 1970 to limit and control the

availability of psychoactive drugs and their use

to treat addiction.

Controlled Substances Act

(1970)

The Controlled Substances Act of 1970 (Public

Law [P.L.] 91ñ513) requires all manufacturers,

distributors, and practitioners who prescribe,

dispense, or administer controlled substances

to register with DEA. A physician seeking 

registration must meet certain standards established by the Secretary of Health and Human

Services and must comply with regulations

established by the U.S. Attorney General

regarding security of opioid stocks and maintenance of records.

Narcotic Addict Treatment

Act (1974)

In passing the Narcotic Addict Treatment Act

of 1974 (P.L. 93ñ281), which amended the

Controlled Substances Act, Congress 

recognized the use of an opioid drug to treat

opioid addiction as critical and, for the first

time in Federal law, defined ìmaintenance

treatment.î To promote closer monitoring of

programs that use opioids for maintenance

treatment, the law required separate DEA 

registration by medical practitioners who dispense opioid drugs in the treatment of opioid

addiction. Previously, any physician with a

DEA registration could prescribe methadone

for pain management or addiction treatment.

This act also increased coordination between

the U.S. Department of Health and Human

Services (DHHS) and DEA. Under its provisions, before a practitioner can obtain registration from DEA, DHHS must determine

that the practitioner is qualified according to

established treatment standards.

The Narcotic Addict Treatment Act also 

established NIDA as an institute independent 

of the National Institute of Mental Health.

Authority to regulate the treatment of opioid

addiction was split between NIDA and FDA.

NIDA became responsible for determining

appropriate standards for medical, scientific,

and public health aspects of drug abuse treatment. FDA received the authority to determine

the safety and effectiveness of drugs and

approve new drugs for opioid addiction 

treatment.

Drug Addiction Treatment

Act (2000)

The Drug Addiction Treatment Act of 2000

(DATA [P.L. 106ñ310 div. B]) amended that

portion of the Controlled Substances Act mandating separate registration for practitioners

who dispense opioids in addiction treatment. It

allows practitioners who meet certain qualifying criteria to dispense or prescribe schedule

III, IV, or V controlled substances specifically

approved by FDA for MAT. Chapter 3

describes the specific requirements that physicians must satisfy under DATA provisions,

including the requirement that physicians must
have the capacity to refer patients for needed

counseling and other ancillary services.

DEA classification of

buprenorphine

On October 8, 2002, DEA completed its 

evaluation of buprenorphine, classifying it as a

schedule III drug (i.e., having potential for

abuse and a currently accepted medical use in

treatment but less potential for addiction than

schedule II drugs). FDA made buprenorphine

the first drug approved for treatment of opioid

addiction in physiciansí offices (CSAT 2004a;

Substance Abuse and Mental Health Services

Administration 2003a; see also chapter 3).

History of Methadone

Regulation

Federal regulation

In 1972, FDA issued regulations governing 

eligibility, evaluation procedures, dosages,

take-home medications, frequency of patient

visits, medical and psychiatric services, counseling, support services, and related details for

methadone treatment

programs. Several

modifications were

made to these regulations during the

1980s. Until 2001,

FDA was responsible

for approving these

programs and ensuring compliance with

FDA regulations.

As experience with

the effectiveness of

methadone grew,

criticism of the 1972

FDA regulations

increased from

physicians, who 

complained that the

regulations placed

burdens on their

practice of medicine, and from addiction 

treatment specialists, who pointed out that 

proscriptive regulations failed to leave room 

for treatment innovation. (See comments on 

the new rules in their proposed form [Federal

Register 64:39812ñ39814].)

The movement away from a compliance 

orientation and toward an accreditation

model was supported by a number of reviews,

including the 1997 NIH consensus development conference on Effective Treatment of

Opiate Addiction and the review of 1972 FDA

regulations by IOM (Institute of Medicine

1995). Interest in accreditation grew because

of its emphasis on self-assessment and

improvement and on integration of quality

assurance and performance elements developed by expert accreditation organizations.

In addition, trends in national health care

fueled movement toward accreditation. 

Many managed care organizations require 

all accredited health care practitioners to

demonstrate quality care. Several States

grant exemptions from State licensing

requirements (called ìdeemed statusî) to

accredited health care facilities.

Final regulations issued by DHHS and the

Substance Abuse and Mental Health Services

Administration (SAMHSA) on January 17,

2001, effective May 18, 2001, govern the use of

methadone and LAAM in both maintenance

and detoxification treatments for opioid addiction. The 1972 FDA regulations were repealed,

and a new accreditation-based regulatory 

system was created. The new system shifted

administration and oversight from FDA to

SAMHSA. The new regulations acknowledged

that addiction is a medical disorder not

amenable to one-size-fits-all treatment. They

recognized that different patients, at different

times, could need vastly different services.

Accreditation itself is a peer-review process

that evaluates a treatment program against

SAMHSAís opioid treatment standards and

accreditation standards of SAMHSA-approved

accrediting bodies (42 Code of Federal

Regulations, Part 8). It includes site visits by

22 Chapter 2

The new 

regulations

acknowledged that

addiction is a 

medical disorder

not amenable to

one-size-fits-all

treatment.
History of Medication-Assisted Treatment for Opioid Addiction 23

specialists with experience in opioid pharmacotherapy and related activities.

The new regulations establish an entirely 

different regulatory and oversight structure for

MAT. The DEA role remains the same, but

FDAís authority to approve and monitor programs has been transferred to SAMHSA.

Instead of detailed proscriptive rules, the new

regulations set forth general certification

requirements and Federal opioid treatment

standards. These are elaborated in bestpractice guidelines and in accreditation 

ìelementsî (or standards) developed by the

SAMHSA-approved accreditation bodies.

SAMHSA has employed a series of expert panels to develop guidelines for an accreditationbased certification system. Placing detailed

practice criteria in accreditation standards

rather than in regulations permits SAMHSA

and the accreditation bodies to update the standards as needed.

The new regulations provide that, once a 

program is accredited, SAMHSA uses accreditation results along with other data to determine whether the program is qualified to

carry out treatment under the standards in

the regulations. SAMHSA maintains oversight

of accreditation elements in its review of

accreditation bodiesí initial and renewal

applications. 

The consensus panel for this TIP expects the

accreditation process to result in an integrated

and individualized approach to services,

increased patient satisfaction, better staff

recruitment, enhanced community confidence

and outcomes, and improvements in quality 

of care. The shift to accreditation enables

SAMHSA to focus its oversight efforts on

improving treatment rather than ensuring that

programs are meeting regulatory criteria.

States

The new Federal regulations preserve Statesí

authority to regulate OTPs. Oversight of treatment medications remains a tripartite system

involving States, DHHS/SAMHSA, and the

U.S. Department of Justice/DEA.

States can monitor the same areas as Federal

agencies, but State rules do not always echo

Federal regulations. Some States have established medical recertification requirements for

continuation of comprehensive, long-term MAT

after a specified period. Other State and local

requirements, such as certificates of need, zoning, and licensure, can affect the number, size,

and location of OTPs. These regulations are not

affected by the change in Federal regulations.

In This

ChapterÖ

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25

3 Pharmacology of

Medications Used To

Treat Opioid Addiction

In This

Chapter...

Pharmacology and

Pharmacotherapy

Dosage Forms

Efficacy

Side Effects

Interactions With

Other Therapeutic

Medications

Safety

This chapter reviews the pharmacology and clinical applications of the

principal medications used to treat opioid addiction in opioid treatment

programs (OTPs), including the opioid agonists methadone and levoalpha acetyl methadol (LAAM), the partial opioid agonist buprenorphine, and the opioid antagonist naltrexone. Coverage of LAAM is brief

because its future availability is uncertain. Coverage of buprenorphine is

short because TIP 40, Clinical Guidelines for the Use of Buprenorphine

in the Treatment of Opioid Addiction (CSAT 2004a), discusses its pharmacology in more detail. Coverage of naltrexone is short because its use

in the United States generally has been limited to easing withdrawal

symptoms for a small portion of patients undergoing medically supervised withdrawal after maintenance treatment. Exhibit 3-1 provides

information about these and other medications for opioid addiction

treatment, including the year of their U.S. Food and Drug

Administration (FDA) approval and their U.S. Drug Enforcement

Administration (DEA) drug schedule assignment.

The most frequently used medication for opioid addiction treatment in

OTPs is methadone, and much of this chapter focuses on methadone

pharmacology. LAAM always has been used much less than methadone,

and its use was reduced further in 2001, after it was associated with cardiac arrhythmia in some patients. That association led FDA to warn that

LAAM be used only for patients not responding well to methadone. That

warning and other factors led the manufacturer to cease production of

LAAM on January 1, 2004 (Schobelock 2003), making its continued

availability uncertain after depletion of existing stocks. Programs were

encouraged to transfer patients using LAAM to other treatments.

Another pharmaceutical company may manufacture and distribute

LAAM in the future.

FDA approved buprenorphine on October 8, 2002, for use in medical

maintenance treatment and medically supervised withdrawal. It is the

first partial opioid agonist in recent U.S. history available for use by certified physicians outside the traditional opioid treatment delivery system

and the strict requirements of the Narcotic Addict Treatment Act of 1974
(see chapter 2). In addition, on May 22, 2003,

an interim rule change made buprenorphine

available for use in OTPs that receive certification from the Substance Abuse and Mental

Health Services Administration (SAMHSA) to

dispense buprenorphine. Physicians working in

medical offices or other appropriate settings

must obtain a waiver from SAMHSA to use

buprenorphine to treat opioid addiction (see

Exhibit 3-2). Qualified physicians may dispense

or prescribe buprenorphine products for up to

30 patients at a time under the provisions of

the Drug Addiction Treatment Act of 2000

(DATA). (More information about DATA and

waivers can be found at www.buprenorphine.

samhsa.gov; also see Boatwright 2002.)

The consensus panel for this TIP expects that

the availability of buprenorphine in multiple

settings will increase the number of patients in

treatment and that its availability in physiciansí offices and other medical and health

care settings should help move medical maintenance treatment of opioid addiction into mainstream medical practice.

26 Chapter 3

Exhibit 3-1 

Pharmacotherapeutic Medications for Opioid Addiction Treatment

Product Formulations

Receptor

Pharmacology

FDA

Approval

DEA

Schedule Treatment Settings

Methadone Oral solution, liquid

concentrate,

tablet/

diskette,

and powder

Full mu 

opioid agonist

Never 

formally

approved

by FDA

II OTP

LAAM Oral 

solution

Full mu 

opioid agonist

1993 II OTP

Buprenorphine

(SubutexÆ)

Sublingual

tablet

Partial mu

opioid agonist

2002 III Physicianís office,

OTP, or other health

care setting

Buprenorphinenaloxone

(SuboxoneÆ)

Sublingual

tablet

Partial 

mu opioid

agonist/mu

antagonist

2002 III Physicianís office,

OTP, or other health

care setting

Naltrexone Oral tablet Mu opioid

antagonist

1984 Not 

scheduled

Physicianís office,

OTP, any substance

abuse treatment 

program
Pharmacology of Medications Used To Treat Opioid Addiction 27

ì To qualify for a waiver under DATA 2000 a licensed physician (MD or DO) must

meet any one or more of the following criteria: 

ï The physician holds a subspecialty board certification in addiction psychiatry

from the American Board of Medical Specialties. 

ï The physician holds an addiction certification from the American Society of

Addiction Medicine.

ï The physician holds a subspecialty board certification in addiction medicine

from the American Osteopathic Association. 

ï The physician has, with respect to the treatment and management of opioidaddicted patients, completed not less than eight hours of training (through 

classroom situations, seminars at professional society meetings, electronic 

communications, or otherwise) that is provided by the American Society of

Addiction Medicine, the American Academy of Addiction Psychiatry, the

American Medical Association, the American Osteopathic Association, the

American Psychiatric Association, or any other organization that the Secretary

[of Health and Human Services] determines is appropriate for purposes of this

subclause.

ï The physician has participated as an investigator in one or more clinical 

trials leading to the approval of a narcotic drug in schedule III, IV, or V for

maintenance or detoxification treatment, as demonstrated by a statement 

submitted to the Secretary by the sponsor of such approved drug. 

ï The physician has such other training or experience as the State medical 

licensing board (of the State in which the physician will provide maintenance or

detoxification treatment) considers to demonstrate the ability of the physician to

treat and manage opioid-addicted patients.

ï The physician has such other training or experience as the Secretary considers to

demonstrate the ability of the physician to treat and manage opioid-addicted

patients. Any criteria of the Secretary under this subclause shall be established

by regulation. Any such criteria are effective only for 3 years after the date on

which the criteria are promulgated, but may be extended for such additional 

discrete 3-year periods as the Secretary considers appropriate for purposes of

this subclause. Such an extension of criteria may only be effectuated through a

statement published in the Federal Register by the Secretary during the 30-day

period preceding the end of the 3-year period involved.î

Source: www.buprenorphine.samhsa.gov/waiver_qualifications.html.

Exhibit 3-2 

Requirements for Physiciansí Waivers To Dispense or Prescribe

Buprenorphine and Buprenorphine-Naloxone to Patients Who

Are Opioid Addicted
28 Chapter 3

Pharmacology and

Pharmacotherapy

Methadone and LAAM

The synthetic opioids methadone and LAAM

are the only long-acting full opioid agonists

approved for opioid pharmacotherapy at this

writing. Opioid agonists bind to the mu opiate

receptors on the surfaces of brain cells, which

mediate the analgesic and other effects of opioids. Methadone and LAAM produce a range

of mu agonist effects similar to those of shortacting opioids. Therapeutically appropriate

doses of these agonist medications produce

cross-tolerance for short-acting opioids such as

morphine and heroin, thereby suppressing

withdrawal symptoms and opioid craving as a

short-acting opioid is eliminated from the body.

The dose needed to produce cross-tolerance

depends on a patientís level of tolerance for

short-acting opioids.

LAAM is longer acting than methadone. Unlike

methadone, it cannot be administered daily

because its longer duration of action would

lead to accumulation of toxic levels in the 

body that could result in death (Roxane

Laboratories, Inc., 2001). Articles by Oda 

and Kharasch (2001) and Walsh and colleagues

(1998), as well as the manufacturerís package

insert for ORLAAMÆ(Roxane Laboratories,

Inc., 2001), provide more information on

LAAMís pharmacology.

When given intramuscularly or orally,

methadone suppresses pain for 4 to 6 hours.

Intramuscular methadone is used only for

patients who cannot take oral methadone, 

for example, patients in medication-assisted

treatment for opioid addiction (MAT) who are

admitted to a hospital for emergency medical

procedures. Methadone should not be given

parenterally in an OTP.

Because of its extensive bioavailability and

longer half-life, an adequate daily oral dose of

methadone suppresses withdrawal and drug

craving for 24 to 36 hours in most patients who

are opioid addicted. Patients with special needs

may require split methadone doses given more

than once daily. Methadone is metabolized

chiefly by the cytochrome P3A4 (CYP3A4)

enzyme system (Oda and Kharasch 2001),

which is significant when methadone is coadministered with other medications that also

operate along this metabolic pathway (see

ìInteractions With Other Therapeutic

Medicationsî below).

After patient induction into methadone 

pharmacotherapy, a steady-state concentration

(i.e., the level at which the amount of drug

entering the body equals the amount being

excreted) of methadone usually is achieved in 5

to 7.5 days (four to five half-lives of the drug).

Methadoneís pharmacological profile supports

sustained activity at the mu opiate receptors,

which allows substantial normalization of many

physiological disturbances resulting from the

repeated cycles of intoxication and withdrawal

associated with addiction to short-acting 

opioids. Therapeutically appropriate doses 

of methadone also attenuate or block the

euphoric effects of heroin and other opioids.

Goodman and Gilmanís Pharmacological 

Basis of Therapeutics (Hardman et al. 2001)

provides a comprehensive description of

methadoneís pharmacological effects.

Methadone is up to 80 percent orally bioavailable, and its elimination half-life ranges

from 24 to 36 hours. When methadone is

administered daily in steady oral doses, its

level in blood should maintain a 24-hour

asymptomatic state, without episodes of overmedication or withdrawal (Payte and Zweben

1998). Methadoneís body clearance rate varies

considerably between individuals. The serum

methadone level (SML) and elimination halflife are influenced by several factors including

pregnancy and a patientís absorption,

metabolism and protein binding, changes in

urinary pH, use of other medications, diet,

physical condition, age, and use of vitamin and

herbal products (Payte and Zweben 1998).

Measuring methadone via SMLs helps 

determine how much is circulating in patientsí
systems. In a typical 24-hour period after 

dosing, SMLs should peak after about 2 to 4

hours and decline gradually to trough levels

thereafter (Payte and Zweben 1998). Although

researchers have noted a strong correlation

between methadone dosage and serum concentrations in some patients, the relationship is 

not necessarily linear, and a high degree of

variation exists among patients (reviewed by

Leavitt et al. 2000). The rate-of-change ratio

between peak and trough SMLs can be useful

clinically; Payte and Zweben (1998) suggested

that peak SMLs should not exceed twice the

trough levels.

Researchers have found that trough SMLs of

150 to 600 ng/mL are necessary to suppress

drug craving (reviewed in Leavitt et al. 2000).

Many treatment providers consider that trough

SMLs of $400 ng/mL provide adequate opioid

cross-tolerance, thereby controlling patientsí

opioid abuse; however, Eap and colleagues

(2002) found no studies that validated these

minimum trough levels.

Methadone has two enantiomeric forms, ì(R)-î

(also called levo- or L-) methadone and ì(S)-î

(dextro- or D-) methadone, which have the

same chemical formula but different spatial

arrangements. OTPs in the United States use a

50:50 racemic mixture of these two enantiomers.

Only (R)-methadone has clinically significant

mu receptor agonist activity, and its potency as

an analgesic is 50 times greater than that of (S)-

methadone (Eap et al. 2002). (R)-methadone

also has a significantly higher mean clearance

rate than (S)-methadone (Eap et al. 1999).

Methadone is metabolized into inactive metabolites, mainly in the liver by CYP450 enzymes,

but probably also by enzymes in the intestines.

These metabolites are then excreted. Drugs

that induce or inhibit this enzyme activity can

affect methadone metabolism. If these enzymes

are stimulated by other medications, the duration of methadoneís effect and SMLs may be

lowered, precipitating withdrawal symptoms. If

these enzymes are inhibited by other medications, methadone metabolism may be slowed,

and the SMLs and duration of methadoneís

effect in patients may be increased (Eap et al.

2002; Leavitt et al. 2000; Payte and Zweben

1998).

Several CYP450 isoforms help metabolize

methadone, including CYP3A4 (the most abundant), CYP2B6, CYP2D6, and possibly, but to

a smaller extent, CYP1A2, CYP2C9, and

CYP2C19 (Cozza and Armstrong 2001; Eap et

al. 2002; Gerber et al. 2004). Different

enzymes metabolize (R)- and (S)-methadone

differently. Numerous genetic and environmental factors affect these

enzymes and account

for variations in

methadone

metabolism among

individuals. Some

enzymes also play a

part in metabolizing

other medications,

such as benzodiazepines, antidepressants, anticonvulsants, antibiotics, and

antiviral agents (e.g.,

HIV protease

inhibitors). Through

their effects on these

enzymes, some medications can raise or

lower patientsí SMLs. Especially during initiation of methadone maintenance, methadone

can increase CYP3A4 activity, thereby accelerating its own metabolism in some individuals

(Eap et al. 2002; Leavitt et al. 2000).

CYP2D6 selectively metabolizes the (R)-

methadone enantiomer. Production of this

enzyme is affected by genetic factors. A small

portion of the population does not produce

much CYP2D6, whereas others have very high

CYP2D6 activity. The latter group may require

much higher methadone doses to compensate

for their high rate of (R)-methadone

metabolism (Eap et al. 2002; Leavitt et al.

2000). Individuals also differ considerably in

CYP3A4 and CYP1A2 activity, accounting in

part for the wide variations in methadone

metabolism (Eap et al. 2002).

Pharmacology of Medications Used To Treat Opioid Addiction 29

[A]n adequate

daily oral dose 

of methadone 

suppresses withdrawal and drug

craving for 24 to

36 hours...
Buprenorphine

Buprenorphine, a derivative of the opium 

alkaloid thebaine, is a synthetic opioid and 

generally is described as a partial agonist at the

mu opiate receptor and an antagonist at the

kappa receptor. Research has demonstrated

that buprenorphineís partial agonist effects at

mu receptors, its unusually high affinity for

these receptors, and its slow dissociation from

them are principal determinants of its pharmacological profile (Cowan 2003).

In the 1990s, researchers determined that, as a

partial mu agonist, buprenorphine does not

activate mu receptors fully (i.e., it has low

intrinsic activity), resulting in a ceiling effect

that prevents larger doses of buprenorphine

from producing greater agonist effects (Walsh

et al. 1994). As a result, there is a greater margin of safety from death by respiratory depression when increased doses of buprenorphine

are used, compared with increased doses of full

opioid agonists. Buprenorphine overdose is

uncommon, although it has been reported in

France, and it is associated almost always with

injection of buprenorphine coupled with ingestion of high doses of benzodiazepines, alcohol,

or other sedative-type substances (Kintz 2001,

2002). Another feature of buprenorphine is

that it can be used on a daily or less-than-daily

basis. Typically, the interdosing interval is

extended by doubling or tripling the daily dose

to permit alternate-day or thrice weekly dosing

(Amass et al. 2000, 2001), which is possible

because, although larger doses do not increase

buprenorphineís agonist activity, they do lengthen its duration of action (Chawarski et al. 1999).

Buprenorphine also may be an excellent agent

to facilitate detoxification from illicit opioids

and abused prescription opioids. Although it

has a relatively short plasma half-life (about 4

to 6 hours), buprenorphine has a long duration

of action resulting from its high affinity for and

correspondingly slow dissociation from the mu

receptor (Cowan 2003). This slow dissociation

likely reduces the magnitude of withdrawal

symptoms during detoxification (Johnson et al.

2003b). Some evidence supports a short-term

course of buprenorphine-naloxone therapy for

detoxification from opioids.

Buprenorphine is metabolized in the liver by

the CYP3A4 subgroup of CYP450 enzymes

(Kobayashi et al. 1998), and, like methadone

and LAAM, its rate of metabolism is affected

by coadministration of other medications

metabolized along this pathway.

Depending on the dosage, buprenorphine activity can be viewed as falling between that of full

agonists, such as methadone and LAAM, and

antagonists, such as naltrexone (Exhibit 3-3)

(Johnson et al. 2003b). Because it is a partial

agonist at higher doses, buprenorphine also

can precipitate opioidlike withdrawal symptoms in patients with high levels of physical

dependence on opioids, making it appear to

function more like an antagonist under these

conditions (see ìInductionî in chapter 5).

Naltrexone

Naltrexone is a highly effective opioid antagonist that tightly binds to mu opiate receptors.

Because it has a higher affinity for these receptors than has heroin, morphine, or methadone,

naltrexone displaces those drugs from receptors

and blocks their effects. It can, therefore, 

precipitate withdrawal in patients who have not

been abstinent from short-acting opioids for at

least 7 days and have not been abstinent from

long-acting ones, such as methadone, for at

least 10 days (OíConnor and Fiellin 2000).

Naltrexone displaces buprenorphine to a lesser

degree, but, in high enough doses, it overrides

buprenorphineís activity as well.

Because naltrexone has no narcotic effect,

there are no withdrawal symptoms when a

patient stops using naltrexone, nor does naltrexone have abuse potential. Early research

concluded that tolerance does not develop for

naltrexoneís antagonist properties, even after

many months of regular use (Kleber et al.

1985). A 50 mg tablet markedly attenuates or

blocks opioid effects for 24 hours, and a 100 to

150 mg dose can block opioid effects for up to

72 hours (OíBrien et al. 1975).

30 Chapter 3
The FDA approved naltrexone for maintenance

treatment in 1984 based on its pharmacological

effects, without requiring proof of its efficacy

in clinical trials for opioid addiction treatment.

Despite its potential advantages, it has had little impact on the treatment of opioid addiction

in the United States, primarily because of poor

patient compliance (OíConnor and Fiellin 2000). 

Dosage Forms

Methadone

Methadone is provided in various forms,

including diskettes, tablets, oral solution, liquid concentrate, and powder. In the United

States, methadone used in MAT almost always

Pharmacology of Medications Used To Treat Opioid Addiction 31

Exhibit 3-3 

Intrinsic Activity of Full Agonist (Methadone), Partial Agonist

(Buprenorphine), and Antagonist (Naloxone) Therapy

Source: Reprinted from Drug and Alcohol Dependence 70(Suppl.) Johnson et al.

Buprenorphine: How to use it right. S59ñS77, 2003b, with permission from Elsevier.
is administered orally in liquid form.

Parenteral administration is prohibited in

OTPs. Parenteral abuse of methadone is not

widespread, and people rarely inject the

methadone dispensed in U.S. OTPs because it

is mixed with substances (e.g., flavored drinks)

that make injection unattractive.

Approved forms of

methadone for oral

administration are

supplied in various

doses and 

concentrations,

allowing OTPs to

choose which to dispense on the basis of

clinic and patient

preferences, convenience, and cost.

The diskette form

comprises scored

tablets, which are

dissolved in water,

mixed with a flavored liquid, and

taken orally.

Advantages are easy

inventory and the

ability for patients to

see what they are

taking before water

is added. The

diskette is not suited, however, for small dose

increments and decrements. Methadone tablets,

which dissolve in water, can be used in conjunction with diskettes for small dose changes;

however, tablets normally are used only for

analgesic applications; OTPs favor forms less

subject to diversion. The liquid concentrate

form offers complete dosing flexibility, particularly with a computer-assisted dispensing pump

system. The powder form can be mixed with

water into a solution.

LAAM

LAAM is supplied to OTPs as a colorless liquid

to be taken orally. When LAAM was approved,

Federal regulations required OTPs to ensure

that ìdosage forms of LAAM and methadone

are easily distinguishedî (21 Code of Federal

Regulations, Part 291 ß 505). Therefore, OTPs

color LAAM to distinguish it from methadone.

Buprenorphine

Buprenorphine is available in sublingual tablets

containing either buprenorphine alone (sometimes called monotherapy tablets and marketed

under the name Subutex) or combined with

naloxone (called combination therapy tablets

with the trade name Suboxone). For the combination therapy tablet, the ratio of buprenorphine to naloxone is 4 mg of buprenorphine to

1 mg of naloxone. The combination tablet was

developed because of problems with injection

abuse of buprenorphine reported outside the

United States, where injection of buprenorphine is not permitted for treatment. Injected

alone, buprenorphine precipitates withdrawal

symptoms in most patients who are opioid

addicted, and the addition of naloxone increases

this likelihood. The combination tablet may precipitate acute withdrawal. Withdrawal also may

be precipitated if too much or too little

buprenorphine is given or if it is administered

while the opioid receptors are highly occupied by

an opioid agonist. Therefore, physicians need to

be careful when timing the initiation of

buprenorphine induction.

Naltrexone

Naltrexone was first produced by DuPont

under the trade name ReviaÆ. However, it is

now produced by Mallinckrodt under the trade

name DepadeÆand is supplied in 25, 50, and

100 mg tablets.

Efficacy

Methadone

Methadone maintenance has been demonstrated

repeatedly to be safe and effective when used

with appropriate safeguards and psychosocial

32 Chapter 3

In a...study comparing the efficacy

of LAAM...,

buprenorphine...,

and methadone...,

all three medications substantially

reduced illicit 

opioid use.
services (OíConnor and Fiellin 2000). Maintenance treatment typically leads to reduction or

cessation of illicit opioid use and its adverse

consequences, including cellulitis, hepatitis,

and HIV infection from use of nonsterile injection equipment, as well as criminal behavior

associated with obtaining drugs. Methadone

pharmacotherapy has been shown to lead 

to improved overall adjustment, including

reductions in psychiatric symptoms, unemployment, and family or social problems. Mattick

and colleagues (2003) provide complete reviews

of the effectiveness of methadone.

LAAM

Controlled clinical trials generally have 

established that LAAM is as effective as

methadone and buprenorphine in reducing

illicit-opioid use and retaining patients in treatment when equipotent doses are compared

(e.g., Johnson et al. 2000; White et al. 2002).

Appel and colleagues (2001) provide more

information on LAAMís efficacy.

Buprenorphine

The primary efficacy of buprenorphine in 

clinical trials was demonstrated via patient

retention and elimination of illicitñopioidpositive drug tests. Compared with equipotent

doses of both methadone and LAAM,

buprenorphine produced similar rates of 

treatment retention and abstinence from illicit

opioids. In a controlled, randomized study

comparing the efficacy of LAAM (75 to 115

mg), buprenorphine sublingual solution (16 to

32 mg), and methadone (60 to 100 mg), all

three medications substantially reduced illicit

opioid use (Johnson et al. 2000).

Johnson and colleagues (2003b) reviewed

numerous studies evaluating the efficacy of

buprenorphine for maintenance treatment lasting up to 1 year. These studies have shown that

daily doses of 8 mg of sublingual solution or 8

to 16 mg of the buprenorphine tablet are safe

and well tolerated. Most studies comparing

buprenorphine and methadone have shown

that 8 mg of sublingual buprenorphine or 16

mg of the tablet per day is equivalent to

approximately 60 mg of oral methadone per

day. A study by Fudala and colleagues (2003)

demonstrated the efficacy and safety of the

buprenorphine-naloxone combination tablet 

in office-based settings.

Naltrexone

Naltrexone is highly effective in preventing

relapse when used as directed. However, most

studies have indicated very high (70 to 80 percent) dropout rates from naltrexone therapy

(Stine et al. 2003). A study by Rothenberg and

colleagues (2002) found especially poor retention

levels for patients who had received methadone

before naltrexone treatment (none of them

completed 6 months of treatment, compared

with 31 percent of patients who had not

received methadone before naltrexone therapy).

Other studies have demonstrated better compliance when naltrexone therapy is supported

with payment scheduling and vouchers (e.g.,

Preston et al. 1999b).

Side Effects

Long-term methadone, LAAM, or buprenorphine therapy is associated with few side

effects. Although patients typically have high

levels of medical and mental disorders, most

result from preexisting problems or the consequences of addiction, not from the treatment

medication (Institute of Medicine 1995).

Chapter 10 provides a review of related medical

problems in patients who are opioid addicted.

The most common adverse effects reported by

patients receiving methadone or LAAM are

constipation, which is caused by slowed gastric

motility, and sweating; a similar side effect 

profile is seen for buprenorphine. Other side

effects include insomnia or early awakening

and decreased libido or sexual performance

(Hardman et al. 2001). Possible side effects

reported after regular use of these medications

are listed in Exhibit 3-4.

Pharmacology of Medications Used To Treat Opioid Addiction 33
34 Chapter 3

Exhibit 3-4 

Possible Side Effects of Opioid Agonist and Partial Agonist Therapy

Whole Body Effects

ï Weakness, loss of energy (asthenia)

ï Back pain, chills

ï Fluid accumulation (edema)

ï Hot flashes

ï Flu syndrome and malaise

ï Weight gain

Gastrointestinal Effects

ï Constipation

ï Dry mouth

ï Nausea and vomiting

ï Abdominal pain

Musculoskeletal Effects

ï Joint pain (arthralgia)

ï Muscle pain (myalgia)

Nervous System Effects

ï Abnormal dreams

ï Anxiety

ï Decreased sex drive

ï Depression

ï Euphoria

ï Headache

ï Decreased sensitivity to tactile 

stimulation (hypesthesia)

ï Insomnia 

ï Nervousness

ï Somnolence

Respiratory Effects

ï Cough

ï Rhinitis

ï Yawning

Cardiac Effects

ï Electrocardiogram changes (possible 

QT prolongation with LAAM or high

doses of methadone)

ï Postural hypotension

ï Slowed heart rate (bradycardia)

Hepatic Effects

ï Abnormal liver function tests

Endocrine Effects

ï Hyperprolactinemia

ï Absence of menstrual periods 

(amenorrhea)

Skin and Appendage Effects

ï Sweating

ï Rash

Special Sensory Effects

ï Blurred vision

Urogenital Effects

ï Difficult ejaculation

ï Impotence
Cardiovascular Effects

Methadone

Methadone has been shown to increase QT

intervals in at least two studies (i.e., Krantz et

al. 2003; Martell et al. 2003). A QT interval is

that part of a patientís electrocardiogram reading that begins at the onset of the QRS complex

and extends to the end of the T wave. The QT

interval represents the time between the start

of ventricular depolarization and the end of

ventricular repolarization. The QT interval

normally varies depending on heart rate, age,

and gender. The QT interval may be influenced

by electrolyte balance, medications, and

ischemia. A prolonged QT interval increases

the risk of developing a cardiac arrhythmia

called torsade de pointes. 

Cases of torsade de pointes have been reported

in patients taking high doses of methadone

(mean daily doses of approximately 400 mg).

Although information about this effect is limited, 6 of 17 patients who developed torsade de

pointes in one study had an increase in their

methadone dose during the month preceding

arrhythmia (Krantz et al. 2003). This finding

supported the possibility that methadone contributed to the development of arrhythmia.

Furthermore, Martell and colleagues (2003)

showed that, regardless of dose, a statistically

significant increase occurred in QT intervals

during the first 2 months of treatment.

Practitioners should be aware of potential QTprolonging effects of methadone, especially at

high doses, and should be aware of interactions

with other medications that also have QTprolonging properties or with medications that

slow the elimination of methadone. 

LAAM

LAAM has been associated with prolonged QT

interval in some patients and, in rare cases,

with death from torsade de pointes arrhythmia.

As a result, it has been taken off the market in

Europe, and it has been given a ìblack boxî

warning (i.e., a required warning on the package insert and other product-related materials)

in the United States by FDA. These findings

have led to discontinuation of LAAM therapy

for new patients by most American OTPs.

Currently, it is labeled for use only when no

other treatment option exists or for continuing

use in patients who already have demonstrated

tolerability for the medication (Roxane

Laboratories, Inc., 2001).

Before a patient is started on LAAM, providers

must follow informed-consent procedures

about QT interval prolongation and provide

information about the possibility of arrhythmia

and sudden death (CSAT 1999b). Patients

should be screened for cardiac risk factors,

including preexisting prolonged QT intervals or

other cardiac problems (Food and Drug

Administration 2001; Schwetz 2001). More

information about LAAM is available from

Roxane Laboratories Technical Product

Information at 800-962-8364 and in chapter 2.

Side Effects of Naltrexone

Approximately 10 percent of patients receiving

naltrexone have gastrointestinal side effects

(e.g., nausea and vomiting) that may necessitate stopping the medication. Most patients,

however, experience only mild, transient 

stomach upset (Stine et al. 2003). Naltrexone

also can cause anxiety, nervousness, insomnia,

headache, joint or muscle pain, and tiredness

in some patients (National Library of Medicine

1997).

Effects on the Immune

System

Short-acting opioids such as heroin and morphine interfere with the normal activity of the

immune system, perhaps through stress hormones such as cortisol, which are known to suppress immune function. These effects are not

seen with methadone, which does not appear to

affect natural killer cell activity, immunoglobulin, or T or B cells (Novick et al. 1989). 

Effects on the Liver

Methadone, LAAM, and buprenorphine are

metabolized by the liver, but no evidence exists

Pharmacology of Medications Used To Treat Opioid Addiction 35
that they are hepatotoxic (Joseph et al. 2000).

Because the liver is a major storage site for

these medications, patients with liver disease

should be expected to metabolize opioid-based

medications more slowly, which might raise

blood levels of these medications but lower

their stores and shorten their duration of

action. Abnormal liver functions among

patients maintained on these drugs usually 

are caused by viral infections, most commonly

hepatitis C acquired from contaminated 

needles, or by cirrhosis secondary to alcoholism

(Marray 1992). Chapter 10 provides information on medical conditions commonly seen in

patients who are opioid addicted.

Although the presence of liver disease is not a

reason to exclude patients from MAT, severe

persistent liver disease in these patients indicates the need to monitor liver functions regularly and to use caution in dosage adjustment.

Severe liver impairment might result in toxic

serum levels of an opioid medication. Symptoms

of toxic levels include poor concentration,

drowsiness, dizziness when standing, and excessive anxiety (sometimes called feeling ìwiredî).

These effects usually can be managed by dose

reduction. The consensus panel and the FDA

labels on Subutex and Suboxone recommend

baseline and periodic liver function testing for

patients receiving buprenorphine.

In evaluating naltrexone to treat alcoholism, 

a Center for Substance Abuse Treatment consensus panel (CSAT 1998a) recommended caution in using naltrexone for patients who have

high (three times normal) serum transaminase

levels. OTPs should perform liver function tests

before naltrexone therapy and periodically

thereafter to ensure healthy liver function. For

the relatively few cases in which liver toxicity

occurs, treatment should be discontinued after

determining that the liver problem has no 

other cause.

Side Effects of Buprenorphine

Johnson and colleagues (2003b) reported that

buprenorphine in solution or tablet and the

combination buprenorphine-naloxone tablet

were well tolerated. Few serious side effects

have been reported in studies involving more

than 5,000 patients, although, like other opioids, buprenorphine can produce constipation,

headache, nausea and vomiting, and dizziness

(Fudala et al. 2003; Ling et al. 1998). Increases

in liver enzymes (aspartate aminotransferase

and alanine aminotransferase) were observed

in individuals receiving buprenorphine who

also were positive for hepatitis C (Petry et 

al. 2000). At this writing, 53 cases of 

buprenorphine-associated hepatitis have been

reported in France since 1996 (Auriacombe et

al. 2003). One report suggested an association

between injection buprenorphine misuse and

liver toxicity, possibly from buprenorphineís

increased bioavailability when administered

parenterally (Berson et al. 2001). The direct

role of buprenorphine in these abnormalities 

is unclear because many individuals in these

studies might have had hepatitis B or C.

Additional studies are needed to clarify this issue.

Interactions With

Other Therapeutic

Medications 

Because methadone, LAAM, and buprenorphine are metabolized chiefly by the CYP3A4

enzyme system (a part of the CYP450 system),

drugs that inhibit or induce the CYP450 system

can alter the pharmacokinetic properties of

these medications. Drugs that inhibit or induce

this system can cause clinically significant

increases or decreases, respectively, in serum

and tissue levels of opioid medications. 

Drugs that induce the CYP450 enzyme system

can precipitate withdrawal in patients receiving

methadone, LAAM, or buprenorphine. Most

notable are certain medications used to treat

HIV infection, such as nelfinavir (McCanceKatz et al. 2000), efavirenz (Clarke, S.M., et al.

2001b), and nevirapine (Clarke, S.M., et al.

2001a; Otero et al. 1999). Other common

inducers are carbamazepine, phenytoin, and

phenobarbital (Michalets 1998).

Psychiatric medications sharing the same

metabolic pathways as methadone and LAAM

36 Chapter 3
include some selective serotonin reuptake

inhibitors (SSRIs), which inhibit the isoenzymes

that metabolize methadone and might increase

SMLs (Nemeroff et al. 1996). Hamilton and 

colleagues (2000), who examined SMLs in

patients who were depressed, receiving the

SSRI sertraline, and undergoing methadone

pharmacotherapy, found that sertraline produced modest increases in SMLs during the

first 6 weeks of treatment. They concluded that

patients who are methadone maintained and

receiving SSRIs should be monitored for

altered SMLs. However, because clinical experience with patients in MAT who take SSRIs

has not indicated that these alterations are 

clinically significant, the consensus panel recommends careful monitoring of these patients

but not routine testing of their SMLs. Of all the

SSRIs, fluvoxamine likely has the most potential to cause excessive SMLs while patients are

receiving it and decreased SMLs after patients

discontinue it (Alderman and Frith 1999).

Fluvoxamine has been implicated in oversedation and respiratory depression when combined

with methadone (Alderman and Frith 1999).

Earlier studies showed that methadone increased

serum levels of tricyclic antidepressants, indicating that the oral doses required for a therapeutic

response to tricyclics might be lower than those

needed for a positive response in patients not

addicted to opioids (Maany et al. 1989).

Finally, rifampin, carbamazepine, phenobarbital (used occasionally for the treatment of

seizure disorders), and some medications to

treat HIV infection (see chapter 10) also may

induce liver enzymes that speed the bodyís

transformation of methadone. Patients taking

these medications might need increases in 

their methadone dosage or split doses to 

maintain stability. 

Exhibit 3-5 summarizes other reported drug

interactions with methadone.

Pharmacology of Medications Used To Treat Opioid Addiction 37

Exhibit 3-5 

Reported Drug Interactions With Methadone

Agent Effect on Methadone Possible Mechanism Remarks

Amitriptyline Decreased clearance Inhibition of one or

several CYP

isozymes (1A2, 2C9,

2C19, 2D6, 3A4)

Clinical relevance unclear

Amprenavir Decreased serum 

levels; possible

decreased opioid

effects

Induction of CYP3A Median 65% decrease of

SMLs in five patients;

association of amprenavir

and abacavir, with amprenavir the likeliest inducing

agent

Amylobarbitone Increased clearance Induction of CYP3A Clearance determined in

patients receiving

methadone for cancer pain

(continued on following page)
38 Chapter 3

Exhibit 3-5 

Reported Drug Interactions With Methadone (continued)

Agent Effect on Methadone Possible Mechanism Remarks

Ciprofloxacin Increased opioid

effects

Inhibition of

CYP1A2 and/or

CYP3A4

One case report of sedation,

confusion, and respiratory

depression

Diazepam Increased opioid

effects

Mechanism unclear;

probably not a 

pharmacokinetic

interaction

Clinical relevance unclear

Efavirenz Decreased plasma

levels and opioid

effects

Induction of CYP3A Mean 57% decrease of AUC*

in 11 patients; 1 case report

of reduction of both 

enantiomers of methadone

Ethanol Increased opioid

effects and added

sedation

Mechanism unclear Clinical relevance unclear

Fluconazole Decreased

methadone clearance

and increased SMLs

Inhibition of

CYP3A4

Increased AUC by 35% in 13

patients after 200 mg/day for

14 days

Fluoxetine Increased SMLs Inhibition of CYP2D6

(stereoselectivity for

(R)-methadone)

Increased plasma 

levels (mean increase 32%)

for (R)- but not (S)-

methadone in seven patients

Fluvoxamine Increased SMLs and

increased opioid

effects

Inhibition of one or

several CYP isozymes

(1A2, 2C19, 3A4,

2C9)

One case report of hypoventilation, severe hypoxemia,

and hypercapnia; two case

reports of withdrawal symptoms when fluvoxamine

stopped; one case report of

fluvoxamine use to decrease

methadone metabolism

induced by barbiturate

Fusidic acid Decreased opioid

effects

Induction of CYP3A

and CYP2C

Reports of withdrawal symptoms after 4-week therapy

Moclobemide Increased opioid

effects

Inhibition of

CYP2D6 and/or

CYP1A2

One case report of withdrawal symptoms when moclobemide stopped

*Area under the concentration-time curve.
Pharmacology of Medications Used To Treat Opioid Addiction 39

Exhibit 3-5 

Reported Drug Interactions With Methadone (continued)

Agent Effect on Methadone Possible Mechanism Remarks

Nelfinavir Decreased SMLs Induction of CYP3A;

possible induction of

P-glycoprotein

Mean decrease about 55% in

two patients

Nevirapine Decreased SMLs and

opioid effects

Induction of CYP3A Case reports of very important

decrease in SMLs and severe

withdrawal symptoms

Paroxetine Increased SMLs Inhibition of

CYP2D6 (stereoselectivity for (R)-

methadone)

Increased (R)-methadone 

plasma levels in eight CYP2C6

extensive metabolizers (32%) but

not in poor metabolizers (3%)

PhenobarbitalDecreased SMLs and

opioid effects

Induction of CYP3A One case report with a 31%

reduction of trough SMLs

Phenytoin Decreased SMLs and

opioid effects

Induction of CYP3A Mean 2.4-fold decrease of SMLs

with moderately severe opioid

withdrawal symptoms

Rifampin Decreased SMLs and

opioid effects

Induction of CYP3A Cases of severe withdrawal

symptoms

Ritonavir Decreased SMLs and

opioid effects

Induction of CYP3A,

possible induction of

P-glycoprotein; induction of CYP2C19

and/or CYP2B6 suggested to explain

greater induction of

metabolism of (S)-

than (R)-methadone

Mean 36% decrease of the AUC

in 11 patients after a 14-day

treatment; high interindividual

variability of decrease in SMLs

Sertraline Increased SMLs Inhibition of one or

several CYP

isozymes (3A4, 2D6,

1A2, 2C9, 2C19)

No side effects from excess

dosage recorded

SpironolactoneIncreased clearance Induction of CYP3A Clearance determined in

patients receiving methadone

for cancer pain

Adapted from Eap et al. 2002, by permission of Adis International.
40

Exhibit 3-6 provides a list of other substances

that are known to induce or inhibit CYP3A4

and potentially could affect levels of

methadone, LAAM, and buprenorphine.

Little information is available on the interaction of naltrexone with other medications.

Lethargy and somnolence have been reported

when naltrexone is used along with ThorazineÆ

(chlorpromazine) or MellarilÆ(thioridazine),

and caution should be taken when naltrexone 

is used with other antipsychotic drugs. Patients

taking naltrexone experience significant blockade of opioid effects from medications taken for

analgesia. However, this blockade is present

only when naltrexone is taken regularly; it will

cease 24 to 72 hours after naltrexone is discontinued (OíConnor and Fiellin 2000).

Strategies To Prevent or

Minimize Harmful Drug

Interactions in MAT

To control patientsí vulnerability to adverse

cardiac and other harmful effects of drug 

interactions with methadone or LAAM, the

consensus panel recommends obtaining a 

thorough drug and medication history, including results of drug and other laboratory tests.

In some cases, particularly when patients are

treated in multiple settings, consolidating this

information can be a challenge.

Treatment providers should rely on their 

experience, intuition, and common sense to

anticipate and circumvent negative drug interactions. The traditional advice when adding

drugs to a therapeutic regimen is to start with

Chapter 3

Exhibit 3-6

Other Inducers and Inhibitors of CYP450 and CYP3A4

CYP3A4 Inducers Expected To Reduce Opioid Medication Levels

Carbamazepine

Dexamethasone

Ethosuximide

Primidone

Rifabutin

Troglitazone

CYP3A4 Inhibitors Expected To Increase Opioid Medication Levels*

Amiodarone

Cannabinoids

Clarithromycin

Erythromycin

Grapefruit juice

Indinavir

Itraconazole

Ketoconazole

Metronidazole

Mibefradil

Miconazole

Nefazodone

Norfloxacin

Omeprazole (slight)

Quinine

Saquinavir

Troleandomycin

Zafirlukast

*Although clarithromycin and erythromycin are CYP3A4 inhibitors, azithromycin does not

inhibit CYP3A4.

Adapted from Michalets 1998, from Pharmacotherapy with permission; with additional

information from Gourevitch and Friedland 2000 and McCance-Katz et al. 2000.
41

low doses, increase slowly, and monitor closely.

In many cases, medication dosages lower than

those recommended by the manufacturer may

be sufficient for the desired therapeutic effect

(Cohen 1999). This is especially prudent for

patients receiving agonist medications who have

a positive diagnosis for cardiac risk factors.

Educating patients about the risks of drug

interaction is essential. The following information should be emphasized:

ï During any agonist-based pharmacotherapy,

abusing drugs or medications that are respiratory depressants (e.g., alcohol, other opioid

agonists, benzodiazepines) may be fatal.

ï Current or potential cardiovascular risk 

factors may be aggravated by opioid agonist

pharmacotherapy, but certain treatment

strategies reduce cardiovascular risk (and

should be included as needed in patientsí

treatment plans).

ï Other drugsóillicit, prescribed, or over 

the counteróhave potential to interact with

opioid agonist medications (specific, relevant

information should be provided).

ï Patients should know the symptoms of

arrhythmia, such as palpitations, dizziness,

lightheadedness, syncope, or seizures, and

should seek immediate medical attention

when they occur.

ï Maintaining and not exceeding dosage 

schedules, amounts, and other medication

regimens are important to avoid adverse drug

interactions.

Researchers (e.g., Cohen 1999; Levy et al.

2000; Piscitelli and Rodvold 2001) have provided other suggestions for treatment providers to

minimize harmful drug interactions in MAT:

ï When possible, substitute alternative 

medications that do not interact with opioid

treatment medications (e.g., azithromycin for

erythromycin [because the latter is a strong

CYP3A4 inhibitor] or divalproex for carbamazepine [because the latter is a potent

CYP3A4 inducer]).

ï When other medications must be coadministered with opioid treatment medications,

select those that have the least potential for

interaction.

ï Consider whether significant adverse drug

interactions might be ameliorated by administering a medication with or without food or

by altering dosing schedules.

ï Be aware that, the more complicated the

medication regimen, the less likely patients

will adhere to it, necessitating increased 

vigilance on the part of treatment providers

as the complexity of medication treatment

increases.

ï When potentially interactive medications are

coadministered, adjust the agonist or partial

agonist dosage based on patient response,

rather than prophylactically basing the

dosage on expected interaction, because

degrees of interaction vary dramatically; 

prejudging the amount of a necessary dosage

adjustment is unlikely to work.

ï When opioid medication dosage must be

adjusted to compensate for the effects of

interacting drugs, observe patients for 

signs or symptoms of opioid withdrawal or

sedation to determine whether they are

undermedicated or overmedicated.

ï When a potentially interactive drug combination must be used and concerns exist about

adverse effects if opioid medication is

increased, for example, in patients with 

preexisting cardiovascular conditions, closely

monitor drug serum concentrations or

increase testing frequency. Advise patients of

the physical signs or symptoms of adverse

interactions, and tell them what to do if these

indicators occur.

ï Be aware of concomitant preexisting diseases

(e.g., diseases that decrease renal or hepatic

function) and preexisting cardiovascular 

conditions that might influence the potential

for adverse drug interactions.

Knowledge about medication interactions 

with methadone and other medications used in

the treatment of opioid addiction is changing

Pharmacology of Medications Used To Treat Opioid Addiction
42

constantly. The reader is advised to check for

the most current information on a regular

basis. A useful Web site is

medicine.iupui.edu/flockhart.

Safety

Methadone and LAAM

The safety profiles of methadone and LAAM

are excellent when these drugs are taken as

directed by the manufacturer and, for LAAM,

when patients are screened carefully for any

cardiac risk factors. However, because both

methadone and LAAM are full mu opioid agonists, overdose and death can occur if they are

taken in larger amounts than directed and in

amounts exceeding patientsí tolerance levels.

Unintended, possibly lethal respiratory depressant effects also can occur if these medications

are used in combination with substances that

depress the central nervous system, such as

alcohol and benzodiazepines.

Buprenorphine

Like methadone, buprenorphine generally is

safe and well tolerated when used as recommended by the manufacturer, and buprenorphineís partial agonist characteristics reduce the

risk of respiratory depression from overdose.

Buprenorphine overdose deaths reported in

France generally have been attributed to the

concurrent parenteral abuse of buprenorphine

and benzodiazepines (Kintz 2001; Reynaud et

al. 1998; Tracqui et al. 1998a, 1998b). Only

two overdose deaths have been attributed to

buprenorphine alone (Kintz 2002). The potential for injection abuse with buprenorphine is

believed lower than with full agonists because,

as a partial agonist, buprenorphine can precipitate withdrawal in individuals who are opioid

addicted. Moreover, use of combination

buprenorphine-naloxone tablets in the United

States should mitigate further the risk of abuse.

As with any agonist-based pharmacotherapy,

however, it is extremely important to educate

patients about the potential lethality of abusing

treatment medication alone or in combination

with respiratory depressants, especially 

benzodiazepines.

Naltrexone

Naltrexone generally is safe when used

according to the manufacturerís directions.

Hall and Wodak (1999) cautioned that overdose rates for patients on naltrexone who

relapse to heroin use might be higher than

among patients receiving other treatments 

for opioid addiction. Further investigation 

is needed to validate this concern.

Chapter 3
43

4 Initial Screening,

Admission Procedures,

and Assessment

Techniques

In This

ChapterÖ

Initial Screening

Admission

Procedures and

Initial Evaluation

Medical Assessment

Induction

Assessment

Comprehensive

Assessment

Initial screening or intake procedures determine an applicantís eligibility

and readiness for medication-assisted treatment for opioid addiction

(MAT) and admission to an opioid treatment program (OTP). Ongoing

assessment should begin as soon as a patient is admitted to an OTP. It

provides a basis for individualized treatment planning and increases the

likelihood of positive outcomes.

No single tool incorporates all the important elements for assessing

patients in MAT. The Addiction Severity Index (ASI) (McLellan et al.

1992), although not comprehensive, can guide collection of the basic

information needed to measure patient conditions and progress objectively. Recent research (e.g., Bovasso et al. 2001) continues to support

the validity of ASI composite scores. The consensus panel recommends

that OTPs develop tools and methods for more extensive assessment.

This chapter describes screening and assessment procedures and 

important considerations that might be made during and shortly after

admission to an OTP, as well as assessment techniques and considerations that are important to ongoing MAT.

Initial Screening

First Contact

The screening process begins when an applicant or family member first

contacts an OTP, often via telephone or a visit to the OTP. This contact

is the first opportunity for treatment providers to establish an effective

therapeutic alliance among staff members, patients, and patientsí families. Careful planning for and interaction with new applicants and their

families contribute to positive MAT outcomes. Staff members should be

prepared to provide immediate, practical information that helps potential applicants make decisions about MAT, including the approximate

length of time from first contact to admission, what to expect during the

admission process, and types of services offered. A brief exploration of
44

applicantsí expectations and circumstances can

reveal other information they need for considering MAT.

Goals of Initial Screening

The consensus panel recommends the following

goals for initial screening:

ï Crisis intervention. Identification of and

immediate assistance with crisis and emergency situations (see ìScreening of Emergencies

and Need for Emergency Careî below)

ï Eligibility verification. Assurance that an

applicant satisfies Federal and State regulations and program criteria for admission to

an OTP

ï Clarification of the treatment alliance.

Explanation of patient and program 

responsibilities

ï Education. Communication of essential 

information about MAT and OTP operations

(e.g., dosing schedules, OTP hours, treatment requirements, addiction as a brain 

disease) and discussion of the benefits and

drawbacks of MAT to help applicants make

informed decisions about treatment

ï Identification of treatment barriers.

Determination of factors that might hinder

an applicantís ability to meet treatment

requirements, for example, lack of childcare

or transportation.

Along with these primary goals, initial screening can begin to identify other medical and 

psychosocial risk factors that could affect 

treatment, including factors related to mental

disorders; legal difficulties; other substance

use; and vocational, financial, transportation,

and family concerns. Cultural, ethnic, and

spiritual factors that affect communication and

might affect treatment planning should be

noted as early as possible. Staff members

should obtain enough information from applicants to accommodate needs arising from any

of these factors if necessary.

Screening of Emergencies and

Need for Emergency Care

The consensus panel recommends that

providers develop medically, legally, and 

ethically sound policies to address patient

emergencies. Emergencies can occur at any

time but are most common during induction 

to MAT and the acute treatment phase (see

chapter 7). In particular, patients who exhibit

symptoms that could jeopardize their or othersí

safety should be referred immediately for inpatient medical or psychiatric care. If possible,

staff members who conduct initial screening

and assessment should make appropriate referrals before applicants are admitted to an OTP.

Identifying and assessing emergencies may

require staff familiarity with the components of

a mental health status examination (see

ìPsychosocial Assessmentî below).

Suicidality

In a study of population data from the U.S.

National Comorbidity Survey, a significant

association was found between opioid addiction

and increased risk of suicide (Borges et al.

2000). Initial screening and periodic assessments should help determine whether those

indicating risks of suicide need additional 

services (e.g., hospitalization for protection or

treatment, outpatient mental treatment, or

evaluation for antidepressant medication).

Exhibit 4-1 lists some indicators of suicidality.

Exhibit 4-2 lists recommended responses.

Homicidality and threats of

violence

Threats should be taken seriously. For example, if an individual with knowledge of OTP

procedures and schedules makes a threat, patterns of interaction between staff and this individual should be shifted. It might be necessary

to change or stagger departure times, implement a buddy system, or use an escort service

(National Institute for Occupational Safety and

Health 1996). Counseling assignments can be

changed, or patients can be transferred to

another OTP.

Chapter 4
Initial Screening, Admission Procedures, and Assessment Techniques 45

Exhibit 4-1

Suicide Risk Factors

Behavioral and Circumstantial Indicators of Suicide Risk

ï Talk about committing suicide 

ï Trouble eating or sleeping 

ï Drastic changes in behavior 

ï Withdrawal from friends or social activities 

ï Loss of interest in hobbies, work, or school 

ï Preparations for death, such as making a

will or final arrangements

ï Giving away prized possessions 

ï History of suicide attempts 

ï Unnecessary risk taking 

ï Recent severe losses 

ï Preoccupation with death and dying 

ï Loss of interest in personal appearance 

ï Increased use of alcohol or drugs

Expressed Emotions That May Indicate Suicide Risk

ï Canít stop the pain 

ï Canít think clearly 

ï Canít make decisions 

ï Canít see any way out 

ï Canít sleep, eat, or work 

ï Canít get out of depression 

ï Canít make the sadness go away 

ï Canít see a future without pain 

ï Canít see oneself as worthwhile 

ï Canít get someoneís attention 

ï Canít seem to get control

Exhibit 4-2 

Recommended Responses to Indicators of Suicidality

ï Be direct. Talk openly and matter-of-factly about suicide. 

ï Be willing to listen. Allow expressions of feelings. Accept the feelings. 

ï Be nonjudgmental. Donít debate whether suicide is right or wrong or feelings are good or

bad. Donít lecture on the value of life. 

ï Get involved. Become available. Show interest and support. 

ï Donít dare an individual to do it.

ï Donít act shocked. This puts distance between the practitioner and the individual. 

ï Donít be sworn to secrecy. Seek support. 

ï Offer hope but not glib reassurances that alternatives are available. 

ï Take action. Remove means, such as guns or stockpiled pills.

ï Get help from persons or agencies specializing in crisis intervention and suicide prevention.

Source: Adapted from American Association of Suicidology n.d.

Source: Adapted from American Association of Suicidology n.d.
46 Chapter 4

The consensus panel recommends that OTP

staff members receive training in recognizing

and responding to the signs of potential patient

violence. OTPs should develop policies and

procedures for homicide and other violent 

situations. The OTPís policy on violence and

threats of violence should be explained at the

beginning of treatment. Emergency screening

and assessment procedures should include 

the following:

ï Asking the patient questions specific to 

homicidal ideation, including thoughts, 

plans, gestures, or attempts in the past year;

weapons charges; and previous arrests,

restraining orders, or other legal procedures

related to real or potential violence at home

or the workplace.

ï Documenting violent incidents and diligent

monitoring of these records to assess the

nature and magnitude of workplace violence

and to quantify risk. When a threat appears

imminent, all legal, human resource, employee assistance, community mental health, and

law enforcement resources should be readied

to respond immediately (National Institute

for Occupational Safety and Health 1996).

Admission Procedures

and Initial Evaluation

After initial applicant screening, the admission

process should be thorough and facilitate timely

enrollment in the OTP. This process usually

marks patientsí first substantial exposure to the

treatment system, including its personnel, other

patients, available services, rules, and requirements. The admission process should be

designed to engage new patients positively while

screening for and assessing problems and needs

that might affect MAT interventions. 

Timely Admission, Waiting

Lists, and Referrals

The longer the delays between first contact, 

initial screening, and admission and the more

appointments required to complete these procedures, the fewer the applicants who actually

enter treatment. Prompt, efficient orientation

and evaluation contribute to the therapeutic

nature of the admission process.

If a program is at capacity, admitting staff

should advise applicants immediately of a 

waiting list and provide one or more referrals

to programs that can meet their treatment

needs more quickly. A centralized intake process across programs can facilitate the admission process, particularly when applicants must

be referred. For example, if an applicant

accepts referral to another provider, telephone

contact by the originating program often can

facilitate the applicantís acceptance into the

referral program. If an applicant goes willingly

to another program for immediate treatment

but prefers admission to the original OTP, the

admission process should be completed and the

applicantís name added to the waiting list.

Patients who prefer to await treatment at the

original site should be added to the waiting list

and contacted periodically to determine

whether they want to continue waiting or be

referred. For individuals who are ineligible,

staff should assess the need for other acute services and promptly make appropriate referrals.

The consensus panel recommends that each

OTP establish criteria to decide which prequalified patients should receive admission priority,

especially when a program is near capacity. For

example, some programs offer high-priority

admission to pregnant women, addicted spouses

of current patients, applicants with HIV infection or other serious medical conditions, or 

former patients who have tapered off maintenance medication but subsequently require

renewed treatment.

Interim Maintenance

Treatment

For eligible individuals who cannot be 

admitted to a public or nonprofit program for

comprehensive maintenance services within a

reasonable geographic area and within 14 days

of applying, 42 Code of Federal Regulations

(CFR), Part 8 ß 12(j), provides for ìinterim

maintenance treatment,î in which medication 
Initial Screening, Admission Procedures, and Assessment Techniques 47

is administered to patients at an OTP for up to

120 days without formal screening or admission

and with only minimal drug testing, assuming

the existence of reasonable criteria at the OTP

to prioritize admissions.

Denial of Admission

Denial of admission to an OTP should be 

based on sound clinical practices and the best

interests of both the applicant and the OTP.

Admission denial should be considered, for

example, if an applicant is threatening or violent. Continuity of care should be considered,

and referral to more suitable programs should

be the rule. Due process and attention to 

applicant rights (see CSAT 2004b) minimize 

the possibility that decisions to deny admission

to an OTP are abusive or arbitrary.

Admission Team

OTPs should have qualified, compassionate,

well-trained multidisciplinary teams (see 

chapter 6) that efficiently collect applicantsí

information and histories, evaluate their needs

as patients, and orient them to MAT. Team

members should be cross-trained in treating

addiction and co-occurring disorders. Those

conducting admission interviews should be 

culturally competent, and their interactions

with applicants should not be stigmatizing.

They also should be able to communicate 

OTP policies and services and make 

appropriate referrals.

Information Collection and

Dissemination

Collection of patient information and dissemination of program information occur by various methods, such as by telephone; through a

receptionist; and through handbooks, information packets, and questionnaires. Medical

assessments (e.g., physical examinations, blood

work) and psychosocial assessments also are

necessary to gather specific types of information. Although collection procedures differ

among OTPs, the consensus panel recommends

that the following types of information be 

collected, documented, or communicated to

patients:

ï Treatment history. An OTP should obtain 

a new patientís substance abuse treatment

history, preferably

from previous treatment providers,

including information such as use of

other substances

while in treatment,

dates and durations

of treatment, patterns of success or

failure, and reasons

for discharge or

dropout. Written

consent from a

patient is required to

obtain information

from other programs

(see CSAT 2004b).

(See below for

details on other components to include in

this history.)

ï Orientation to MAT.

All patients should receive an orientation to

MAT, generally extending over several sessions and including an explanation of treatment methods, options, and requirements

and the roles and responsibilities of those

involved. Each new patient also should

receive a handbook (or other appropriate

materials), written at an understandable level

in the patientís first language if possible, that

includes all relevant program-specific information needed to comply with treatment

requirements. Patient orientation should be

documented carefully for medical and legal

reasons. Documentation should show that

patients have been informed of all aspects 

of the multifaceted MAT process and its

information requirements, including (1) 

the consent to treatment (CSAT 2004b), (2)

program recordkeeping and confidentiality

requirements (e.g., who has access to records

and when, who can divulge information 

The admission

process should be

designed to engage

new patients 

positively while

screening for and

assessing problems

and needs...
48 Chapter 4

without patient consent [see CSAT

2004b]), (3) program

rules, including

patient rights,

grievance procedures, and circumstances under which

a patient can be discharged involuntarily, and (4) facility

safety instructions

(e.g., emergency exit

routes). OTPs

should require

patients to sign or

initial a form documenting their participation in the orientation process. Also, patients must receive

and sign a written consent to treatment form

(see Appendix 4-A; see also CSAT 2004b),

which is kept on file by the OTP.

ï Age of applicant. Persons younger than age

18 must meet specific Federal and State

requirements (at this writing, some States

prohibit MAT for this group), and an OTP

must secure parental or other guardian 

consent to start adolescents on MAT (see 

discussion below of exemptions from the

Substance Abuse and Mental Health Services

Administrationís [SAMHSAís] 1-year 

dependence duration rule).

ï Recovery environment. A patientís living 

environment, including the social network,

those living in the residence, and stability of

housing, can support or jeopardize treatment.

ï Suicide and other emergency risks. (See

above.)

ï Substances of abuse. A patientís substance

abuse history should be recorded, focusing

first on opioid use, including severity and age

at onset of physical addiction, as well as use

patterns over the past year, especially the

previous 30 days. A baseline determination of

current addiction should meet, to the extent

possible, accepted medical criteria. Many

people who are opioid addicted use other

drugs and alcohol; this multiple substance use

has definite implications for treatment outcomes (see ìSubstance Use Assessmentî below

and chapter 11). Therefore, screening and

medical assessment also should identify and

document nonopioid substance use and determine whether an alternative intervention

(e.g., inpatient detoxification) is necessary 

or possible before an applicant is admitted to

the OTP.

ï Prescription drug and over-the-counter 

medication use. All prescription drug and

over-the-counter medication use should be

identified. Procedures should be in place to

determine any instances of misuse, overdose,

or addiction, especially for psychiatric or

pain medications. The potential for drug

interactions, particularly with opioid treatment

medications, should be noted (see chapter 3).

ï Method and level of opioid use. The general

frequency, amounts, and routes of opioid use

should be recorded. If opioids are injected,

the risk of communicable diseases (e.g.,

HIV/AIDS, hepatitis C, endocarditis) increases. Patient reporting helps providers

assess patientsí substance addiction and tolerance levels, providing a starting point to

prescribe appropriate treatment medication

for stabilization (American Psychiatric

Association 2000; Mee-Lee et al. 2001a).

ï Pattern of daily preoccupation with opioids.

A patientís daily pattern of opioid abuse

should be determined. Regular and frequent

use to offset withdrawal is a clear indicator of

physiological dependence. In addition, people

who are opioid addicted spend increasing

amounts of time and energy obtaining, using,

and responding to the effects of these drugs.

ï Compulsive behaviors. Patients in MAT

sometimes have other impulse control disorders. A treatment provider should assess

behaviors such as compulsive gambling or

sexual behavior to develop a comprehensive

perspective on each patient.

ï Patient motivation and reasons for seeking

treatment. Prospective patients typically 

present for treatment because they are in

withdrawal and want relief. They often are

[A]ddressing 

concerns about

and stressing the

benefits of MAT

...are essential to

long-term treatment retention...
Initial Screening, Admission Procedures, and Assessment Techniques 49

preoccupied with whether and when they can

receive medication. Because successful MAT

entails not only short-term relief but a

steady, long-term commitment, applicants

should be asked why they are seeking treatment, why they chose MAT, and whether they

fully understand all available treatment

options and the nature of MAT. Negative attitudes toward MAT may reduce patient motivation. However, concerns about motivation

should not delay admission unless applicants

clearly seem ambivalent. In such cases, treatment providers and applicants can discuss

the pros and cons of MAT. The consensus

panel believes that identifying and addressing

concerns about and stressing the benefits of

MAT as early as possible are essential to

long-term treatment retention and maintaining patient motivation for treatment.

ï Patient personal recovery resources. A

patientís comments also can identify his or

her recovery resources. These include comments on satisfaction with marital status and

living arrangements; use of leisure time;

problems with family members, friends, 

significant others, neighbors, and coworkers;

the patientís view of the severity of these

problems; insurance status; and employment,

vocational, and educational status. Identification of patient strengths (e.g., stable

employment, family support, spirituality,

strong motivation for recovery) provides a

basis for a focused, individualized, and 

effective treatment plan (see chapter 6).

ï Scheduling the next appointment. Unless 

the program can provide assessment and

admission on the same day, the next visit

should be scheduled for as soon as possible.

To facilitate an accurate diagnosis of opioid

addiction and prompt administration of the

initial dose of medication when other documentation of a patientís condition is unavailable, the applicant should be instructed to

report to the OTP while in mild to moderate

opioid withdrawal.

Medical Assessment

Medical assessment plays a substantial role in

determining MAT eligibility. Some assessment

tools and methods mentioned briefly in this

chapter are explained further in chapter 10.

The results of medical assessment, including

toxicology tests, other laboratory results, and

psychosocial assessment, usually are reviewed

by a program physician and then submitted to

the medical director in preparation for pharmacotherapy. Programs should minimize delay

in administering the first dose of medication

because, in most cases, applicants will present

in some degree of opioid withdrawal.

Determination of Opioid

Addiction and Verification of

Admission Eligibility

Federal regulations on 

eligibility

Federal regulations state that, in general, 

opioid pharmacotherapy is appropriate for

persons who currently are addicted to an opioid drug and became addicted at least 1 year

before admission (42 CFR, Part 8 ß 12(e)).

Documentation of past addiction might include

treatment records or a primary care physicianís report. When an applicantís status is

uncertain, admission decisions should be based

on drug test results and patient consultations.

Exemptions from SAMHSAís

1-year dependence duration

rule

If appropriate, a program physician can invoke

an exception to the 1-year addiction history

requirement for patients released from correctional facilities (within 6 months after release),

pregnant patients (program physician must 

certify pregnancy), and previously treated

patients (up to 2 years after discharge) (42

CFR, Part 8 ß 12(e)(3)).
50 Chapter 4

A person younger than 18 must have undergone at least two documented attempts at

detoxification or outpatient psychosocial 

treatment within 12 months to be eligible for

maintenance treatment. A parent, a legal

guardian, or an adult designated by a relevant

State authority must consent in writing for an

adolescent to participate in MAT (42 CFR,

Part 8 ß 12(e)(2)). Patients younger than 18

should receive age-appropriate treatments, 

ideally with a separate treatment track (e.g.,

young adult groups). 

Cases of uncertainty

When absence of a treatment history or withdrawal symptoms creates uncertainty about an

applicantís eligibility, OTP staff should ask the

applicant for other means of verification, such

as criminal records involving use or possession

of opioids or knowledge of such use by a probation or parole officer. A notarized statement

from a family or clergy member who can attest

to an individualís opioid abuse might be feasible. 

The consensus panel does not recommend use

of a naloxone (NarcanÆ) challenge test (see

chapter 5) in cases of uncertainty. Physical

dependence on opioids can be demonstrated by

less drastic measures. For example, a patient

can be observed for the effects of withdrawal

after he or she has not used a short-acting 

opioid for 6 to 8 hours. Administering a low

dose of methadone and then observing the

patient also is appropriate. Administering

naloxone, although effective, can initiate severe

withdrawal, which the consensus panel believes

is unnecessary. It also requires invasive injection, and the effects can disrupt or jeopardize

prospects for a sound therapeutic relationship

with the patient. The panel recommends that

naloxone be reserved to treat opioid overdose

emergencies.

History and Extent of

Nonopioid Substance Use and

Treatment

The extent and level of alcohol and nonopioid

drug use and treatment also should be determined, and decisions should be made about

whether these disorders can be managed safely

during MAT (see ìSubstance Use Assessmentî

below and chapter 11). 

Medical History

A complete medical history should include

organ system diagnoses and treatments and

family and psychosocial histories. It should

cover chronic or acute medical conditions such

as diabetes, liver or renal diseases, sickle cell

trait or anemia, and chronic pulmonary 

disease. Documentation of infectious diseases,

including hepatitis, HIV/AIDS, tuberculosis

(TB), and sexually transmitted diseases

(STDs), is especially important. Staff should

note patientsí susceptibility to vaccinepreventable illnesses and any allergies and

treatments or medications received for other

medical conditions. Womenís medical histories

also should document previous pregnancies;

types of delivery; complications; current pregnancy status and involvement with prenatal

care; alcohol and drug use, including over-thecounter medications, caffeine, and nicotine,

before and during any pregnancies; and 

incidences of sudden infant death syndrome.

Complete Physical

Examination

Each patient must undergo a complete, fully

documented physical examination by the program physician, a primary care physician, or

an authorized health care professional under

the direct supervision of the program physician, before admission to the OTP. The full

medical examination, including the results of

the serology and other tests, must be documented in the patientís record within 14 days

following admission. States may have additional requirements, and OTPs must comply with
these requirements. The examination should

cover major organ systems and the patientís

overall health status and should document indications of infectious diseases; pulmonary, liver,

and cardiac abnormalities; dermatologic sequelae of addiction; vital signs; general appearance

of head, eyes, ears, nose, throat, chest,

abdomen, extremities, and skin; and physical

evidence of injection drug use and dependence,

as well as the physicianís clinical judgment of

the extent of physical dependence. Women

should receive a pregnancy test and a gynecological examination at the OTP site or by 

referral to a womenís health center. Again, the

results of all tests, laboratory work, and other

processes related to the initial medical examination are to be contained in the patientís file

within 14 days following admission.

Laboratory Tests

Although Federal regulations no longer require

OTPs to conduct a full panel of laboratory

tests, some States do. The consensus panel recommends that laboratory tests include routine

tests for syphilis, hepatitis, TB, and recent

drug use. SAMHSA regulations stipulate ìat

least eight random drug abuse testsî annually

per patient, performed according to accepted

OTP practice (CFR 42, Part 8 ß 12(f)(6)).

Given that some drugs are metabolized extensively and excreted quickly, it is important that

analytic procedures provide the highest sensitivity for substances of interest, such as breath

testing for alcohol use.

TB testing

The risk of TB infection and disease is high

among individuals involved with drugs (Batki

et al. 2002). Rates of active TB among people

who use substances and are HIV infected are

high (Gourevitch et al. 1999), and cases of 

multidrug-resistant TB in this group are

increasing. All patients should undergo screening and medical examination for TB every 12

months. Anergy panel tests should be administered to anergic patients (those with diminished

reactivity to certain antigens). Patients who are

immune system compromised might have a 

negative purified protein derivative test, even

with active infection. A chest x ray or sputum

analysis should be done if there is doubt. If a

patient has a positive TB test, medical staff

should treat the patient accordingly (see chapter 10) or refer him or her to a primary care

clinic for treatment.

Hepatitis testing

People who inject drugs are at high risk for

hepatitis virus infection (see chapter 10) and

should be tested at

admission to an OTP.

Hepatitis A is an

important liver 

infection that affects

people who abuse

drugs at higher rates

than people who do

not. Most patients in

OTPs are seropositive

for surface antigen or

antibody to hepatitis

B virus (HBV) core

antigen, and some

exhibit signs of 

chronic hepatitis. Any

patients whose tests

are negative for hepatitis A virus or HBV

infection should be vaccinated for these 

infections at the OTP or by referral.

Hepatitis C virus (HCV) accounts for most new

hepatitis cases among people who inject drugs,

infects between 70 and 96 percent of this population, and is the countryís leading cause of

chronic liver disease (Sylvestre 2002b). The

consensus panel strongly recommends that

HCV diagnosis and referral be an integral component of initial MAT assessment. Programs

that do not offer onsite HCV antibody testing

should provide appropriate referrals. (A simple

blood test for hepatitis C antibodies is available; a positive result does not necessarily 

signal current infections, only that antibodies

have developed.)

Initial Screening, Admission Procedures, and Assessment Techniques 51

[R]esults of...the

medical examination are to beÖin

the patientís file

within 14 days following admission.
HIV testing

OTPs are required to provide adequate medical services, and the program sponsor must be

able to document

that these services

are fully and reasonably available to

patients. HIV testing

on site or by referral, with pretest and

posttest counseling,

is a recommended

medical service.

OTPs should make

HIV testing part of

their medical services as recommended by the Centers

for Disease Control

and Prevention

(2001a). Medical

care and other supportive services can

be offered if patientsí HIV and HCV statuses

are known early in treatment and monitored

continuously.

Rapid HIV tests have been approved by the

U.S. Food and Drug Administration (FDA) and

are recommended by the U.S. Public Health

Service to facilitate early diagnosis of HIV

infection among at-risk populations involved in

substance abuse (Centers for Disease Control

and Prevention 2002a). Rapid tests can detect

antibodies to HIV in blood obtained by 

fingerstick or venipuncture, or in oral fluid and

provide reliable and valid results in 20 minutes

or less. Thus, the rapid HIV test provides a

measure of exposure to HIV and requires confirmatory testing for a diagnosis of HIV infection. In studies by the manufacturer, the blood

antibody test correctly identified 99.6 percent

of people infected with HIV and 100 percent of

those not infected, which is comparable to the

results of FDA-approved enzyme immunoassays.

FDA expects clinical laboratories to obtain similar results (Centers for Disease Control and

Prevention 2003b). OTPs performing rapid

HIV tests should comply with the guidelines

provided in SAMHSAís Rapid HIV Testing

Initiative (www. samhsa.gov/HIVHep/

rhti_factsheet.aspx). As a preliminary positive

test, positive results should be confirmed by supplemental HIV testing. In addition, some States

have other requirements for laboratory testing

in general and HIV testing specifically.

STD testing

Early testing for STDs in patients receiving

MAT usually is a State health requirement.

Persons who inject drugs are at higher risk of

STDs, primarily from increased likelihood of

involvement in sex trading to finance drug use

and the disinhibiting effects of psychoactive

substances (Sullivan and Fiellin 2004).

Therefore, all patients in MAT should receive

serologic screening for syphilis and, for women

and symptomatic men, genital cultures for 

gonorrhea and chlamydia (Sullivan and Fiellin

2004). In the early stages of admission and

treatment, patients should be educated about

the effects of STDs and their correlation with

other communicable diseases, such as HIV/AIDS

and hepatitis C, to increase patientsí knowledge

of the ways they can avoid these risks. 

For many patients who are opioid addicted,

sexual activities are intertwined with drug use

behaviors (Calsyn et al. 2000b). Documenting

the sexual histories of heterosexual and lesbian,

gay, and bisexual (LGB) patients, in terms of

timing of sexual encounters and partners, is

essential to determine their potential exposure

to HCV, HIV, and other STDs, as well as the

risk of infection for other sexual partners.

Several studies have pointed to increased highrisk sexual behavior among populations that

are substance addicted, homeless, and mentally

ill, in addition to higher levels of psychological

distress and psychiatric symptoms (McKinnon

et al. 2002; Stoskopf et al. 2001).

Additional drug testing

After initial drug testing, subsequent assessment

should include further review of urine, blood,

oral fluid, or other drug test results. Ideally,

drug tests should be conducted regularly and

52 Chapter 4

Clinical examination and an 

applicantís medical history are

keys to determine

the appropriateness of MAT.
randomly during treatment. The first test is

especially important because it is part of the

initial evaluation and may serve as documentation of current opioid use. As noted in Federal

regulations, the presence of opioids in test

results does not establish a diagnosis of opioid

addiction, and the absence of opioids does not

rule it out. Clinical examination and an applicantís medical history are keys to determine the

appropriateness of MAT. Chapter 9 discusses

drug-testing procedures and Federal regulations

governing these procedures.

Womenís Health

Women in MAT should receive information on

their particular health needs, for example,

family planning, gynecological health, and

menopause (see the forthcoming TIP Substance

Abuse Treatment: Addressing the Specific

Needs of Women [CSAT forthcoming f]).

Women of childbearing age should be counseled

on pregnancy testing during admission before

making decisions about detoxification (42 CFR,

Part 8 ß 12(e)(3)). Pregnancy testing, along

with onsite access to or referral for family 

planning services, should be available in all

OTPs as part of an overall womenís health 

initiative (see chapter 13). 

Induction Assessment

Induction is the riskiest stage of MAT (see

chapter 5), and proper medical assessment during induction requires an understanding of the

pharmacology of treatment medication (see

chapter 3). A patient should be assessed at least

daily during induction for signs of overmedication or undermedication, and dose adjustments

should be made accordingly.

Comprehensive

Assessment

Completion of induction marks the beginning 

of stabilization and maintenance treatment 

and ongoing, comprehensive medical and 

psychosocial assessment conducted over 

multiple sessions. This assessment should

include, but not be limited to, patient 

recollections of and attitudes about previous

substance abuse treatment; expectations and

motivation for treatment; level of support for

a substance-free lifestyle; history of physical

or sexual abuse; military or combat history;

traumatic life events; and the cultural, religious, and spiritual basis for any values and

assumptions that might affect treatment. This

information should be included in an integrated

summary in which data are interpreted,

patientsí strengths and problems are noted,

and a treatment plan is developed (see chapter

6) that matches each patient to appropriate 

services.

Data should be collected in a respectful way,

taking into consideration a patientís current

level of functioning. Motivational interviewing

techniques (Miller and Rollnick 2002) can help

engage applicants early. The information collected depends on program policies, procedures, and treatment criteria; State and

Federal regulations; and the patientís stability

and ability to participate in the process. The

psychosocial history can reveal addictionrelated problems in areas that might be overlooked, such as strengths, abilities, aptitudes,

and preferences. Most information can be analyzed by using standardized comprehensive

assessment instruments tailored to specific populations or programs, such as those described

by Dodgen and Shea (2000).

SAMHSA regulations require that patients

ìaccepted for treatment at an OTP shall be

assessed initially and periodically by qualified

personnel to determine the most appropriate

combination of services and treatmentî (42

CFR, Part 8 ß 12(f)(4) [Federal Register

66(11):1097]). Treatment plans should be

reviewed and updated, initially every 90 days

and, after 1 year, biannually or whenever

changes affect a patientís treatment outcomes.

Ongoing monitoring should ensure that services

are received, interventions work, new problems

are identified and documented, and services

are adjusted as problems are solved. Patientsí

views of their progress, as well as the treatment

teamís assessment of patientsí responses to

Initial Screening, Admission Procedures, and Assessment Techniques 53
treatment, should be documented in the 

treatment plan.

Patient Motivation and

Readiness for Change

Patient motivation to engage in MAT is a predictor of early retention (Joe et al. 1998) and is

associated with increased participation, positive

treatment outcomes, improved social adjustment, and successful treatment referrals (CSAT

1999a).

Starting with initial contact and continuing

throughout treatment, assessment should focus

on patient motivation for change (CSAT

1999a). OTP staff members help patients move

beyond past experiences (e.g., negative relationships with staff, inadequate dosing) by focusing

on making a fresh start, letting go of old

grievances, and identifying current realities,

ambivalence about change, and goals for the

future. It often is helpful to enlist recovering

patients in motivational enhancement 

activities. TIP 35, Enhancing Motivation for

Change in Substance Abuse Treatment (CSAT

1999a), provides extensive information about

stages of change, the nature of motivation, 

and current guidelines for enhancing patient

motivation to change.

Substance Use Assessment

As discussed previously, a patientís lifetime

substance use and treatment history should be

documented thoroughly. The following areas

should be assessed:

ï Periods of abstinence (e.g., number, duration,

circumstances)

ï Circumstances or events leading to relapse

ï Effects of substance use on physical, 

psychological, and emotional functioning

ï Changing patterns of substance use, withdrawal signs and symptoms, and medical

sequelae.

Reports of psychiatric symptoms during abstinence help treatment providers differentiate

drug withdrawal from mental disorder 

symptoms and can reveal important clues 

to effective case management, for example, 

the need to refer patients for treatment of 

co-occurring disorders.

Chapter 11 discusses treatment methods and

considerations for patients with histories of

multiple substance abuse. Most of these

patients fall into one of three groups, which

should be determined during assessment: those

who use multiple substances (1) to experience

their psychoactive effects, (2) to self-medicate

for clinically evident reasons (e.g., back pain,

insomnia, headache, co-occurring disorders),

or (3) to compensate for inadequate treatment

medication (Leavitt et al. 2000). Multiple substance use should be identified and addressed

as soon as possible because of the risk of possible overdose for patients who continue to abuse

drugs or alcohol during treatment. Continued

substance abuse while in MAT might indicate

that another treatment option is more appropriate. A challenge in treating patients who

abuse substances for clinically evident reasons

is to determine whether the patients are

attempting to medicate undiagnosed, misdiagnosed, or undertreated problems. If so, then

effectively addressing these related problems

may reduce or eliminate continuing drug or

alcohol abuse and improve outcomes.

Cultural Assessment

A comprehensive assessment should include

patientsí values and assumptions; linguistic

preferences; attitudes, practices, and beliefs

about health and well-being; spirituality and

religion; and communication patterns that

might originate partly from cultural traditions

and heritage (Office of Minority Health 2001).

Staff knowledge about diverse groups is 

important for effective treatment services. Of

particular importance are experiences and 

coping mechanisms related to assimilation and

acculturation of groups into mainstream

American culture that may affect how they 

perceive substance abuse and MAT. Gathering

pertinent information often must rely on 

subjective sources (e.g., interviews and 

54 Chapter 4
questionnaires). Even so, staff members

involved in screening and assessment should 

be cautioned against making value judgments

about cultural or ethnic preferences or

assumptions about ìaverageî middle-class

American values and beliefs. (See the forthcoming TIP Improving Cultural Competence 

in Substance Abuse Treatment [CSAT 

forthcoming b].)

A shared staffñpatient cultural identity is

attractive to some patients entering treatment.

To the extent possible, patient preferences for

staff members who share their cultural identity

should be honored. Multilingual educational

materials and displays of culturally diverse

materials in the OTP help patients feel more at

ease when English is not their primary language.

Psychosocial Assessment

The components and objectives of psychosocial

assessment also are applicable to patients in

MAT. A psychosocial assessment typically identifies the relevant dynamics of patientsí lives

and functioning both before the onset of illness

(e.g., depression, anxiety) and currently. It

identifies patientsí specific strengths and

resources (e.g., employment, supportive family

relationships) as a basis for focused, individualized, effective treatment planning. 

History of co-occurring 

disorders and current mental

status

Mental status assessments identify the threshold

signs of co-occurring disorders and require

familiarity with the components of a mental

status examination (i.e., general appearance,

behavior, and speech; stream of thought,

thought content, and mental capacity; mood

and affect; and judgment and insight) as outlined in Diagnostic and Statistical Manual of

Mental Disorders, Fourth Edition, Text

Revision (American Psychiatric Association

2000). A mental status assessment also should

look for perceptual disturbances and cognitive

dysfunction.

Qualified professionals should train all staff

members involved in screening and assessment

to recognize signs and symptoms of change in

patientsí mental status. This training

should be ongoing.

After reviewing their

observations with the

program physician,

staff members should

refer all patients still

suspected of 

having co-occurring

disorders for psychiatric evaluation. This

evaluation should

identify the types of

co-occurring disorders and determine

how they affect

patientsí comprehension, cognition, and

psychomotor functioning. Persistent

neuropsychological

problems warrant formal testing to diagnose their type and severity and to guide treatment. Consultations by psychologists or physicians should be requested or referrals made for

testing. (See chapter 12 for typical methods of

psychiatric screening and diagnosis in an OTP.)

Sociodemographic history

Sociodemographic data about an applicant

should include employment, educational, legal,

military, family, psychiatric, and medical histories, as well as current information, and should

be supplemented by documents for identification, such as a driverís license, birth or baptismal certificate, passport, Social Security

card, Medicaid card, public assistance card, or

identification card from another substance

abuse treatment program.

Initial Screening, Admission Procedures, and Assessment Techniques 55

A psychosocial

assessmentÖ

identifies the 

relevant dynamics

of patientsí lives

and functioning

both before the

onset of illness and 

currently.
Family and cultural background, relationships, and

supports

The effect of substance use on a patientís 

family cannot be overestimated, and family

problems should be expected for most patients

entering treatment. The comprehensive assessment should include questions about family

relationships and problems, including any 

history of domestic violence, sexual abuse, and

mental disorders (see below). When possible,

the assessment should include input from relatives and significant others. Because families

with members who abuse substances have

problems directly linked to this substance

abuse, at least one staff member should be

trained in family therapy or in making appropriate referrals for this intervention. 

During assessment, program staff should be

sensitive to various family types represented in

the patient population. For example, programs

treating significant numbers of single parents

should consider onsite childcare programs.

Structured childcare services also enable OTP

staff to observe and assess a patientís family

functioning, which can be valuable in treatment planning.

Any counselor or treatment provider who

might confront emergencies related to child or

spousal abuse should be trained in how to identify and report these problems. TIP 25,

Substance Abuse Treatment and Domestic

Violence (CSAT 1997b), provides screening,

assessment, and response guidance when

domestic violence is suspected. TIP 36,

Substance Abuse Treatment for Persons With

Child Abuse and Neglect Issues (CSAT 2000d),

focuses on screening and assessment when

patients are suspected of being past victims or

perpetrators of child abuse. Staff members

should be trained to listen and prepared to

hear traumatic stories and handle these situations, for example, by monitoring any intense

symptoms and seeking special assistance when

necessary (CSAT 2000d). Staff should be able

to identify individuals who exhibit certain signs

and symptoms associated with abuse (e.g.,

posttraumatic stress disorder [PTSD]) and

provide or coordinate immediate services to

address it (CSAT 1997b, 2000d).

Child abuse. All States require mandatory

reporting of child abuse by helping professionals

including OTP staffóparticularly Statelicensed physicians, therapists, nurses, and

social workers (CSAT 2000d). Most States

require that this reporting be immediate and

offer toll-free numbers. Most also require that

reports include the name and address of a parent or caretaker, the type of abuse or neglect,

and the name of the alleged perpetrator.

Failure to report indications of abuse that

results in injury to a child can lead to criminal

charges, a civil suit, or loss of professional

licensure. Mandated reporters generally are

immune from liability for reports made in good

faith that later are found to be erroneous

(CSAT 2000d).

Staff members who suspect domestic violence

should investigate immediately whether a

patientís children have been harmed. Inquiries

into possible child abuse can occur only after

notice of the limitations of confidentiality in

MAT (42 CFR, Part 8 ß 12(g)) has been given

to the patient, who must acknowledge receipt of

this notice in writing. Patients also must be

informed, during orientation and when otherwise applicable, that substance abuse treatment

providers are required to notify a childrenís

protective services agency if they suspect child

abuse or neglect.

Spousal or partner abuse. Generally, if a

patient believes that she or he is in imminent

danger from a batterer, the treatment provider

should respond to this situation before addressing any others and, if necessary, suspend the

screening or assessment interview to do so.

Exhibit 4-3 summarizes the steps a treatment

provider should follow. He or she should refer

a patient to a shelter, legal services, or a domestic violence program if indicated. Providers

should be familiar with relevant Federal, State,

and local regulations on domestic violence (e.g.,

the 1994 Violence Against Women Act [visit

www.ojp.usdoj.gov/vawo/laws/vawa/vawa.htm])

56 Chapter 4
and the legal resources available (e.g., restraining orders, duty to warn, legal obligation to

report threats and past crimes, confidentiality).

Romans and colleagues (2000) identified the

following methods for exploring potential

domestic violence situations, which can be

incorporated into effective assessment tools:

ï Always interview patients in private about

domestic violence.

ï Begin with direct, broad questions and move

to more specific ones; inquire how disagreements or conflicts are resolved (e.g., ìDo you

want to hit [him or her] to make [him or her]

see sense?î); ask whether patients have trouble with anger or have done anything when

angry that they regret; combine these questions with other types of lifestyle questions.

ï Ask about violence by using concrete examples and specific hypothetical situations

rather than vague, conceptual questions.

ï Display information about domestic violence

in public (e.g., waiting room) and private

(e.g., restroom) locations.

ï Use opportunities during discussions (e.g.,

comments about marital conflict situations or

poor communication with partners) to probe

further.

ï Obtain as complete a description as possible

of the physical, sexual, and psychological 

violence perpetrated by or on a patient

recently; typically, those who commit domestic violence minimize, deny, or otherwise

obscure their acts.

History of physical or sexual

abuse

Some patients enter an OTP with a history of

physical or sexual abuse, which frequently

causes additional psychological distress (Schiff

et al. 2002). Information about these types of

abuse is important in treatment planning but

not always easily accessible using specific

assessment tools, especially early in treatment.

Initial Screening, Admission Procedures, and Assessment Techniques 57

Exhibit 4-3

Recommended Procedures for Identifying and

Addressing Domestic Violence*

ï Look for physical injuries, especially patterns of untreated injuries to the face, neck,

throat, and breasts, which might become apparent during the initial physical examination.

ï Pay attention to other indicators: history of relapse or treatment noncompliance; inconsistent explanations for injuries and evasiveness; complications in pregnancy; possible stressand anxiety-related illnesses and conditions; sad, depressed affect; or talk of suicide.

ï Fulfill legal obligations to report suspected child abuse, neglect, and domestic violence.

ï Never discuss a patient without the patientís permission; understand which types of subpoenas and warrants require that records be turned over to authorities.

ï Convey that there is no justification for battering and that substance abuse is no excuse. 

ï Contact domestic violence experts when battery has been confirmed.

*State laws may include other requirements.
Some patients with abuse histories might deny

their victimization. Many women are less likely

to admit abuse to male counselors. Male staff

should know when to request a staff change for

counseling about physical or sexual abuse.

Patients might not be ready to address the

problem, think it is unrelated to substance

abuse, or be ashamed. Gathering information

from them about abuse, therefore, requires

extreme care and respect during screening and

assessment. Once patients are stabilized and

their practical needs are addressed, counseling

by qualified treatment providers can focus on

this problem.

Peer relations and support

The extent of social deterioration, interpersonal

loss, and isolation that patients have experienced should be documented thoroughly during

screening and assessment. Assessment of a

patientís support systems, including past 

participation in mutual-help groups (e.g.,

Alcoholics Anonymous, Methadone Anonymous

[MA]), is critical to identifying peer support

networks that provide positive relationships

and enhance treatment outcomes. Some 12-

Step groups are ill-informed about MAT and

may be unaware of the treatment goals of MAT

and less than supportive; in these

cases, providers

should help patients

identify other

sources of support

(e.g., MA groups)

and encourage continued development

of some type of peer

support network. In

areas with limited

resources, patients

may be able to overcome initial discriminatory behavior in

existing groups by

increasing their

knowledge of MAT

and their ability to

self-advocate.

Housing status and safety

concerns

Based on year 2000 estimates, approximately

10 percent of patients in MAT are homeless or

living as transients when admitted to treatment

(Joseph et al. 2000). Moreover, those who are

not homeless often live with people who are

addicted or in areas where substance use is

common. In the opinion of the consensus panel,

early intervention to arrange safe, permanent

shelter for these patients should be a high priority, and a patientís shelter needs should be

ascertained quickly during screening and

assessment. OTPs should establish special 

support services to help patients secure 

appropriate living arrangements, such as referral agreements with housing agencies or other

programs to locate housing that addresses the

special needs of homeless patients. 

Criminal history and legal

status

Another purpose of screening and assessment is

to identify legal issues that might interrupt

treatment, such as outstanding criminal

charges or ongoing illegal activity to support

substance use; however, pending or unresolved

charges are not a contraindication for MAT.

Assessment may involve exploring personal 

circumstances such as child custody and related

obligations. In the consensus panelís experience, many patients ignore legal problems 

during periods of substance use, but these

problems pose a serious threat to recovery. In

addition, a patientís arrest record, including

age at first arrest, arrest frequency, nature of

offenses, criminal involvement during childhood, and life involvement with the criminal

justice system, should be clarified.

Insurance status

Patientsí resources to cover treatment costs

should be determined during screening and

assessment. Often they are uninsured or have

not explored their eligibility for payment assistance. The consensus panel believes that OTPs

are responsible for helping patients explore

58 Chapter 4

[A]ssessment and

treatment...

should focus on

stopping the 

substance abuse

that interferes

with patientsí 

well-being.
payment options so that they have access to a

full range of treatment services, including medical care, while ensuring payment to the OTP.

In situations of inadequate funding or patient

ineligibility for funds, another source of payment should be identified. OTP staff can assist

patients in applying for public assistance or

inquiring whether personal insurance will reimburse MAT costs. Counselors can help patients

make decisions about involving their insurance

companies and address fears that employers

will find out about their substance use or that

benefits for health care will be denied.

Employment history

Another important component of psychosocial

assessment is a patientís employment history.

Based on year 2000 estimates, only 20 percent of

patients in MAT were employed when admitted

to an OTP (Joseph et al. 2000). Until they are

stabilized, employed patients often experience

substance-related difficulties at the workplace,

including lack of concentration, tardiness and

absences, inability to get along with coworkers,

on-the-job accidents, and increased claims for

workersí compensation. Early identification of

these difficulties can help staff and patients 

create a more effective treatment plan. 

Patients who are employed often are reluctant

to enter residential treatment or take the time

to become stabilized on medication; however,

most of these patients would take medical or

other leave time if they were hospitalized for

other illnesses, and they should be encouraged

to take their addiction as seriously. A physicianís note recommending time off work for

some period might help, but it should be on letterhead that does not reference drug treatment.

Military or other service 

history

A patientís military or other service history can

highlight valuable areas in treatment planning.

In particular, was military service generally a

positive or negative experience? If the former,

treatment providers can help patients identify

areas of strength or personal achievement,

such as the ability to cope under stress, receipt

of medals for service accomplishments, and

honorable discharge; patients can learn to

build on past strengths in current challenging

situations and to progress in treatment. If the

latter, providers should review patientsí negative military experiences, including loss of

friends and loved ones, onset of substance use,

war-related injuries, chronic pain, PTSD, and

co-occurring disorders (e.g., depression). This

information might indicate patterns of behavior

that continue to affect recovery.

Patientsí military history also might reveal

their eligibility for medical and treatment

resources through U.S. Department of

Veterans Affairs programs and hospitals or

social service agencies.

Spirituality

ìSpiritualityî in this TIP refers to willing

involvement in socially desirable activities or

processes that are beyond the immediate details

of daily life and personal self-interest. Attention

to the ethics of behavior, consideration for the

interests of others, community involvement,

helping others, and participating in organized

religion are expressions of spirituality.

A patientís spirituality can be an important

treatment resource, and persons recovering

from addiction often experience increased

interest in the spiritual aspects of their lives. A

study by Flynn and colleagues (2003) of 432

patients admitted to 18 OTPs found that those

who remained in recovery for 5 years credited

religion or spirituality as one factor in this outcome. Staff should assess patientsí connections

with religious institutions because these institutions often provide a sense of belonging that is

valuable in the rehabilitative process. 

Miller (1998) found a lack of research exploring the association between spirituality and

addiction recovery but concluded that spiritual

engagement or reengagement appeared to be

correlated with recovery. In studies reviewed

by Muffler and colleagues (1992), individuals

with a high degree of spiritual motivation to

Initial Screening, Admission Procedures, and Assessment Techniques 59
recover reported that treatment programs that

included spiritual guidance or counseling were

more likely to produce positive outcomes than

programs that did not. OTPs should assess

spiritual resources adequately. Counselors and

other mental health professionals could benefit

from training in patient spirituality if it is 

difficult for them to explore.

Sexual orientation and 

history

The assessment and treatment needs of heterosexual and LGB populations are similar and

should focus on stopping the substance abuse

that interferes with patientsí well-being.

Assessment of risk factors associated with sexual

encounters and partners is essential. What

often differs for an LGB population is the

importance of assessing patientsí sexual or gender orientation concerns, such as their feelings

about their sexual orientation (CSAT 2001b).

OTP staff should pay strict attention to confidentiality concerns for LGB patients because

they may be at increased risk of legal or other

actions affecting employment, housing, or child

custody. Treatment modalities and programs

should be accessible to all groups, and programs providing ancillary services should be

sensitive to the special needs of all patients

regardless of sexual orientation (CSAT 2001b).

Patientsí ability to manage

money

Financial difficulties are common among

patients in MAT, who often have spent 

considerable money on their substance use that

otherwise would have paid for rent, food, and

utilities. Financial status and money management skills should be assessed to help patients

understand their fiscal strengths and weaknesses as they become stabilized. Patients often

need assistance to adjust to loss of income

caused by reduced criminal activity and develop

skills that enhance their legitimate earning

power. Once financial factors are clarified,

patients may be better prepared to devise 

realistic strategies to achieve short- and longterm goals.

Recreational and leisure

activities

Recreational and leisure activities are important in recovery; therefore, assessment should

determine any positive activities in which

patients have participated before or during

periods of substance use. Identifying existing

recreational and leisure time preferences and

gaining exposure to new ones can be significant

steps in developing a recovery-oriented lifestyle.

60 Chapter 4
Appendix 4-A. Example of Standard Consent to

Opioid Maintenance Treatment

Consent to Participation in Opioid Pharmacotherapy Treatment

Patient’s Name: ________________________________ Date: _________________________

I hereby authorize and give voluntary consent to the Division and its medical personnel to dispense

and administer opioid pharmacotherapy (including methadone or buprenorphine) as part of the

treatment of my addiction to opioid drugs. Treatment procedures have been explained to me, and

I understand that this will involve my taking the prescribed opioid drug at the schedule determined

by the program physician, or his/her designee, in accordance with Federal and State regulations.

It has been explained that, like all other prescription medications, opioid treatment medications

can be harmful if not taken as prescribed. I further understand that opioid treatment medications

produce dependence and, like most other medications, may produce side effects. Possible side

effects, as well as alternative treatments and their risks and benefits, have been explained to me.

I understand that it is important for me to inform any medical provider who may treat me for any

medical problem that I am enrolled in an opioid treatment program so that the provider is aware

of all the medications I am taking, can provide the best possible care, and can avoid prescribing

medications that might affect my opioid pharmacotherapy or my chances of successful recovery

from addiction.

I understand that I may withdraw voluntarily from this treatment program and discontinue the

use of the medications prescribed at any time. Should I choose this option, I understand I will be

offered medically supervised tapering.

For Female Patients of Childbearing Age: There is no evidence that methadone pharmacotherapy is harmful during pregnancy. If I am or become pregnant, I understand that I should 

tell my medical provider right away so that I can receive appropriate care and referrals. I understand that there are ways to maximize the healthy course of my pregnancy while I am in opioid

pharmacotherapy.

_____________________________________ _________________________ ____________

Signature of Patient Date of Birth Date

Witness: _______________________________________________________________________

Adapted with permission from Department of Psychiatry and Behavioral Sciences, Albert Einstein

College of Medicine, Division of Substance Abuse, Bronx, NY.

Initial Screening, Admission Procedures, and Assessment Techniques 61

In This

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63

5 Clinical

Pharmacotherapy

This chapter describes pharmacotherapy in opioid treatment programs

(OTPs), in particular the clinical use of methadone, with limited discussion of levo-alpha acetyl methadol (LAAM) and buprenorphine. More

limited coverage is provided on the opioid antagonist naltrexone, which

is not used widely for opioid addiction treatment in the United States. As

explained in chapter 3, at this writing most OTPs have discontinued the

use of LAAM for new patients, and its continued availability is uncertain. TIP 40, Clinical Guidelines for the Use of Buprenorphine in the

Treatment of Opioid Addiction (CSAT 2004a), provides more detailed

information about buprenorphine.

In general, the choice of medication used in medication-assisted treatment for opioid addiction (MAT) is based on safety and efficacy, patient

preferences, and treatment goals. Methadone maintenance treatment has

the longest successful track record in patients addicted to opioids for

more than a year and has been shown to control withdrawal symptoms,

stabilize physiologic processes, and improve functionality. Studies also

have found that methadone maintenance treatment reduces criminality,

noncompliance with HIV/AIDS therapy, seroconversion to HIV/AIDS,

and mortality associated with opioid addiction (Appel et al. 2001; Ball

and Ross 1991). Since 2001, LAAM, although effective in opioid pharmacotherapy, has carried a restrictive label precluding its use as the initial

medication for MAT. As reviewed in chapter 3, the effectiveness of

buprenorphine has been found to be similar to that of methadone and

LAAM (Johnson et al. 2000). Sublingual buprenorphine formulations

have been approved for use in OTPs and by physicians in office-based

and other health care settings. Some patients prefer buprenorphine

maintenance in an office-based opioid treatment (OBOT) setting to the

daily observed dosing that is part of methadone maintenance in an OTP.

However, patients who progress in MAT while in an OTP eventually may

qualify for take-home medication lasting up to 30 days at a time, as

detailed below, and patients desiring ongoing buprenorphine pharmacotherapy now can receive buprenorphine on a less-than-daily basis in

either an OTP or OBOT setting. For some patients, these options may

reduce the attendance requirements for MAT in an OTP.

In This

Chapter...

Contraindications

to Opioid

Pharmacotherapy

Stages of

Pharmacotherapy

Medically

Supervised

Withdrawal

Take-Home

Medications

Office-Based Opioid

Therapy
For patients who do not qualify for or do not

prefer opioid maintenance treatment (see

ìContraindications to Opioid Pharmacotherapyî

below), a primary issue during treatment is

what to do about withdrawal symptoms.

Naturally occurring opioid withdrawal is almost

never life threatening, but it can produce discomfort severe enough to warrant urgent intervention. Treatment for withdrawal symptoms

usually involves administration of a long-acting

opioid medication such as methadone or

buprenorphine, which can be followed by gradual tapering of the medication as withdrawal

symptoms diminish.

Control of withdrawal symptoms often is insufficient treatment to prevent a relapse to opioid

abuse, and detoxification alone may yield only

short-term benefits. Research has shown that

retention in treatment over an extended period

is key to successful outcomes for opioid addiction in many patients, just as it is for other

chronic diseases like hypertension, diabetes,

and asthma (McLellan et al. 2000). Therefore,

when detoxification from short-acting opioids is

provided, the consensus panel recommends

linkage to ongoing psychosocial treatment, with

or without additional maintenance therapy

with an opioid antagonist such as naltrexone.

Comprehensive, long-term opioid agonist maintenance remains the treatment with the best

track record of controlling opioid use and saving lives, although opioid partial agonist therapy is promising. Access and easy transfer to

this care should remain available as part of any

detoxification program.

Contraindications 

to Opioid

Pharmacotherapy

The consensus panel believes that few psychiatric or medical diagnoses categorically should

rule out admission to an OTP or access to opioid pharmacotherapy. Inclusion rather than

exclusion should be the guiding principle.

Types of people who possibly should not be

admitted to an OTP and should receive other

interventions include

ï Individuals who abuse opioids but whose 

conditions do not meet criteria for opioid

dependence outlined in the Diagnostic and

Statistical Manual of Mental Disorders,

Fourth Edition, Text Revision (DSM-IV-TR)

(American Psychiatric Association 2000). If a

clear history of opioid abuse or addiction

exists but a person currently is not addicted,

regulations allow admission to an OTP in two

cases in which a person might relapse without

treatment: pregnancy and release from incarceration (42 Code of Federal Regulation

[CFR], 8 Part ß 12(e)(3)).

ï Individuals with less than 1 year of opioid

addiction and no addiction treatment history,

except patients receiving OBOT with

buprenorphine. Detoxification might be

attempted with applicants who have a shorter

history of addiction. Applicants receiving

buprenorphine may be admitted to an OTP

for either medically supervised withdrawal or

maintenance treatment.

ï Applicants who cannot attend treatment 

sessions regularly, especially for medication

dosing (unless a clinical exception can be

obtained [see chapter 7]); this requirement is

less of a hindrance for patients receiving

OBOT with buprenorphine.

ï Previous patients who have had allergic reactions to methadone, LAAM, or buprenorphine.

ï For LAAM, applicants with cardiac abnormalities such as prolonged QT interval.

In addition, people who are opioid addicted

and meet DSM-IV-TR criteria for alcohol or

sedative dependence might be problematic candidates for opioid pharmacotherapy because

the combined effects of alcohol or sedatives

that depress the central nervous system (CNS)

can cause serious adverse events during MAT

(see discussion of drug interactions in chapter

3). Some treatment providers require detoxification from alcohol and sedatives before opioid

pharmacotherapy, followed by careful monitoring such as daily BreathalyzerJ tests, ongoing

drug tests, and reduction or withholding of

medication if a test is positive. The consensus

panel endorses this strategy, provided that 

adequate alcohol or sedative detoxification

64 Chapter 5
Clinical Pharmacotherapy 65

facilities are readily available. If not, both opioid addiction and alcohol or sedative dependence should be treated concurrently at the

OTP site with a combination of psychosocial

and pharmacological interventions.

Stages of

Pharmacotherapy

The stages of pharmacotherapy with methadone,

LAAM, or buprenorphine include induction,

stabilization, and maintenance. The stages of

naltrexone pharmacotherapy may differ.

Induction

Induction procedures for methadone, LAAM,

and buprenorphine depend on the unique

pharmacologic properties of each medication,

prevailing regulatory requirements, and patient

characteristics. Regardless of the medication

used, safety is key during the induction stage. 

General considerations

Timing. When to begin the first dose of opioid

treatment medication is important. Most treatment providers begin treating new patients

when there are no signs of opioid intoxication

or sedation and some beginning signs of opioid

withdrawal. Administration of the first dose

also should await a physical assessment to rule

out any acute, life-threatening condition that

opioids might mask or worsen (see chapter 4

for more information on medical assessment).

For naltrexone, patients should be abstinent

from all short-acting opioids for at least 7 days

and from long-acting opioids, such as

methadone, for at least 10 days before beginning the medication to prevent potentially

severe withdrawal symptoms (OíConnor and

Fiellin 2000).

Other substance use. The presence of sedatives

such as benzodiazepines or alcohol should be

ruled out before induction to minimize the 

likelihood of oversedation with the first dose.

OTP staff should ensure that patients known 

to abuse sedatives, tranquilizers, tricyclic

antidepressants, benzodiazepines, alcohol, or

other CNS depressants are told in clear language of the dangers of adverse effects if they

take these substances while being stabilized or

maintained on methadone, LAAM, or

buprenorphine.

Observed dosing. Observed dosing with

methadone, LAAM, or buprenorphine should

be part of the medical safety procedure and

diversion control plan in an OTP and is recommended during induction with buprenorphine.

Observed dosing is the only way to ensure that

a patient ingests a

given dose and to

monitor a patientís

response. In observed

dosing, staff members

who dispense medication first carefully

identify patientsó

sometimes by requiring them to remove

hats or dark glasses,

for exampleóand

then provide the 

medication.

To ensure that patients swallow oral doses of

methadone or LAAM, they should be required

to speak before and after ingesting at least 2

ounces of liquid in which an appropriate dose

of medication is dissolved. For buprenorphine,

a sublingual tablet should be observed to have

dissolved completely under the tongue. After

the first dose, patients should wait in an observation area and be checked 30 to 60 minutes

later for acute adverse effects. If same-day 

dosing adjustments must be made, patients

should wait 2 to 4 more hours after the additional dosing, for further evaluation when peak

effects are achieved. The consensus panel recommends that patients be observed for several

hours after the first dose of any opioid treatment medication. This observation is particularly important for patients at higher risk of

overdose, including those naive to methadone,

LAAM, and buprenorphine; those receiving

other CNS-depressant medications or known to

abuse CNS depressants; and severely medically

Regardless of the

medication used,

safety is key 

during the

induction stage.
66 Chapter 5

ill, frail, or elderly patients. Naltrexone 

typically is prescribed without observed dosing,

but poor patient compliance with ongoing 

naltrexone therapy has led some investigators

to look at using family members to ensure that

patients take their medication (Fals-Stewart

and OíFarrell 2003).

Initial dosing. The first dose of any opioid

treatment medication should be lower if a

patientís opioid tolerance is believed to be low,

the history of opioid use is uncertain, or no

signs of opioid withdrawal are evident. Some

former patients who have been released from

incarceration or are pregnant and are being

readmitted because they have a history of

addiction might have lost their tolerance. Loss

of tolerance should be considered for any

patient who has abstained from opioids for

more than 5 days. In general, the safety principle ìstart low and go slowî applies for early

medication dosages in an outpatient OTP. The

amount of opioid abuse estimated by patients

usually gives only a rough idea of their tolerance and should not be used as a dosing guide

for induction, nor should initial dosages be

determined by previous treatment episodes or

patient estimates of dollars spent per day on

opioids. Patients

transferred from

other treatment programs should start

with medication

dosages identical to

those prescribed at

their previous OTPs.

Dosage adjustments

in the first week of

treatment should be

based on how

patients feel at the

peak period for their

medication (e.g., 

2 to 4 hours after a

dose of methadone is

administered), not

on how long the

effects of a medication last. As stores 

of medication accumulate in body tissues (see

below), the effects begin to last longer.

Steady state. Initial dosing should be followed

by dosage increases over subsequent days until

withdrawal symptoms are suppressed at the

peak of action for the medication. Methadone,

LAAM, and buprenorphine are stored in body

tissues, including the liver, from which their

slow release keeps blood levels of medication

steady between doses. It is important for physicians, staff members, and patients to understand that doses of medication are eliminated

more quickly from the bloodstream and medication effects wear off sooner than might be

expected until sufficient levels are attained in

tissues. During induction, even without dosage

increases, each successive dose adds to what is

present already in tissues until steady state is

reached. Steady state refers to the condition in

which the level of medication in a patientís

blood remains fairly steady because that drugís

rate of intake equals the rate of its breakdown

and excretion.

Steady state is based on multiples of the elimination half-life. Approximately four to five

half-life times are needed to establish a steady

state for most drugs. For example, because

methadone has a half-life of 24 to 36 hours, its

steady stateóthe time at which a relatively

constant blood level should remain present in

the bodyóis achieved in 5 to 7.5 days after

dosage change for most patients. However,

individuals may differ significantly in how long

it takes to achieve steady state.

Patients should stay on a given dosage for a

reasonable period before deciding how it will

ìhold.î During induction, patients should be

instructed to judge their doses by how they feel

during the peak period (the point of maximum

concentration of medication in the blood [for

methadone, 2 to 4 hours after taking a dose]),

rather than during the trough period (the low

point of medication concentration in blood just

before the next dose [for methadone, approximately 24 hours after ingestion]). Patients who

wake up sick during the first few days of opioid

pharmacotherapy might become convinced that

[T]he safety 

principle ìstart

low and go slowî

applies for early

medication

dosages in an 

outpatient OTP.
they need a dose increase, when in fact they

need more time for tissue stores to reach steady

state. In contrast, patients who wake up sick

after the first week of treatmentówhen tissue

stores have reached steady-state levelsómight

indeed need higher doses.

In closely monitored settings such as inpatient

programs, multiple split doses can be administered per day based on patientsí symptoms at

peak blood levels. Outpatient programs are

limited in this approach because patients can

be monitored only when they are at the OTP

site. (Split dosing is discussed further below.)

Because buprenorphineís safety profile makes

overdose less of a concern, some providers opt

to give even new patients receiving buprenorphine some take-home medication for multiple

dosing during induction (CSAT 2004a).

Induction with methadone

and LAAM

Because methadone overdose deaths have

occurred in the first few days of treatment

(Caplehorn and Drummer 1999; Zador and

Sunjic 2000), it is important to adjust

methadone dosage carefully until stabilization

and tolerance are established. Federal regulations require that methadone initially be given

daily under observation for either 6 or 7 days

per week. (A take-home dose is allowed for all

patients when the OTP is closed on Sunday.)

LAAM must continue to be given under observation and administered no more than every 2

to 3 days.

Initial dosing. For a patient actively abusing

opioids, a typical first dose of methadone is 20

to 30 mg (Joseph et al. 2000) and is limited by

regulations to no more than 30 mg. If withdrawal symptoms persist after 2 to 4 hours, the

initial dose can be supplemented with another 5

to 10 mg (Joseph et al. 2000). The total firstday dose of methadone allowed by Federal regulations is 40 mg unless a program physician

documents in the patient record that 40 mg was

insufficient to suppress opioid withdrawal

symptoms (42 CFR, Part 8 ß 12(h)(3)(ii)).

Since 2001, LAAM has carried a restriction

that precludes its use as an initial medication

for pharmacotherapy because of concerns

about its cardiovascular effects. Although

direct induction with LAAM can be accomplished with an initial dose of 20 to 40 mg every

48 hours, LAAM has been used almost exclusively in cases involving transfer of patients

from methadone maintenance. LAAM must

never be given on 2 consecutive days because

its extended duration of action can result in

toxic blood levels leading to fatal overdose.

Variations in individual response and optimal

dosing. Most differences in patient response to

methadone can be explained by variations in

individual rates of absorption, digestion, and

excretion of the drug, which in turn are caused

by such factors as body weight and size, other

substance use, diet, co-occurring disorders and

medical diseases, and genetic factors. Because

variation in response to methadone is considerable, the consensus panel believes that the

notion of a uniformly suitable dosage range 

or an upper dosage limit for all patients is

unsupported scientifically. Whereas 60 mg of

methadone per day may be adequate for some

patients, it has been reported that some

patients require much more for optimal effect.

Treatment providers should avoid thinking of

ìhigh dosageî as being above a certain uniform

threshold; however, there are few data on the

safety of methadone doses above 120 mg/day.

For example, diversion of very high doses can

be associated with significant risk because the

tolerance of the person taking the diverted dose

may be insufficient to avoid overdose.

The way a person presents at the OTP is often

the best indicator for determining optimal

dosage. Looking for clinical signs and listening

to patient-reported symptoms related to daily

doses or changes in dosage can lead to adjustments and more favorable outcomes (Leavitt et

al. 2000). Exhibit 5-1 illustrates the use of signs

and symptoms to determine optimal methadone

dosages. Generally, the disappearance of opioid

withdrawal symptoms indicates adequate dosing and serum methadone levels (SMLs) within

the therapeutic comfort zone.

Clinical Pharmacotherapy 67
68 Chapter 5

Research indicates that patients diagnosed with

mental disorders or hepatitis C along with substance addiction may need increases of 50 percent or more in methadone dosage to achieve

stabilization (Leavitt et al. 2000; Maxwell and

Shinderman 2002).

Exhibit 5-2 illustrates how blood levels of

methadone rise with repeated dosing until steady

state is reached. It is important to understand

that steady state is achieved after a dosage

change. In Exhibit 5-2, because the last change

(to 100 mg) occurred on day 5, steady state was

not achieved until approximately day 10.

Induction with buprenorphine

Because buprenorphine has lower abuse potential than methadone or LAAM and is less likely

to produce respiratory depression if diverted

or misused, qualified practitioners can prescribe buprenorphine without the control

structure of an OTP when they meet Drug

Addiction Treatment Act of 2000 requirements.

No stated requirement exists for observed dosing with buprenorphine, although guidelines

strongly recommend dosage monitoring early in

treatment (CSAT 2004a).

Exhibit 5-1 

Using Signs and Symptoms To Determine Optimal Methadone Levels

Adapted from Leavitt et al. (2000), modified with permission from Mount Sinai Journal

of Medicine.
69

Initial dosing. Awaiting signs of withdrawal

before administering the first dose is especially

important for buprenorphine induction

because, as explained in chapter 3, buprenorphine can precipitate withdrawal in some circumstances (Johnson and Strain 1999).

Precipitated withdrawal usually is more sudden

and can be more severe and uncomfortable

than naturally occurring withdrawal. The 

typical first dose of buprenorphine is 4 mg. If

withdrawal symptoms persist after 2 to 4 hours,

the initial dose can be supplemented with up to

4 mg for a maximum dose of 8 mg of buprenorphine on the first day (Johnson et al. 2003b).

Three national evaluations of the 

buprenorphine-naloxone combination tablet

found that direct induction with buprenorphine alone was effective for most people who

were opioid addicted. However, buprenorphine

tablets without naloxone (sometimes called

monotherapy tablets) are recommended during

the first 2 days of induction for patients

attempting to transfer from a longer acting 

opioid such as sustained-release morphine or

methadone (Amass et al. 2000, 2001) because

most of these patients will experience withdrawal effects from the naloxone in the 

combination tablets. When patientsí tissue 

levels of a full agonist are a factor and the

buprenorphine-naloxone tablet is administered, it may be difficult to determine whether

precipitated withdrawal is caused by the partial agonist buprenorphine or small amounts of

absorbed naloxone.

For most patients who are appropriate 

candidates for induction with the combination

tablet, the initial target dose after induction

should be 12 to 16 mg of buprenorphine in 

Clinical Pharmacotherapy

Exhibit 5-2

Induction SimulationóModerate to High Tolerance

Adapted from Payte 2002, with permission.
a 4-to-1 ratio to naloxone (i.e., 12/3 to 16/4 mg

[buprenorphine/naloxone]). Bringing patients

to this target dosage may be achieved over the

first 3 days of treatment by doubling the dose

each successive day after initial administration.

An initial dose of 4/1 mg (buprenorphine/

naloxone) is recommended, followed in 2 to 4

hours with an additional 4/1 mg if indicated.

The dosage should be increased on subsequent

days to the target dosage (ranging from 12/3 to

16/4 mg per day). During dose induction,

patients may need to visit their OTP or physicianís office daily for dose adjustments and

clinical monitoring. Further information and

guidelines for buprenorphine induction and use

can be found in TIP 40, Clinical Guidelines for

the Use of Buprenorphine in the Treatment of

Opioid Addiction (CSAT 2004a).

Induction with naltrexone

The standard procedure for induction to naltrexone therapy is first to make certain that

there is an absence of physiological dependence

on opioids. This often is done by using a

Narcan challenge after a 7- to 10-day period

during which opioids are not used. Then the

patient is given 25 mg of naltrexone initially,

followed by 50 mg the next day if no withdrawal

symptoms occur after the first 25 mg dose.

Thereafter, the patient is given 50 mg per day

or up to 350 mg per week in three doses during

the week. The first dose usually is smaller to

minimize naltrexoneís side effects, such as nausea and vomiting, and to ensure that patients

have been abstinent from opioids for the 

requisite time (Stine et al. 2003).

Stabilization

The terms ìsteady stateî and ìstabilizationî

should be differentiated. Steady state is

achieved when a treatment medication is eliminated from the blood at the exact rate that

more is added. In contrast, a patient is stabilized when he or she no longer exhibits drugseeking behavior or craving. The correct

(steady-state) medication dosage contributes to

a patientís stabilization, but it is only one of

several factors, as discussed elsewhere in this

TIP. The stabilization stage of opioid pharmacotherapy focuses on finding the right dosage

for each patient. The potential for undermedication or overmedication can be avoided by a

flexible approach to dosing, which sometimes

requires higher dosages of treatment medication than expected, and by taking into account

patient-reported symptoms (Leavitt et al. 2000).

Dosage determination

It is critical to successful patient management in

MAT to determine a medication dosage that will

minimize withdrawal symptoms and craving

and decrease or eliminate opioid abuse. Dosage

requirements for methadone, LAAM, and

buprenorphine must be determined on an individual basis. There is no single recommended

dosage or even a fixed range of dosages for all

patients. For many patients, the therapeutic

dosage range of methadone may be in the

neighborhood of 80 to 120 mg per day (Joseph

et al. 2000), but it can be much higher, and

occasionally it is much lower.

The desired responses to medication that 

usually reflect optimal dosage include (Joseph

et al. 2000)

ï Prevention of opioid withdrawal for 24 hours

or longer, including both early subjective

symptoms and objective signs typical of 

abstinence

ï Elimination of drug hunger or craving

ï Blockade of euphoric effects of selfadministered opioids (This is not a true

blockade like that achieved by naltrexone but

reflects cross-tolerance for other opioids,

attenuating or eliminating desired sensations

when illicit or prescription opioids are selfadministered in usual ìstreet doses.î The

increasing purity of heroin and availability of

highly potent prescription opioids have made

it increasingly difficult to achieve complete

blockade in patients through cross-tolerance;

consequently, some patients require dosages

considerably greater than 120 mg per day to

achieve this effect.)

70 Chapter 5
ï Tolerance for the sedative effects of treatment

medication, creating a state in which patients

can function normally without impairment of

perception or physical or emotional response

ï Tolerance for most analgesic effects produced

by treatment medication (see ìPain

Managementî in chapter 10).

Unfortunately, no exact way exists to determine

optimal dosage for each patient. However, the

consensus panel recommends that OTPs avoid

exclusive reliance on drug test results and preconceived notions of correct dosage; instead,

OTPs should determine dosage based primarily

on patient response. Even when a medication

dosage is controlled for body weight (Leavitt et

al. 2000), patient responses, such as absence of

withdrawal symptoms without oversedation and

remission from illicit-opioid use, are the best

indicators of appropriate dosage. In addition,

the extent of other drug use and alcohol consumption should be considered when determining dosage adequacy. Finally, a patientís complaints (or lack thereof) are also important

indicators of dosage adequacy. A patient can

experience opioid craving or withdrawal but

manage to abstain from illicit opioids. 

Methadone. Strong evidence supports the use

of daily methadone doses in the range of 80 mg

or more for most patients (Strain et al. 1999),

but considerable variability exists in patient

responses. Some do well on dosages below 80 to

120 mg per day, and others require significantly higher dosages (Joseph et al. 2000). OTPs

should exercise additional caution with higher

dosages, guarding against diversion of takehome methadone to individuals who are opioid

intolerant because higher dosages can be lethal

for such individuals.

Buprenorphine. Buprenorphine dosage should

be determined in a manner similar to that used

for methadone or LAAM. The recommended

dosage of buprenorphine to begin stabilization

is 12 to 16 mg per day for most patients, with

increases provided thereafter as applicable

(Johnson et al. 2003b). As reviewed by Johnson

and colleagues (2003b), if patients continue to

show evidence of opioid abuse or withdrawal,

the dosage should be increased using the same

types of guidelines as for methadone. For

example, if the goal is to suppress opioid withdrawal symptoms, then dose increases can be

less frequent (e.g., weekly or biweekly) because

the desired therapeutic response likely will

become detectable more slowly.

Most patients are likely to remain stable on 12

to 24 mg per day, although some might need

dosages of up to 32 mg per day. Increasing the

buprenorphine dosage

to 24 mg per day or

higher has been

shown to prolong the

duration of its effects

and usually is necessary if patients are to

be dosed every other

day, which is an

option with buprenorphine; however, such

an increase usually

does not increase

buprenorphineís 

opioid agonist effects

to the same degree

because of its partial

agonist properties

(Johnson et al.

2003b). Because

buprenorphine is a

partial agonist,

patients who continue

to abuse opioids after sufficient exposure to

buprenorphine treatment and ancillary psychosocial services or who experience continued

symptoms of withdrawal at optimal daily doses

of buprenorphine (12 to 32 mg) should be 

considered for therapy with methadone or

LAAM (CSAT 2004a; Johnson et al. 2003b).

As with all medications used for MAT, when

buprenorphine dosage changes are contemplated, the intensity and frequency of other available psychosocial services (see chapter 8) affect

patientsí ability to refrain from opioid abuse

(Bickel et al. 1997) and should be considered.

Clinical Pharmacotherapy 71

Dosage requirements for

methadone,

LAAM, and

buprenorphine

must be determined on an individual basis.
LAAM. Most patients who begin LAAM are

being transferred from methadone and should

have been screened for cardiac risk. Equivalency dosing tables for methadone and LAAM

are available in the ORLAAMÆpackage insert

(Roxane Laboratories, Inc., 2001), and transfer can be done easily. Because of the longacting nature of LAAM, a patientís reaction

should be monitored closely during the first 

2 weeks of treatment and adjustments in dosage

made accordingly.

Patients may request transfer from methadone

to LAAM for various reasons: (1) to avoid the

hardship of methadoneís daily observed dosing,

(2) to provide negative drug test results at work

(LAAM is less likely to show up on screening

tests), (3) because they are not doing well on

methadone (Borg et al. 2002), (4) because

LAAM can be less sedating, and (5) because the

patients are rapid metabolizers of methadone

and would benefit from LAAM because it is

longer acting.

LAAM can be given every other day if an OTP

is open all week or three times per week (i.e.,

two 48-hour doses and one 72-hour dose) if

that is more convenient. Although some

patients take the same dose on Monday,

Wednesday, and Friday, most benefit from an

increase on Friday (i.e., 10 to 40 percent more

than the Monday and Wednesday doses) with

or without an additional small dose of

methadone to be taken home and used on

Sunday. For stable patients, the best option is a

regular LAAM dose on Friday and a full

methadone dose (80 percent of the LAAM dose)

as a take-home dose for Sunday. The efficacy

of LAAM dosing is determined clinically and by

patient history and examination; an affordable

means to determine blood levels of LAAM and

its metabolites is unavailable at this writing.

Naltrexone. Naltrexone can be administered

either daily (usually at a dosage of 50 mg per

day) or thrice weekly. For the latter, the usual

practice is to give 100 mg on Monday and

Wednesday and 150 mg on Friday (Stine et al.

2003).

Studies of the importance of

dosing

Much evidence shows a positive correlation

between medication dosage during MAT and

treatment response (e.g., Strain et al. 1999).

Higher dosages in some studies probably produced greater cross-tolerance. Cross-tolerance

occurs when medication diminishes or prevents

the euphoric effects of heroin or other shortacting opioids so that patients who continue to

abuse opioids no longer feel ìhigh.î The medication dosage needed for this result depends on

how long and how recently a patient has

abused heroin or other opioids and how much

he or she has used, along with individual differences in the level of brain receptor adaptation

induced by chronic opioid use.

An Australian study connected the importance

of dosage with patient retention in MAT

(Caplehorn and Bell 1991). The importance of

retention for successful treatment outcomes is

discussed further in chapter 8. In addition to

the benefits of eliminating illicit opioids (see

below), reductions in the threats of HIV and

hepatitis B and C make adequate dosing and

treatment retention high priorities and justify

additional studies on the safety and efficacy of

methadone doses exceeding 120 mg.

In their classic study, Ball and Ross (1991)

clearly demonstrated an inverse relationship

between frequency of recent heroin use and

methadone dosage. The data in Exhibit 5-3 are

based on their study of 407 patients who

received methadone maintenance treatment.

These data support the premise that lower

methadone dosages are less effective than higher or adequate dosages in facilitating abstinence from heroin among patients in MAT. The

low end of the effective range has been accepted widely as about 60 mg for most patients

(reviewed in Faggiano et al. 2003).

Another study (Maxwell and Shinderman 2002)

monitored 144 patients who were not doing well

at 100 mg of methadone per day and reported

excellent results after raising dosages based on

clinical signs and symptoms. Patients receiving

72 Chapter 5
more than 200 mg per day (mean 284.9 mg per

day) had improved responses with no apparent

increase in adverse events. However, additional

controlled research is needed to determine the

safety of very high doses of methadone or other

medications used in MAT.

With the increased availability of blood testing

in OTPs, measurements of blood concentrations of methadone at peak and trough are

used more commonly as aids to determine 

individual methadone dosage requirements. A

study in England (Wolff et al. 1991) showed a

positive correlation between methadone

dosages and concentrations in serum (Exhibit

5-4). Moreover, mean SMLs near or above 

400 ng/mL are gaining increasing consensus as

ideal levels for treatment effectiveness (Payte 

et al. 2003). Although mean SMLs of 400 ng/mL

Clinical Pharmacotherapy 73

Exhibit 5-3 

Heroin Use in Preceding 30 Days 

(407 Methadone-Maintained Patients by Current Methadone Dose)

Adapted from Ball and Ross, The Effectiveness of Methadone Maintenance Treatment:

Patients, Programs, Services, and Outcome, Appendix B, p. 248, with permission from

Springer-Verlag  1991.
generally are considered to be sufficient to

block the effects of illicit opioids and prevent

withdrawal symptoms, some patients may

require higher SMLs for stabilization. More

research is needed to understand better the

relationship between methadone blood levels

and cessation of opioid abuse. SML results

should continue to be considered along with

patient symptoms. For example, a patient with

an SML below 400 ng/mL with no symptoms 

of discomfort would not require a dosage

increase, whereas a patient with an SML of 

600 ng/mL but with persisting withdrawal

symptoms would.

Okruhlica and colleagues (2002) investigated 

69 patients receiving methadone dosages of 

10 to 270 mg per day and found a significant

positive relationship between dosage and mean

SMLs, although, at each dosage level, patientsí

resulting SMLs differed widely. Some had 

relatively low (subtherapeutic) SMLs, even at

daily doses considerably above 100 mg, which

would be expected to affect treatment negatively (Leavitt et al. 2000). Given these and similar

data, it is incorrect to conclude that a particular methadone dosage causes a specific SML;

many other factors are likely to affect SMLs for

individual patients. However, measuring SMLs

can be useful to determine why a relatively

high methadone dosage does not appear to benefit a patient. In such cases, a blood test may

show that a patientís SML remains low and

that he or she requires a higher dose.

In their review, Leavitt and colleagues (2000)

noted a broad range of SMLs among patients in

MAT. They suggested that individual differences in metabolic enzyme activity and other

factors may lead to higher or lower serum 

74 Chapter 5

Exhibit 5-4 

Methadone Dose/Mean Plasma Levels

Adapted from Wolff et al. (1991) by permission of the AACC.
levels of the (R)-methadone enantiomer,

explaining some of the variation in dosage

ranges needed for clinical effectiveness. In one

study of the clinical uses of methadone blood

level measurements, it was suggested that the

peak level should be no more than twice the

trough level and that, if it is more, the patient

should be considered a ìfast metabolizerî and

be administered split dosing. When split dosing

is used, patients receive two or three doses per

day to achieve the targeted peak-to-trough

ratio in blood level measurements and to avoid

withdrawal symptoms for 24 hours (Payte et al.

2003). Exhibit 5-5 shows 24-hour SML curves

at both inadequate and adequate dosages.

These curves include peak SMLs at roughly 4

hours after dose ingestion (0 hour) and trough

SMLs at 24 hours after ingestion. Data were

derived by averaging a series by Inturrisi and

Verebely (1972) and another one by Kreek

(1973). Exhibit 5-6 shows an example of plasma

levels in a fast metabolizer, illustrating that

when a dayís dose is split into two (lower curve),

the peak SML achieved after each of the two

split doses is lower than the peak achieved after

a single daily dose (upper curve), and the

trough SML reached just before the next split

dose is higher than the trough level reached just

before the next single dose.

The consensus panel recommends that a maintenance dosage of methadone not be predetermined or limited by policy if that policy does

not allow adjustments for individual patients. 

Other common dosing issues

Signs and symptoms associated with lesser

degrees of withdrawal and acute opioid overdose are well known, but patient changes 

associated with overmedicating and undermedicating are less dramatic and often more 

subjective.

Clinical Pharmacotherapy 75

Exhibit 5-5 

Blood Plasma Levels Over 4 and 24 Hours With an Adequate and

Inadequate Methadone Dose
76 Chapter 5

Certain medical factors may cause a patientís

dosage requirements to change, including (but

not limited to) starting, stopping, or changing

the dosage of other prescription medications;

onset and progression of pregnancy; onset of

menopause; progression of liver disease; significant increase or decrease in weight; or aging

(elderly patients are sometimes more sensitive

to drugs such as opioids). Patient complaints of

opioid craving, withdrawal symptoms, medication side effects, or intoxication always should

be investigated and never should be dismissed.

Overmedication. Mildly to moderately overmedicated patients might show ìnoddingî 

and closing of the eyes or might fall asleep at

inappropriate times. These patients might

scratch their faces continuously, especially their

noses. In some cases, sedation might occur but

be unapparent, and some overmedicated

patients might feel mildly stimulated. Nausea

also can occur, particularly in newer patients.

Patients should be told when overmedication 

is suspected, and their dosage should be

reduced. Patients also might report feeling high

or ìloadedî and ask for a reduced dosage.

Such a reduction can be helpful for patients

committed to abstinence rather than ongoing

medication maintenance because they may find

physical reminders of intoxication discouraging,

frightening, or relapse triggering.

Vomited doses. Patients who report that they

have vomited their medication pose special

problems. The consensus panel recommends

that only doses lost to witnessed emesis be

replaced. Emesis 30 minutes after dosing can be

handled by reassuring patients that the full

dose has been absorbed. Emesis at 15 to 30

minutes after dosing can be handled by replacing half the dose, and the whole dose should be

replaced if emesis occurs within 15 minutes of

dosing. If vomiting persists, it is important to

remember that only a portion of the gut is 

emptied with forceful emesis; therefore, the

risk of accumulated toxicity increases with

repeated dose replacements. Causes of emesisó

including pregnancyóshould be explored.

Exhibit 5-6 

SMLs After Single and Split Methadone Dosing in a Fast Metabolizer
Clinical Pharmacotherapy 77

Ingestion of smaller amounts of medication

over a few minutes can be helpful and prudent,

as can the occasional use of antiemetic

medicines.

“Triggered” withdrawal. Environmental cues,

including people, places, things, and feelings

associated with drug taking, can be associated

strongly with opioid craving and withdrawal.

Such reactions may be identical to opioid withdrawal symptoms and can stimulate drug craving and relapse long after opioid use has

stopped and physical dependence has been controlled (Self and Nestler 1998). Environmental

changes and other stressors can cause patients

to perceive that a dose on which they were stabilized is no longer adequate and to experience

increased drug craving. Events that increase

the availability of substances of abuse, such as

another person who uses drugs moving into a

patientís home or new sources of illicit drugs,

can intensify craving. When their discomfort

resumes after a period of abstinence, patients

might feel that they are weak willed. They need

reassurance that this reaction is a condition of

their brain chemistry, not a weakness of will. In

animal models, withdrawal symptoms have

been conditioned to appear with environmental

cues after months of abstinence from opioids

(Self and Nestler 1998). The consensus panel

believes that increased medication dosages are

appropriate in such cases, although efforts also

should focus on resolving the troublesome situations such as developing ways to avoid people,

places, and things that trigger opioid craving or

relapse. Conversely, diminished triggers and

reduced drug availability can diminish drug

craving and might indicate the possibility of

decreasing medication dosage if a patient prefers.

Contingent use of dosage. The consensus panel

believes that any manipulation of dosage as

either a positive or a negative consequence of

behavior is inappropriate and has no place in

MAT. The only type of contingency contracting

related to medication that should be supported

in MAT is that associated with take-home medication. Take-home medication is controlled by

Federal regulations, and access is based on several factors, including drug abstinence, OTP

attendance, length of time in treatment, and

overall functioning. An increase in medication

dosage should not be a reward for positive

behavior change, although not everyone in the

MAT field shares this viewpoint. For example,

extensive work has demonstrated the effectiveness of using increased dosage (as well as extra

take-home doses) as an incentive to decrease

substance abuse and increase treatment program attendance (e.g., Stitzer et al. 1986, 1993;

see also Petry 2000). Although the consensus

panel acknowledges important behavioral

aspects of addiction and the value of contingency management as an aid to behavioral change,

using medication dosage as a reward or punishment is considered inappropriate.

Maintenance

Pharmacotherapy

The maintenance stage of opioid pharmacotherapy begins when a patient is responding

optimally to medication treatment and routine

dosage adjustments are no longer needed.

Patients at this stage have stopped abusing 

opioids and other substances and have resumed

productive lifestyles away from the people,

places, and things associated with their addictions. These patients typically receive scheduled

take-home medication privileges. Patients who

continue to abuse substances, do not seek

employment, or remain connected to their drugusing social networks have not reached this

stage. Along with continued observed medication

treatment, these latter patients are candidates

for intensified counseling and other services to

help them reach the maintenance stage.

During the maintenance stage, many patients

remain on the same dosage of treatment medication for many months, whereas others

require frequent or occasional adjustments.

Periods of increased stress, strenuous physical

labor, negative environmental factors, greater

drug availability, pregnancy, or increased drug

hunger can reawaken the need for increased

dosages over short or extended periods. Serious

emotional crises may require long-term or 

temporary dosage adjustments. Although the

counseling relationship and patient interview
78 Chapter 5

are paramount, drug test reports and medication blood levels are useful for dosage determination and adjustment during and after transition from stabilization to the maintenance stage.

Medically Supervised

Withdrawal

When stable patients in the maintenance stage

ask for dosage reductions, it is important to

explore their reasons. They might believe that

they can get by on less medication, or they

might be responding to external pressures.

Patients often perceive that those on lower

dosages are ìbetter patients.î These situations

require physicians or other staff members to

educate patients and their significant others

about the importance of adequate dosage and

how individual differences in absorption, body

weight, metabolism, and tolerance can affect

the dosage necessary to achieve stability

(Leavitt et al. 2000).

Voluntary Tapering and

Dosage Reduction

For various reasons, some patients attempt

reduction or cessation of maintenance medication. Some studies indicate high relapse rates,

often 80 percent or more, for this group,

including patients judged to be rehabilitated

before tapering (e.g., Magura and Rosenblum

2001). However, the likelihood of successful

dose tapering also depends on individual factors such as motivation and family support.

The possibility of relapse should be explained

to patients who want to dose taper, especially

those who are not stable on their current

dosage, as part of the informed-consent process. Patients who choose tapering should be

monitored closely and taught relapse prevention strategies. They and their families should

be aware of risk factors for relapse during and

after tapering. If relapse occurs or is likely,

additional therapeutic measures can be taken,

including rapid resumption of MAT when

appropriate (American Society of Addiction

Medicine 1997).

Ideally, withdrawal should be attempted when

it is desired strongly by a stable patient who

has a record of abstinence and has adjusted

positively on MAT. However, sometimes dose

tapering is necessary for administrative reasons, such as a response to extreme antisocial

behavior, noncompliance with minimal program standards, or a move to a location where

MAT is unavailable. In such cases, providers

should refer patients to other programs that

are more reasonable and practical in terms of

the patientsí overall situation (e.g., motivation,

resource availability, ability to pay).

In a review of research on withdrawal from

MAT, Magura and Rosenblum (2001) noted

that many treatment providers lacked effective

ways to improve outcomes for patients who

undertook planned withdrawal and that opioid

craving remained prevalent in this group, even

after successful physiological withdrawal. They

concluded, therefore, that planned withdrawal

from opioid pharmacotherapy should be

undertaken conservatively.

Relapse prevention techniques should be 

incorporated into counseling and other support

services both before and during dosage reduction. Such structured techniques can be useful

safeguards in preventing and preparing for

relapse. Use of mutual-help techniques (see

chapter 8) is recommended highly, especially

during dosage reduction.

Although most data about outcomes after

tapering from opioid medication come from

studies of methadone maintenance, the consensus panel believes that success rates are likely

to be similar for patients who taper from

buprenorphine or LAAM, and similar cautions

and monitoring processes should be in place.

Methadone dosage reduction

The techniques and rates of graded methadone

reduction vary widely among patients. One

common practice is to reduce daily doses in

roughly 5- to 10-percent increments with 1 to 2

weeks between reductions, adjusting as needed

for patient conditions. Because reductions
79

become smaller but intervals remain about the

same, many months may be spent in such graded reductions. The rate of withdrawal can be

increased or decreased based on individual

patient response. A slow withdrawal gives

patients and staff time to stop the tapering or

resume maintenance if tapering is not working

and relapse seems likely.

Regardless of the rate of withdrawal from

methadone, a point usually is reached at which

steady-state occupancy of opiate receptors is no

longer complete and discomfort, often with

drug hunger and craving, emerges. This point

may occur at any dosage but is more common

with methadone when the dosage is below 40

mg per day. Highly motivated patients with

good support systems can continue withdrawal

despite these symptoms. Some patients appear

to have specific thresholds at which further

dosage reductions become difficult.

Physicians and other staff members should be

alert to the possibility of patients attempting

dose tapering by substituting other psychoactive substances, such as alcohol, cocaine, 

sedatives-hypnotics, or other nonopioid 

substances for their maintenance medication.

Some patients might request blind dosage

reduction, that is, withdrawal from medication

without their awareness of dose reductions at

each step. Blind dosage reduction is appropriate only if requested by a patient. It should be

discussed and agreed on before it is implemented. It is inappropriate, clinically and ethically,

to withdraw a patient from maintenance medication without his or her knowledge and consent. The consensus panel recommends that

OTP staff always disclose dosing information

unless patients have given specific informed

consent and have requested that providers not

tell them their exact dosages.

Withdrawal and termination

from LAAM maintenance

Few studies have addressed medically supervised withdrawal from LAAM. Because LAAM

is longer acting than methadone, withdrawal

should be expected to have a delayed onset and

protracted course,

although symptoms

might be less intense

than with other opioids. Patients tend to

dislike longer periods

of withdrawal,

regardless of symptom

intensity. Special

counseling might be

needed to address 

this aspect of withdrawal from LAAM.

For patients on

LAAM who wish to be

medication free,

dosage can be

reduced gradually at

a rate determined by

their response. Patients who prefer less 

protracted withdrawal can be converted to and

then tapered from methadone. As with tapering

from methadone (Moolchan and Hoffman

1994), tapering from LAAM should take into

account a patientís level of stability, past

functioning without medication, and fear 

of withdrawal.

Medically Supervised

Withdrawal After

Detoxification

For patients who neither qualify for nor desire

opioid maintenance treatment, methadone or

buprenorphine may be used to control withdrawal from illicit opioids or from abuse of

prescription opioids (detoxification) and then

can be tapered gradually (medically supervised

withdrawal). Regulations specify two kinds of

detoxification with methadone: short-term

treatment of less than 30 days and long-term

treatment of 30 to 180 days. These regulations

specify that patients who fail two detoxification

attempts in 12 months must be evaluated for a

different treatment (42 CFR, Part 8 ß 12(e)(4)). 

Clinical Pharmacotherapy

Patients who

choose tapering

should be monitored closely and

taught relapse prevention strategies.
80 Chapter 5

Dosing decisions in medically supervised 

withdrawal are related to the intended 

steepness of tapering. Patients undergoing

short-term withdrawal may never achieve

steady state, and tapering from methadone

may be too steep if it begins at a dose greater

than about 40 mg. In long-term withdrawal,

stabilization of dosage at a therapeutic range 

is followed by more gradual reduction (see

Exhibit 5-7).

Involuntary Tapering or

Dosage Reduction

When patients violate program rules or no

longer meet treatment criteria, involuntary

tapering might be indicated although it should

be avoided if possible (see chapter 8). For

example, if many days of dosing are missed and

repeated attempts to help a patient comply with

daily dosing requirements have failed, maintenance pharmacotherapy no longer may be 

possible. Treatment decisions should be made

in the patientís best interest. If patient progress

is unsatisfactory at a particular level of care,

the physician should explore the possibility of

increasing that patientís care while maintaining

him or her on methadone. Involuntary tapering and discontinuation of maintenance medication may be necessary if a patient is unwilling

to comply with treatment or tapering or discontinuation of medication appears to be in the

patientís best interest.

If a patient is intoxicated repeatedly with alcohol or sedative drugs, the addition of an opioid

medication is unsafe, and any dose should be

withheld, reduced, or tapered. Disruptive or

violent behavior or threats to staff and other

patients might be reasons for dismissal without

Exhibit 5-7 

Types of Detoxification From Illicit Opioids
tapering or for immediate transfer to another

facility where a patient may be treated under

safer conditions.

Administrative tapering for nonpayment of fees

may be part of the structure to which patients

agree on admission. It should be noted that, in

addiction treatment, a patientís sudden lack of

funds is a marker of possible relapse.

LAAM

When involuntary withdrawal from LAAM is

unavoidable, patients can be transferred to

methadone before withdrawal because clinical

experience with methadone withdrawal is more

extensive.

Incarceration

When patients know that they must serve time

in jail or prison, planned withdrawal is the best

course of action. At this writing, few correctional institutions offer methadone maintenance to nonpregnant inmates (National Drug

Court Institute 2002). Many jails do not provide methadone for detoxification. When a

patient in MAT is arrested, program staff

should make every effort to communicate with

the criminal justice authorities involved and to

recommend that the patient be withdrawn

gradually from medication. Regardless of

which opioid medication is used, maintenance

or medically supervised withdrawal is preferable to sudden discontinuation of the medication. The consensus panel recommends that

opioid pharmacotherapy be made available

during incarceration for patients who are

already in MAT when incarcerated.

Take-Home

Medications

Take-home medication refers to unsupervised

doses. Any OTP patient may receive a single

take-home dose for a day when the OTP is

closed for business, including Sundays and

State and Federal holidays. Beyond this, 

decisions on dispensing take-home medication

are determined by the medical director in

accordance with eight criteria for take-home

medication specified in Federal regulations 

(42 CFR, Part 8 ß 12(i)): 

1. Absence of recent drug and alcohol abuse

2. Regular OTP attendance

3. Absence of behavioral problems at the OTP

4. Absence of recent criminal activity

5. Stable home environment and social 

relationships

6. Acceptable length of time in comprehensive

maintenance treatment

7. Assurance of safe storage of take-home 

medication

8. Determination that rehabilitative benefits of

decreased OTP attendance outweigh the

potential risk of diversion.

Once these clinical criteria are met, maximum

take-home doses must be further restricted

based on length of time in treatment as follows:

ï First 90 days (months 1 through 3): one 

take-home dose per week

ï Second 90 days (months 4 through 6): two

take-home doses per week

ï Third 90 days (months 7 through 9): three

take-home doses per week

ï Fourth 90 days (months 10 through 12): 6

daysí supply of take-home doses per week

ï After 1 year of continuous treatment: 2

weeksí supply of take-home medication 

ï After 2 years of continuous treatment: 1

monthís supply of take-home medication, but

monthly OTP visits are still required. 

Additional restrictions are imposed in some

States. No take-home doses are permitted for

patients in short-term detoxification or interim

maintenance treatment.

Clinical Pharmacotherapy 81
82 Chapter 5

Specific Clinical Considerations

in Take-Home Status

Demands of a concurrent

medical disorder

The existence and severity of a concurrent

medical disorder (see chapter 10) are additional

considerations in determining whether takehome medication is appropriate. For patients

with concurrent diseases causing impaired

ambulation, reduced OTP attendance might 

be required to aid recovery and prevent 

complications. In these cases, OTPs should

consider seeking medical exceptions for

patients who would not otherwise be permitted

to receive take-home doses of medication.

These patient exceptions should be requested

on Substance Abuse and Mental Health

Services Administration (SAMHSA) form 

SMA-168, Exception Request and Record of

Justification. Form SMA-168 is available at

dpt.samhsa.gov/Exception168Final.htm.

When a new medication treatmentósuch

as rifampin, highly

active antiretroviral

therapy (HAART),

or phenytoinóthat

is known to interact

with an opioid treatment medication is

introduced, a MAT

patient might need a

dosage adjustment

(see chapter 3 for

further discussion of

medications that

interact with opioid

treatment medications). Take-home

medication should be

avoided until a

patient is stable on

these new medications and the risks of an undesirable outcome

have diminished. In these instances, more 

frequent observations are important to monitor

concurrent disease, to avoid methadone-related

complications of a concurrent medical disorder, and to ensure that the pharmacological

benefits of administering methadone are maintained during the course and treatment of the

concurrent disease.

Enhancement of rehabilitative

potential

Another important issue in take-home 

medication involves reviewing whether it is 

likely to help rehabilitate a patient. Take-home

medication may enable patients to engage in

employment, education, childcare, or other

important endeavors.

Emergency circumstances

During emergency situations or unforeseen 

circumstances such as personal or family

crises; bereavement; or medical, family, or

employment hardships, the need may arise for

unscheduled take-home medication. An OTP

can facilitate emergency or hardship access to

medication for a patient by submitting SAMHSA

form SMA-168. The OTPís policies should

explain who can request exceptions and how 

it is done. Courtesy dosing at a distant OTP

usually can be arranged if unstabilized patients

are traveling.

Positive drug tests, diversion

control, and take-home 

medications

The consensus panel believes that take-home

medications are inadvisable for patients who

continue to abuse illicit drugs or misuse prescription medications, as evidenced by drug

testing or other assessment information, and

for those whose drug tests do not reflect medication ingestion. Under the disinhibiting effects

of other substances, patients might be unable

to safeguard or adequately store their takehome doses. They should be encouraged to

keep their medication in a locked cabinet away

from food or other medicines and out of the

reach of children. Some programs require

No take-home

doses are 

permitted for

patients in 

short-term detoxification or interim

maintenance 

treatment.
Clinical Pharmacotherapy 83

patients to bring a locked container to the OTP

when they pick up their take-home medication

to hold it while in transit. This policy should be

considered carefully because most such containers are large and visible, which might serve

more to advertise that a patient is carrying

medication than to promote safety. 

Methadone is stable and does not need refrigeration when in diskette or tablet form. However,

when methadone diskettes are reconstituted or

liquid methadone oral concentrate is used and

diluted with juice or some other sugar-based

liquid, the mixture may not remain stable

beyond a few days without refrigeration.

Manufacturer instructions call for adding a

minimum of 30 mL or 1 fluid ounce of liquid

per dose when reconstituting methadone. 

Although methadone has a significant street

value, a National Institutes of Health consensus

statement refers to it as ìa medication that is

not often diverted to individuals for recreational or casual use but rather to individuals with

opiate dependence who lack access to

[methadone maintenance treatment] programsî (National Institutes of Health 1997b, p.

20). Nevertheless, reported deaths attributed

to methadone have increased significantly in

some States. According to data from the Drug

Abuse Warning Network, more than 10,000

emergency room visits related to methadone

were reported in 2001 compared with more

than 5,000 in 1999 (Crane 2003). This increase

has occurred in the context of overall increases

in abuse of prescription opioids, in particular

hydrocodone and oxycodone. Local reports

indicate that most diverted methadone comes

from medical prescriptions because it has

gained acceptance as an excellent chronic pain

treatment (Belluck 2003). Although the slow

onset of methadone makes it less attractive

than prescription opioids to potential abusers,

it also makes methadone more dangerous

because respiratory depression can become 

significant hours after ingestion. To guard

against the possibility of methadone-related

respiratory depression, the consensus panel

recommends the following diversion control

policies for take-home medication:

ï Require patients to return all empty dose 

bottles on their next OTP visit after takehome dosing. Staff members who accept these

bottles should inspect them to ensure that

they are coming from the indicated patient

during the appropriate period.

ï Institute procedures for responding to

patients who frequently fail to return or 

have unverified reasons for failing to return

empty take-home bottles. Staff should 

consider discontinuing take-home medication

for these patients. 

ï Stay open 7 days a week for dispensing. In

this way, take-home doses can be provided

only to stable patients with a record of

adherence to treatment, rather than to all

patients regardless of their status with the

program.

Behavior, social stability, and

take-home medications

Patients appearing intoxicated; demonstrating

aggressive, seriously impaired, or disordered

behavior; or engaging in ongoing criminal

behavior are poor candidates for take-home

medication. Their home environments also are

keys to the safety and storage of medication.

Where social relationships are unstable, a 

significant risk exists that methadone takehome doses will be secured inadequately from

diversion or accidental use (e.g., by children).

If patients with take-home privileges develop

altered mental competency, such as in dementia, frequent loss of consciousness, or delusional

states, then take-home privileges should be

reevaluated.

Monitoring Patients Who

Receive Take-Home

Medications

Monitoring should ensure that patients with

take-home medication privileges are free of

illicit drug use and consume their medication as

directed. This goal can be met through random

drug testing and periodic interdisciplinary

assessment of continuing eligibility. OTPs
84 Chapter 5

should consider carefully whether to use pill

counts or callbacks of dispensed take-home

doses to verify adherence to program rules. In

a pill count or callback, the patient receives an

unannounced phone call and must show up at

the OTP within a reasonable period (e.g., 24 to

36 hours) with all MAT medications. The number of pills remaining must correspond to the

number expected based on prescribed ingestion. A physician should review periodically the

status of every patient provided with take-home

medication. When these strategies are followed,

programs should state their policies clearly to

patients. Callbacks should be used selectively,

not be applied across the board, and focus on

high-risk patients who have given OTP staff

members reason to be concerned.

Issues for review

The rationale for providing take-home 

medication should be reviewed regularly 

and documented to determine whether initial

justifications continue to apply. For example, if

employment was a reason for take-home medication, the patientís continued employment

should be verified. If a concurrent medical 

disorder was the basis, a medical reassessment

is necessary to determine whether the clinical

status of the concurrent medical disease still

warrants reduced OTP attendance.

Reviewing the original rationale for take-home

medication is a necessary but insufficient 

condition for increased patient monitoring. The

monitoring process also should include an

assessment of whether medical, psychological,

or social reasons exist to rescind these privileges.

Treatment interruptions

Many circumstances, such as work-related

travel, illness, funerals, planned vacations, 

and emergencies, might require patients to miss

OTP visits. Some unstable patients might miss

days because of chaotic social situations. OTPs

should have policies to address treatment 

interruptions.

Disability or illness. When disability or illness

prevents patients from coming to the OTP,

authorized staff may use home delivery and

observed-dosing procedures to ensure treatment continuity. OTPs should evaluate the

need for continuity of other support services,

as well as medication, in these circumstances.

Hospitalization. OTPs are responsible for

ensuring continuity of treatment when patients

are hospitalized for medical or psychiatric

problems (see chapters 10 and 12). The best

practice is for OTP staff to educate and stay in

touch with a patientís hospital clinicians about

MAT. For example, hospital staff might be

unaware that certain drugs, such as partial

agonists or mixed agonists and antagonists for

pain management, should be avoided for

patients receiving LAAM or methadone for 

opioid addiction (pain management is discussed

in chapter 10). It usually is helpful to provide

psychiatric consultation to medical or surgical

staff members, especially for patients with cooccurring disorders. Written patient consent is

necessary for this kind of program-to-hospital

communication; however, if a medical emergency poses a threat to a patientís health, the OTP

should use the medical emergency exception 

for treatment when it lacks patient consent. A

publication by the Center for Substance Abuse

Treatment (CSAT 2004b) provides a description

of the confidentiality regulationsí medical 

emergency exception.

Hospitalization, particularly of unconscious

patients, raises the issue of using identification

(ID) cards. Patients can get OTP-specific Medic

Alert ID Cards from Advocates for Recovery

Through Medicine (www.methadonetoday.org/

armhelp.htm; telephone 615-354-1320), which

can include a patientís name, OTP contact

information, and a list of contraindicated medications. Some large urban OTPs provide

patients with a photographic ID card to gain

admittance to the OTP. Their experience has

been that some patients use their OTP cards as

generic photographic IDs in lieu of a driverís

license; for example, they use them to cash

checks, despite the fact that the cards identify

them as being in treatment. Smart cards containing a complete medical history are already

in use in the United States, Israel, and the
85

Netherlands and may be useful in OTPs. These

cards contain electronically encoded information needed to identify and monitor a patient

without outwardly identifying the cardholder as

a patient.

Missed doses. When doses are missed, it is critical to evaluate patientsí presenting condition.

Concerns should include whether a patient has

been using illicit drugs or taking other medications, has lost tolerance for previous doses (i.e.,

whether a previously tolerated dosage is still

safe to administer), or is intoxicated.

One dose missed. For patients who miss one

scheduled dose and come to the OTP the next

dayófor example, 3 to 4 days after the last

LAAM or 2 days after the last methadone

doseóthe dosage can remain unchanged, and

dosing should resume on schedule. For patients

on LAAM who miss a dose and come to the

OTP 2 days later (i.e., 4 to 5 days after their

last LAAM dose), the scheduled dose still is

usually well tolerated.

More than 5 days missed. For patients who are

out of treatment for a significant time and

might have lost tolerance, dosage reduction or

reinduction is advisable. Thereafter, increases

of 5 to 10 mg per dose up to the previous level

can be ordered because it is unlikely that the

dosage needed to maintain stability will change

in 1 week. Patients might have to be reminded

about steady state and that they may not feel

back to normal until tissue stores have built 

up as well.

Office-Based Opioid

Therapy

OTPs should consider assisting with transfer

arrangements for long-term methadonemaintained patients who prefer to use a 

physician in the community for ongoing care.

Various forms of this treatment have been studied in the United States and found to be safe

and efficacious (King et al. 2002; Schwartz et

al. 1999).

Patient selection for this treatment option

should focus on a history of negative drug tests,

a required length of stability in treatment (at

least 1 year), social stability, and minimal need

for psychosocial services. Methadone can be

ordered by private physicians, through an affiliation or other arrangement with an OTP, and

patients can obtain their medication at specially registered pharmacies under a SAMHSAapproved protocol. Under this arrangement,

patients on extended take-home-dosing schedules (up to 1 month) no longer must ingest their

doses under observation. Outcomes have been

uniformly positive, with few relapses and little

or no diversion reported (King et al. 2002;

Schwartz et al. 1999). Patient satisfaction has

been found to be significantly better compared

with OTP dosing (Fiellin et al. 2001) but not

significantly different from a comparable 

OTP-based monthly medical maintenance and

take-home schedule (King et al. 2002).

Clinical Pharmacotherapy

6 PatientñTreatment

Matching: Types of

Services and 

Levels of Care

In This

ChapterÖ

Steps in

PatientñTreatment

Matching

Patients With

Special Needs

Treatment Planning

This chapter describes a multidimensional, clinically driven strategy for

matching patients in medication-assisted treatment for opioid addiction

(MAT) with the types of treatment services and levels of care that optimize treatment outcomes, primarily within or in conjunction with opioid

treatment programs (OTPs). Level of care refers to the intensity of a

treatment (in terms of frequency, type of serviceóindividual, group,

familyóand medication) and the type of setting needed for treatment

delivery. For information on criteria and methods to determine levels of

care in substance abuse treatment, see the American Society of

Addiction Medicine (ASAM) patient placement criteria (Mee-Lee et al.

2001b). As explained by Mee Lee and colleagues (2001b), the ASAM

model conceptualizes opioid pharmacotherapy as a service that can be

provided at any level of care, although it is delivered most often in an

outpatient setting (i.e., ASAM level I).

The chapter also provides information on developing a treatment plan

with short- and long-range goals for each patient. In some cases,

patientñtreatment matching and treatment planning involve changes that

can move a patient out of comprehensive MAT to a setting that better

meets the patientís needs. Because this TIP is primarily about outpatient

MAT in OTPs, other settings and programs are discussed only briefly.

In general, patientñtreatment matching involves individualizing, to the

extent possible, the choice and application of treatment resources to

each patientís needs. The chapter explains recommended elements of a

patientñtreatment-matching process, including ways to accommodate

special populations with distinct needs and orientations that affect their

responses to specific treatments and settings.

Patients enter OTPs at various points along a continuum of substance

abuse and addiction. Many also have co-occurring medical and mental

health conditions that can be lifelong. Because of the complexity of

patientsí circumstances and needs and the range of services required to

address these needs, MAT includes not only opioid pharmacotherapy

but also other forms of treatment in a comprehensive treatment program

87
88 Chapter 6

designed to address multiple disorders and

needs (see chapter 8).

The consensus panel believes that OTPs not

already offering comprehensive MAT services

and those lacking resources to adjust levels of

care to patient needs either should augment

basic opioid pharmacotherapy with services

that meet the mental health, medical, and

social needs of patients who are opioid addictedóat the level of care each patient needsóor

should provide referrals to programs that provide such services.

Steps in

PatientñTreatment

Matching

Patient Assessment

Patientñtreatment matching begins with a thorough assessment to determine each patientís

service needs (see chapter 4); then these needs

are matched to appropriate levels of care and

types of services. Assessment should include

the extent, nature, and duration of patientsí

opioid and other substance use and their treatment histories, as well as their medical, psychiatric, and psychosocial needs and functional

status. A comprehensive assessment should

include a patientís gender, culture, ethnicity,

language, motivation to comply with treatment,

and recovery support outside the OTP.

Type and Intensity of

Treatment Services Needed 

Psychosocial treatment 

services 

In a comprehensive MAT setting, patients often

have access to a variety of psychosocial services, including individual, family, and group

counseling, as well as case management (see

chapter 8). Some programs may provide psychosocial services to patients in other settings.

Both residential and outpatient programs may

offer intensive individual and group counseling

or counseling on a periodic or as-needed basis

(De Leon 1994; Margolis and Zweben 1998).

Ideally, service intensity should depend on the

level of care required to help patients achieve

and maintain successful treatment outcomes.

Most patients in the acute phase of treatment

need to see a counselor daily for counseling or

case management, just to become stabilized,

whereas others, who may be highly functioning

with less severe addiction-related psychosocial

problems, require fewer counseling services.

Mutual-help programs 

Although not a form of treatment, mutual-help

programs (e.g., 12-Step programs, Secular

Organization for Sobriety groups, Women for

Sobriety groups) offer effective reinforcement

and motivation for individuals during and after

discontinuation of active treatment. Such programs provide social support from others who

are in recovery from addiction (Washton 1988).

Many patients in MAT participate in mutualhelp groups. However, patients with opioid

addiction who are maintained on treatment

medication can feel out of place in some group

settings where continued opioid pharmacotherapy may be misunderstood. Researchers have

described a variety of specialized groups and

inventive strategies for mutual-help programs

that meet the support needs of patients in MAT

(Zweben 1991). Chapter 8 presents some of

these strategies.

Matching Treatment Service

Needs to Settings

After the types and intensities of services that

patients need are defined, the next crucial step

in patientñtreatment matching is to identify the

most appropriate available setting or settings

for these services. MAT has been offered 

primarily in a dedicated outpatient OTP.

However, as the importance of treating

patientsí varied medical, psychological, social,

and behavioral needs as part of addiction

recovery has become evident, more varied 

programs and settings have emerged.
Throughout this TIP, the consensus panel recommends that OTPs lacking the resources to

accommodate all their patientsí needs develop

cooperative relationships with and refer

patients to other treatment providers as appropriate. However, OTPs should coordinate these

services. Based on its assessments of patients,

the treatment team should collaborate with

patients to determine the most appropriate

treatment services, intensities of services, and

settings needed to meet patient needs. This 

collaboration should continue throughout

MAT, and patient progress should be the basis

for adjustments in treatment services and

intensities.

Patientsí service needs may change throughout

MAT. For example, one patient may need referral to an inpatient program for detoxification

from alcohol or benzodiazepines and then

return to the OTP setting. Another may need

the environment of a residential treatment 

program while continuing MAT. Therefore,

treatment matching in some cases can lead to

multiple settings for an individualís treatment.

In most cases, the originating OTP should 

provide case management and liaison for all

treatment services.

Types of settings and 

programs offering opioid

addiction treatment services

The following are examples of treatment programs and settings that offer some or all of the

comprehensive services recommended in MAT.

Outpatient OTPs. Outpatient OTPs ideally

treat patients who are opioid addicted during

all phases of treatment and at most levels of

care. In reality, many OTPs have capacity or

resource limitations or payment requirements

that cause them to refer at least some patients

to other specialized treatment providers and

settings, such as those described below, for services that match patient needs. Either on site

or through other care providers, OTPs offer a

wide spectrum of treatment services and levels

of care for diverse patients.

Appropriate patients for treatment in outpatient OTPs are those who meet Federal and

State requirements for opioid addiction treatment (e.g., 42 Code of Federal Regulations,

Part 8), those who have done poorly in other

types of programs (e.g., medically supervised

withdrawal or residential treatment programs),

and those who require opioid pharmacotherapy for long-term stabilization.

OTPs in hospital-based outpatient settings may

provide a more enhanced continuum of care

than freestanding

OTPs because access

to medical and psychosocial services is

readily available. This

availability, in turn,

increases the likelihood that patients in

MAT will engage in

and adhere to other

medical and psychosocial treatment

regimens. 

Hospital-based MAT

programs are appropriate for some

patients who also are

medically ill and

require coordinated

services or care by

special teams. In

addition, because hospitals can provide a one-stop-shopping model

of care by incorporating some primary care

services with MAT, some patients with histories

of poor treatment compliance may be more

likely to adhere to medical treatment. For

example, one report from a 16-month prospective study of nearly 500 persons in a hospitalbased outpatient methadone program found

that 81 percent also used onsite primary care

services (Selwyn et al. 1993). At this writing,

the number of hospital-based programs offering MAT is limited in the United States.

Residential treatment programs. Residential

treatment programs offer cooperative living

PatientñTreatment Matching 89

[S]ervice intensity

should depend on

the level of care

required to help

patients achieve

and maintain 

successful treatment outcomes.
arrangements for patients in recovery, but they

vary in their willingness or ability to accept

MAT patients

(Margolis and

Zweben 1998). A

residential treatment

setting is indicated

for patients who

require residential

placement to support treatment and

ensure their physical

or psychological

safety and who are

unlikely to continue

MAT otherwise.

Such patients generally exhibit high

relapse potential,

evidenced by an

inability to control

substance use

despite active participation in less intensive outpatient programs (Margolis and

Zweben 1998). On

completion of treatment in these settings, patients should return to

an outpatient setting to continue MAT.

If a patient in an OTP is referred to a residential program that does not offer or allow onsite

opioid pharmacotherapy (i.e., when other residential options are unavailable) or methadone

or buprenorphine dispensing or administration, some programs allow resident patients to

travel to the OTP for medication. Some States

allow exceptions to regulations governing OTP

attendance and take-home medications so that

concurrent treatment is possible. 

Mobile treatment units. The success of mobile

treatment unitsóthat is, mobile vansóin such

cities as Baltimore, Boston, San Francisco, and

Seattle (Greenfield et al. 1996; Schmoke 1995)

highlights the importance of program accessibility as a factor affecting length of stay in treatment and positive treatment outcomes

(Greenfield et al. 1996). Mobile substance abuse

treatment programs either offer comprehensive

maintenance services (with medication, collection of samples for drug testing, and counseling

provided in one or several mobile units) or

work in conjunction with fixed-site outpatient

programs that offer medical care and counseling and other psychosocial services, while 

medication is delivered via the mobile units. 

Appropriate patients for treatment in mobile

treatment units are those in locations where

fixed-site programs are unavailable, those with

ambulatory disabilities, and those initially stabilized in an OTP and then transferred to a

mobile unit for continued treatment. Mobile

units not staffed on weekends are appropriate

only for patients who meet State and Federal

regulations for weekend take-home medications.

Office-based opioid treatment settings. After

achieving biomedical and psychosocial stabilization in an OTP, some patients might be eligible for referral to less intensive physicianís

office-based opioid treatment (OBOT) for medical maintenance. In these settings, patients

receive the same level of monitoring and intervention as patients receiving other types of

health care. When available, OBOT programs

offer several advantages (Fiellin and OíConnor

2002), including

ï Less intensive service requirements for stable

patients (e.g., less restrictive environments,

focus on maintenance with stable doses of

opioid medication, provision of only those

psychosocial services needed to prevent

relapse)

ï Minimized stigma associated with addiction

treatment

ï Increased opportunity for new treatment

admissions to OTPs

ï Expansion of treatment to geographic areas

where there are no OTPs or there are waiting

lists for admission to OTPs.

Criminal justice settings. At this writing, relatively few jails or prisons offer comprehensive

MAT or selected MAT services, but these numbers are likely to increase (for information

about substance abuse treatment in criminal

90 Chapter 6

The success of

mobile treatment

units...highlights 

the importance 

of program 

accessibility as a

factor affecting...

positive treatment 

outcomes.
justice settings, see TIP 44, Substance Abuse

Treatment for Adults in the Criminal Justice

System [CSAT 2005a]). As a result, MAT 

services are often interrupted or discontinued

when patients are incarcerated. Rikers Island,

New York Cityís central jail facility, is an example of a model program that provides comprehensive MAT for this patient group (Magura et

al. 1993). Patients who receive MAT there are

guaranteed a slot at a community-based program in New York City after their incarceration. Other corrections facilities provide rapid

medically supervised withdrawal from maintenance medication to patients. When this withdrawal is the only option, OTPs should work

with criminal justice institutions to ensure that

appropriate dose-tapering procedures are followed. Patients released from a criminal justice

setting should be offered referral to an OTP

when referral is desirable and feasible.

Other treatment settings. Numerous other settings and specialized programs offer some services and levels of care needed by patients who

are opioid addicted. Any of these programs can

be sources of referral by OTPs or can function

as satellite OTPs to ensure that patients receive

services and levels of care they need.

Choice of Medications

The consensus panel recommends that OTPs

offer a variety of treatment medications.

Chapters 3 and 5 provide more details about

the pharmacology and appropriate use of

methadone, levo-alpha acetyl methadol,

buprenorphine, and naltrexone.

Patients With Special

Needs

Effective treatment for opioid addiction should

address the unique needs of each patient

(OíConnor and Fiellin 2000; Rowan-Szal et al.

2000a). Culturally competent and creative

treatment planning, implementation, and 

referrals should address the distinct needs of

patients from different backgrounds. More

staff training and research are required on the

unique constellations of treatment needs for

various populations served by OTPs. Findings

for particular groups are summarized below.

Other treatment groupings may be identified,

for example, high-profile persons for whom

unique treatment schedules and settings may 

be needed to protect confidentiality (CSAT

forthcoming e).

Patients With Serious Medical

Disorders

If a serious medical condition is discovered

during medical evaluation or patient assessment, the patient should receive appropriate

medical treatment either on site or by referral

to a medical center. Chapter 10 describes 

medical conditions commonly encountered

among patients in MAT and provides treatment

recommendations. Most OTPs offer only basic

medical services. OTPs should develop and

maintain referral networks for patients who

present for MAT and have other medical conditions. Moreover, OTP staff should coordinate

referrals and follow up as needed to ensure

compliance with medical treatments and to act

as consultants about MAT and medication

interactions.

Patients With Serious 

Co-Occurring Disorders

Many studies have focused on the cooccurrence of substance use and mental 

disorders (see chapter 12). The existence of 

co-occurring disorders should not prevent

patientsí admission to an OTP; however, 

diagnosis of these disorders is critical to match

patients with appropriate services and settings.

Therefore, OTPs should include professional

staff trained to screen for the presence of cooccurring disorders, develop appropriate 

referrals to services (e.g., psychopharmacology

or psychotherapy) for these disorders, and provide coordination of care (CSAT 2005b). Most

staff members can be trained to recognize and

flag major symptoms of co-occurring disorders.

The OTP should maintain communication and

followup with referral resources.

PatientñTreatment Matching 91
Patients With Housing, Family,

or Social Problems

The following psychosocial problems should be

addressed during or directly after admission to

increase the likelihood that patients will engage

successfully in treatment:

ï Lack of stable housing

ï Broken ties with family members; nonexistent

or dysfunctional family relationships

ï Poor social skills and lack of a supportive

social network

ï Unemployment; lack of employable skills.

Once these needs are identified during assessment, referrals can be made. Although some

OTPs have social workers on site to manage the

assessment and referral processes, most OTPs

rely on counselors to assume this role. Case

management duties should include arrangements for provision of psychosocial care when

indicated. Family members need education

about MAT, including information on how to

support a partner or loved one in recovery,

self-care of family members, signs and symptoms of active addiction, and support and 

assistance from family members willing to 

participate in family counseling. Programs can

offer monthly classes to patients, their families,

and the community, which can reduce the 

stigma connected with MAT.

Patients With Disabilities

OTPs should try to provide access for patients

with physical disabilities. Treatment interventions for these patients usually include vocational rehabilitation, physical therapy, and

social services that help procure prosthetic

limbs, wheelchairs, and other assistive devices

(CSAT 1998c). Alternative approaches in MAT,

specifically those that reduce OTP visits,

include take-home dosing and requests for

medical exceptions through visiting-nurse 

services to provide equal access to treatment

for persons with disabilities (see chapter 10).

Mobile medication units and office-based or

home-nursing services may offer viable 

treatment options for patients with disabilities

(Fiellin and OíConnor 2002; Greenfield et al.

1996). OTP staff should address these challenges with patients so that barriers to treatment are overcome.

The consensus panel recommends that OTPs

engage in discussions with their Federal and

State agencies to develop solutions for treating

patients with disabilities. Such discussions

should balance the medical needs of these

patients and the safety issues involved in providing take-home medications for patients with

disabilities who continue to engage in substance

abuse or create a risk of medication diversion.

Adolescents and Young Adults

Adolescents and young adults present a unique

challenge for MAT. Often, ethnic background,

peer affiliations, and aspects of the ìyouth 

cultureî require staff training and special

expectations from both staff and patients.

Differences in routes of administration for

heroin or prescription opioids and in treatment

needs between adolescents or young adults and

older adults who are opioid addicted might be

attributable in part to generational characteristics and life experiences. For example, older

adults typically present for treatment after

years (sometimes decades) of chronic substance

abuse accompanied by loss of family, health,

and employment and deterioration in other

psychosocial domains. Youth who are opioid

addicted tend to present after only a few years

of addiction and with different attitudes toward

addiction and the recovery process and distinct

treatment needs. These youth may be more difficult to evaluate, because, as a result of other

modes of administration (i.e., intranasally and

by smoking), they do not exhibit some physical

markers of opioid use (e.g., track marks).

Treatment for adolescents and young adults

should integrate knowledge of their specific

developmental and psychosocial concerns and

needs. Some needs are related to identity formation and peer group preoccupation (e.g., the

strong desire to be viewed as fearless or to feel

invincible), legal complications regarding 

92 Chapter 6
consent for treatment (see CSAT 2004b), and,

often, factors leading them to run away from

their homes. TIP 32, Treatment of Adolescents

With Substance Use Disorders (CSAT 1999d),

provides background information.

Other risk factors for this group include possible sexual and physical abuse, young age at

first sexual experience, incidents of trading sex

for drugs (Astemborski et al. 1994; Fullilove et

al. 1990), and co-occurring disorders (Fuller 

et al. 2002; Hawkins et al. 1992). These risk

factors also can contribute to increased risk 

for HIV infection (Doherty et al. 2000; Fuller

et al. 2001) and other sexually transmitted 

diseases (STDs).

The interaction of developmental and psychosocial factors affects the ability of adolescents and young adults to engage in MAT and

therefore complicates the recovery process.

OTPs should provide psychosocial services that

address the unique needs of this age group,

especially those needs that affect their substance use and recovery, or they should establish referrals and links to youth-oriented psychosocial counseling services.

Buprenorphine may be a particularly satisfactory treatment for some adolescents. Because

buprenorphine can be administered in an

OBOT setting, it should become more widely

available and offer more privacy and less 

stigma for young patients (see CSAT 2004a).

Women

Pregnancy

The special needs of women who are opioid

addicted and pregnant should be assessed 

thoroughly through a comprehensive medical

evaluation, as discussed in chapter 13.

Treatment matching for pregnant patients in

MAT should provide optimal, comprehensive,

and intensive services related to pregnancy and

birth including prenatal care, maternal nutrition, and psychosocial rehabilitation, along

with MAT. The integration of a womenís overall

health initiative into MAT improves an OTPís

capacity to meet the special needs of these

patients, to address potential biomedical and

obstetrical complications, and to avoid adverse

effects of substance use on the fetus (Finnegan

and Kandall 1992). Chapter 13 offers a

detailed overview of MAT for pregnant women

(also see CSAT forthcoming f).

OTPs are required by

regulation or accreditation standards to

test for pregnancy,

but the provision of

prenatal care and

ancillary services for

pregnant women

varies depending on

the treatment setting.

Hospital-based programs may be better

suited for pregnant

women in some cases

because hospitals

offer easy access to

referrals and links to

specialty care (on or

off site).

Sexual or physical abuse

Patientsí risks of ongoing abuse in their 

current relationships should be addressed, 

and appropriate plans or referrals made. Cooccurring disorders such as posttraumatic

stress disorder can occur among both women

and men who have experienced sexual or physical abuse. The best treatment settings to

address womenís needs in these cases include

OTPs with onsite care provided by psychiatrists, psychologists, licensed social workers, or

mental health professionals with special training in this area. In lieu of onsite services, OTPs

should establish referral links to programs

offering such services. Many social service

agencies, as well as agencies responsible for

domestic violence, offer training and support to

OTP staff. TIP 36, Substance Abuse Treatment

for Persons With Child Abuse and Neglect

Issues (CSAT 2000d), provides further details.

PatientñTreatment Matching 93

Case management

...should include

arrangements 

for... 

psychosocial care

when 

indicated.
Complex medical problems

The complex medical problems commonly 

diagnosed in women in MAT include gynecological infections, amenorrhea, hypertension, and

pneumonia (Brown et al. 1992). It is optimal to

provide primary care services on site; hospitalbased programs and OTPs with formalized

medical referral systems are best equipped to

deliver such services. Chapter 10 of this TIP

and the forthcoming TIP Substance Abuse

Treatment: Addressing the Specific Needs 

of Women (CSAT forthcoming f) provide 

additional information.

Parents

Because many patients in MAT are parents, the

lack of adequate childcare services is often a

barrier to OTP attendance and successful

treatment. One solution is supervised onsite

childcare services,

which also may provide opportunities to

observe how patients

relate to their children. Problems in

parenting skills 

can be addressed 

in treatment planning and through

parenting groups 

for patients with

children. However,

onsite childcare 

services are available

in few programs

because of limited

resources and licensing and insurance

requirements. These

obstacles might

cause missed appointments or lack of privacy

and concentration for parents who must bring

their children to treatment and counseling 

sessions. Insufficient treatment may result.

The consensus panel recommends that OTPs

seek opportunities and funding for onsite childcare where appropriate and feasible to help

patients with children engage successfully in

psychosocial services. Where childcare is

unavailable, program staff should offer referrals to community daycare agencies.

In most States, OTPs are mandated reporters

of child abuse and neglect. When children are

at imminent risk of harm or appear neglected,

OTPs are required to notify local childrenís

protective services (CPS) agencies so that an

investigation can be conducted. This requirement can create conflict between an OTP and a

patient, and the OTP should try to address this

issue in a supportive way. Programs and treatment providers should not discriminate against

patients because they have entered into pretreatment agreements or have difficulties with

CPS agencies (see chapter 13).

Lesbian, Gay, and Bisexual

Patients

Just as important as sensitivity to cultural differences based on race or ethnicity is providing

a treatment climate that is available and sensitive to lesbian, gay, or bisexual (LGB) patients

by openly acknowledging their heterogeneity

and variations in sexual orientation and treating these individuals with dignity and respect

(CSAT 2001b; Lombardi and van Servellen

2000). OTP staff should be prepared to assist

LGB patients in coping with problems related

to their sexual orientation and the need for

HIV/AIDS and STD risk avoidance. Providers

should help patients obtain appropriate medical care and secure their safety if, for example,

they are threatened. OTPs also should acknowledge the unique social support structures of

LGB patients, which can provide a way to 

counteract isolation and separation from community, peers, and immediate and extended

family members (Hughes and Eliason 2002; also

see CSAT 2001b). Finally, the consensus panel

recommends that OTPs identify and refer LGB

patients to community counseling, support, and

spiritual and religious organizations that are

sensitive to these groups and address any 

sexual- or gender-orientation concerns these

patients have that could affect treatment.

94 Chapter 6

Most patients can

be maintained 

on their MAT

dosage while 

taking short-acting 

opioids for pain

relief...
Aging Patients

MAT treatment planners should consider the

stressors common to the aging patient, such as

loss of family, retirement, loneliness, and boredom, which can contribute to high risk of selfovermedication and addiction to alcohol and

medications. The consensus panel recommends

that OTPs focus on the following areas when

working with elderly patients:

ï Monitoring the increased risk for dangerous

drug interactions; elderly patients often are

prescribed multiple medications.

ï Differentiating between co-occurring disorders

and symptoms and disorders associated with

aging (including dementia) (Lawson 1989).

ï Differentiating between depression and

dementia.

ï Screening for and treating physical and 

sexual abuse (see chapter 4).

ï Developing referral sources that meet the

needs of elderly patients. Relationships with

skilled nursing facilities and nursing homes

are particularly important (Lawson 1989).

ï Training staff to be sensitive to the elderly

patient population.

ï Providing psychosocial treatment for ageassociated stressors and medical screening

and referral for common medical conditions

affected by the aging process (see CSAT

1998b).

ï Assessing and adjusting dosage levels of 

medication for the slowed metabolism of

many elderly patients.

Patients With Pain

Patients in MAT often are undertreated or

denied medication for acute or chronic pain

management (Compton and Athanasos 2003).

Health care workers may misperceive pain

medication requests by patients in MAT as

drug-seeking behavior, in part because of

patientsí higher tolerance for opioids and, usually, their need for higher doses. Many physicians who treat pain do not have the necessary

education to treat pain in this population

(Prater et al. 2002). MAT providers should

evaluate patient treatment needs for pain 

management and assist patients directly in

obtaining optimal pain treatment. Medical

providers in MAT should work collaboratively

with primary care providers and pain and 

palliative-care clinicians to ensure establishment of appropriate pain interventions for

patients in MAT. Providers need education

about maintaining current opioid levels while

adding sufficient immediate-release treatment

agents to manage acute or chronic pain. More

frequent dosing and short-term increased

demand for pain treatment medication should

be expected. Referrals to specialty pain clinics

often provide patients a full spectrum of pain

care, including pharmacological and psychological or behavioral treatments to alleviate pain

symptoms. These services most often are accessible through hospital-based programs or referral linkages. Most patients can be maintained

on their MAT dosage while taking short-acting 

opioids for pain relief; however, individualized

pain treatment is usually necessary.

Treatment Planning

After patientsí individual needs are assessed

and the best available treatment services and

most appropriate levels of care are determined,

a treatment plan should be developed with the

patient, as required by accreditation guidelines

(CSAT 1999b).

Developing a Treatment Plan

Treatment planning for MAT should involve a

multidisciplinary team, including physicians,

counselors, nurses, case managers, social workers, and patients. Based on a thorough patient

history and assessment, a treatment plan

should be realistic and tailored to each

patientís needs, strengths, goals, and objectives. Good treatment plans contain both shortand long-term goals and specify the actions

needed to reach each goal. Treatment plans

should indicate which goals and objectives

require referral to and followup with outside

PatientñTreatment Matching 95
resources and which are provided by the OTP

itself. Treatment plans should contain specific,

measurable treatment objectives that can be

evaluated for degree of accomplishment.

Role of the counselor in plan

formulation

Counselors should ensure that treatment plans

incorporate strategies to develop therapeutic

relationships with patients, based on respect

for patientsí autonomy and dignity, while 

motivating patients to become willing partners

in the change process (CSAT 1999a). This role,

which places great responsibility on the counselor, usually incorporates cognitive behavioral

approaches in which providers strive to

enhance patient motivation for change by

focusing on patient strengths and respecting

patient decisions (CSAT 1999a). To engage

patients in the process of treatment planning,

counselors should encourage the inclusion of

motivational enhancement strategies that highlight appropriate, realistic treatment goals (Di

Clemente 1991). Research has shown that confrontational counseling or the use of negative

contingencies often predicts treatment failure

(Miller and Rollnick 2002). 

Role of the patient in plan

formulation

A patient in MAT should be an integral member of the treatment team with his or her needs

and expectations considered respectfully and

incorporated into the treatment plan. Patients

who agree with the treatment rationale or therapeutic approach tend to experience increased

determination to improve (Hubble et al. 1999).

A patientís participation in treatment planning

can enhance motivation to adhere to change

strategies, leading to positive treatment outcomes such as higher rates of abstinence and

better social adjustment (CSAT 1999a). When

possible, the treatment plan should be written

in a patientís own words to describe his or her

unique strengths, needs, abilities, and preferences as well as his or her challenges and 

problems. The plan also should contain 

mutually approved goals that reflect awareness

of and sensitivity to a patientís informed 

choices, cultural background, age, and medical

status or disability. 

Other factors in plan 

formulation

Treatment plans should incorporate an 

assessment of linguistic and cultural factors

that might affect treatment and recovery either

positively or negatively (U.S. Department of

Health and Human Services 2001). Treatment

providers should work collaboratively with

patients to identify health-related cultural

beliefs, values, and practices and to decide how

to address these factors in the treatment plan

(U.S. Department of Health and Human

Services 2001).

Motivation for treatment

Patient motivational strategies should be incorporated throughout the treatment plan. As part

of this process, the treatment team can benefit

from an understanding of stages of change and

their effects on patient progress. Prochaska

and colleagues (1982, 1986, 1992), who formulated a useful model that explains how people

change, observed five stages of readiness for

change during addiction treatment: contemplation, determination, action, maintenance, and

relapse. An earlier stage (precontemplation)

also plays a role. Patients and treatment

providers ideally should develop recommended

treatment options in the plan based on each

patientís readiness for treatment, which can be

determined by identifying the patientís stage-ofchange readiness. The stages-of-change model

and corresponding counseling responsibilities

are described in TIP 35, Enhancing Motivation

for Change in Substance Abuse Treatment

(CSAT 1999a).

Elements of a Treatment Plan

Because some patients require assistance in

many functional areas, treatment plans should

address measurable, achievable goals relevant

to the patientís current situation. Short-term

goals, such as vocational rehabilitation 

96 Chapter 6
assessment or computer training, can evolve

from a long-term goal, such as full-time

employment. However, treatment plans should

be simple and not so comprehensive that they

overpower a patient with the tasks that must be

achieved. Although both short- and long-term

goals should be considered, the patientís

involvement in defining measurable, achievable

goals is important. Treatment plans should be

modified periodically when progress can be

assessed. Most OTPs have forms to use for

treatment planning, many of which were developed to meet regulatory and accreditation

requirements, specifying goals, actions, responsible parties, and measurable outcomes. The

panel urges that these forms not be overly complex or overwhelming to the patient. Patients

should receive a copy of the plan. Exhibit 6-1

provides a case study and an example of a treatment plan.

PatientñTreatment Matching 97

Patient is a 30-year-old Hispanic mother of two children who has been divorced for 3 years.

She dropped out of high school at age 15 when she became pregnant. As a single mother on

public assistance, she first began using heroin intranasally at age 17 and began injecting 1

year later.

Patient was born in Puerto Rico, and her family came to the United States when she was 10

years old. She is the youngest of five children. Her father was an unemployed painter and

alcoholic who physically abused her mother. He died in Puerto Rico from cirrhosis of the

liver. Patientís relationship with her mother always has been strained. Her mother has had

numerous relationships that the patient resented. Patient stated that, as the youngest child,

she feels that she never received enough attention or love from her mother. 

To support her lifestyle, which includes alcohol, cocaine, and heroin use, patient earned

money through prostitution, which led to selling drugs, theft, and other criminal activities.

Patient married after giving birth to her second child. Patient has an arrest history and a

pending case for selling cocaine. After a divorce, patient lived with her mother. An anonymous call was made to CPS reporting her chronic drug abuse and criminal history. As a

result, her children were placed in foster care. After the patientís arrest and the removal 

of her children, patientís mother asked her to move out of the house; she then lived with

whomever she could.

Patient has enrolled in an OTP, motivated by her desire to regain custody of her children.

She considers cessation of her cocaine habit secondary to cessation of her heroin abuse. 

She initially stated that she wanted to change her life, including having her own permanent

housing, and she wanted to stop prostituting. Although stabilized on methadone, she 

continued to use cocaine on a regular basis during her first 6 months in treatment. While 

in the program, she tested positive for HIV infection. She was assessed as having severe

depression, with suicidal ideation, and escalation of cocaine abuse.

Although attempts have been made to motivate patient to stop cocaine use, these attempts

have been unsuccessful. 

Patientís treatment plan might include the following short- and long-term goals:

Exhibit 6-1 

Case Study: PatientñTreatment Planning in MAT

(continued on following page)
98 Chapter 6

Exhibit 6-1

Case Study: PatientñTreatment Planning in MAT (continued)

Short-term goals

1.Address imminent danger of suicide by developing a service plan in conjunction with

mental health provider.

ï Objective: To rule out suicide; to overcome patientís depression and assess need for 

medication.

ï Action: Have patient sign a consent form for a psychiatric evaluation and communication

between provider and OTP staff; set up appointment with psychiatrist; obtain evaluation,

diagnosis, and treatment recommendations from the psychiatrist.

ï Target date: Immediately for suicidal ideation; within 1 month for ongoing mental 

health needs.

ï Responsible persons: Patient, counselor or caseworker, and psychiatrist.

ï Measurable outcome: Patient is stable and no longer at high risk; medication needs 

are assessed.

ï Long-term goal: Stable mental health status with ongoing treatment plan. 

2.Obtain housing for patient, with long-term goal of stable permanent housing.

ï Objective: To refer to a shelter.

ï Action: Make appointment to apply for housing assistance program. 

ï Target date: Immediately.

ï Responsible persons: Patient, counselor or caseworker, and housing staff.

ï Measurable outcome: Copy of lease, patient self-report, or both.

ï Long-term goal: Access to stable housing.

3.Obtain HIV counseling.

ï Objective: To provide support and education about HIV status.

ï Action: Provide education, resources, and counseling about safe sex and spread of HIV.

ï Target date: 4 to 6 months.

ï Responsible persons: Medical staff, counselor, and patient.

ï Measurable outcome: Patient has obtained and integrated accurate information; myths

are dispelled; patient reports readiness to explore treatment options.

ï Long-term goal: Initiation of antiretroviral treatment.

4.Address cocaine abuse.

ï Objective: To educate the patient on the psychological and physiological effects of cocaine

abuse; to develop a recovery intervention.
PatientñTreatment Matching 99

Exhibit 6-1 

Case Study: PatientñTreatment Planning in MAT (continued)

ï Action: Assess level of use and readiness for change; develop plan with patient to address

use (e.g., motivational groups, Cocaine Anonymous, skill-building interventions, drug

testing).

ï Target date: 2 to 4 months.

ï Responsible persons: Patient, counselor, group leader, and medical staff members.

ï Measurable outcome: Patient decreases cocaine use, based on self-report, observable

behavior, drug testing, and attendance to counseling plan.

Long-term goals

1.Manage or eliminate depression.

ï Objective: To stabilize depression; to increase self-esteem and motivation to work on

treatment goals.

ï Action: Provide regular psychiatric treatment on site or by referral; communicate with

providers.

ï Target date: 6 months.

ï Responsible persons: Patient, counselor, and psychiatric providers.

ï Measurable outcomes: Patient regularly attends to psychiatric treatment plan, adherence

to medication regimen if prescribed, elimination of or reduction in depression (as assessed

by patient report, depression assessment tools, observed behavior).

2.Regain custody of children once in stable housing situation.

ï Objective: To reconcile the patient with her family; to maintain a stable living situation.

ï Action: Assist patient in obtaining public assistance to ensure stable, safe, appropriate

environment for children; access legal assistance for custody issues; obtain permission to

communicate with CPS; assist patient in remaining abstinent from substance use.

ï Target date: 1 year.

ï Responsible persons: Patient, counselor or caseworkers, internal or external social 

services worker, and lawyer.

ï Measurable outcomes: Patient self-report, family and CPS agency reports, rent receipts,

progress toward obtaining custody of children.

3.Continue HIV medical care.

ï Objective: To obtain ongoing HIV education and treatment.

ï Action: Provide access and communication with HIV and primary care providers; 

provide referral to support group meetings for individuals who are HIV positive.

ï Target date: Ongoing.

ï Responsible persons: Patient, health care providers, counselor and caseworkers, and

group counselor or facilitator.

ï Measurable outcomes: Patient self-report, health care providersí report, laboratory

reports, and group leader reports about adherence to health care needs. 
100 Chapter 6

The Multidisciplinary Team

Approach

The complexities of treatment planning for

patients who receive MAT require a multidisciplinary treatment team, the composition 

of which varies with OTP resources and the

population being treated. The consensus panel

recommends that the treatment team consist of

the following:

ï A physician trained in addiction psychiatry,

who provides leadership, health care, and

medical stabilization; conducts detailed 

evaluations of the patient; monitors medications; and provides needed substance abuse

interventions when indicated

ï Nonphysician medical staff members (e.g.,

registered nurse, nurse practitioner, physicianís assistant), who administer medications,

assist in medical evaluations, maintain

records, and facilitate referrals for medical

and psychiatric treatments

ï A pharmacist or pharmacy assistant, who 

dispenses (and sometimes administers) 

medications, orders controlled substances,

maintains records, and consults with program

staff on all aspects of patient care, particularly

drug interactions

ï Nonmedical professional staff members (e.g.,

case coordinator, social worker, psychologist,

vocational and educational specialist), who

provide a range of psychosocial services,

including counseling and case management,

psychotherapy and family therapy, psychological testing and evaluation, health education,

and vocational skills assessment and training

ï A certified or licensed addiction specialist or

drug counselor 

ï Nontreatment and administrative staff members (e.g., office manager, clerical staff,

receptionist, secretary), who often provide

information to treatment teams and whose

responsibilities include operational management, billing, receipt of payments, review of

records, observation of patient interactions,

and telephone coverage

ï Security personnel, who ensure the safety

and well-being of patients and staff on site.

More information on the multidisciplinary team

approach is presented in chapter 14.
101

7 Phases of Treatment

The consensus panel recommends that medication-assisted treatment for

opioid addiction (MAT) as provided in opioid treatment programs

(OTPs) be conceptualized in terms of phases of treatment so that interventions are matched to levels of patient progress and intended outcomes.

The sequential treatment phases described in this chapter apply primarily to comprehensive maintenance treatment, rather than other treatment

options such as detoxification or medically supervised withdrawal. When

MAT is organized in phases, patients and staff better understand that it

is an outcome-oriented treatment approach comprising successive, integrated interventions, with each phase built on another and directly related

to patient progress. Such a model helps staff understand the complex

dynamics of MAT and the potential sticking points and helps counselors

organize interventions based on patient needs.

The model described in this chapter comprises either five or six patientcentered phases for planning and providing MAT services and evaluating

treatment outcomes in an OTP, including the (1) acute, (2) rehabilitative,

(3) supportive-care, (4) medical maintenance, (5) tapering (optional),

and (6) continuing-care phases.

Rationale for a Phased-Treatment

Approach and Duration

Research on the effectiveness of organizing MAT into phases is limited,

partly because MAT is a relatively long-term process, often with no fixed

endpoint and with a variety of possible approaches, and partly because

patients often leave and then return to MAT, which makes systematic

studies difficult. Although research is limited, the consensus panel

believes that the notion of phased progression is implicit in treatment

and underlies most of a patientís time in MAT. Many OTPs operate

according to an informal phased-treatment model, and others use phases

at least to develop treatment plans.

In This

Chapter...

Rationale for a

Phased-Treatment

Approach and

Duration

Phases of MAT

Transition Between

Treatment Phases

in MAT

Readmission to the

OTP
Hoffman and Moolchan (1994) recognized the

value of treatment phases in OTPs and described

a highly structured model. This chapter builds

on, adapts, and

extends their model

as part of an overall

strategy for matching

patients with treatments. The phases

described below are

suggested as guidelinesóa way of

organizing treatment

and looking at

progress on a care

continuumóand 

as an adjunct to 

the levels of care

specified by the

American Society of

Addiction Medicine

in its patient placement criteria (Mee-Lee et al. 2001a) and

referred to by accreditation agencies.

The model is not one directional; at any point,

patients can encounter setbacks that require a

return to an earlier treatment phase. Therefore,

the chapter includes strategies for addressing

setbacks and recommendations for handling

transitions between phases, discharge, and

readmission. In terms of medication, the model

includes two distinct tracks, one of continuing

medication maintenance and the other of 

medication tapering (medically supervised

withdrawal). The implications of both tracks

are discussed. Although most patients would

prefer to be medication free, this goal is difficult for many people who are opioid addicted.

Maintaining abstinence from illicit opioids and

other substances of abuse, even if that requires

ongoing MAT, should be the primary objective.

Variations Within Treatment

Phases

The phase model assumes that, although many

patients need long-term MAT, the types and

intensity of services they need vary throughout treatment and should be determined by

individual circumstances. For many patients,

MAT is the entry point for diagnosis and treatment of, or referral for, other health care and

psychosocial needs. In general, most patients

need more intensive treatment services at entry,

more diversified services during stabilization,

and fewer, less intensive services after benchmarks of recovery begin to be met (McLellan et

al. 1993; Moolchan and Hoffman 1994).

The consensus panel emphasizes that treatment

phases should not be viewed as fixed steps with

specific timeframes and boundaries but regarded as a dynamic continuum that allows patients

to progress according to individual capacity.

Some patients progress rapidly and some 

gradually. Some progress through only some

phases, and some return to previous phases.

Treatment outcomes should be evaluated not

only on how many phases have been completed

or whether a patient has had to return to an

earlier phase but also on the degree to which

the patientís needs, goals, and expectations

have been met. As described in chapter 4,

assessment of patient readiness for a particular

phase and assessment of individual needs

should be ongoing.

Duration of Treatment Within

and Across Phases

Decisions concerning treatment duration (time

spent in each phase of treatment) should be

made jointly by OTP physicians, other members

of the treatment team, and patients. Decisions

should be based on accumulated data and 

medical experience, as well as patient participation in treatment, rather than on regulatory

or general administrative policy. 

Phases of MAT

Acute Phase

Patients admitted for 

detoxification

Although the phases of treatment model is structured for patients admitted for comprehensive

102 Chapter 7

[T]reatment

phases should not

be viewed as fixed

steps with specific

timeframes and

boundaries... 
Phases of Treatment 103

maintenance treatment, some patients may be

admitted specifically for detoxification from opioids (see 42 Code of Federal Regulations [CFR],

Part 8 ß 12(e)(4)). These patients usually do

not wish to be admitted for or do not meet

Federal or State criteria for maintenance treatment. Patients admitted for detoxification may

be treated for up to 180 days in an OTP. The

goals of detoxification are consistent with those

of the acute treatment phase as described

below, except that detoxification has specific

timeframes and MAT endpoints. Detoxification

focuses primarily on stabilization with medication (traditionally using methadone but

buprenorphine-naloxone tablets are now 

available), tapering from this medication, and

referral for continuing care, usually outside 

the OTP. During this process, patientsí basic

living needs and their other substance use, cooccurring, and medical disorders are identified

and addressed. Patients also may be educated

about the high-risk health concerns and problems associated with continued substance use.

They usually are referred to community

resources for ongoing medical and mental

health care.

Patients admitted for detoxification should

have access to maintenance treatment if their

tapering from treatment medication is unsuccessful or they change their minds and wish to

be admitted for comprehensive MAT. If these

patients meet Federal and State admission criteria, their medically supervised withdrawal

from treatment medication should end, their

medication should be restabilized at a dosage

that eliminates withdrawal and craving, and

their treatment plans should be revised for

long-term treatment.

Patients admitted for 

comprehensive maintenance

treatment

The acute phase is the initial period, ranging

from days to months, during which treatment

focuses on eliminating use of illicit opioids and

abuse of other psychoactive substances while

lessening the intensity of the co-occurring 

disorders and medical, social, legal, family, and

other problems associated with addiction. The

consensus panel believes that front-loading

highly intensive services during the acute

phase, especially for patients with serious 

co-occurring disorders or social or medical

problems, engages patients in treatment and

conveys that the OTP is concerned about all

the issues connected to patientsí addiction.

Exhibit 7-1 summarizes the main treatment

considerations, strategies, and indicators of

progress during the acute phase.

Goals of the acute phase

A major goal during the acute phase is to 

eliminate use of illicit opioids for at least 24

hours, as well as inappropriate use of other

psychoactive substances. This process involves

ï Initially prescribing a medication dosage that

minimizes sedation and other undesirable

side effects

ï Assessing the safety and adequacy of each

dose after administration 

ï Rapidly but safely increasing dosage to 

suppress withdrawal symptoms and cravings

and discourage patients from self-medicating

with illicit drugs or alcohol or by abusing

prescription medications 

ï Providing or referring patients for services to

lessen the intensity of co-occurring disorders

and medical, social, legal, family, and other

problems associated with opioid addiction

ï Helping patients identify high-risk situations

for drug and alcohol use and develop alternative strategies for coping with cravings or

compulsions to abuse substances.

Chapter 5 details the procedures for determining medication dosage.

Indications that patients have reached the goals

of the acute phase can include

ï Elimination of symptoms of withdrawal, 

discomfort, or craving for opioids and 

stabilization 
104 Chapter 7

Exhibit 7-1 

Acute Phase of MAT

Treatment Issue Strategies To Address Issue

Indications for Transition to

Rehabilitative Phase

Alcohol and drug use ï Schedule weekly drug and

alcohol testing

ï Educate about effects of alcohol and drugs; discourage their

consumption

ï Ensure ongoing patient dialog

with staff

ï Intensify treatment when 

necessary

ï Meet with program physician 

to ensure adequate dosage of

treatment medication

ï Elimination of opioidwithdrawal symptoms,

including craving

ï Sense of well-being

ï Ability to avoid situations

that might trigger or perpetuate substance use

ï Acknowledgment of 

addiction as a problem and

motivation to effect lifestyle

changes

Medical concerns

ï Infectious diseases (e.g.,

HIV/AIDS, hepatitis,

tuberculosis [TB])

ï Sickle cell disease

ï Surgical needs, such as

skin or lung abscesses

ï Refer patients immediately to

medical providers 

ï Vaccinate as appropriate (e.g.,

for hepatitis A and B) 

ï Resolution of acute medical

crises

ï Established, ongoing care

for chronic medical 

conditions

Co-occurring disorders 

ï Psychotic, anxiety,

mood, or personality 

disorders

ï Identify acute co-occurring 

disorders that may need immediate intervention

ï Identify chronic disorders that

need ongoing therapy

ï Resolution of acute mental

crises

ï Established, ongoing care 

for chronic disorders

Basic living concerns

ï Legal and financial 

concerns

ï Threats to personal 

safety

ï Inadequate housing

ï Lack of transportation

ï Childcare needs

ï Pregnancy

ï Advocacy

ï Assess needs

ï Refer patient to appropriate

services 

ï Work cooperatively with 

criminal justice system

ï Explore transportation options

ï Link to legal advocate, caseworker, or social worker

ï Identify financial resources

ï Provide ongoing case 

management

ï Satisfaction of basic food,

clothing, shelter, and safety

needs

ï Stabilization of living 

situation 

ï Stabilization of financial

assistance

ï Resolution of transportation

and childcare needs 
ï Expressed feelings of comfort and wellness

throughout the day

ï Abstinence from illicit opioids and from

abuse of opioids normally obtained by 

prescription, as evidenced by drug tests

ï Engagement with treatment staff in 

assessment of medical, mental health, and

psychosocial issues

ï Satisfaction of basic needs for food, shelter,

and safety.

Phases of Treatment 105

Exhibit 7-1 

Acute Phase of MAT (continued)

Treatment Issue Strategies To Address Issue

Indications for Transition to

Rehabilitative Phase

Therapeutic relationship

ï Establishing trust and 

feeling of support

ï Addressing myths about

MAT

ï Advocate adequate dosage

ï Remain consistent, flexible,

and available; minimize

waiting times

ï Provide incentives and

emphasize benefits of

treatment

ï Dispel myths about MAT

ï Educate patient about

goals of MAT

ï Build support system

ï Build trust

ï Regular attendance at 

counseling sessions

ï Positive interaction with

treatment providers

ï Focus on treatment goals

Motivation and readiness for

change 

ï Ambivalent attitudes

about substance use

ï Avoidance of counseling 

(noncompliance)

ï Negative relationships with

staff

ï Inadequate dosage

ï Negative attitude about

treatment

ï Involuntary discharge

ï Ensure adequate dosage

ï Address ambivalence

ï Empower patient

ï Emphasize treatment 

benefits

ï Emphasize importance of

making a fresh start

ï Commitment to treatment

process

ï Acknowledgment of 

addiction as a problem

ï Lifestyle changes and

addressing addictionrelated issues
106

Alcohol, opioid, and other

drug abuse

During the acute phase, OTP staff members

should pay attention both to patientsí continuing

opioid abuse and to their use of other addictive

and psychoactive substances. Patients should

receive information about how other drugs,

nicotine, and alcohol interact with treatment

medications and why medication must be

reduced or withheld when intoxication is evident. When substance abuse continues during

the acute phase, the treatment team should

review patientsí presenting problems and revise

plans to address them, including changes in

dosage, increased drug testing, or other intensified interventions. Chapter 11 discusses treatment options to address multiple substance use.

In addition, the consensus panel believes that

frequent contact with knowledgeable and caring staff members who can motivate patients to

become engaged in program activities, especially in the acute phase, facilitates the elimination

of opioid abuse. Engaging the patient by

scheduling extra individual or group counseling

sessions provides additional support and communicates staff concern for the patient.

Intensified treatment in the OTP is an effective

response and provides improved outcomes

when compared with more infrequent counseling sessions (Woody 2003).

Co-occurring disorders

Many people entering OTPs have mental disorders. Persistent, independent co-occurring 

disorders (i.e., mental disorders that arise from

causes other than substance use and need 

ongoing therapy) and substance-induced cooccurring disorders (i.e., mental disorders

directly related to substance use and addiction

that probably will improve as the addiction is

controlled) should be identified during initial

assessment and the acute phase of treatment so

that appropriate treatment or referral can be

arranged. Patients should be monitored closely

for symptoms that interfere with treatment

because immediate intervention might prevent

patient dropout. Such disorders can be 

disruptive at the start of MAT and require

immediate treatment. The course of recovery

from substance-induced co-occurring disorders

usually follows that of the substance use disorder itself, and these co-occurring disorders

typically do not require ongoing treatment after

the acute phase. Some patients may require

focused, short-term pharmacotherapy, psychotherapy, or both. However, many patients 

may have co-occurring disorders requiring a

thorough psychiatric evaluation and long-term

treatment to improve their quality of life. (See

chapters 4 and 12 for more information on

assessing these conditions and chapter 12 for

more information on psychiatric diagnosis and

treatment in MAT.)

Medical and dental problems

Patients often present with longstanding,

neglected medical problems. These problems

might require hospitalization or extensive 

treatment and could incur substantial costs for

people often lacking financial resources. In

addition, many patients in MAT have neglected

their dental health (Titsas and Ferguson 2002).

Once opioid abuse is stopped, these patients

often experience pain because the analgesic

effects of the opioids have been removed. Such

conditions must be recognized, assessed, and

treated, either within an OTP or via referral.

(See chapter 10 for discussion of the diagnosis

and treatment of medical problems for patients

in MAT.)

Legal problems

Most correctional systems do not allow MAT.

The consensus panel believes that sudden,

severe opioid withdrawal caused by precipitous

incarceration can endanger health, especially

that of patients already experiencing comorbid

medical illness, and can increase the risk of suicide in individuals with co-occurring disorders.

Therefore, it is critical to address patientsí

legal problems and any ongoing criminal activity as soon as possible, preferably in the acute

phase. On behalf of those on probation or

parole or referred by drug courts, program

staff members should work cooperatively with

Chapter 7
107

criminal justice agencies, educating them about

MAT and, with patientsí informed consent (see

CSAT 2004b), reporting patient progress and

incorporating continuing addiction treatment

into the probation or parole plan. OTPs should

work with local prisons and jails to provide as

much support and consultation as possible.

When medical care is provided in jails or 

prisons by contracted health agencies, OTPs

should establish contacts directly with these

medical providers to improve the care of incarcerated patients in MAT. (See TIP 44, Substance

Abuse Treatment for Adults in the Criminal

Justice System [CSAT 2005a].)

Basic needs

The consensus panel recommends that

patientsí basic needs such as food, clothing,

housing, and safety be determined during the

acute phase, if possible, as discussed in chapter

4, and that referrals be made to appropriate

agencies to address these needs.

Patientsí living situations should be relatively

stable and secure so that treatment can move

beyond the acute phase. Before they transition

to the rehabilitative phase, patients should

begin to develop the coping skills needed to

remove themselves from situations of inevitable

substance use. A patientís inability to gain this

control may necessitate revision of the treatment plan to assist the patient in moving past

the acute phase. The process often includes

meeting directly with the patient to assess motivation and adequacy of dosage and to define

treatment goals clearly.

Therapeutic relationships

Positive reinforcement of a patientís treatment

engagement and compliance, especially in the

acute phase, is important to elicit a commitment to therapy. Chapter 8 addresses the

importance of the therapeutic bond between

patients and treatment providers and reviews

practical techniques to address common 

problems in counseling.

Furthermore, participation in peer support

services and mutual-help groups (provided that

these groups support MAT) can be helpful to

patients. OTPs can provide information about

appropriate meetings and peer support.

The consensus panel recommends that patients

be introduced to key OTP staff members as

early as possible during the acute phase to 

foster an atmosphere of safety, trust, and

familiarity. Patients consistently report that a

strong therapeutic relationship is one of the

most critical factors

influencing treatment

outcomes and that

therapistsí warmth,

positive regard, and

acceptance are major

elements in relationship development

(Metcalf et al. 1996).

Treatment providers

should minimize waiting times during

scheduled appointments to demonstrate

that they value

patientsí time. In

addition, when

providers remain flexible and available

during the acute

phase, they contribute

to patientsí sense of

security. Knowing how

to reach staff in an emergency can foster

patientsí trust in treatment providers.

Motivation and patient 

readiness

As discussed in chapter 4, patient motivation 

to engage in treatment is a predictor of retention and should be reassessed continually.

Counselors should explore and address

patientsí negative treatment experiences. It

might help to acknowledge the weaknesses of

past staff efforts and to focus on future actions

to move treatment forward. Counseling and

motivational enhancement are discussed in

detail in chapter 8.

Phases of Treatment

Patients...report

that a strong 

therapeutic 

relationship is one

of the most critical

factors influencing

treatment 

outcomes...
The level of patient engagement during the

acute phase is critical. Research has shown that

patient motivation, staff engagement, and the

trust developed during orientation and the

acute phase are linked more closely to treatment outcomes than patientsí initial reasons for

entering an OTP (Kwiatkowski et al. 2000;

Marlowe et al. 2001).

Transition to the rehabilitative

phase

The panel recommends the following criteria for

transition from the acute to the rehabilitative

phase:

ï Amelioration of signs of opioid withdrawal

ï Reduction in physical drug craving

ï Elimination of illicit-opioid use and reduction

in other substance use, including abuse of

prescription drugs and alcohol

ï Completion of medical and mental health

assessment

ï Development of a treatment plan to address

psychosocial issues such as education, vocational goals, and involvement with criminal

justice and child welfare or other social 

service agencies as needed

ï Satisfaction of basic needs for food, clothing,

shelter, and safety.

Rehabilitative Phase

The primary goal of the rehabilitative phase of

treatment is to empower patients to cope with

their major life problemsódrug or alcohol

abuse, medical problems, co-occurring disorders, vocational and educational needs, family

problems, and legal issuesóso that they can

pursue longer term goals such as education,

employment, and family reconciliation.

Stabilization of dosage for opioid treatment

medication should be complete, although

adjustments might be needed later, and patients

should be comfortable at the established dosage

for at least 24 hours before the rehabilitative

phase can proceed. Exhibit 7-2 summarizes 

the treatment issues addressed during the 

rehabilitative phase, strategies for addressing

them, and indicators for subsequent transition

to the supportive-care phase.

As stated for the acute phase, during the 

rehabilitation phase treatment, providers

should continue to assist or provide referrals

for patients who need help with legal, educational, employment, medical, and financial

problems that threaten treatment retention

(Condelli 1993).

Throughout this phase, efforts should increase

to promote participation in constructive activities such as full- or part-time employment, 

education, vocational training, child rearing,

homemaking, and volunteer work. As patients

attend to other life domains, requirements for

frequent OTP attendance or group participation should not become barriers to employment,

education, or other constructive activities or

medical regimens. Consequently, program policies in areas such as take-home medications and

dosing hours should be more flexible in the

rehabilitative phase, especially when patients

must travel long distances to their OTP or

receive medication at restricted hours.

The consensus panel recommends that information about outside support groups, including

faith-based, community, and 12-Step groups,

be reviewed with patients in the rehabilitative

phase and that patients be urged to participate

in such groups, assuming that these groups support MAT. As discussed in chapter 14, OTPs

also should cultivate direct relationships with

organizations that might lend support for

patient recovery. Faith-based organizations

can provide spiritual assistance, a sense of

belonging, and emotional support, as well as

opportunities for patients to contribute to their

communities, and in the process can educate

community members about MAT.

Relapse triggers or cues such as boredom, 

certain locations, specific individuals, family

problems, pain, or symptoms of co-occurring

disorders might recur during the rehabilitative

phase and trigger the use of illicit drugs or

abuse of prescription drugs or alcohol. Helping

108 Chapter 7
Phases of Treatment 109

Exhibit 7-2 

Rehabilitative Phase of MAT

Treatment Issue Strategies To Address Issue

Indications for Transition 

to Supportive-Care Phase

Alcohol and drug use

ï Continued opioid use 

ï Continued abuse of

other substances (e.g.,

alcohol, cocaine, 

nicotine)

ï Begin behavioral contracting 

ï Start short-term inpatient 

treatment 

ï Introduce disulfiram for alcohol abuse 

ï Provide pharmacotherapy and

cessation groups for tobacco

use

ï Intensify treatment services 

ï Introduce positive incentives:

take-home medication, recognition of progress 

ï Adjust dosage as necessary to 

prevent continued opioid use 

ï Encourage participation in

support groups and family

therapy

ï Ability to identify and 

manage relapse triggers 

ï Repertoire of coping skills 

ï Demonstrated changes 

in life circumstances to 

prevent relapse 

ï Discontinuation of opioid

and other drug use 

ï Absence of problem 

alcohol use 

ï Smoking cessation plan

Medical concerns 

ï Chronic diseases (e.g.,

diabetes, hypertension,

seizure disorders, cardiovascular disease) 

ï Infectious diseases (e.g.,

HIV/AIDS, TB, hepatitis B and C, sexually

transmitted diseases)

ï Susceptibility to 

vaccine-preventable

diseases 

ï Dental problems, 

nicotine dependence

ï Womenís health issues

(e.g., pregnancy, family

planning services)

ï Ensure onsite primary care or

link to other services 

ï Provide integrated treatment

approach

ï Provide routine TB testing as

appropriate

ï Provide education on diet, 

exercise, smoking cessation

ï Provide vaccinations as 

indicated

ï Adjust other medications that

interfere with treatment medication or adjust dosage of

treatment medication

ï Assess need and refer patient

for pain management 

ï Compliance with treatment for chronic diseases 

ï Improved overall health

status 

ï Improved dental health

and hygiene 

ï Regular prenatal care 

ï Stable medical and mental

health status 

(continued on following page)
110 Chapter 7

Exhibit 7-2 

Rehabilitative Phase of MAT (continued)

Treatment Issue Strategies To Address Issue

Indications for Transition

to Supportive-Care Phase

Co-occurring 

disorders

ï Psychotic, anxiety,

mood, posttraumatic stress, or personality disorders

ï Evaluate status

ï Teach coping skills 

ï Ensure early identification and referral for co-occurring disorders 

ï Refer for psychotropic medication or

psychotherapy as indicated 

ï Stable mental status 

and compliance with 

psychiatric care

Vocational and 

educational needs 

ï Unemployment/

underemployment 

ï Low reading skills 

ï Illiteracy 

ï Learning disabilities

ï Identify education deficiencies 

ï Provide onsite general equivalency

diploma (GED) counseling or referral 

ï Provide literacy and vocational training with community involvement 

ï Provide training on budgeting of 

personal finances 

ï Provide employment opportunities

or referral to a job developer

ï Stable source of income 

ï Active employment

search

ï Involvement in productive activity: school,

employment, volunteer

work 

Family issues 

ï Absence of family 

support system 

ï Emergence of family

problems (e.g.,

traumatic family

history, divorce,

other problem 

situations) 

ï Involve community or faith-based,

fellowship, recreation, or other peer

group 

ï Increase involvement in family life

(in absence of family dysfunction

that impedes progress) 

ï Provide for well-child care 

ï Social support system

in place 

ï Absence of major 

conflict within support

system 

ï Increased responsibility for dependents 

Legal problems 

ï Criminal charges 

ï Custody battles 

ï Ongoing illegal

activities 

ï Provide access to legal counsel 

ï Encourage patient to take responsibility for legal problems 

ï Identify obstacles to eliminating illegal

activities and replace them with constructive activities 

ï Resolution of, or 

ongoing efforts to

solve, legal problems 

ï Absence of illegal 

activities 
patients develop skills to cope with triggers

should be emphasized in this phase (Sandberg

and Marlatt 1991) and might involve individual, group, or family counseling or participation

in groups focused on relapse prevention. (For a

discussion of relapse prevention, see chapter 8.)

Many factors that receive emphasis in the acute

phase should continue to be addressed in the

rehabilitative phase:

ï Continued alcohol and prescription drug

abuse and use of illicit drugs

ï Ongoing health concerns

ï Acute and chronic pain management

ï Employment, formal education, and other

income-related areas

ï Family relationships and other social supports

ï Legal problems

ï Co-occurring disorders

ï Financial problems.

Continued alcohol and 

prescription drug abuse and

use of illicit drugs

The consensus panel recommends that elimination of alcohol abuse, illicit-drug use, and inappropriate use of other substances be required

to complete the rehabilitative phase. Evidence

of heavy alcohol use might warrant that a

patient return to the acute phase. If a patient is

using medications, particularly drugs of potential abuse prescribed by a nonprogram physician, the patient should be counseled to advise

his or her OTP physician of these prescriptions

and should sign an informed consent statement

permitting OTP staff and the outside physician

to discuss these prescriptions. If drug use is

illicit or unapproved by the OTP physician,

then group, family, and individual counseling

should continue, and the patient should remain

in the rehabilitative phase. Patients who continue to use illicit drugs or demonstrate alcohol

use problems are not eligible for take-home

medication. Take-home medication should 

not be considered until these patients have

demonstrated a period of abstinence. Patients

also should receive information on the risks of

smoking, both for their own recovery and for

the health of those around them. (See chapter

11 for techniques to treat continued substance

use during MAT and chapter 8 for counseling

and behavior modification strategies.) 

The frequency of drug testing during the 

rehabilitative phase and all subsequent phases

should depend on a patientís progress in treatment. The consensus panel recommends that,

once a patient is progressing well and has consistently negative drug tests, the frequency of

random testing be decreased to once or twice

per month. The criteria for this should be part

of the treatment plan. (See chapter 9 for a

detailed discussion of drug testing.)

Ongoing health concerns

As patients advance in the rehabilitative phase,

they should attend to other medical problems,

and OTP staff should help them navigate the

medical- and dental-care systems, while educating practitioners about MAT. Onsite primary

health care is optimal and has been instituted

successfully in many OTPs and can result in

better outcomes for patients (Weisner et al.

2001), although it requires careful coordination

of activities and staff (Herman and Gourevitch

1997). When lack of resources precludes onsite

medical services in an OTP, referral arrangements with other service providers should be

in place.

The consensus panel recommends a more 

integrated approach to patient health in the

rehabilitative phase. A patientís health needs

should be diagnosed and treated immediately.

Education about topics with longer term benefits, such as nutrition, exercise, personal

hygiene, sleep, and smoking cessation, can be

started. Eventually, patients should demonstrate adherence to medical regimens for their

chronic conditions and address any acute 

conditions before they are considered for transition from the rehabilitative phase to subsequent treatment phases.

Phases of Treatment 111
Acute and chronic pain 

management

Patients in OTPs are at high risk of undertreatment for pain (Jamison et al. 2000;

Rosenblum et al. 2003; Scimeca et al. 2000).

Chapter 10 provides recommendations for pain

management. Because acute pain treatment

usually involves opioid medications, programs

should work with patients to recognize the risk

of relapse and provide supports to prevent it

(Jamison et al. 2000). 

Employment, formal 

education, and other 

income-related issues

The consensus panel believes that some of the

most difficult obstacles to a stable life for MAT

patients include unemployment and inadequate

funds to live comfortably and safely. Most such

limitations should be addressed during the

rehabilitative phase. (See chapter 8 for detailed

discussion.)

Individuals who need access to high-quality

social services should be identified during the

rehabilitative phase for educational, literacy,

and vocational programs that will equip them

with the skills needed to function independently.

Chapters 6 and 8 discuss such assistance. TIP

38, Integrating Substance Abuse Treatment and

Vocational Services (CSAT 2000c), provides

more information on this topic.

Ideally, OTPs should provide onsite GED

counseling and assistance or make referrals to

local adult education programs that are sensitive

to the needs of patients in MAT. Efforts can 

be made to encourage business, industry, and

government leaders to create income-generating

enterprises that provide patients with job skills

and opportunities for entry into the job market

and to preclude employment discrimination 

for patients.

Patients in MAT face unique employment 

challenges, especially as employers increasingly

impose preemployment drug testing and

patients must wrestle with whether to disclose

their status. The panel recommends that 

vocational training provided in an OTP include

basic education about drug testing, including

the fact that methadone may be detected.

Patients should be advised to answer all job

application questions honestly and should be

counseled on ways to manage disclosure of their

treatment status. Patients with disabilities

should be educated about the basics of the

Americans with Disabilities Act and any local

antidiscrimination legislation and enforcement.

By the end of the rehabilitative phase, patients

should be employed, actively seeking employment, or involved in a productive activity such

as school, child rearing, or regular volunteer

work. They should have a stable source of legal

income, whether from employment, disability

benefits, or other legitimate sources, ensuring

that they can avoid drug dealing or other 

criminal activities to obtain money.

Family relationships and

other social supports

Broken trust, disappointment, anger, and 

conflict with family members and acquaintances are realities that patients should face

during the rehabilitative phase. Many need to

reconcile with their families, reunite with or

regain custody of their children, and handle

other family issues. Some patients have had 

little or no family contact during the period of

their opioid addiction. Counselors need to help

patients improve their social supports and relationships and begin to rebuild and heal severely

damaged family relationships. Chapter 8

expands on these goals for patients in MAT.

Transition from the rehabilitative phase should

require that patients have a social support system in place that is free of major conflicts and

that they assume increased responsibility for

their dependents (e.g., by reliably providing

child support).

Legal problems

The stress associated with patientsí legal 

problems can precipitate relapse to illicit drug

112 Chapter 7
use or abuse of alcohol or prescription drugs.

Counselors should probe patientsí legal circumstances, such as child custody obligations, and

patients should be encouraged to take responsibility for their actions; however, counselors

should help patients remain in treatment while

resolving pending legal problems. During the

rehabilitative phase, counselors should help

patients overcome guilt, fear, or uncertainty

stemming from their legal problems. In addition, OTP staff should ensure that patients have

access to adequate legal counsel, for instance,

through a public defender. All major legal problems should be in the process of resolution

before patients move beyond the rehabilitative

phase. Drug courtsí referrals of patients can

result in reporting requirements and specialized

protocols (see CSAT 2005a).

Co-occurring disorders

The consensus panel recommends that, before

patients move beyond the rehabilitative phase,

co-occurring disorders be alleviated or stabilized. Although symptoms might continue to

arise, patients should have adequate coping

skills to avoid relapse to opioid abuse. Chapter

12 provides specific information about cooccurring disorders in MAT.

Supportive-Care Phase

After meeting the criteria for transition from

the rehabilitative phase, patients should

progress to the supportive-care phase, in which

they continue opioid pharmacotherapy, participate in counseling, receive medical care, and

resume primary responsibility for their lives.

During this phase, patients should begin to

receive take-home medication for longer periods

and be permitted to make fewer OTP visits.

Depending on regulations (State regulations

often are more stringent than Federal), these

patients might visit their OTP as infrequently as

every other week. Often, supportive care provided in an OTP can be augmented by supportive activities through mutual-help, community,

faith-based, peer, and acculturation groups.

Exhibit 7-3 summarizes the treatment issues

that should be addressed during the supportivecare phase, strategies for addressing them, and

indicators for the subsequent transition from

the supportive-care phase to medical maintenance or tapering.

Patients should have discontinued alcohol and

prescription drug abuse and all illicit-drug use,

as well as any involvement in criminal activities,

before entering the supportive-care phase.

Heavy or problem substance use should result

in patientsí return to the acute phase. Patients

in supportive care should be employed, actively

seeking employment, or involved in other productive activities, and they should have legal,

stable incomes. Even though all treatment

plans and patientsí progress should be assessed

individually, if any requirements largely are

unmet, counselors should consider returning

these patients to the rehabilitative phase to

address areas of renewed concern rather than

advancing them to the medical maintenance or

tapering phase.

After patients in supportive care are abstinent

from illicit drugs or are no longer abusing 

prescription drugs (as confirmed by treatment

observation and negative drug tests) for a

specified period, they

should be considered

for transition to either

the medical maintenance or the tapering

phase. Opinions vary

on the length of time

patients should be

free from illicit-drug

use and abuse of prescription drugs before

being allowed to move

to the next phase.

However, to receive

the maximum 30-day

supply of take-home

medication, a patient must be demonstrably

free from illicit substances for at least 2 years

of continuous treatment (42 CFR, Part 8 ß

12(i)(3)(vi)). The consensus panel believes that

Phases of Treatment 113

Heavy or problem

substance use

should result in

patientsí return to

the acute phase.
114 Chapter 7

a period of treatment compliance lasting

between 2 and 3 years usually is appropriate.

However, the length of time a patient remains

in supportive care should be based entirely on

his or her needs and progress, not on an

imposed timetable. Patientsí progress in coping

with their life domains should be assessed at

least quarterly to determine whether patients

are eligible and ready for transition from supportive care to either the medical maintenance

or tapering phase.

In some cases, patients who stop opioid abuse

and demonstrate compliance with program

rules do not make progress in other life

domains. Although such patients might do well

in MAT, they still need the ongoing support and

pharmacotherapy provided by the OTP and, in

the opinion of the consensus panel, should be

deemed ineligible or inappropriate candidates

for either medical maintenance or tapering.

Instead, these patients should continue to

receive take-home medication for brief periods

(e.g., 1 to several days) along with other services

as needed.

The criteria for transitioning to the next phase

of treatment depend on whether the patient is

entering the medical maintenance phase or the

tapering and readjustment phase.

Medical Maintenance Phase

In the medical maintenance phase, stabilized

patients who continue to require medication to

remain stable are allowed longer term (up to

30-day) supplies of take-home medication and

further reductions in the frequency of treatment visits, generally without the suite of services included in comprehensive MAT. Medical

Exhibit 7-3 

Supportive-Care Phase of MAT

Treatment

Issue Strategies To Address Issue

Indications for Transition

to Next Phase

Alcohol and

drug use

ï Monitor use

ï Increase frequency of drug screening

ï Discontinued drug use

and no problems with

alcohol use

Medical and

mental health

concerns

ï Monitor compliance with medical/psychiatric

regimens

ï Maintain communication with patientsí

health care and mental health care providers

ï Stability

Vocational

and educational needs

ï Monitor vocational status and progress

toward educational goals

ï Assist in addressing workplace problems

ï Stable source of income

Family issues ï Monitor family stability and relationships

ï Refer for family therapy as needed

ï Stability

Legal issues ï Monitor ongoing legal issues

ï Provide needed support 

ï Resolution
Phases of Treatment 115

maintenance with methadone can be administered through an OTP or through the office of

a qualified physician who operates under

Substance Abuse and Mental Health Services

Administration (SAMHSA) approval as a 

ìmedication unitî (42 CFR, Part 8 ß 11(h)) and

is linked formally to an OTP. Federal regulations (42 CFR, Part 8 ß 12(i)(3)(vi); 42 CFR,

Part 8 ß 11(h)) permit various levels of takehome medication for unsupervised use, with the

amount linked to the length of time that

patients have been abstinent from illicit opioids

or have stopped abusing prescription opioids

and to other specified conditions. Some State

regulations (e.g., New York) further restrict the

amount of take-home opioid treatment medication and supersede Federal regulations. 

The consensus panel recommends the following

criteria to determine a patientís eligibility for

the medical maintenance phase of treatment:

ï 2 years of continuous treatment

ï Abstinence from illicit drugs and from abuse

of prescription drugs for the period indicated

by Federal and State regulations (at least 2

years for a full 30-day maintenance dosage)

ï No alcohol use problem

ï Stable living conditions in an environment

free of substance use

ï Stable and legal source of income

ï Involvement in productive activities (e.g.,

employment, school, volunteer work)

ï No criminal or legal involvement for at least 

3 years and no current parole or probation

status

ï Adequate social support system and absence

of significant unstabilized co-occurring 

disorders. 

During the medical maintenance phase, OTPs

may play various roles in patientsí primary

medical and mental health care. OTPs that

provide only limited health care services should

integrate their services with those of other

health care providers (see chapters 10 and 

12 about related medical problems and cooccurring disorders, respectively). Exhibit 7-4

summarizes treatment issues and strategies in

the medical maintenance phase of MAT and

provides indicators for transition to physicianís

office-based opioid treatment (OBOT) or the

tapering or continuing-care phases.

In addition, evaluation of life domains 

including substance use, co-occurring medical

and mental problems, vocational and educational needs, family circumstances, and legal

issues should continue during the medical

maintenance phase, regardless of the setting.

Although patients in medical maintenance may

not require psychological services, they may

need occasional dosage adjustments based on

their use of other prescription medication or on

such factors as a change in metabolism of

methadone (see chapter 5).

The consensus panel recommends random drug

testing and callbacks of medication during the

medical maintenance phase to make sure that

patients are adhering to their medication

schedules (see chapter 9). Patients in medical

maintenance should be monitored for risk of

relapse. Positive drug test results should be

addressed without delay, and patients should

be returned to the rehabilitative phase when

appropriate.

The consensus panel recommends that, as part

of the diversion control plan required for all

OTPs by SAMHSA (see chapters 5 and 14), 

evidence of medication diversion by a patient in

medical maintenance result in reclassification of

that patient to the most appropriate previous

phase of treatment and in adjustment of 

treatment, other services, and privileges.

Reinstatement into medical maintenance

should occur only after the phase-regressed

patient is observed over a reasonable period 

(at least 3 to 6 months) and has demonstrated

required progress.

Considerations for OBOT with

methadone

OBOT may be considered for patients receiving

methadone in MAT in an OTP who have

demonstrated stability in all domains for at
116

least 2 consecutive years of treatment. If a

patient in medical maintenance who is receiving

treatment through OBOT relapses (to opioid,

other drug, or alcohol abuse) or needs the

structure of an OTP for psychosocial reasons,

the treating physician is responsible for 

referring the patient back to an OTP. There

are some exceptions in which patients, early in

treatment, can be transferred from an OTP to

OBOT with methadone (e.g., when travel to an

OTP is impossible or there are medical reasons),

but these exceptions must be preapproved by

SAMHSA (see chapter 5).

Coordination of care is critical in the OBOT

model so that patients get the full range of services needed to remain abstinent. Treatment

issues listed in Exhibits 7-1, 7-2, and 7-3 also

are applicable to patients who receive OBOT.

Regardless of the opioid treatment medication

used, treatment of opioid addiction requires a

comprehensive and individualized treatment

approach that includes medication and counseling services. Even for patients who are 

rehabilitated and stable enough to qualify for

medical maintenance, medication alone often is

inadequate to treat their opioid addiction

(Joseph et al. 2000).

Tapering and Readjustment

Phase

ì Taperingî and ìmedically supervised withdrawalî are terms commonly used to describe

the gradual reduction and elimination of maintenance medication during opioid addiction

treatment. (The term ìdetoxificationî in this

TIP refers to tapering from illicit drugs, from

inappropriate use of prescription drugs, or

from alcohol abuse, not to tapering from treatment medication, to avoid the implication that

treatment medications are toxic.) Studies show

that most patients who are opioid addicted try 

Chapter 7

Exhibit 7-4 

Medical Maintenance Phase of MAT

Treatment Issue Strategies To Address Issue

Indications for Transition

to OBOT or Tapering or

Continuing-Care Phases

Alcohol and drug use ï Monitor use

ï Perform drug testing

ï Continuous stability for

2 years

Medical and mental

health concerns

ï Monitor compliance

ï Maintain communication

ï Stability

Vocational and educational needsï Monitor progress

ï Remain available to address workplace problems

ï Stability

Family issues ï Monitor family stability

ï Refer to family therapy as needed

ï Stability

Legal issues ï Monitor ongoing legal issues

ï Provide support as needed

ï Stability
117

to taper from treatment medication one or

more times after reaching and maintaining stability. With proper support systems and skills,

many patients succeed in remaining abstinent

from opioids without treatment medication for

years or even life, but studies have shown that

some relapse to opioid abuse (Condelli and

Dunteman 1993; Hubbard et al. 1989; Kreek

1987). Chapter 5 describes procedures and

other key considerations in tapering. In the

phased model presented here, tapering is considered an optional branch.

It is important that any decision to taper from

opioid treatment medication be made without

coercion and include careful consideration of a

patientís wishes and preferences, level of motivation, length of addiction, results of previous

attempts at tapering, family involvement and

stability, and disengagement from activities

with others who use substances. A patient considering dose tapering should understand that

the chance of relapse to drug use remains

(Magura and Rosenblum 2001) and some level

of discomfort exists even if the dose is reduced

slowly over months (Moolchan and Hoffman

1994). Patients should be assured that they

temporarily can halt the reductions or return

to a previous methadone dosage if tapering

causes problems.

As medication is being tapered, intensified services should be provided, including counseling

and monitoring of patientsí behavioral and

emotional conditions. Patients considered for

medication tapering should demonstrate sufficient motivation to undertake this process,

including acceptance of the need for increased

counseling. Tapering from medication can be

difficult, and patients should understand the

advantages and disadvantages of both tapering

from and continuing on medication maintenance as they decide which path is best for

them. Exhibit 7-5 presents treatment issues

during the tapering phase, strategies to address

these issues, and indicators for return to a previous phase.

Reasons for tapering

Sometimes decisions to taper are motivated by

the hardships of OTP attendance and other

requirements or by the stigma often associated

with MAT. The consensus panel urges OTPs to

identify such situational motives and ensure

that patients who choose medically supervised

withdrawal from MAT are motivated instead by

legitimate concerns about health and relapse.

Patients and treatment providers might fail to

realize or understand that continuing or longterm MAT is the best choice for some patients.

OTP staff members consciously or inadvertently might convey that tapering is more desirable

or expected than continuing opioid pharmacotherapy, through such practices as celebrating patientsí tapering but not the accomplishments of others who successfully continue in

MAT. The consensus panel believes that a basic

grounding in MAT pharmacology, the biology

of addiction, and the endorphin system helps

patients and treatment providers understand

that both successful tapering from and continued compliance with medical maintenance

treatment are legitimate goals and commendable accomplishments.

Relapse after tapering

The risk of relapse during and after tapering is

significant because of the physical and emotional stress of attempting to discontinue medication (Magura and Rosenblum 2001). The consensus panel recommends that patients be

encouraged to discuss any difficulties they

experience with tapering and readjustment so

that appropriate action can be taken to avoid

relapse. Patients should be persuaded to

return to a previous phase if the need is indicated at any time during tapering. Patients also

should be told that they can taper at their own

rate, that successful tapering sometimes takes

many months, and that they can stop tapering

or increase their dosage at any time without a

sense of failure. Patients should be educated

about how to reenter MAT if they believe that

relapse is imminent.

Phases of Treatment
118

Readjustment

Many patients who complete tapering from 

opioid medication continue to need support

and assistance, especially during the first 3 to

12 months, to readjust to a lifestyle that is 

free of both maintenance medication and 

substances of abuse. During this period, treatment providers should focus on reinforcing

patientsí coping and relapse prevention skills.

Patientsí primary goals should be to increase

self-sufficiency and maintain balanced, stable,

and productive lifestyles. Participation in 

12-Step or other mutual-help groups is recommended as reliance on the OTP is gradually

reduced. Motivated patients might be helped

by continued naltrexone therapy (see chapter

3), which blocks opioid effects for 2 to 3 days

in appropriate doses. Care must be taken 

to initiate naltrexone well after tapering is 

completed to avoid precipitating withdrawal

symptoms. Other patients might benefit from

continued counseling to strengthen relapse 

prevention skills. Some patients might find the

support of continued drug testing helpful after

tapering. Other recommended strategies

include problemsolving counseling approaches,

reinforcement of positive behaviors and attitudes, an open-door policy to maximize availability of counselors and providers, steps to

strengthen patientsí own support systems, and

development of a relapse prevention plan,

including how to return to MAT if necessary.

Chapter 7

Exhibit 7-5 

Tapering Phase of MAT

Treatment Issue Strategies To Address Issue

Indications for Return to a

Previous Treatment Phase

Alcohol and drug use ï Monitor use

ï Increase drug testing

ï Increase counseling support

ï Relapse or concern about

relapse to opioid use

ï Positive drug test for an illicit

substance

Medical and mental

health concerns

ï Monitor compliance

ï Maintain communication with

health care providers

ï Continue education

ï Unstable health issues

Vocational and educational needsï Monitor progress

ï Be available to address 

workplace problems 

ï Instability

ï Loss of employment

Family issues ï Monitor family stability

ï Refer to family therapy as

needed

ï Instability

ï Death or loss of loved one

ï Unstable housing

Legal issues ï Monitor ongoing legal issues

ï Provide support as needed

ï New criminal involvement
Reversion to MAT

The consensus panel recommends that all

patients attempting tapering be counseled that

a return to medication and a previous phase

does not represent failure but simply that medical maintenance is more appropriate for some

patients in general and for others at particular

times in their lives.

Indicators for transition

Successful discontinuation of medication is a

key indicator for transition from the tapering

phase to the continuing-care phase. Another

key indicator is a positive self-image as someone

who feels and functions well without medication. Adoption of a socially productive lifestyle

without involvement with substances of abuse

also is critical to completing this phase and to

continued recovery. The absence of signs and

symptoms of abuse or dependence, as defined

by the Diagnostic and Statistical Manual of

Mental Disorders, Fourth Edition, Text

Revision, (DSM-IV-TR) (American Psychiatric

Association 2000) indicates successful completion of tapering. 

Continuing-Care Phase

Continuing care is the phase that follows successful tapering and readjustment. Treatment

at this stage comprises ongoing medical followup by a primary care physician, occasional

check-ins with an OTP counselor, and participation in recovery groups. Ongoing treatment,

although less intense, often is necessary

because the chronic nature of opioid addiction

can mean continuous potential for relapse to

opioid abuse for some patients.

Patients in continuing care should have a socially productive lifestyle, no involvement with

drugs or problem involvement with alcohol, and

improved coping skills demonstrated over at

least 1 year. Significant co-occurring disorders

should be well under control. People in this

phase should continue to participate regularly

in mutual-help groups, but regular attendance

at an OTP should be unnecessary, except to

return to a more intensive level of treatment if

necessary for continuation of recovery.

The panel recommends that appointments with

the OTP continue to be scheduled every 1 to 3

months, although many programs prefer that

patients in continuing care maintain at least

monthly contact. Although many programs 

curtail this contact after 6 to 12 months, others

maintain ongoing contact with patients to assist

them in maintaining their medication-free

lifestyle. Some patients might not need 

continuing-care services after tapering, preferring instead a complete break from the OTP.

Others might need more extensive continuing

care, perhaps including referral to a non-MAT

outpatient program that more closely fits their

needs.

Transition Between

Treatment Phases in

MAT

Characteristics of the recommended treatment

phases are not immutable, and the criteria for

transition between phases are not intended to

be rigidly interpreted or enforced. The treatment system should be flexible enough to allow

for transition according to a patientís progress

and circumstances. The program should modify

treatment based on the best interests of patients,

rather than infractions of program rules.

Occasional relapses to drug use might not

require that a patient return to the acute phase

but instead that he or she receive intensified

counseling, lose take-home privileges, or

receive a dosage adjustment. If a patient is in

the medical maintenance phase or the tapering

and readjustment phase, a relapse often

requires a rapid response and change of phase.

In these cases, the patient might be reclassified

into the rehabilitative phase. After providing

evidence that problems are under control, the

patient might be able to return to the 

supportive-care or medical maintenance phase.

Phases of Treatment 119
120

Readmission to the

OTP

The consensus panel emphasizes that patients

almost always should be encouraged to remain

in treatment at some level and that pharmacotherapy should be reinstituted unreservedly

for most previously discharged patients if and

when relapse occurs or seems likely. Feelings of

shame, disappointment, and relapse-related

guilt, especially for rehabilitated patients who

have close relationships with staff members,

should not be allowed to inhibit patients from

seeking reentry to treatment. The consensus

panel recommends that all patients be informed

at entry to the OTP that subsequent reentry is

common and can be accomplished more quickly than initial intake because regulations waive

documentation of past addiction for returning

patients (42 CFR, Part 8 ß 12(e)(3)). All obstacles to reentry should be minimized.

Chapter 7
121

8 Approaches to

Providing 

Comprehensive Care

and Maximizing

Patient Retention

In This

ChapterÖ

Core Services

Retaining Patients

in MAT

Counseling and

Case Management,

Behavioral

Treatments, and

Psychotherapy

Benefits of Family

Involvement

Integrative

Approaches

Relapse Prevention

Referral to Social

Services

Involuntary

Discharge From

MAT

Patient Advocacy

A core group of basic- and extended-care services is essential to the effectiveness of medication-assisted treatment for opioid addiction (MAT) in

opioid treatment programs (OTPs). Numerous studies support the belief

that psychosocial interventions contribute to treatment retention and

compliance by addressing the social and behavioral problems and cooccurring disorders affecting patients in MAT (e.g., Brooner and Kidorf

2002; Joe et al. 2001). The consensus panel agrees that a well-planned

and well-supported comprehensive treatment program increases patient

retention in MAT and the likelihood of positive treatment outcomes.

Core Services

Basic-Care Services

The minimum required services for MAT are outlined in Federal regulations (42 Code of Federal Regulations [CFR], Part 8), but individual

program requirements vary according to State standards, accreditation

requirements, and local factors. The consensus panel recommends that

OTPs offer at least the following services:

ï Comprehensive psychosocial assessment (see chapter 4)

ï Initial and yearly medical assessment (physical examination and laboratory testing [see chapter 10])

ï Medication dispensing (see chapter 5)

ï Drug tests (see chapter 9)

ï Identification of co-occurring disorders and neuropsychological problems (see chapter 12)

ï Counseling to stop substance abuse and manage drug craving and urges

ï Evaluation of and interventions to address family problems

ï HIV and hepatitis C virus (HCV) testing, education, counseling, and

referral for care

ï Referral for additional services as needed.
122

Extended-Care Services

Many patients in MAT have other problems

affecting their recovery, including medical,

social, family, vocational, and legal problems

and co-occurring disorders. Assessing and

addressing these problems are important to

facilitate recovery from addiction. Various

strategies have been developed, including psychosocial and biomedical interventions and

peer-support approaches.

Managing an OTP To Meet

Service Needs

Substances of abuse

Increasingly since the 1980s, patients have

entered OTPs with other addictions, particularly to alcohol, cocaine, marijuana, nicotine,

or other sedatives and stimulants. In addition,

adolescent and young adult patients often

smoke or snort rather than inject heroin, and

more patients are addicted to opioid analgesics,

such as oxycodone, taken orally (see chapter

11). To manage these developments, OTPs

should evaluate and modify their core substance abuse treatment services continuously,

based on the changing needs of their patient

populations.

Medical needs

People addicted to opioids are at greater risk

for sexually transmitted diseases (STDs), pneumonia, and other debilitating conditions that

require intensive medical services. Infected

injection sites, cellulitis, and abscesses are

increasingly common. Bacterial endocarditis

remains a concern. Long-term tobacco use contributes to other diseases. Chapter 10 details

the medical problems of todayís patients in

MAT and the treatment approaches recommended in OTPs.

Staffing needs

Program administrators need to develop 

comprehensive patient population profiles for

planning, staffing, and resource allocation.

Managers should provide an appropriate mix of

staff for specific patient characteristics and

needs and should determine the range of services that can be provided with available funds.

Unfunded services should be covered by referral to affiliated agencies. Positive, sustained

outcomes are more attainable in a therapeutic

environment with readily available, supportive,

qualified caregivers. It is difficult to provide

high-quality care and facilitate favorable treatment outcomes in a chaotic OTP environment

with unqualified or overburdened staff and

managers and unreasonable caseloads.

Offsite treatment options

The consensus panel urges OTPs to provide as

many basic- and extended-care services as possible on site. OTPs that lack the resources to

provide or sponsor the comprehensive list of

services recommended in this TIP should

engage in active case management while working with other agencies and specialized service

providers and educating these collaborators

about MAT. Accreditation requirements

increasingly are motivating OTPs to pursue

these collaborations.

Retaining Patients 

in MAT

Importance of Retention

Studies of patients who left MAT prematurely

have determined that length of retention was

the most important indicator of treatment outcomes (e.g., Simpson, D.D., et al. 1997b).

Patients who stayed in treatment a year or

longer abused substances less and were more

likely to engage in constructive activities and

avoid criminal involvement than those who left

treatment earlier, although all patients benefited from treatment, for instance, through less

exposure to and transmission of infectious diseases (Hartel and Schoenbaum 1998). Their

communities benefited as well.

Chapter 8
Improving Patient Retention

Factors affecting patient

retention

Patient characteristics, behavior, and other

factors unrelated to treatment have been found

to contribute relatively little to retention in

MAT. One comprehensive study found that

retention was determined almost entirely by

what happened during treatment, not before,

although two factors, older age and less

involvement with the criminal justice system,

predicted longer retention (Magura et al. 1998,

1999). Another factor found to affect retention

was motivation or readiness for treatment (Joe

et al. 1998).

In other studies, how patients entered OTPs,

whether voluntarily or by a court referral, did

not affect treatment retention (Brooner et al.

1998; Fallon 2001). Rhoades and colleagues

(1998) reported that patients who previously

received methadone were more likely to remain

in MAT than first-time patients. Some patients

require several attempts at treatment before

becoming stabilized for extended periods

(Koester et al. 1999). OTPs should not consider

patientsí prior failures indicative of future

compliance or retention or use these failures as

reasons to reject those seeking readmission.

Some patients may need longer periods of

adjustment to MAT before making a long-term

commitment.

Recommended steps to

improve patient retention

Individualize medication dosages. Adequate,

individualized medication dosages are probably

the most important factor in patient retention

(Joseph et al. 2000) because they contribute to

patient comfort and satisfaction by reducing

withdrawal symptoms and craving and enabling

more attention to other concerns (reviewed in

Leavitt et al. 2000; Strain et al. 1999). (See

chapter 5 for further discussion of prescribing

practices in MAT.)

Clarify program goals and treatment plans.

Treatment providers should explain program

goals and treatment plans to every patient.

Inconsistent messages adversely affect patient

retention, particularly when these messages are about the

advisability of

remaining in MAT

versus tapering from

medication (Magura

and Rosenblum

2001). Goals related

to medication should

be individualized and

respectful of patientís

wishes and goals, but

they should incorporate knowledge and

research about retention in MAT.

Treatment planners

should realize that,

regardless of OTP recommendations, some

patients want to taper from maintenance medication more quickly than seems advisable. Staff

should work with these patients to achieve their

goals in a reasonable timeframe.

OTP practices and communication with

patients should conform to best treatment practices. Setting maximum lengths of stay for all

patients or emphasizing low-dose medication

goals can discourage retention and produce

poor outcomes (Magura and Rosenblum 2001).

Rigid operating practices (e.g., requiring 

extensive travel, inconvenient hours, long

waits, frequent pickups) may lower retention

and disrupt treatment. Patients have cited

other factors that discourage retention, such as

staff insensitivity, lack of treatment skills and

knowledge, and limited contact.

Simplify the entry process. Shortening 

intake results in better program retention (see

chapter 4). 

Attend to patients’ financial needs. Patientsí

inability to pay may limit both treatment entry

and retention, especially in States where MAT

Providing Comprehensive Care and Maximizing Patient Retention 123

[R]etention was

determined almost

entirely by what

happened during

treatment, not

before...
124 Chapter 8

is not covered by Medicaid, State funds, or private insurance. One study found that randomly

offering prospective patients either cost-free

treatment or moderate fee rates significantly

increased treatment entry and retention for the

cost-free patients (Kwiatkowski et al. 2000).

OTP staff members should work proactively

with patients to apply for benefits covering

treatment costs, investigate health insurance

and work with existing insurers, and develop

hardship payment plans.

Reduce the attendance burden.

Attendance requirements can exert powerful effects on

retention. Rhoades

and colleagues

(1998) found that

patients who were

required to visit an

OTP less frequently

were less likely to

drop out of treatment and no more

likely to use other

drugs than patients

on a daily attendance schedule.

Provide useful treatment services as early as

possible. Patients were more likely to stay in

treatment when they were motivated strongly

and engaged earlier in useful activities

(Simpson, D.D., et al. 1997b). In the critical

first 90 days of treatment, higher service intensities, especially for practical services that

helped patients achieve basic goals, have been

associated with higher retention. Examples

include attentive case management, psychiatric

services, introduction to peer groups, and

assistance with insurance, transportation, and

housing (Grella and Wugalter 1997).

Enhance staff–patient interactions. Good staff

attitudes and interactions with patients have

been associated with higher retention. In one

study, patientsí frequent contact with staff

members and the involvement and visibility of

OTP administrators increased patient retention

(Magura et al. 1999). Some treatment providers

have found that patients are more likely to

remain in treatment when they are involved in

its planning and management. Increased interaction with staff increases communication and

information flow, limits problems, and contributes to patientsí sense of well-being.

Unfortunately, funding constraints often

reduce communication training for staff and

opportunities to improve patient-to-staff ratios.

Improve staff knowledge and attitudes about

MAT. OTP staff members should understand

MAT and appreciate the wealth of science supporting it, and they should be aware of recommended treatment practices so that they can

interact effectively and constructively with

patients. However, Bell (2000) pointed to studies showing that staff training, favorable

patient-to-staff ratios, and better facilities did

not eliminate opioid abuse, and he concluded

that staff attitudes contributed more directly to

outcomes. Staff members should express confidence in MAT when communicating with

patients. Attitudes critical of extended pharmacotherapy have been found to be common (even

dominant) among many counselors (Kang et al.

1997) and evoke frequent patient complaints.

Counseling and Case

Management,

Behavioral Treatments,

and Psychotherapy

Counseling and Case

Management

Patient counseling in individual, family, or

group sessions offers a venue for many treatment approaches and educational interventions. It provides support for a substance-free

lifestyle and abstinence from substances of

abuse. Studies have found that OTPs providing

regular, structured, substance abuse-focused

counseling had better outcomes than OTPs

providing little or no counseling (Kidorf et al.

Staff members

should express

confidence in 

MAT when communicating with

patients.
1999; Magura et al. 1999). Others have 

concluded that good counseling rapport was

related to improved abstinence and reductions

in criminality (e.g., Joe et al. 2001).

The consensus panel recommends that counseling in MAT focus on

ï Providing support and guidance, especially to

eliminate substance use

ï Monitoring other problematic behaviors

ï Helping patients comply with OTP rules

ï Identifying problems that need extended services and referring patients for these services

ï Identifying and removing barriers to full

treatment participation and retention

ï Providing motivational enhancement for 

positive changes in lifestyle.

The standard components of substance abuse

counseling should include

ï Assistance in locating and joining mutual-help

groups or peer support groups such as

Narcotics Anonymous (NA) or Methadone

Anonymous (MA)

ï Education about addiction and the effects of

substances of abuse

ï Education about relapse prevention strategies

ï Identification of unexpected problems needing attention, such as sudden homelessness

ï Assistance in complying with program rules

and regulations

ï Information about stress- and timemanagement techniques

ï Assistance in developing a healthy lifestyle

involving exercise, good nutrition, smoking

cessation, and avoidance of risky sexual

practices

ï Assistance in joining socially constructive

groups such as community organizations and

faith-based groups

ï Continuing education on health issues (particularly HIV/AIDS and hepatitis). 

Counseling sessions to relieve patientsí anxiety

about MAT and reassure them about its efficacy are of paramount importance during the

first weeks of treatment. Usually, individual

sessions during the acute phase (see chapter 7)

are more intensive than those that follow,

although individual needs should dictate the

frequency and duration of counseling.

Individual counseling

As MAT progresses, patients should continue

meeting with counselors in individual sessions,

once per month to several times per week

depending on need, the phase of treatment,

and State regulations. In some States, Medicaid

regulations and contracts require or limit counseling frequency. MAT counselors should continue to identify patientsí needs and refer them

to or arrange for other services (e.g., housing,

medical and psychiatric care, legal services).

A typical individual counseling session, as envisioned by the consensus panel, might include

any of the following activities:

ï Reviewing how a patient feels, is coping with

cravings, or is changing his or her lifestyle

ï Reviewing drug test results and what they

mean

ï Identifying emergencies and deciding how to

address them

ï Reviewing the treatment plan

ï Identifying measurable goals and reasonable

timeframes

ï Reviewing progress in achieving goals, including abstinence and related behaviors

ï Discussing dosage and take-home medications

ï Discussing legal concerns, such as reporting

to probation officers and complying with the

terms of probation or parole

ï Discussing family concerns

ï Providing liaison services (e.g., with physicians, courts, social service agencies)

ï Addressing routine issues (e.g., transportation, childcare).

Medical staff should educate counselors about

patientsí medical problems so that counselors

can help patients understand the importance of

keeping appointments for and complying with

Providing Comprehensive Care and Maximizing Patient Retention 125
126

medical treatment. Counselors should convey

observations to medical staff about patientsí

conditions and information about other aspects

of patientsí lives that might clarify health problems. Although counselors are not expected to

understand medical treatments, pathophysiology, or pharmacotherapy in the same way as

medical professionals do, they should have general knowledge of common medical conditions

affecting patients in MAT and their treatmentsóespecially how treatments for these

conditions can interact with addiction treatment medications. Counselors can help patients

cope with hepatitis C and adhere to its treatment regimens. Many patients have been

exposed to HCV infection (see chapter 10), and

effective treatment requires motivation and

support from the entire treatment team.

Group counseling

Group counseling has some advantages over

individual counseling and therapy (see TIP 41,

Substance Abuse Treatment: Group Therapy

[CSAT 2005c]). It can reduce patientsí sense of

isolation and help them cope with addiction

and other life problems by providing feedback

from peers, social skill training and practice,

structure, discipline, and encouragement.

Through peer interaction, patients contribute

to one anotherís recovery. Trained individuals

should lead these groups. Some State agencies

offer courses in group process and dynamics.

The following types of groups are used commonly in MAT:

ï Psychoeducational groups

ï Skill development groups, such as relapse

prevention, stress management, and substance use cessation groups, which help

patients learn skills to attain and maintain

abstinence

ï Cognitive behavioral groups, in which

patients learn to alter pervasive thoughts and

actions

ï Interpersonal-process groups, which delve

into developmental issues contributing to

addiction or interfering with recovery

ï Support groups, which buoy members and

provide a forum to share pragmatic information about maintaining abstinence and managing a day-to-day substance-free lifestyle.

In some OTPs, group membership is linked to

the phase of a patientís treatment. Some groups

keep the same membership but stay together

for a short time; others are longer term and

have a rolling membershipóthat is, frequent

membership changes, with new members 

entering when they are ready. Neither type of

group needs a predetermined end point or set

timeframe. Using a manual with a structured

curriculum enables counselors and other staff

members to lead some groups (Exhibit 8-1).

Manuals increase flexibility in resource-limited

OTPs and the likelihood that groups cover

standard information. Manuals for group

counseling in MAT are less common than for

general substance abuse counseling. However,

the consensus panel believes that the principles

used for non-MAT groups can be adapted 

easily to groups in MAT.

Some patients resist group counseling and

avoid sessions. Offering smaller groups might

ease their concerns while therapists explore the

reasons for their resistance (e.g., fear of talking

in groups or confidentiality concerns). In general, an OTP should consider a groupís patient

mix. Some patients with co-occurring disorders

do better in groups with members who have

similar conditions. However, some patients

with severe co-occurring disorders cannot participate in groups, and some have problems

that require individual counseling.

A patientís gender or sexual orientation can be

important in choosing individual or group

counseling. Some women are uncomfortable in

male-dominated groups and do better in

women-only groups. Others feel embarrassed

about personal subjects related to their addiction. Gay men, lesbians, and bisexuals might

feel isolated in predominantly heterosexual

groups. In such cases, the consensus panel 

recommends individual, women-only, or 

sexual-orientation-specific groups.

Chapter 8
Social services case 

management 

Some researchers have investigated the usefulness of social service-focused case management

in addiction treatment settings such as OTPs.

McLellan and coworkers (1999) described a

system with an active case management component to help patients access services for housing, medical care, and legal and parenting

assistance. Six months after the systemís implementation, patients receiving these services

showed greater reduction in alcohol use and

improvement in medical conditions, family

relations, and legal status than patients receiving

none of these services. The authors concluded

that social service-focused case management 

was an important and effective adjunct to 

addiction treatment.

Cognitive and Behavioral

Therapies

Other interventions, both in use and under

study, include cognitive-enhanced techniques to

increase treatment participation, modify

behavior, and address patientsí social, emotional, and behavioral problems, as well as any

co-occurring disorders. Behavioral treatments

such as contingency management (see below),

Providing Comprehensive Care and Maximizing Patient Retention 127

Exhibit 8-1

Resource Materials for Psychoeducational, Skill-Building, and

Group Counseling Sessions

ï Anger Management for Substance Abuse and Mental Health Clients: A Cognitive

Behavioral Therapy Manual (Reilly and Shopshire 2002)

ï Anger Management for Substance Abuse and Mental Health Clients: Participant

Workbook (Reilly et al. 2002)

ï Cognitive-Behavioral Coping Skills Therapy Manual (Kadden et al. 1992)

ï Cognitive Therapy of Substance Abuse (Beck et al. 1993)

ï A Family Like Yours: Breaking the Patterns of Drug Abuse (Sorensen and

Bernal 1986)

ï National Institute on Drug Abuseís Therapy Manuals for Drug Addiction Series

(www.drugabuse.gov)

ï Recovery Training and Self-Help: Relapse Prevention and Aftercare for Drug

Addicts (National Institute on Drug Abuse 1993b)

ï Relapse Prevention Workbook for Recovering Alcoholics and Drug-Dependent

Persons (Daley 2002)

ï Seeking Safety: A Treatment Manual for PTSD and Substance Abuse (Najavits

2002)

ï ìSupportive-expressive dynamic psychotherapy of opiate drug dependenceî

(Luborsky et al. 1995)

ï Treatment of Opioid Addiction With Methadone: A Counselorís Manual

(McCann et al. 1994)
in which patients enter into agreements that

provide positive incentives for treatment 

compliance, have been especially effective in

MAT (see Brooner and Kidorf 2002; Robles et

al. 1999). 

Behavioral treatments in MAT are derived

from principles of cognitive learning and

behavioral change developed by psychologists

and behavior scientists. The consensus panel

believes that substance abuse and addiction

involve major learning elements and are influenced by patientsí environments and circumstances. Many elements of cognitive behavioral

therapy (CBT)ófor example, emphases on

identifying high-risk circumstances that may

trigger an event and developing coping responsesóare accepted and incorporated widely

into substance abuse education and counseling

(Ryan 2002). CBT is associated with increased

treatment compliance and improved treatment

outcomes.

Node-link mapping

Node-link mapping is a cognitive-enhanced

technique that uses flowcharts and other visual

aids to diagram relationships between patientsí

thoughts, actions, and feelings and their substance use and to increase patient participation

in counseling (Czuchry and Dansereau 2003).

Studies have found that node-link mapping

encouraged communication about topics such

as family, job, and substance use (Dees et al.

1997; Pitre et al. 1997) and improved participantsí motivation, self-esteem, and rapport

with counselors. Patients with poor attention

stamina were found to have greater success in

mapping-enhanced counseling than in standard

counseling (Czuchry and Dansereau 2003).

Less educated patients exposed to mappingenhanced counseling also had better 12-month

followups than those in standard counseling

(Pitre et al. 1996). According to Dansereau and

colleagues, ìThe use of node-link mapping

appears to reduce cultural, racial, and class

barriers by providing a visual supplement and

a common language that enhances counselorñ 

client interchangesî (Dansereau et al. 1996, 

p. 363).

Community reinforcement

approach

The community reinforcement approach

(CRA), originally developed to treat alcoholism, is another effective model for MAT.

This multicomponent treatment facilitates

change in a patientís daily environment. CRA

counselors work with patients to identify

aspects of their lives that reinforce abstinence

and to understand how these reinforcers can

serve as alternatives to substance use. CRA has

been found to reduce opioid use and produce

other positive outcomes either with or without

voucher-based incentives (Abbott et al. 2003;

Higgins and Abbott 2001).

Contingency management

Contingency management reinforces desired

behavior with immediate incentives (Griffith et

al. 2000). Its efficacy has been demonstrated in

several well-designed studies (e.g., Rawson et

al. 2002; Robles et al. 1999). Incentives were

found to increase such desirable outcomes in

MAT as negative drug tests, attendance at

counseling and medical appointments, working,

and volunteering. This approach is useful for

treatment planning because it sets concrete

goals and emphasizes positive behavioral

changes. Exhibit 8-2 summarizes this strategy

in MAT.

The consensus panel emphasizes that effective

contingencies usually involve positive reinforcement. Positive contingencies or rewards are

more effective than negative, punishing contingencies or threats (Gruber et al. 2000).

Negative consequences tend to drive patients

from treatment. In one study, a balance of positive and negative reinforcements, as part of a

well-constructed contingency management

plan, helped patients reduce their drug use

(Crowley 1999). Tangible rewards, such as

take-home medication privileges, should be

paired with social reinforcements, such as

praise from the counselor or other patients, to

optimize their value.

128 Chapter 8
A popular, effective reward in OTPs is the

medication take-home privilege (Chutuape et

al. 1998). Other incentives may include special

scheduling for medication administration, meal

vouchers, gift certificates, entertainment tickets, or toys for patientsí children. Designing

such programs requires significant effort, yet

the rewards can add an important dimension to

MAT. Kidorf and colleagues (1997, 1998, 1999)

demonstrated the effectiveness of behaviorcontingent incentives in OTPs. They used 

take-home medication privileges to increase 

the involvement of significant others and

improve patientsí job acquisition. They also

used behavior-contingent treatment availability

to improve drug test results and counseling

attendance.

To be most effective, behavior contingencies

should be defined clearly and implemented consistently. Contingencies may be individualized

based on each patientís targeted areas of

behavioral change or implemented on a uniform, programwide basis. Tailoring behavioral

contingencies to patientsí needs has been found

to work better (Silverman et al. 1999). Piane

(2000) effectively combined contingency incentives with systematic desensitization for patients

whose anxiety blocked the benefits of contingency incentives alone. When combined with progressive muscle relaxation and desensitization,

contingency management had a demonstrated

record of effectiveness, whereas systematic

desensitization alone was less effective in 

eliminating opioid use but reduced fear of withdrawal and general anxiety (Piane 2000).

Brooner and Kidorf (2002) described a program of motivational stepped-care levels in

which clear contingencies were matched with

treatment responses. Patients who responded

poorly were moved to a more intensive level of

care. Those who responded well received less

intensive care. The authors concluded that this

approach increased treatment participation

and that a stepped-care system was effective

and cost sensitive. In another study comparing

contingency vouchers (which had monetary

value and were exchangeable for goods and services) with methadone dosage increases, both

incentives increased negative drug test results,

but only contingency vouchers increased durations of drug abstinence (Preston et al. 2000).

Dosage increases should be based on evidence

of withdrawal symptoms and other medical

assessments, not good behavior.

Providing Comprehensive Care and Maximizing Patient Retention 129

Exhibit 8-2

Strategy for Contingency Management in MAT

ï Pick a target behavior that can be measured easily (e.g., stopping opioid abuse).

ï Select a reward that can be given as soon as the desired behavior (e.g., three consecutive negative drug test results) is documented. The reward should be nonmonetary (e.g., nonrefundable movie passes, take-home medication privileges).

ï Specify the link between targeted behavior and the reward. For example, a negative drug test result might earn one take-home medication dose (other treatment

and program variables must be taken into account, including Federal and State

regulations).

ï Put the contract in writing, specifying its duration and any changes over time in

contingencies (e.g., after 3 substance-free weeks, the patient can receive takehome privileges).
The consensus panel emphasizes that, when

contingency management is used to control use

of short-acting drugs, objective measures

should provide the basis for withholding incentives. Testing frequency (both randomly and,

when feasible, regularly at least once per week)

must be adequate to detect short-acting drugs.

(See chapter 9 for a complete discussion of 

drug testing.)

Motivational enhancement

Motivational enhancement has emerged as a

component of counseling in MAT, although the

effectiveness of motivational interviewing in

MAT needs more investigation. One study

(Saunders et al. 1995) found that brief motivational intervention improved outcomes in MAT.

Patients in this study demonstrated greater

commitment to abstinence, reported more 

positive outcomes and fewer opioid-related

problems, and relapsed less quickly or frequently than did the control group.

Motivational enhancement interventions influence patients to give up secondary substances

of abuse, address health issues, and change

their social circumstances. TIP 35, Enhancing

Motivation for Change in Substance Abuse

Treatment (CSAT 1999a), provides a thorough

discussion of motivational therapy. Another

valuable guide is Motivational Interviewing:

Preparing People for Change (Miller and

Rollnick 2002).

Psychotherapy

Psychotherapy is a form of verbal-expressive

therapy in which a trained therapist uses 

psychological principles to modify or remove

problematic thoughts, feelings, and behaviors

(Kidorf et al. 1999). Whereas counseling focuses

on the here-and-now, decisionmaking, values,

self-concept, strengths, and goal setting, psychotherapy focuses on changes in personality,

and psychoanalytic psychotherapy attends to

the subconscious. Both counseling and psychotherapy can be short term and solution

directed, but psychotherapy more often is used

to resolve chronic psychological and social

problems. 

Research has shown that psychotherapeutic

interventions enhance the efficacy of MAT ó

particularly for patients with co-occurring disorders who show little response to counseling

alone (OíBrien et al. 1995; Woody et al. 1995b).

Patients in MAT who have benefited from psychotherapy include those whose anxiety or

depression required more than routine, 

behavior-oriented counseling. Several authors

have described effective psychotherapeutic

approaches for these patients (reviewed by

Woody [2003]).

Because many patients are unstable during the

acute phase of MAT, providers usually delay

psychotherapy until later in the acute phase or

in the rehabilitative phase, but views differ on

when psychotherapy is appropriate. The consensus panel believes that psychotherapy has

an important role in MAT but that it usually

should be deferred until patients are stabilized.

Exhibit 8-3 summarizes consensus panel recommendations for psychotherapy in MAT.

Staff qualifications

Staff members responsible for psychotherapy

should have more specialized training than

those responsible for drug-focused counseling.

Psychotherapists should possess advanced

degrees and undergo supervised training. If

OTPs lack staff or resources for psychotherapy,

patients should be referred elsewhere. OTPs

should verify and document the degrees and

licensure of those providing psychotherapeutic

services.

Group psychotherapy

Group psychotherapy and group counseling

with an interpersonal, process, or psychodynamic focus can be effective interventions in

MAT. These groups should be flexibly structured and focus on interpersonal-relationship

building, self-insight, reflection, and discussion

(Vannicelli 1992). Patients should be selected

carefully for these groups and should be able to

130 Chapter 8
commit to the process. Group treatment can

provide a sense that individuals are not alone

in addressing problems, even serious ones.

Such normalization is often a first step toward

feeling less isolated and developing new coping

strategies. (For a thorough presentation of

group therapy in substance abuse treatment,

see TIP 41, Substance Abuse Treatment:

Group Therapy [CSAT 2005c].)

Other Topics

Effects of sexual abuse 

The consensus panel recommends specialized

training for counselors and therapists treating

patients who have been sexually abused or

referral of these patients to qualified mental

health care providers. TIP 36, Substance

Abuse Treatment for Persons With Child Abuse

and Neglect Issues (CSAT 2000d), includes

information about the effects, symptoms, and

treatment of sexual abuse for patients during

substance abuse treatment.

Counseling for HIV/AIDS and

hepatitis C

Counseling about the increased risks of HIV

and HCV infection arising from drug injection

and risky sexual behavior is essential for

patients in MAT. TIP 37, Substance Abuse

Treatment for Persons With HIV/AIDS (CSAT

2000e), thoroughly examines HIV education,

which is mandatory for MAT in some States.

Many States require that patients receive specialized HIV counseling before and after they

receive HIV antibody tests and require that

patients be encouraged to ask questions about

HIV. Pretest HIV counseling should be factual

and medically based. For patients who test negative for HIV, posttest counseling should

address how they can reduce infection risk.

Patients with positive HIV test results need

Providing Comprehensive Care and Maximizing Patient Retention 131

Exhibit 8-3

Common Strategies for Psychotherapy in MAT

ï Devote part of each session to addressing patientsí most recent successes and failures regarding their substance use.

ï Adopt a more active therapist role than typically required for co-occurring 

disorders.

ï Strengthen patientsí resolve to stop substance use (help them visualize or recall

life without drugs to replace memories of enjoyable drug use).

ï Teach patients to recognize warning signs of relapse and develop coping skills.

ï Support patientsí rearranging priorities so that they are not preoccupied with

substance use. This might involve their acquiring job skills, developing hobbies,

or rebuilding relationships.

ï Assist patients in managing painful affects. (From a psychodynamic approach,

this involves exploring the causes of such feelings.)

ï Help patients enhance interpersonal functioning and social supports so that the

rewards of friendship and relationships replace those of substance use.

ï Use psychotherapy only after a strong therapeutic alliance has developed with

the patient or other supportive structures are in place to guard against relapse.
referrals for medical care and counseling about

what the tests mean, coping with problems and

issues raised by the results, treatment options,

participation in clinical trials if available, 

support groups, and behaviors to prevent

infecting others or contracting another HIV

strain. Rapid HIV tests have been approved by

the Food and Drug Administration and are recommended by the U.S. Public Health Service

for point-of-care diagnosis of HIV infection in

settings such as OTPs (see chapter 4). If an

OTP cannot provide onsite testing and counseling, it should develop referral relationships

for outside diagnosis and treatment. The consensus panel recommends onsite counseling

whenever possible. (For further discussion, see

chapter 10.)

Coping with patients 

who resist counseling and

psychotherapy

Some patients resist counseling, psychotherapy,

and other treatments out of fear and distrust.

They may perceive that proposed treatments

will not meet their needs, or they find staff

insensitive or uneducated. Some patients may

begin MAT to address other aspects of their

lives rather than to stop substance use. Others

have been pressured into MAT by the courts.

Strategies to engage these patients in treatment

are described in chapter 6.

Patient Education and

Psychoeducation

Patient education and psychoeducation are useful in comprehensive MAT and can be performed in group or individual sessions. Both

types of education may involve presenting information about substance abuse and addiction to

patients alone, in groups, or with their families.

Psychoeducation addresses the full range of

patient needs, including education, personal

development, recreation, health, and vocational

or relationship needs (Stark and Campbell

1991), while addressing patient attitudes and

feelings to ensure that a message is understood

and internalized. Psychoeducational models,

when used with other treatment approaches,

increase a patientís ability to function independently and meet his or her daily needs outside

the OTP. Exhibit 8-4 summarizes strategies for

psychoeducation in MAT.

Recovery Training and Self-Help: Relapse

Prevention and Aftercare for Drug Addicts

(National Institute on Drug Abuse 1993b) provides educational and public health perspectives and educational discussions adaptable to

MAT. A helpful, straightforward handbook for

patients is About Methadone (Lindesmith

Center-Drug Policy Foundation 2000).

Common topics in patient educational sessions

include

ï Physical and psychological effects of opioid

and other substance abuse

ï Health education information, including medical problems related to addiction, smoking

cessation, improving nutritional habits

(including special needs of persons with

HIV), and exercise, including aerobic and

meditative exercises (e.g., yoga)

ï Effects of drug use on family and other 

relations

ï Introduction to mutual-help groups such as

MA

ï Effects and side effects of addiction treatment

medications and interactions with other

drugs 

ï Symptoms of co-occurring disorders

ï Compulsive behaviors besides substance

abuse (e.g., gambling, sexual behaviors)

ï Skills to attain and sustain abstinence, 

such as anger management and coping with

cravings

ï Developing nonñdrug-related leisure activities

ï Stress management and relaxation 

ï Communication skills and assertiveness 

training

ï Time management

ï Parenting skills

ï Avoidance of STDs and promotion of 

responsible sexual behavior

132 Chapter 8
ï Vocational planning and employment (sometimes linked with cognitive testing and 

conducted with vocational agencies).

Benefits of Family

Involvement

The consensus panel believes that family

involvement in treatment provides strong 

support for patient recovery and that family

members also benefit. The concept of ìfamilyî

should be expanded to include members of the

patientís social network (as defined by the

patient), including significant others, clergy,

resource people from the community, and others.

Types of Family Interventions

Family involvement usually takes the form of

family counseling or family education. Some

OTPs hold short family education sessions

about MAT, substance use disorders and their

effects on the family, and family dynamics.

Holding sessions for several families can be cost

effective, supportive, and mutually beneficial.

Family counseling usually consists of one or

more discussion sessions that provide information and allow participants to express their feelings and concerns. Some OTPs have monthly

family nights or informal gatherings for ongoing

communications between patient families and

counselors. These continuing forums help

secure family support for patient treatment

and identify acute family problems needing

focused therapy.

Providing Comprehensive Care and Maximizing Patient Retention 133

Exhibit 8-4

Strategies for Psychoeducation in MAT

ï Introduce psychoeducation at the beginning of treatment so that it serves as an

orientation to both OTP operational and recovery processes.

ï Involve family members and selected friends, with a patientís informed consent.

Provide guidance in how to support the patientís recovery efforts.

ï Adapt educational strategies and materials to the patientís culture and family.

ï Discuss methadone and other treatment medications, and dispel the myths related to their use (e.g., ìmethadone rots the bones,î ìitís impossible to get off

methadoneî).

ï Discuss the implications of continuing substance abuse. Question assumptions

about alcohol and drug use, and clarify that such use undermines recovery.

ï Discuss sexual behaviors that may affect relapse, including exchanging sex for

drugs, drug use to function sexually or enhance sex, sexual abstinence, and intimacy or sex while substance free.

ï Discuss the power of triggers with patients and families. For example, merely 

discussing heroin can be a trigger for resuming its use.

ï Incorporate special groups to discuss parenting, childcare, womenís issues, and

coping with HIV/AIDS and HCV infection. Use generic names for HIV/AIDS

groups (e.g., ìhealth care issuesî group) to avoid stigma.
The consensus panel recommends that, because

complex factors affect patientsí families, family

therapy should be provided only by trained

staff and reserved for families with serious

problems with behaviors or attitudes that 

contribute to patientsí addictions, which, if

unchecked, might affect recovery. Because

many OTPs do not provide family therapy,

referrals to community-based services often are

needed, and the consensus panel urges that

such connections be established. Family therapy

may be more effective for some patients than

individual counseling, group therapy, or family

psychoeducation (Stanton and Shadish 1997).

TIP 39, Substance Abuse Treatment and

Family Therapy (CSAT 2004c), provides 

more information.

Children of Patients in MAT

Many children of patients in MAT have 

emotional and cognitive problems. They are

more vulnerable to physical and sexual abuse

and neglect and may exhibit more behavioral

problems, substance use, criminal involvement,

conduct problems, and other social and intellectual impairments than other children (CSAT

2000d; Dawe et al. 2000). Child assessment

requires trained personnel and may be unrealistic for some OTPs. OTPs can make referrals

to appropriate resources and are encouraged to

provide parenting support groups, skill development groups, family therapy, or referral for

child and family therapy (Juliana and

Goodman 1997).

Counselors should be aware of reporting

requirements in their State, and patients

should be advised that confidentiality protections do not apply if a patient must be reported

to authorities for child abuse or neglect (see

CSAT 2004b). A counselor who determines that

a patient is neglecting or abusing young children

is required to report the neglect or abuse.

Licensed professional staff members (physicians, psychologists, nurses, social workers) are

mandated to report child neglect and abuse. In

some States, any person who observes this situation is required by law (42 CFR, Part 2 ß 22)

to report it to local authorities (CSAT 2000d).

Few OTPs are equipped to address the needs of

children whose family members abuse opioids

(Dawe et al. 2000). Nunes and colleagues (1998b)

recommended that treatment providers ask

about the mental health and adjustment of

patientsí children and consider routine psychiatric screening and early intervention and

treatment for these children. Dawe and 

colleagues (2000) reported improved

parentñchild relations and positive outcomes

for children with conduct problems after

behavioral training that provided their parents

with improved parenting techniques.

Parenting Groups

Many patients entering OTPs are in danger of

losing custody of their children or already have

lost custody. Some patients in MAT might have

separate agreements with childrenís protective

services (CPS) agencies about what they must

do to keep or regain custody of their children.

OTPs should treat these patients with respect

and avoid displaying negative feelings about

their involvement with CPS agencies. In cases

in which child custody is at issue, the consensus

panel recommends that, once these patients are

stable, treatment focus on concerns about custody, children, and parenting. Parenting

groups are one useful approach.

Some parenting groups are educational,

addressing topics such as interacting with CPS

agencies, resource availability, daycare services, and breast-feeding during MAT. Skillbuilding groups for parents in MAT often

address process issues, such as setting limits,

appropriate and consistent discipline, divorce,

visitation, noncustodial parenting, and tending

to sick children.

Psychodynamic parenting groups take a more

intensive approach, exploring topics such as

ambivalence about losing child custody, fear of

parenting, and coping with anger, shame, or

guilt. OTPs should develop parenting groups

based on the needs expressed by patients.

134 Chapter 8
Domestic Violence

Men and women in MAT may be victims of

domestic violence. It is estimated that at least

three-quarters of women in MAT experienced

partner violence (El-Bassel et al. 2000, 2001).

Counselors should incorporate appropriate

assessment procedures, referrals, or treatment

responses for violence. They might have to help

patients remove themselves from dangerous situations. Counselors should have a broad view of

domestic violence that includes female (to male)

aggression, same-sex physical and emotional

abuse, and issues related to elder abuse. TIP 25,

Substance Abuse Treatment and Domestic

Violence (CSAT 1997b), provides a detailed discussion of this subject. Because many patients

are in domestic violence situations, OTPs should

provide general didactic groups or seminars and

other resources addressing domestic violence.

Treatment resources for victims should be 

integral parts of treatment strategies. 

Integrative

Approaches

Integrative approaches to MAT complement

and enhance OTP efforts with resources from

the community. Peer support, or mutual-help,

programs are the most common such resources

(Chappel and DuPont 1999). OTPs offering

comprehensive treatment should have the 

flexibility and resources to integrate available,

beneficial services from the community.

Peer Support, or Mutual-Help,

Programs

The most popular, widely used mutual-help

models are 12-Step recovery programs, such 

as Alcoholics Anonymous (AA), NA, MA, and

Cocaine Anonymous (CA), which have been

effective in helping people remain abstinent

from substances and can be important augmentations to therapy. They are sources for social

support, peer identification, relapse prevention, and treatment reinforcement, and they

provide role models for successful recovery

(Chappel and DuPont 1999). Members of support groups gain strength and security from

others who understand and share their concerns and who offer practical strategies for 

surviving ìone day at a time.î McAuliffe (1990)

saw peer support groups as providing the longterm support necessary to reinforce addiction

recovery. His program, Recovery Training and

Providing Comprehensive Care and Maximizing Patient Retention 135

Conflict Between MAT and Some 

Mutual-Help Programs

Because 12-Step and other mutual-help programs vary widely in attitudes toward medications and some are particularly negative about opioid pharmacotherapy, many patients in

MAT feel uncomfortable attending meetings for fear of criticism. If they do attend, some try

to hide their participation in MAT (Nurco et al. 1991), and some insist on group acceptance

of MAT. Some patients, unable to handle rejection, have chosen not to return, others have

chosen prematurely to taper from maintenance medication, and some have used this difficulty as justification to self-medicate. Therefore, a decision to encourage patient participation entails some risk. MA groups emerged largely in response to the discrimination perceived by patients in MAT from other 12-Step programs. MA has chapters in most States.

OTPs lacking an MA group are encouraged to start one. For information, contact the

National Alliance of Methadone Advocates (212-595-6262 or www.methadone.org).
136 Chapter 8

Self-Help (RTSH), helps people become part of

a recovery community. He found that participants in RTSH were less likely than controls to

relapse to opioid use, and there were favorable

effects on employment and criminal behavior. 

More information on the above programs is 

available on the World Wide Web:

ï AA, www.alcoholics-anonymous.org

ï NA, www.na.org

ï MA, www.methadonetoday.org

ï CA, www.ca.org

ï RTSH, www.smartrecovery.org.

Decreases in substance abuse among group

participants have been associated with attending meetings frequently, obtaining a sponsor,

ìworkingî the 12 Steps, and leading meetings

(American Psychiatric Association 1995, 1996;

Landry 1997). However, 12-Step groups are

not for everyone. Some groups do not support

MAT, and many advocate an approach that

may conflict with a patientís personal beliefs.

Patients should not be pressured to attend support groups. Rather, an OTP staff member

should explain that participation has helped

many patients. Resistance to attendance should

be discussed and respected. Every effort

should be made to help a patient find an

appropriate peer support program. Many creative strategies have evolved to promote 

mutual-help programs, such as simulated meetings to introduce patients to the language, customs, and rules of groups.

Other Support Groups

Groups also exist for friends and relatives of

persons in recovery (e.g., Nar-Anon) and of

others who refuse treatment. The following

groups offer support and teach participants to

curb their destructive behaviors:

ï Chemically Dependent Anonymous,

www.cdaweb.org 

ï Cocaine Anonymous, www.ca.org 

ï Double Trouble in Recovery, 

www.doubletroubleinrecovery.org 

ï Dual Disorders Anonymous

ï Dual Recovery Anonymous,

www.draonline.org 

ï Families Anonymous, 

www.familiesanonymous.org 

ï Women for Sobriety, 

www.womenforsobriety.org

ï Secular Organizations for Sobriety (SOS),

www.cfiwest.org/sos

ï SMART Recovery Self-Help Network (SelfManagement and Recovery Training),

www.smartrecovery.org.

Other Approaches

In acupuncture, thin needles are inserted 

subcutaneously at points on the body for therapeutic purposes. Some believe that acupuncture can relieve pain, anxiety, and withdrawal

symptoms related to substance abuse, although

little empirical evidence exists. Some patients

appear to benefit from acupuncture as an

adjunct to MAT. Its use to treat opioid withdrawal was first reported in 1973. Efficacy, in

that case, remained unclear, owing in part to

study design limitations (Alling et al. 1990).

However, a National Institutes of Health 

consensus statement lists addiction as one condition for which acupuncture treatment might

be useful. Although the mechanism of acupuncture is not understood, some researchers have

focused on the analgesic effects of opioid peptides released during the procedure (National

Institutes of Health 1997a). 

Other approaches to self-help and peer support

that might be integrated with MAT include

meditation classes; exercise programs; classes

in diet, nutrition, and health; and trauma

groups. More research is needed on the benefits of these activities and treatments in MAT.

Relapse Prevention

Because opioid addiction is a chronic relapsing

disease, the consensus panel recommends that

strategies specifically directed at relapse prevention be an important part of comprehensive
Providing Comprehensive Care and Maximizing Patient Retention 137

MAT in any OTP. A useful manual is Relapse

Prevention Workbook (Daley 2002). Exhibit 

8-5 lists consensus panel recommendations for

assisting patients in building their relapse prevention skills.

Education about relapse is a key part of treatment. Educational approaches should teach

concrete strategies to avoid drug relapse and

should address the goals listed in Exhibit 8-5.

Additional topics may include cataloging and

avoiding high-risk situations and coping with

drug cravings and slips to prevent full-blown

relapses. Relapse prevention strategies often

distinguish between slips and relapses, with

slips defined as milder episodes of use. Of

course, no level of opioid use should be condoned, but when a relatively mild and isolated

episode occurs, the consensus panel recommends that OTP staff members focus on 

implementing the best available prevention

strategy to ensure that a severe relapse is

avoided.

Relapse Prevention Strategies

for Multiple Substance Use

Patients who abuse multiple substances may

require modified relapse prevention strategies.

Patients may use formerly coadministered substances separately, which can increase the

chance of sequential lapses leading to full

relapse (Kosten 1991). Separate interventions

may be necessary for each substance because

the associated risks of relapse are different for

each. Perceptions of actual relapse risks for

the same drug can differ among patients. For

example, a patient may associate heroin use

with socializing and cocaine use with alleviating

depression.

ï Understand relapse as a process, not an event.

ï Develop new coping skills for high-risk situations.

ï Make lifestyle changes to decrease the need for drugs.

ï Increase participation in healthy activities.

ï Understand and address social pressures to use substances.

ï Develop a supportive relapse prevention network (e.g., with significant others).

ï Develop methods of coping with negative emotional states.

ï Learn methods of coping with cognitive distortions.

ï Develop a plan to interrupt a slip or relapse.

ï Recognize relapse warning signs, including internal and external triggers and warning

signs.

ï Combat memories of drug abuse-associated euphoria.

ï Reinforce recollections of negative aspects of drug use.

ï Overcome the desire to attempt to regain control over use of illicit drugs or abuse of alcohol or prescription drugs.

ï Avoid people, places, and things that might trigger drug use.

ï Develop pleasurable and rewarding alternatives to drug use.

Exhibit 8-5

Patient Goals in Building Relapse Prevention Skills
138 Chapter 8

Some researchers have noted that an abstinence violation effect may occur when a patient

abstains from a substance but then relapses

and possibly overuses it. The patientís reaction

varies and often is contingent on how much he

or she perceives relapse as a personal failure.

When a slip or lapse occurs, the patientís selfesteem can be lowered, which he or she may

attempt to repair by continuing or increasing

substance use. Treatment providers should be

alert to this phenomenon and educate patients

about it (Marlatt 1985; Marlatt and Gordon

1980).

Recognizing Relapse Warning

Signs

Indications of a patientís mistaken beliefs or

rationalization might precede relapse and provide intervention points for a therapist. It is

critical that a counselor or therapist know

these warning signs, including the following

(Washton 1988):

ï The illusion of feeling cured after a few weeks

or months of abstinence

ï The belief that one can control his or her

substance use and can use substances socially

ï Idealized recollections of drug-induced euphoria; remembering the pleasurable effects but

selectively forgetting adverse effects

ï Overreactions to urges and cravings, leading

to beliefs that treatment is ineffective or

abstinence is unsustainable

ï Denial of vulnerability to and refusal to

accept the possibility of relapse, leading to

overreaction when relapse occurs (causing

patients to drop out of treatment)

ï Entry into high-risk situations, denial of

risks, and self-testing or self-sabotage.

Extinction Therapy

Behavior therapy using cue exposure treatment

(extinction) was designed to reduce drug craving

by repeated exposures to an experience that

previously triggered drug use (Childress et al.

1992). However, a recent review of cue exposure

treatment for relapse prevention concluded

that these treatments, although studied for

years, were ineffective (Conklin and Tiffany

2002). 

Patient Followup Strategies

Patient followup and continuing care have been

found to be critical to preventing relapse and

ensuring that patients remain abstinent (e.g.,

Zanis et al. 1996). When relapse occurs, OTPs

should facilitate reentry into MAT. Followup

and continuing-care services ensure a continuum of support, and the consensus panel recommends that these efforts continue, with necessary funding to sustain them. (See the discussion of the continuing-care phase of treatment

in chapter 7.)

Referral to Social

Services

Most patients in MAT need vocational, educational, housing, or other social services. One

review found that an estimated 50 to 80 percent

of patients in publicly funded OTPs were

unemployed, yet fewer than 5 percent received

employment-related interventions (Zanis and

Coviello 2001). In another study, social services

other than Temporary Assistance for Needy

Families (Public Law 104ñ193) often were less

readily available to patients in MAT (Widman

et al. 1997). OTPs should be proactive in educating social service providers about patient

needs and facilitating these services. Patients in

OTPs that provide assistance with social services have shown improved outcomes after

treatment (Rowan-Szal et al. 2000a).

Involuntary Discharge

From MAT

Unfortunately, involuntary discharge from

MAT, sometimes called administrative discharge, occurs frequently. The consensus panel

believes that these discharges are, in many

cases, evidence of program shortcomings. A

number of recent changes, including the
Substance Abuse and Mental Health Services

Administration (SAMHSA)-administered OTP

accreditation system with its emphasis on

patient care and rights and requirements for

consistent policies and procedures (CSAT

1999b, amended 2001 [Federal Register

66:4076]), require OTPs to consider and document the reasons and methods for administrative

discharges far more carefully than in the past.

Other specific details vary from State to State.

In their review of numerous studies, Magura

and Rosenblum (2001) concluded that patients

who were discharged from medical maintenance

or long-term detoxification treatment had consistently worse outcomes than patients who

remained in treatment. Zanis and Woody

(1998) found substantial increases in death

rates among those involuntarily discharged for

continued drug use. The consensus panel

strongly recommends that involuntary discharge

be avoided if possible, especially when patients

would like to remain in and might benefit from

MAT. When discharge is unavoidable, it should

be handled fairly and humanely, following procedural safeguards that comply with Federal

regulations and accreditation guidelines.

Reasons for Administrative

Discharge

SAMHSA accreditation guidelines mention

ìviolence or threat of violence, dealing drugs,

repeated loitering, [and] flagrant noncompliance resulting in an observable, negative

impact on the program, staff, and other

patientsî as well as ìnonpayment of feesî and

ìincarceration or other confinementî as possible causes for administrative discharge (CSAT

1999b, pp. 17ñ18). 

Patient and employee safety

OTPs are responsible for the safety and security of both patients and employees and for maintaining order in the facilities. Threats of violence should be taken seriously, and interventions should be rapid. Staff should document

problem behavior. (For discussion about the

ethics of discharging patients, see Appendix D.) 

Discharge for continued 

substance abuse

The consensus panel recommends that patients

receive every chance to continue treatment and

that treatment last as long as it is effective.

Program effectiveness may be determined by

comparing a patientís

substance use and

overall adjustment at

admission with his or

her current status.

The Addiction

Severity Index (see

chapter 4), an assessment tool used in

many substance abuse

treatment programs,

lends itself to such

comparisons. Studies

have shown significant

improvement in

patients even when

complete abstinence

was not achieved (e.g., Strain et al. 1999);

therefore, caution should be used in judging

patientsí progress in MAT based solely on drug

tests. Treatment for other substance use and

addiction should be offered to patients coping

with dual addictions (see chapter 11). Patients

should understand that the ultimate goals of

treatment are abstinence from heroin and other

illicit drugs and appropriate use of prescription

medications.

Discharge for nonpayment

An OTP should advise patients to inform the

program of impending financial problems as

soon as possible. OTPs should focus on helping

patients who need financial assistance to pay

for their treatment, through changes in their

payment pattern or the identification of additional funds through Medicare, Medicaid, the

U.S. Department of Veterans Affairs, health

plan coverage, and other possible sources. If all

of these avenues are exhausted and a patient

must be discharged for inability to pay fees,

then formal notice should precede discharge.

Whenever possible, discharge should include

Providing Comprehensive Care and Maximizing Patient Retention 139

When discharge is

unavoidable, it

should be handled

fairly and

humanelyÖ
referral to a program with a sliding fee scale or

to an OTP receiving funding support through

its State Authority. To ensure that patients are

not cut off abruptly from medication, some

OTPs seek payment for both the first and last

months at admission. However, this may present serious obstacles for many patients, especially those in self-pay OTPs. OTPs should

assist patients in seeking short-term loans or

allow payments in smaller, more frequent

installments if that will solve the problem. In

2003, the American Association for the

Treatment of Opioid Dependence released new

guidelines for addressing involuntary withdrawal from treatment for nonpayment. These

guidelines can be found at www.aatod.org/

policy_otp.html.

Discharge for incarceration

Unfortunately, MAT almost always is discontinued when patients are incarcerated. When

patients face extended incarceration, OTPs

should work with correctional facilities to

ensure that appropriate and humane 

medication-tapering procedures are followed

and that medical safeguards are in place.

Patients should be informed that, on release,

they are eligible for readmission to their OTP

without having to demonstrate signs and symptoms of withdrawal. They should be reassessed

to determine the appropriate treatment phase 

(42 CFR, Part 8 ß 12(e)(3); CSAT 1999b). In

cases of short-term detention, OTPs should

determine whether the correctional system is

continuing to medicate inmates with prescribed

medications and, if it is not, OTPs should consider the practicality of offsite dosing.

Preventing and Finding

Alternatives to Administrative

Discharge

Communicating program

rules clearly

Including program rules in patient orientation

and education is the first step to prevent

administrative discharge. The consensus panel

recommends that all OTPs develop, disseminate,

and consistently enforce guidelines for patient

behavior. Clear communication and awareness

by both patients and staff members are important factors in preventing administrative 

discharge. 

Staff members should identify behavioral 

problems as they emerge and respond to them

promptly. Training in interpersonal techniques

to handle aggressive or upset patients in nonprovocative ways should be part of training for

all staff. The first responses to a behavioral

problem should be to identify it, review the

treatment plan, discuss the plan with the

patient, and modify or intensify treatment to

match the patientís treatment status. Remedial

approaches to consider include the following:

ï Reevaluate medication dosage, plasma levels,

and metabolic responses, and adjust dosage

for adequacy and patient comfort

ï Assess co-occurring disorders, and provide

psychotherapy and pharmacotherapy as

needed

ï Intensify counseling or add other types of

counseling or ancillary services

ï Treat medical or other associated problems

ï Consider alternative medications

ï Provide inpatient detoxification from substances of abuse, while maintaining patients

on opioid pharmacotherapy

ï Change counselors if indicated

ï Reschedule dosing to times when more staff

members are available

ï Provide family intervention.

Dosing should not be a behavioral tooló

patients should not be disciplined by having

their medication dosage decreased or withheld,

nor should they be rewarded for good conduct

by having their dosage increased. Programs 

are encouraged to develop nonpunitive ways to

set limits and contain disruptive behavior.

However, in some cases, involuntary discharge

becomes necessary.

140 Chapter 8
Finding alternative 

treatment arrangements 

Concerns that patients will discontinue medical

treatment for or transmit disease (such as

HIV/AIDS or hepatitis C) may lead staff members to ignore noncompliance problems to

retain patients in a program. At times, such

patients may have to be discharged, and the

program should make referrals to a more

appropriate level of care or type of treatment

(CSAT 2000e).

Procedures for Administrative

Discharge

Ethical criteria for discharge include review and

appeals processes, a suitable dosage protocol for

withdrawal from medication, and a readmission

procedure that includes a behavioral contract.

Exact procedures depend on the reason for discharge. For behavioral problems, the approach

should include escalating warnings and specified

consequences including referral.

Review and appeals 

processes

CSAT accreditation guidelines recommend, and

accreditation body standards require, due process and documentation during administrative

discharge (CSAT 1999b, sections XVI and

XVII). OTP policies should include written

guidelines, including confidentiality guidelines,

under which cases of involuntary discharge can

be appealed and examined by treatment and

administrative staffs. Some States have developed regulations to guide this process. OTPs

should have a formal appeal mechanism, and

patients should be made aware of their rights.

Staff members not directly involved with a disciplinary action should conduct a review of

that action. OTPs should develop working relationships so that, when patients break rules

and need to be discharged, they can be transferred to other programs. 

Reviews and appeals

should be handled

promptly, with attention to procedural 

regularity and a

patientís extenuating

circumstances and

point of view.

Procedures should 

be fair and impartial

because other

patientsí view of the

program may be

influenced by any

perceived lack of 

fairness.

If a decision to 

discharge is made,

supervised withdrawal of medication

should begin after the

review process is completed. Involuntary discharge should be done with the understanding

that, if identified preconditions are met, the

patient may return to the OTP within a 

specified time. Obstacles to reentry should 

be minimized. It is advisable to schedule a date

on which the patient may return to talk about

whether he or she may reenter the program. 

Medically supervised tapering and discontinuation

Whatever the reason for discharge, patients

should be made as comfortable as possible 

during medically supervised withdrawal. Exact

schedules require medical determination (see

chapter 5), but tapering should be as gradual

as possible so that patients can find and enter

other facilities.

Members of the consensus panel agree that

blind withdrawal (withdrawing a patient from

medical maintenance or adjusting dosages 

without his or her knowledge) is unethical

unless requested by the patient to aid in the

withdrawal process. 

Providing Comprehensive Care and Maximizing Patient Retention 141

If a decision to 

discharge is made,

supervised 

withdrawal of

medication should

begin after the

review process 

is complete.
Patient Advocacy

Advocacy by and for patients in MAT and their

supporters has emerged as a force on the treatment landscape (Woods 2001). Several national

and local advocacy groups with slightly different emphases have been organized, including

the National Alliance of Methadone Advocates

(www.methadone.org), International Center for

Advancement of Addiction Treatment

(www.OpiateAddictionRx.info), and Advocates

for Recovery through Medicine

(www.methadonetoday.org/armhelp.htm).

These groups believe that MAT is a lifesaving

treatment, stigma must be reduced, and

patients should be educated about their treatment and encouraged to participate in it. In

general, these advocacy groups are made up 

of stable, long-term patients.

At the OTP level, advocacy groups focus on

patient education and support, assistance with

practical aspects of treatment, and public education about the benefits of MAT and constructive roles played by patients in many spheres.

OTP-based patient advisory committees are

becoming increasingly common. Participation

in these organizations helps empower patients

and enhance patient skills in social interaction.

Other benefits include practice in group interaction and problemsolving. Patients gain a

greater understanding of OTP operations and

perspectives, educate others, identify problems

and misinformation, and provide a channel of

communication to OTP administration. Because

accreditation agencies are concerned with input

from patients, such involvement by patients

usually is viewed favorably by these agencies.

142 Chapter 8
143

9 Drug Testing as a Tool

In This

Chapter...

Purposes of Drug

Testing in OTPs

Benefits and

Limitations of Drug

Tests

Drug-Testing

Components and

Methods

Development of

Written Procedures

Other

Considerations in

Drug-Testing

Procedures

Interpreting and

Using Drug Test

Results

Reliability, Validity,

and Accuracy of

Drug Test Results

Purposes of Drug Testing in OTPs

Since the inception of medication-assisted treatment for opioid addiction

(MAT), drug testing has provided both an objective measure of treatment

efficacy and a tool to monitor patient progress. Important changes have

occurred in current knowledge about and methods for drug testing in

opioid treatment programs (OTPs) since the publication of TIP 1, State

Methadone Treatment Guidelines (CSAT 1993b). Testing now is performed extensively to detect substance use and monitor treatment compliance. Analysis of test results provides guidance for OTP accreditation,

as well as information for program planning and performance improvement. In addition, other agencies concerned with patient progress (e.g.,

child welfare and criminal justice agencies) routinely request and use

drug test results with patientsí informed consent (see CSAT 2004b).

Increasing emphasis on treatment outcomes as evidence of program

effectiveness has added significance to drug tests in OTPs.

Administrators use drug test results in response to quality assurance

requirements. For example, an OTP that prescribes adequate maintenance medication should report relatively few illicit-opioid-positive drug

tests. Ball and Ross (1991) found that the most effective programs had

less than 10-percent positive tests. However, these findings emerged

before the purity of heroin markedly increased in recent years and

before the ratio of OTP staff to patients decreased in many programs as

a result of funding cuts. These events have been associated with increases

in opioid positive urine tests in most OTPs. Given the regional variability

in factors affecting addiction, for example, differences in heroin purity

and availability or in prescription opioid abuse, the consensus panel 

recommends that OTPs develop new measures to improve outcomes if

they report an average of more than 20-percent positive drug tests for

patients with at least 1 to 3 years of MAT. Equally important, OTP drug

test results should be nearly 100-percent positive for treatment medication because lower percentages could indicate medication diversion,

which requires investigation and a corrective-action plan. (Federal regulations require OTPs to maintain diversion control plans as part of their

quality assurance efforts [see chapter 14].)
Drug test results help policymakers and OTP

administrators detect and monitor emerging

trends in substance abuse that may signal a

need to redirect resources. Drug use patterns

have changed markedly in recent decades; for

example, benzodiazepines, amphetamines,

methamphetamine, and cocaine have increased

in popularity while barbiturate use has diminished. New substances of abuse or combinations of substances and methods of ingestion

present new treatment challenges and funding

concerns.

Testing for Treatment

Compliance

At a minimum, most specimens from patients

maintained on methadone should be tested for

methadone and its metabolites (testing for

metabolites prevents patients from simply

adding methadone to a sample), which can be

done efficiently and at reasonable cost.

Currently, no precise test measures buprenorphine in a patient specimen, although it can be

detected in urine, blood, or hair by gas chromatography/mass spectrometry (GC/MS) (Lisi

et al. 1997; Vincent et al. 1999) and, as reported by Cirimele and colleagues (2003), by

enzyme-linked immunosorbent assay in urine.

Until new, commercially available tests are

developed, drug testing of patients receiving

buprenorphine primarily should be to detect

substances of abuse. No reagent is commercially

available at reasonable cost to test any specimen

type for levo-alpha acetyl methadol (LAAM),

although LAAM can be detected in urine by

thin-layer chromatography (TLC) and GC/MS

(Moody et al. 1995). Therefore, the consensus

panel recommends direct monitoring of

patients receiving LAAM (American Association

for the Treatment of Opioid Dependence, n.d.),

assuming that its availability continues (see

chapter 3).

Testing for Substances of

Abuse

At a minimum, OTPs should test for opioids,

cocaine, and benzodiazepines and consider

testing for other drugs (e.g., methamphetamine),

depending on local substance use patterns. OTP

administrators should decide whether to test

routinely for alcohol and marijuana or only as

needed. Because of the increased depressive

effects of alcohol combined with an opioid such

as methadone, it is important for OTPs to avoid

providing opioid medication to patients who are

intoxicated with alcohol. However, no standard

cutoff scores for permissible alcohol levels exist

across OTPs. Because urine tests for alcohol are

highly variable (Warner 2003), breath and blood

tests are more useful in OTPs to determine the

presence or degree of acute alcohol intoxication.

Because breath tests are much simpler and

faster and are less invasive than blood tests, they

are the most common alcohol testing method

used in OTPs.

Exhibit 9-1 summarizes necessary minimum (or

cutoff) concentrations for detection of some

illicit and prescription drugs in urine, as well as

their reliable detection times for both initial

patient testing and confirmation of positive

results.

Benefits and

Limitations of 

Drug Tests

The consensus panel cautions that drug test

results should not be the only means to detect

substance abuse or monitor treatment compliance and that the needs of patients whose test

results show no immediate problems should not

be overlooked. Too often, overworked counselors and caseworkers scan drug test results to

determine services, without investing time to

develop the trust and concern inherent in a

sound counseling relationship. Training and

educating staff members about the benefits and

limitations of drug tests should ameliorate this

situation. Staff members should understand,

for example, that certain prescribed and overthe-counter medications and foods might generate false positive and false negative results for

different substances. Some drug-testing laboratories provide training about drug testing for

144 Chapter 9
Drug Testing as a Tool 145

OTP staff. Frank discussions of the issues

involved for patients and for the OTP help

staff members understand the importance of

using test reports appropriately. 

Urine drug testing remains the most common

method of drug testing in OTPs. The Substance

Abuse and Mental Health Services Administration (SAMHSA) has notified OTPs that they

may use oral-fluid testing to satisfy the drugtesting requirements in 42 Code of Federal

Regulation (CFR), Part 8, if a programís 

medical director deems this method adequate

Exhibit 9-1

Typical Testing and Confirmation Cutoff Concentrations and Detection

Times for Various Substances of Abuse

Drug

Initial Testing

Cutoff

Concentrations

(ng/mL*)

Analytes Tested in

Confirmation

Confirmation

Cutoff

Concentrations

(ng/mL)

Urine Detection

Time (Days)

Amphetamine 1,000 Amphetamine 500 2ñ4

Barbiturates 200 Amobarbital, 

secobarbital, other

barbiturates

200 2ñ4 for short acting;

up to 30 for long

acting

Benzodiazepines200 Oxazepam,

diazepam, others

200 Up to 30 for long

acting

Cocaine 300 Benzoylecgonine 150 1ñ3 for sporadic

use; up to 12 for

chronic use

Codeine 300 Codeine, morphine 300, 300 1ñ3

Heroin 300 Morphine, 6-

acetylmorphine

300, 10 1ñ3

Marijuana 100, 50, 20 Tetra-hydrocannabinol (THC)15 1ñ3 for casual use;

up to 30 for chronic

use

Methadone 300 Methadone 300 2ñ4

Methamphetamine1,000 Methamphetamine,

amphetamine 

500, 200 2ñ4

Phencyclidine 25 Phencyclidine 25 2ñ7 for casual use;

up to 30 for chronic

use

*ng/mL: nanograms per milliliter.

Adapted from Cone 1997.
146 Chapter 9

(Clark 2003). As other drug-testing methods

are developed and attain Federal and State

approval, OTPs should consider using them 

as well.

Alternatives to urine and oral-fluid testing have

benefits and limitations. Some investigators

(e.g., George and Braithwaite 1999; Moolchan

et al. 2001) have maintained that concentrations

of methadone in blood plasma are the ìgold

standardî to assess treatment compliance in

patients maintained on methadone. However,

blood testing is

impractical, costly,

and difficult, and

the same investigators recognized that

urine drug testing is

likely to be the dominant method in

OTPs for the foreseeable future.

Some investigators

evaluating optimal

approaches to

assessing MAT compliance and determining continued

substance use have

found patients forthcoming about their

drug use and not

particularly motivated to avoid detection. Two

studies evaluated patientsí self-reports of drug

use and concluded that they are at least as reliable as urine drug tests (Zanis et al. 1994) and

sometimes more sensitive (Howard et al. 1995).

Both studies suggested that a combination of

self-reporting and urine testing is more useful

than either alone. Another study (Katz and

Fanciullo 2002) has challenged these findings.

Urine Drug Testing

Despite its limitations, urine drug testing is

dominant in OTPs because obtaining specimens

is relatively easy (Moolchan et al. 2001) and

testing is affordable. In addition, the technique

is well studied, has been in use for a long time,

and has well-established cutoff levels and other

laboratory guidelines (Cone and Preston 2002).

According to one survey (Jones et al. 1994),

most patients accept urine testing in an OTP

although many do not like it. Concerns usually

relate to the specimen collection process or the

sensitivity and specificity of results, as well as

the possibility of tampering, the need to preserve patient privacy and dignity, risks of collection to staff, and the possibility that substance interactions may confound results.

A patientís physical condition can affect test

sensitivity and specificity. Urine testing is not

feasible for patients with renal failure (e.g.,

those on dialysis) or other bladder control

impairments. George and Braithwaite (1999)

found that variations in metabolism and excretion could affect urine concentrations of

methadone or its metabolites. Moolchan and

colleagues (2001) noted that renal methadone

clearance varies for subjects with certain medical conditions (e.g., renal disease) and those

taking other prescribed or illicit drugs. As a

result, urine drug tests for patients on relatively low methadone dosages may be methadone

negative even though subjects have ingested

medication as prescribed (i.e., a false negative

result). Furthermore, individuals with paruresis (ìshy bladder syndromeî) have a social

anxiety disorder that may leave them unable to

urinate under observation (Labbate 1996ñ 

1997; Vythilingum et al. 2002). 

Just as some patients metabolize methadone or

other treatment medications at different rates

and some medications affect the metabolism of

others (see chapter 3), certain medications, for

example, HIV medications, change the

metabolism of addiction medications and can

affect drug test results. OTP staff members

should remain current on these interactions as

more data become available (see De Maria

2003). A Web site that provides up-to-date

information on the pharmacokinetics of

methadone and HIV medications is at 

www.hiv-druginteractions.org.

Baker and colleagues (1995) found similar

urine drug test results regardless of whether

[U]rine drug 

testing is dominant

in OTPs because

obtaining specimens is relatively

easy and testing is

affordable.
patients were notified of tests in advance. In

that study, some patients stated that unannounced urine tests deterred them from substance use, but 53 percent said it did not.

Contrary to assumptions by some providers

that substance abuse is more likely over weekends (presumably resulting in more positive

drug tests on Mondays), Compton and colleagues (1996) found that urine drug test

results did not vary by day of the week.

Oral-Fluid Drug Testing

Oral-fluid drug testing is an alternative to urine

drug testing in OTPs that is approved by

SAMHSA (Clark 2003; for a recent review of

oral-fluid drug testing, see Kintz and Samyn

2002), but only when a qualified offsite laboratory performs the specimen analysis. According

to SAMHSAís interim guidance on the use of

oral-fluid testing in OTPs, sent to OTPs in July

2003 (Clark 2003), offsite drug testing using

oral fluid may be considered adequate for the

purpose of 42 CFR, Part 8 ß 12(f)(6). The

choice of drug-testing methodology is an

informed medical judgment decision. It is

SAMHSAís view that there is sufficient information to confirm the adequacy of oral-fluid

testing in the OTP setting. CSAT noted that

OTPs still must conform to State laws and 

regulations in this area (Clark 2003).

Many patients in OTPs react more favorably to

the use of oral swabs than to observed urine

collection. Researchers have confirmed other

benefits of oral-fluid testing. Moore and colleagues (2001) reported that it was highly sensitive and specific for methadone and opioids of

abuse and that samples could be stored or sent

to a laboratory for analysis. Braithwaite and

colleagues (1995) noted that oral-fluid testing

ensured privacy and was less susceptible to

tampering than urine testing and that specimens required little preparation.

Results of oral-fluid testing generally are 

similar to those obtained by urine drug testing,

but differences exist, and OTP staff members

should understand these differences. Concentrations of some substances are lower in saliva

than in urine. Some drugs remain detectable

longer in urine than in saliva. Drug residue in

the oral or nasal cavity was found to contaminate saliva specimens (Swotinsky and Smith

1999). The consensus panel recommends oralfluid testing when drug testing must be

observed because it is more respectful and less

invasive and observation does not require

watching patients void. Oral-fluid collection

requires no temperature strips or other devices

to ensure that a specimen was just provided.

Blood Drug Testing

OTPs rarely if ever use blood testing routinely;

most often, they use this method to monitor

plasma methadone levels when necessary.

Testing for the presence of methadone in

serum, although more costly than urine testing,

is the most accurate method currently available

to determine whether other prescribed medications influence methadone metabolism or a

patient is a rapid metabolizer. Serum testing is

more accurate than other methods to address

issues related to the effects of metabolism on

methadone dosage. 

Blood testing has limitations besides cost.

Blood offers a smaller drug detection window

than oral fluid or urine; most drugs are undetectable in blood after 12 hours (DuPont 1999).

Trained personnel must obtain blood specimens. Concerns about blood-borne pathogens

make routine blood testing impractical, and, as

discussed in chapter 3, some medications and

diseases affect methadone levels in plasma.

Sweat Drug Testing

Sweat patches usually are used as an adjunct to

other forms of testing. They provide a longer

specimen collection period than either urine or

blood and may be less susceptible to tampering

than urine. Sweat patches are tolerated well by

patients and are considered less invasive and

less potentially embarrassing. Taylor and colleagues (1998) found that women were more

likely than men to prefer a sweat patch to urine

testing. The patch has not been found to deter

substance use (Taylor et al. 1998). Preston and

Drug Testing as a Tool 147
colleagues (1999a) compared the patch method

with urine testing for detection of cocaine 

and found good concordance between the two

methods. 

Playing-card-sized, waterproof adhesive 

patches are available. Each patch is imprinted

with a unique number to track its chain of custody. After a patch is worn for about 1 week, a

laboratory can extract about 2 mL of sample to

be tested. Compared with urine specimens,

sweat yields higher proportions of parent

drugs, such as cocaine, heroin, or marijuana.

Drug use is assessed cumulatively, but uniform

cutoff levels have not been established, and

external contamination is a possibility

(Swotinsky and Smith 1999).

Hair Drug Testing

Hair analysis provides a longer term look at

drug use than other methods because hair

retains drugs longerófor example, weeks or

months, compared with the 2 or 3 days that

cocaine or heroin is detectable in urine.

Collecting hair specimens also is less invasive

than urine or blood sampling. However, 

drawbacks include expense, possible ethnic

bias (Kidwell et al. 2000), and environmental

contamination. Studies of hair analysis have

been hampered by poor design, small specimen

size, and lack of confirmation. More research

is needed.

Drug-Testing

Components and

Methods

Methods and uses of drug tests vary widely

among OTPs. Improvements in standards and

technology have made a variety of testing and

analytical alternatives available. Drug testing is

a multistep process that starts with specimen

collection. Specimens are analyzed by one of

numerous techniques. The results are recorded

and interpreted. When an initial test analysis is

positive for a substance of abuse or unexpectedly negative for a treatment medication such

as methadone, providers should discuss the

results with the patient as soon as possible. If

the patient insists that a result is inaccurate, an

OTP should recheck the existing report via

confirmatory analysis or a retest if the laboratory still has the specimen in question.

Preferably, a different analytical method with

higher sensitivity is used for confirmation or

retesting. A confirmed analysis should be

viewed as only one basis for modifying a

patientís treatment plan.

The consensus panel recommends that programs incorporate Federal and State regulatory

requirements and their own treatment needs

into written policies and procedures for drug

testing and integrate these policies and procedures into treatment planning and practices.

OTP administrators should consider the factors

discussed below in establishing and maintaining

drug-testing procedures that ensure the integrity and utility of results, as well as compliance

with regulations.

Specimen Collection

Setting and approach

The consensus panel emphasizes that specimen

collection and testing should be performed in a

therapeutic, humane environment and results

should be used to help guide patient care, modify treatment plans, and confirm clinical

impressions. Specimen collection methods

should protect patientsí dignity and privacy

while minimizing opportunities for falsification.

The bathrooms used for urine collection should

be cleaned frequently and supplied with soap

and other toilet articles. Collection procedures

should be in writing (see ìDevelopment of

Written Proceduresî below). Patients should

be informed during admission and early treatment about how drug-testing specimens are collected and patientsí responsibility to provide

specimens when asked. Patients should receive

a copy of OTP policies on and procedures for

drug testing, including whether and when

direct observation is indicated. 

148 Chapter 9
Most OTPs assign a staff member to greet

patients and determine whether a urine 

specimen is required before patients can

receive medication. This determination may be

based on staff judgment or a random list generated by computer or by OTP managers. In most

cases, urine specimens should be obtained randomly based on patientsí OTP visit schedules. 

When indicated, a patient is sent to the bathroom to provide a urine specimen in a labeled

container. Most programs monitor the bathroom to ensure that only one patient uses it at a

time and that patients leave parcels outside the

bathroom. The person receiving the urine 

specimen checks the container to determine

whether it is a valid specimen. The specimen

then is packaged and sent to a laboratory 

for testing.

To ensure patient confidentiality, programs

should store specimens and related documents

and material so that only authorized personnel

can access and read them. Handling specimens

also raises questions about staff safety

(Braithwaite et al. 1995) and the reliability of

the chain of custody for samples (Moran et al.

1995). Universal safety precautions for handling urine specimens should be followed; for

example, staff members collecting specimens

need to wear gloves.

Direct observation versus

other methods

Collecting urine specimens, especially when collection is supervised, can be embarrassing for

both subjects and supervisors and raises concerns about patientsí privacy rights (Moran et

al. 1995). Some patients and treatment

providers perceive direct observation of urination as a violation of trust and respect

(Moolchan et al. 2001). In addition, patients

with paruresis should not be penalized;

instead, treatment providers should consider

unobserved urine testing, oral-fluid testing, or

another drug-testing method.

The consensus panel recommends that OTP

staff members use their clinical judgment

regarding the need for direct observation of

urine collection. Temperature strips, adulterant checks, and other methods should be used

when possible to ensure test validity. Moran

and colleagues (1995) determined that unsupervised urine collection with a temperature indicator and a minimum 50-mL specimen was

practical and reliable and ensured individual

privacy and dignity. Many OTPs do use direct

observation (Calsyn et al. 1991), but some use

one-way mirrors and even video cameras to

ensure reliable sample collection.

OTPs that use observed collection have many

options, including random observation, observation to ensure treatment compliance before a

schedule change, or

observation because

of suspected drug use.

Some OTPs use direct

observation only during initial stabilization. Oral-fluid testing

is another option.

Each OTP should

decide whether, when,

and how it uses direct

observation in specimen collection and

should include guidance for direct observation in its written

policies and procedures. Some States

mandate urine drug

testing and direct

observation of specimen collection. For programs that elect unobserved collection, other

effective options for sample validation exist,

such as temperature strips and ambienttemperature ìgunsî (see below).

Analytical Methods Used in

Drug Testing

Knowledge gained from testing enhances 

the treatment process and ameliorates some

regulatory concerns and issues facing OTPs.

However, it is important for practitioners and

Drug Testing as a Tool 149

[S]pecimen 

collection and 

testing should be

performed in a

therapeutic,

humane 

environment...
State and Federal regulators to understand the

limits of the drug testing and analytical methods used in most OTPs (Moolchan et al. 2001;

Verebey et al. 1998).

Because of the volume and cost of urine testing,

most OTPs use TLC or enzyme immunoassay

(EIA) to analyze test specimens. The Enzyme

Multiplied Immunoassay Technique (EMIT) is

the EIA method used most often in this country

because its costs are lower, it allows for short

analysis time, it can be automated for largescale samples, and it can be used on site by

small programs (Hawks 1986; Manno 1986).

Immunoassays use antibodies with specific surface sites to which drugs or metabolites bind.

For urine drug testing, either of two immunoassay typesóradioimmunoassay (RIA) or EIAó

can be used. RIA uses radioactive markers and

requires an incubation period and centrifugation of the sample. EIA uses an enzyme as its

marker. Currently, no commercially available

EIA tests exist for LAAM, buprenorphine, or

the buprenorphine-naloxone combination

tablet.

EIA permits detection of extremely small 

quantities of substances but lacks specificity to

determine which drug in a class is present

(Saxon et al. 1990). For example, EIA can

detect opioids but cannot distinguish between

morphine (the metabolite of heroin excreted in

urine), codeine, and other opioids, including

150 Chapter 9

Exhibit 9-2

Common Immunoassays

Immunoassay Brand Name(s) Manufacturer(s) Comments

EIA EMIT, CEDIA Syva, Boehringer

Mannheim/

Microgenics

Used widely; inexpensive; equipment

available for automated, highvolume rapid analysis; sensitive to

some adulterants

Fluorescence

polarization 

Adx, TDx Abbott Diagnostics Resistant to several adulterants; 

reasonably good quantitative estimates of concentrations; slower and

more expensive than EIA and KIMS

Kinetic 

interaction 

of microparticles (KIMS)

OnTrak,

TesTcup,

OnLine

Roche Diagnostics Equipment available for automated,

high-volume rapid analysis; used by

some large laboratories

Colloidal

metal (CMI)

Triage Biosite Diagnostics Used in onsite testing

RIA Abuscreen Roche Diagnostics Labor intensive; resistant to several

adulterants; not used widely

Adapted from Swotinsky and Smith 1999, with permission of Medical Review Officer

Certification Council.
those from poppy seeds used in baked goods.

EIA does not distinguish oxycodone (e.g.,

PercodanÆ, OxyContinÆ). In areas where these

drugs are abused, OTPs should take additional

steps and use other methods to test for oxycodone. Exhibit 9-2 describes several widely

available immunoassays.

Chromatographic analyses use flows of liquid

or gas to separate molecules and isolate any

drugs or drug metabolites in specimens. TLC,

one of the oldest of these methods, is inexpensive but less accurate than EIA, and its accuracy depends on the skill of the laboratory technician (Hawks 1986). TLC can distinguish

between drugs in a class (a limitation of EIA),

but it also can produce false negative reports

because it requires relatively large amounts of

drugs in specimens before these drugs can be

detected. Programs working with laboratories

that use TLC should be aware that low doses of

addiction treatment medication occasionally

yield negative reports. When methadone is used

in treatment, periodic assays for its primary

metabolite, EDDP (2-ethylidene-1,5-dimethyl3,3-diphenylpyrrolidine), are advised. Unlike

methadone, EDDP is pH independent when

excreted, so the absence of EDDP from urine

may be a more accurate sign of tampering, 

substitution, or diversion. GC/MS is a sensitive

method that can be used to confirm results from

EMIT or TLC.

Development of

Written Procedures

Procedures for drug testing in an OTP should

be described clearly in a written document

such as that shown for urine specimen collection in Exhibit 9-3. Similar policies can be

developed for oral-fluid testing. Each OTP

should develop policies and procedures for

drug testing based on its mission, service philosophy, and practices.

Drug Testing as a Tool 151

It is the policy of the [name of program] to monitor the use of drugs by collecting

random, observed, and/or temperature-monitored urine samples at a frequency

determined by clinical staff in accordance with Federal and State regulations.

Purpose

Urine samples are collected and tested to assist in stabilizing a patient on the

proper dosage of methadone or buprenorphine. Drug test results may suggest that

a patientís dosage needs adjustment or that a more intensive level of care is needed. Positive drug tests alone do not confirm that a patient is not engaged in treatment or is not in compliance. The entire clinical picture must be considered. Drug

tests are not used to punish patients or as the sole reason to discharge them from

treatment. Patients must be assured that the results are confidential and will be

released only with their permission or pursuant to a court order (21 CFR, Part 2).

Exhibit 9-3

Sample OTP Guidelines for Monitoring Urine Drug Test 

Specimen Collection

(continued on following page)
152 Chapter 9

General Information and Desired

Outcome

In accordance with program policy and State and Federal regulations, each new

patient is asked to provide one random urine sample per week for the first 6

months and samples less frequently thereafter, based on treatment progress. No

patient is monitored less than once a month.

Urine samples are collected randomly. A patient is not told when he or she will be

asked to provide a urine sample so that a more accurate assessment of drug abuse

patterns can be made.

The urine is tested for several drugs of abuse and for the presence of treatment

medication. Testing for EDDP, a methadone metabolite, is a more sensitive measure of the presence of ingested methadone than testing for the parent compound

(methadone) alone. This type of testing helps distinguish ingested methadone from

methadone that has been added to a urine specimen as an adulterant.

Patients may refuse to provide valid urine specimens for many reasons but are

encouraged to provide them. If a patient refuses to provide a specimen, then urine

is collected on the next dosing appointment. If a patient fails to provide a valid

specimen at the next appointment, a review of take-home dosages and progress in

treatment takes place and may result in more frequent required clinic visits. When

patients refuse to provide samples, the counseling, nursing, and medical staffs are

notified and consulted.

Procedure

The following guidelines for observing or temperature-monitoring urine specimens

help increase the validity of each sample.

ï If a urine specimen is collected with a temperature higher than 99.8F, the

patientís temperature is taken (if the patientís temperature is elevated, the 

temperature of the urine specimen also may be elevated).

ï Before a patient enters a bathroom stall, he or she is asked to leave coat, outer

garments, purse, and bags outside the bathroom to prevent falsification of the

sample. A patient is asked to wash and dry his or her hands before and after 

giving samples to prevent urine contamination. Bacterial overgrowth invalidates

a urine specimen. To the extent possible, staff members ensure that patients do

not conceal falsified urine specimens on their persons.

Exhibit 9-3

Sample OTP Guidelines for Monitoring Urine Drug Test 

Specimen Collection (continued)
Drug Testing as a Tool 153

Exhibit 9-3

Sample OTP Guidelines for Monitoring Urine Drug Test 

Specimen Collection (continued)

ï If collection of a urine sample is observed directly (versus temperature 

monitored), the following steps are performed to ensure an accurate specimen: 

ñ The patient is observed to ensure that he or she does not add water to the

urine from the toilet or sink to dilute it. (Where health department regulations

permit, hot water in the bathroom should be turned off.)

ñ Female: A female observer accompanies a female patient into the restroom. The

patient is asked to void into a urine container and not to flush the toilet. A

wide-mouth collection container may be used and the contents then transferred

to a smaller container. The staff member observes collection of the specimen

directly. The collection site observer also flushes the toilet.

ñ Male: A male observer accompanies a male patient into the restroom. The client

uses a urinal and is asked to void into a urine container. This is observed

directly.

ï The patient provides 50 cc of urine.

ï The sample is checked for color, temperature (90.5ñ99.8F/32.5ñ37.7C), and

any contamination. The temperature is checked 30 seconds after the specimen is

provided.

ï After a sample is obtained, a staff member verifies the urine temperature and

checks the container for pinholes before placing it in a plastic envelope. 

ï If the urine sample is not sent immediately to the laboratory, it is stored properly

in a refrigerator that is used exclusively for laboratory samples.

ï Proper security of urine specimens is maintained to prevent loss or switching of

urine. Specimens are placed in a locked refrigerator in a locked room.

If a patient is unable to provide a urine specimen, he or she is asked to drink 

plenty of water. Special considerations are given to patients with health problems

that interfere with urination, including renal failure, neurological disorders, and

paruresis. Any patient who still is unable to provide a urine sample must be prepared to give the sample on the following day.

If a patient refuses to provide a sample, he or she must be referred to a counselor.

After a clinical review, the treatment plan and the frequency of clinic visits may 

be modified.

Source: Adapted from the University of New Mexico Hospitals, Addictions and

Substance Abuse Programs. 
Other Considerations

in Drug-Testing

Procedures

Frequency of Testing

Given concerns about the cost and reliability of

drug tests, some OTPs limit testing and others

assume that results are unreliable in many

cases. Decisions about how to use drug testing

require thought and balance. In addition to

conforming to Federal and State regulations,

the frequency of testing should be appropriate

for each patient and should allow for a caring

and rapid response to possible relapse. Drug

tests should be performed with sufficient frequency and randomness to assist in making

informed decisions about take-home privileges

and responses to treatment.

For patients who continue to abuse drugs or

test negative for treatment medication, the consensus panel recommends that OTPs institute

more frequent, random tests. Increased testing

provides greater protection to patients vulnerable to relapse because only short periods pass

before a therapeutic intervention can be initiated. However, as emphasized throughout this

chapter, programs should avoid making treatment decisions affecting patientsí lives that are

based solely on drug test reports. 

SAMHSA requires eight drug tests per year for

patients in maintenance treatment (42 CFR,

Part 8 ß 12(f)(6)). In the opinion of the consensus panel, this is a minimal requirement. The

actual frequency of testing should be based on

a patientís progress in treatment, and more testing should be performed earlier in treatment

than later, when most patients are stabilized.

Most OTPs develop policies and procedures on

testing frequency that meet or exceed Federal

requirements and accreditation standards to

assist staff in planning treatment, assessing

patient progress, and granting take-home 

privileges. 

Some States require more frequent testing than

that required by SAMHSA. Some also require

that specific drug-testing methodologies or decision matrices be followed. OTPs must adhere to

the more stringent of either the Federal or State

regulations. In States with no specific requirements, Federal regulations are the only applicable standard, but, as previously noted, these

requirements should be considered minimal

and regulatory. 

The consensus panel recommends at least one

drug test at admission to an OTP. Onsite testing

kits are available so that admission can continue while test results are pending (see ìOnsite

Test Analysisî below), although some States

may disallow these kits. For patients in shortterm detoxification, one initial drug test is

required, whereas patients receiving longer

term MAT are required to have initial and

monthly random tests. 

Laboratory Selection

The laboratory selected by an OTP to analyze

patient specimens must comply with Health

Insurance Portability and Accountability Act

regulations (CSAT 2004b) and the Clinical

Laboratory Improvement Amendments (CLIA)

(see discussion below). OTPs should understand a laboratoryís analytical methods and

know whether and how often the laboratory

confirms positive findings, how long specimens

are retained for testing, and when results are

made available to OTPs. A laboratory should

collaborate with an OTP regarding custody of

specimens, confidentiality and reporting of

results, turnaround times for results, and specimen retention for retesting. Programs also

should understand a laboratoryís minimum

cutoff levels for determining and reporting 

positive results.

In a review of requirements for efficient, reliable urine testing for substances of abuse,

Braithwaite and colleagues (1995) emphasized

the importance of quality control in laboratories. They listed aspects of high-quality assessment, including performing analyses according

to manufacturerís instructions, evaluating 

control samples for every analysis, participating in external quality assessment, adequately

154 Chapter 9
training and supervising staff, and carefully

reporting results. They also recommended that

laboratories analyze at least 20 to 30 specimens

per week from each OTP, have a scientist with

expertise in drug addiction and drug testing on

staff, and report results confidentially within 2

to 3 days of specimen receipt.

Onsite Test Analysis

Onsite (also known as near-patient or pointof-care) drug test analysis can provide rapid

results but may have limitations such as

increased cost or reduced accuracy. Some State

regulations disallow onsite test analysis. In an

extensive review, D. Simpson and colleagues

(1997) found that immediately available drug

test results improved patient cooperation and

program management. In their review of available commercial analytical methods, they found

that all were rapid, reliable, and useful but

required confirmation of positive results, and

some lacked sensitivity, specificity, or both. A

more recent review by George and Braithwaite

(2002, p. 1639) concluded that onsite analytical

devices for drugs of abuse were ìan expensive

and potentially inaccurate means to monitor

patient treatment and drug abuse states.î 

Onsite analysis of test specimens also requires

that staff be trained in calibration of the testing

device and interpretation of results. OTPs 

need ongoing quality assessment procedures.

Analyses performed outside a laboratory setting require special facilities to ensure safety.

Onsite specimen analysis also raises questions

about the chain of custody, provision, stability,

and storage of samples (Simpson, D., et al.

1997). However, the U.S. Department of

Health and Human Services is developing

guidelines for onsite analytical methods in

workplace drug-testing programs, which suggests that this approach will become more 

common (Cone and Preston 2002). The use of

onsite specimen analysis for decisionmaking

may subject OTPs to the requirements of

CLIAóFederal guidelines for any entity doing

laboratory analysis of specimens from

humansóand require these OTPs to obtain

approval from their State health departments.

If an OTP falls under CLIA requirements, it

must register or seek a waiver to continue its

own laboratory analysis of test specimens.

Exhibit 9-4 provides a list of commercial

resources, manufacturers, and contact information for onsite analytical methods.

Interpreting and Using

Drug Test Results

Test results should be documented in patient

records along with appropriate justifications

for subsequent treatment decisions, particularly

in unusual situations such as when take-home

medications are continued despite test results

that are consistently positive for substances.

OTPs should confirm

positive results whenever possible, bearing

in mind the factors

that can confound

results (e.g., using

over-the-counter 

medications, eating

foods containing

poppy seeds).

OTP directors should

ensure that results are

not used to force

patients out of treatment and that no

treatment decisions

are based on a single

test result. Patients

should be informed of

positive results for

substances of abuse or 

negative results for treatment medication as

soon as possible and should have an opportunity to discuss these results with OTP staff. A

patient who refutes test results should be taken

seriously, particularly when results are inconsistent with the treatment profile and progress

of that patient.

OTPs should use drug test results clinicallyó

not punitivelyófor guidance, treatment planning, and dosage determination. OTPs should

Drug Testing as a Tool 155

[P]rograms should

avoid making

treatment decisions affecting

patientsí lives that

are based solely on

drug test reports.
156 Chapter 9

retest (using more sensitive analytical methods

if necessary) when results indicate continuing

problems; monitor carefully the chain of custody for specimens; document results, patient

responses, and action plans in the case record;

respond rapidly to relapse indications; and

ensure that positive results for substance abuse

or negative results for treatment medication

trigger treatment, relapse prevention counseling, HIV counseling, and other intensified

interventions. Continued use of heroin or other

opioids (and possibly other substances) should

generate a review of a patientís addiction medication dosages.

Responding to Unfavorable

Drug Test Results

Patients who continue to abuse substances

while receiving addiction treatment medication

create concern among OTP staff members for

their progress in treatment, negative perceptions of OTPs, and community concerns that

may lead to regulatory actions by SAMHSA,

accrediting bodies, or the U.S. Drug

Enforcement Administration. 

Most OTPs must review a significant number of

unfavorable drug test results. Again, the consensus panel emphasizes that results should be

used to explore different treatment interventions and treatment plans that will reduce and

eliminate substance use and improve treatment

compliance. Reports indicating substance abuse

Exhibit 9-4

Examples of Onsite Analytical Methods for Drug Tests

Test Manufacturer Contact

Abuscreen OnTrak

OnTrak TesTcup

Roche Diagnostics, Somerville, New

Jersey

www.roche-diagnostics.com

Triage

Triage Screening 

Cassette

Biosite, Inc., San Diego, California www.biosite.com

E-Z SCREEN American Biomedica, Ancramdale,

New York

www.americanbiomedica.com

Bionike One Step Bionike Laboratories, South San

Francisco, California

AcuSign Drug Test Resources International,

Boca Raton, Florida

drugtest4u@aol.com

Verdict MedTox, St. Paul, Minnesota www.medtox.com

Micro Line Casco Standards, Yarmouth, Maine www.microgenics.com
Drug Testing as a Tool 157

should signal the need for a medical review of

medication dosage and for intensification of

counseling and education aimed at preventing

HIV and hepatitis transmission. Also, because

of regulatory concern about medication diversion, reports indicating absence of treatment

medication should be evaluated carefully.

Because dose, pH, and urine concentration can

limit detection of treatment medications, staff

members should consider all these areas in conducting their medical reviews and deciding on a

plan of action.

When patients deny substance use despite a

positive laboratory result, a careful history of

their prescribed or over-the-counter drug use

should be obtained and discussed with a

pathologist or chemist to determine whether

these drugs might produce false positive results

or otherwise confound tests. Whenever possible, a questionable test should be redone (if the

specimen is available) and the result confirmed

by another method. If this is impossible, confirmatory analysis should be performed for all

subsequent tests. More accurate testing methods such as RIA or GC/MS can be used to verify laboratory reports. Specimens can be collected under direct observation, and a chain of

custody can be maintained to assure a patient

that every effort is being made to prevent

errors and respond to his or her denial.

Confirmations of positive drug test results generally are conducted in a laboratory rather

than at the OTP. D. Simpson and colleagues

(1997) emphasized the need to confirm unexpected negative as well as positive results with

additional analyses. Their exhaustive review

concluded that TLC is a simple, inexpensive

way to confirm the absence of methadone in a

urine drug test, but gas chromatography is the

best choice for rapid, reliable results. GC/MS

usually is reserved for confirmation in cases

with legal implications. High-performance liquid chromatography is an improving technology with an increasing role in testing for and

confirming the presence of methadone and its

metabolites, as well as other drugs.

Patient Falsification of Test

Results

False negatives can occur as a result of patient

falsification of drug test results or laboratory

error. Braithwaite and colleagues (1995) summarized some ways in which patients tamper

with or obscure the results of urine drug tests,

including substituting urine from another person, diluting urine specimens, or adding other

substances (such as bleach or salt) to samples. 

Strategies to minimize sample falsification

should be balanced by sound treatment ethics

and the overall goals of the programórecovery

and rehabilitation. Common strategies include

ï Turning off hot water in bathrooms to 

prevent patients from heating specimens

brought from elsewhere (although not feasible

in States where other regulations prohibit

this step)

ï Using bathrooms within eyesight of staff to

preclude use by more than one person at a

time and feeling specimen containers for

warmth as soon as received (freshly voided

specimens should be near body temperature

[37C])

ï Using temperature and adulterant strips or

collection devices that include temperature

strips

ï Using a temperature ìgunî (infrared 

thermometer [visit www.coleparmer.com]) to

measure the temperature of urine specimens

ï Using direct observation by staff of specimen

collection.

The consensus panel believes that falsification

is reduced when patients understand that urine

test results are not used punitively to lower

doses of addiction treatment medication.

Continued use of drugs requires counseling,

casework, medical review, and other interventions, not punishment. In the past, some OTPs

reduced medication dosages as a direct result

of positive drug tests although this has proved

ineffective and sets up an adversarial relationship between patients and the OTP. When it is

clear that interventions for substance abuse
158

are ineffective, moving patients to a higher

level of care, rather than discharging them, 

is warranted.

Patients should be encouraged to discuss their

substance use with OTP physicians, caseworkers, or counselors and to trust them with this

information. Ideally, once trust has developed,

drug test results will confirm what already has

been revealed in individual or group sessions.

Nevertheless, some patients fear loss of takehome privileges or remain in denial about their

drug use and do not disclose their noncompliance willingly; drug test results are necessary

to alert OTPs to these patientsí noncompliance.

Reliability, Validity,

and Accuracy of Drug

Test Results

Another critical concern is the reliability of

drug testing, which varies by methodology

(Blanke 1986; Verebey et al. 1998). Accuracy

also depends on the choice of laboratory, use of

proper equipment and methods, quality control, and adherence to high-quality standards

by all involved. As in all laboratory testing,

human errors, confounding results, a poorly

controlled chain of custody for samples, and

other problems lower test reliability.

In the opinion of the panel, urine drug testing

is reliable and valid. A number of studies

have examined the validity and accuracy of

various urine drug-testing analytical methods.

Studies generally report that urine analysis by

EIA techniques is at least 70 percent as accurate as that for RIA or GC/MS (Caplan and

Cone 1997). 

On the basis of cost, the consensus panel

believes that EIA and TLC usually are adequate analytical methods in OTP drug testing.

When results are contested or confusing, confirmation analyses should be performed. For

example, when EIA indicates the presence of

illicit drugs but the patient denies any drug 

use or has progressed well in treatment, 

confirmatory GC/MS can be useful. Confirmatory analysis offsets the limitations 

of single tests.

False Positive and False

Negative Drug-Testing Results

Numerous medications and substances can

produce false positive results in urine drug

tests (see Graham et al. 2003, p. 338). Some

researchers have compared quantitative versus

qualitative testing, that is, testing to measure

the amount and frequency of substance use

versus testing to identify the presence or

absence of a substance. Wolff and colleagues

(1999) noted that false positive results can arise

from incorrect identification of a drug or misinterpretation of a finding. Cone and Preston

(2002) pointed out that EIA analysis lacks the

specificity to distinguish among opioids, and

Narcessian and Yoon (1997) reported a case in

which consumption of a poppy seed bagel

resulted in a positive urine EIA for morphine.

Although EIA can produce some false positive

results, TLC may be less sensitive than EIA,

causing more false negative results (Verebey et

al. 1998). In addition, laboratory and clerical

errors and other problems cause inaccuracies.

To check for any of the above problems, 

unexpected results should be discussed with 

the laboratory before they are conveyed to 

the patient.

Cone and Preston (2002) also addressed the

pitfalls of qualitative testing, such as the

increased possibility that with frequent testing

a single drug use episode might trigger multiple

positive test results (and result in consequences

for the patient). In a comparative study,

Preston and colleagues (1997) found that quantitative urine drug testing provided more information about patterns and frequency of

cocaine use during treatment than qualitative

testing. McCarthy (1994) similarly argued that

quantifying the amount and frequency of drug

use (including methadone) is more useful for

treatment assessment and decisionmaking than

qualitative analysis that simply identifies the

presence or absence of a drug.

Chapter 9
159

Responses to Test Results

Staff members should discuss drug test results

with patients using a therapeutic, constructive

approach. For example, staff members might

express concern to patients over any tests that

are positive for illicit drugs and seek additional

information to explain these results. If a

patient receives medication from a physician

outside the OTP, staff should request informed

consent to contact the physician and coordinate

treatment, ask the patient to bring in prescription bottles, and record these prescriptions in

patient records. OTP physicians should review

prescriptions to determine whether and for

how long their use is appropriate, particularly

when medications have abuse potential. 

Ultimately, if a positive drug test represents

continuing drug use or a relapse after a period

of abstinence, the counselor and patient should

explore strategies to eliminate future use.

Medication dosage and triggers to substance

use should be examined, motivation for abstinence should be explored, and the patient

should be taught skills to manage triggers and

cravings. If drug tests continue to be positive,

the medication dosage, amount of counseling,

and number of OTP visits should be evaluated

and may need adjustment. Furthermore, the

patient might need the support provided by

increasing counseling sessions and drug tests.

These changes should be reflected in an 

updated treatment plan.

Medication Diversion

Since methadone treatment gained prominence

in the late 1960s, concerns have existed about

the diversion of medication from legitimate

treatment use through theft, robbery, or

patients or staff selling or giving away medication. SAMHSA-approved accrediting bodies

pay particular attention to drug test results and

whether an OTP appropriately monitors and

follows up with patients who receive take-home

medications (see chapter 5). The accrediting

bodies require all OTPs to develop and implement a diversion control plan as part of their

quality assurance program and to integrate the

plan into both patient and staff orientations.

The diversion control plan must contain specific measures to reduce the possibility of 

diversion and assign specific implementation

responsibility to medical and administrative

staff (see chapter 14). 

Decisions About Take-Home

Medication

Although drug test reports are a key factor in

take-home medication decisions, OTPs should

consider and document other considerations, such as employment and medical

problems. Current

Federal regulations

(42 CFR, Part 8) outline eight criteria that

the medical director

of the OTP must consider when granting

take-home privileges

(see chapter 5). The

physician also is

required to reevaluate

the appropriateness of

take-home medications at least every 3

months. 

Sometimes privileges are revoked simply to

prevent possible medication diversion, without

a concomitant programmatic response to

address an unfavorable drug test report. When

this occurs without discussion or explanation,

OTPs create barriers between themselves and

patients and appear to function more as monitoring and surveillance units than as treatment

programs. If patients who are receiving takehome medications have positive drug test

results, OTPs should consider such steps as a

review of medication dosage and an increase if

indicated, revision of the patient treatment

plan, or an increase in the level of care, in

addition to cessation or reduction in takehome doses.

Drug Testing as a Tool

When results 

are contested 

or confusing, 

confirmation 

analyses should be

performed.

10 Associated Medical

Problems in Patients 

Who Are Opioid

Addicted

In This

ChapterÖ

Integrated Versus

Referral Services

Routine Testing and

Followup for

Medical Problems

Acute, LifeThreatening

Infections

Infectious Diseases

Patients With

Disabilities

Pain Management

Hospitalization of

Patients in MAT

General Medical

Conditions and

MAT

This chapter identifies medical problems commonly encountered in 

people addicted to opioids, discusses their treatment in opioid treatment

programs (OTPs), and notes important considerations in deciding which

medical services will be provided in an OTP and which can best be performed as a referred service. The chapter also covers medical screening

and diagnostic services that are required by Federal and State regulations

or Substance Abuse and Mental Health Services Administration accreditation guidelines. As such they should be available in or through OTPs.

Some medical problems are more prevalent and often more severe in

people addicted to opioids than in the general population. Many are

infections, including some that can be acutely life threatening, such as

cellulitis, wound botulism, necrotizing fasciitis, and endocarditis. Diseases

that are transmissible pose serious public health threats and are life

threatening, such as HIV/AIDS, hepatitis, syphilis, and tuberculosis (TB).

Many patients in medication-assisted treatment for opioid addiction

(MAT) have chronic diseases such as diabetes, asthma, or hypertension,

as well as conditions such as severe dental problems or seizure disorders,

which may have been neglected or poorly managed for years. Some

patients have chronic obstructive pulmonary disease (COPD), hypertension, coronary artery disease, or other illnesses related to long-term

heavy tobacco use. Management of chronic pain for patients in MAT is

particularly challenging because of the role of opioids in pain treatment.

In addition, opioid intoxication may result in head trauma or other bodily injury. Criminal activity may produce severe physical injuries such as

gunshot wounds. The general approach in OTPs for these and other

medical problems is to remain alert and knowledgeable, facilitate preventive measures, and provide ongoing medical care and emergency

treatment to the extent possible.

161
162

Integrated Versus

Referral Services

Given that many OTPs lack resources to treat

acute and chronic medical problems associated

with addiction, applicants with these medical

issues may sometimes be denied treatment

admission for addiction because an OTP cannot manage their other medical needs. Even

when people with difficult medical problems

are admitted to an OTP, unavailable or fragmented medical and psychiatric services may

cause these patients to leave MAT prematurely,

relapse to substance use, or resort increasingly

to inpatient, emergency, or other expensive 

services because proactive care is lacking.

The consensus panel believes that many medical problems associated with opioid addiction

should be treated either within the OTP or

through liaisons with outside specialists and

programs. One randomized, controlled

trial in a large health

maintenance organization showed that

integrating addiction

treatment and medical care was cost

effective and

improved patient

outcomes (Weisner et

al. 2001). Integrating

medical and addiction treatments is

both a challenge and

an opportunity to

match strategies for

more cost-effective

interventions.

Medical services for

at least the most

common problems

(such as soft-tissue

infections, hepatitis,

HIV infection,

hypertension, diabetes, and COPD) should be

provided at the OTP with expansion to other

medical services as resources permit. Several

studies have shown the public health benefits of

this arrangement (e.g., Batki et al. 2002;

Umbricht-Schneiter et al. 1994). 

The consensus panel recommends that each

OTP clearly define the medical services it

offers on site versus by referral. Safety, practicality, and efficacy are important considerations in these decisions. For example, patients

needing treatment for acute conditions such as

bacterial endocarditis, those needing treatment

for severe liver disease, or those requiring

obstetric and gynecologic services generally are

referred to primary or specialty care providers

because most OTPs lack the resources to provide those services. The panel recommends that

OTPs establish sound links with medical

providers and programs skilled in treating

problems that go beyond the direct services of

the OTPs.

It is important for patients to understand an

OTPís policies regarding services provided on

site versus by referral. For example, an OTP

might offer testing for infectious diseases but

refer patients for treatment of these diseases.

Such distinctions, as well as whether and how

staff members will follow up to ensure that

patients comply with offsite treatment, should

be clear. Referral services should be part of a

patientís opioid addiction treatment plan. The

consensus panel recommends that primary care

responsibility be established either on site or

through a community provider because specialists are more likely to accept patients if their

primary care responsibility has been assigned.

OTPs also should inform local hospitals about

their services and willingness to provide medical information (e.g., dosage information for

addiction treatment medications, assuming a

patientís informed consent) when a patient in

MAT is admitted to a hospital for medical

treatment.

In many cases, patients need help to understand their testing and treatment experiences at

other sites, and they may feel uncomfortable

asking offsite providers questions. OTP staff

should be ready to help patients understand

Chapter 10

OTPs [should]

establish sound

links with medical

providers and programs skilled in

treating problems

that go beyond the

direct services of

the OTPs.
Associated Medical Problems 163

procedures and care received off site and what

these experiences mean for their overall care.

Routine Testing and

Followup for Medical

Problems

Because medical problems associated with 

opioid abuse sometimes emerge or are resolved

during MAT, OTPs should establish protocols

for both assessment of acute problems and

periodic reassessments. The consensus panel

recommends periodic (every 6 to 12 months)

testing for hepatitis A, B, and C; syphilis and

other sexually transmitted diseases (STDs);

TB; HIV infection; hypertension; and diabetes.

Liver and kidney functions also should be 

evaluated routinely. With the exception of HIV

testing, these tests can be performed during

routine evaluation. HIV testing requires a

patientís written permission, along with counseling before and after the test (see TIP 37,

Substance Abuse Treatment for Persons With

HIV/AIDS [CSAT 2000e]). Some OTPs repeat

physical examinations annually, and others do

so every 2 years. The consensus panel believes

that physical examinations of patients in MAT

should be performed at least annually.

Tuberculin skin tests should be performed

every 6 to 12 months, depending on the epidemiology of the region and recommendations

from public health authorities.

Acute, Life-Threatening

Infections

OTP medical staff, in particular those performing intake assessments, should recognize most

potentially life-threatening infections related to

opioid abuse. Some of these conditions can

mimic opioid or intoxication withdrawal. In

many cases, patients may be unaware of the

severity of their conditions or may attribute

their symptoms to withdrawal. Because patients

are focused on avoiding withdrawal, their

descriptions of their histories may be unhelpful.

The most common of these life-threatening 

conditions are discussed below.

Endocarditis

Endocarditis is an infection, usually bacterial,

of the inner lining of the heart and its valves. A

diagnosis of possible endocarditis should be

considered in any patient with recent injection

marks and fever or a newly appearing heart

murmur. A history of previously treated endocarditis might produce persistent heart murmur. Patients who have survived endocarditis

by having a valve replacement are at increased

risk of recurrent endocarditis. Fever in

patients with a heart murmur always merits

careful clinical investigation.

Soft-Tissue Infections

Soft-tissue infections, such as abscesses and 

cellulitis, involve inflammation of skin and 

subcutaneous tissue, including muscle.

Contaminated injection sites often swell and

become tender. When swelling and tenderness

persist, infection is likely. A fluctuant abscess

might need incision and drainage. Depending

on its severity, cellulitis may require treatment

with intravenous antibiotics. Patients with

abscesses or cellulitis might not have fever. 

Necrotizing Fasciitis

Necrotizing fasciitis, sometimes called flesheating infection, usually is caused by introduction of the bacterium Streptococcus pyogenes

into subcutaneous tissue via a contaminated

needle. It is uncommon, and cases caused by

other bacteria also have been reported (Noone

et al. 2002). The infection spreads along tissue

planes and can cause death from overwhelming

sepsis within days without much evidence of

inflammation. Some patients may lose large

areas of skin, subcutaneous tissue, and even

muscle, requiring grafting. Case fatality rates

from 20 to more than 50 percent have been

reported (Mulla 2004). This infection should be

considered when pain at an injection site is

more severe than expected from the redness or
164

warmth at the site. Edema (fluid accumulation

and swelling), fever, hypotension, and high

white blood cell counts are additional clues.

Treatment includes extensive debridement 

(cutting away of infected tissue) and intravenous

antibiotics. Earlier ingestion of antibiotics, especially if these antibiotics were unprescribed,

may result in partial treatment of necrotizing

fasciitis and modify its diagnosis and course

(Smolyakov et al. 2002). 

Wound Botulism

Botulism is caused by the neurotoxin of

Clostridium botulinum, a bacterium usually

found in contaminated food. Botulism causes

loss of muscle tone, including respiratory muscle weakness, making it life threatening. The

presenting symptoms and signsódifficulty

swallowing (dysphagia), difficulty speaking

(dysphonia), blurred vision, and impaired body

movements (descending paralysis)ómay mimic

signs of intoxication (Anderson et al. 1997). An

epidemic of botulism poisoning among people

who injected drugs occurred in the 1990s in

several areas, particularly California (Werner

et al. 2000). Several cases in people who injected

drugs have been reported in Europe and Great

Britain (Jensen et al. 1998; McGarrity 2002).

Infectious Diseases

Some infectious diseases that are prevalent

among patients in MAT, including TB, viral

hepatitis, HIV infection, and STDs, are 

monitored closely by the Centers for Disease

Control and Prevention (CDC), which provides

recommendations about testing, evaluation,

classification, and treatment and publishes

surveillance data. This information changes

periodically, and the most recent data can be

obtained from CDCís Web site (www.cdc.gov)

and its publications.

The incidence of reported cases of TB and

syphilis in the general population in the United

States peaked in 1992. Groups identified to be

at high risk included individuals who were

homeless, incarcerated, or infected with HIV,

as well as some immigrant groups. Intensive

public health efforts decreased reported cases

of syphilis from the 1990s through 2000, but

reported cases increased 2.1 percent in 2001

(Centers for Disease Control and Prevention

2003c). Reported TB cases continued to

decrease during the same period (Centers for

Disease Control and Prevention 2002b).

TB

Public health statutes in all States require that

the U.S. Public Health Service be notified of all

cases of known or suspected active TB. State

and Federal laws mandate appropriate followup and treatment of anyone whose TB might

have been acquired from known exposure to an

individual with active TB.

Frequency and types of 

testing

The consensus panel recommends that patients

in MAT be screened for TB every 12 months

unless local epidemiology and transmission patterns and the recommendations of local health

authorities indicate that more frequent testing

is needed. High-risk groups, for example,

patients still injecting drugs and health care

workers who must treat them, should be

screened more frequently (e.g., every 6

months). New staff members should be

screened for TB, and all staff members should

be retested regularly, depending on local prevalence. Patients should receive a purified protein derivative (PPD) skin test for TB both on

admission and annually, unless local health

authorities indicate that more frequent testing

is needed or patients are known to be PPD positive. In addition, treatment providers should

look for and question patients about other

symptoms of active TB, such as persistent

cough, fever, night sweats, weight loss, and

fatigue. OTPs should use the Mantoux test,

which injects five tuberculin units of PPD

intradermally. Patients who are HIV positive

are considered PPD positive if an induration of

5 mm or more appears. Those who are HIV

negative are considered PPD positive if an

Chapter 10
Exhibit 10-1

Classification of TB

Class Type Description

0 No TB exposure No history of exposure; negative skin test for TB

1 TB exposure; no 

evidence of infection

History of exposure; negative skin test for TB

2 TB infection; no disease Positive skin test for TB; no clinical, bacteriologic, or

radiographic evidence of active TB

3 TB infection; clinically

active

Mycobacterium tuberculosis-positive culture (if done);

clinical, bacteriologic, or radiographic evidence of 

active TB

4 TB infection; not 

clinically active now;

clinically active in past

History of TB episodes

or

Abnormal but stable radiographic findings; negative 

bacteriologic studies (if done); positive skin test for TB

and

No clinical or radiographic evidence of active disease

5 TB suspected Diagnosis pending

165

induration of 10 mm or more appears. The

standard classification system for TB is shown

in Exhibit 10-1.

Positive PPD. The PPD skin test detects the

immune response when a patient has been

infected with TB. However, patients who have

received a Bacillus Calmette-Guerin (usually

called BCG) vaccination will have a positive

PPD, and a chest x ray is indicated. Infections

need not be active to be detected. Earlier

infections controlled by the immune system are

inactive, but they cause positive test results. In

these cases, patients do not have symptoms of

TB, and chest x rays show no evidence of active

TB. These patients are considered to have class

2 TB and should receive prophylaxis with isoniazid to prevent later activation of infection

(Centers for Disease Control and Prevention

2002b). Patients with class 2 TB do not transmit

the disease. Those who have a history of 

exposure (e.g., when a family member has TB)

but remain uninfected (i.e., their skin tests are

negative) are considered to have class 1 TB and

sometimes are treated prophylactically.

The consensus panel recommends following

CDC guidelines on frequency of chest x rays for

patients in MAT who are PPD positive. The

medical staff should facilitate referrals for such

patients to be evaluated at appropriate facilities

(e.g., county TB clinics, affiliated or local hospitals, patientsí private physicians) and should

ensure necessary followup.

Associated Medical Problems

Source: Centers for Disease Control and Prevention 2000, p. 15. 
166 Chapter 10

Negative PPD. A negative PPD means one of

three things: there is no TB infection (class 0),

the infection is in the incubation period, or the

patient is unable to respond to the skin test

(i.e., is anergic) (see Exhibit 10-1). Because

many patients who are immunocompromised

and HIV infected are immunologically anergic,

chest x rays are considered a routine part of

their HIV care.

Prevention of TB in MAT

Adequate room ventilation is important for TB

prevention (Centers for Disease Control and

Prevention 2000).

Special attention

should be paid to

waiting rooms, corridors, and offices.

Patients with active

TB who are coughing in an unventilated room are most

likely to spread the

disease and should

receive masks or

special precautions

should be taken to

prevent transmission pending medical evaluation. OTP

staff should be educated about this

risk. Patients diagnosed with active TB are quarantined in a hospital when treatment begins and generally are

not released until their sputum tests revert to

negative. Undiagnosed cases of TB increase the

exposure risk in communities; therefore,

aggressive evaluation and screening are crucial.

Treatment of TB during MAT

Isoniazid is used with vitamin B6 for prophylaxis

to prevent active TB. Isoniazid is combined

with other medications when patients have

active TB (Centers for Disease Control and

Prevention 2000). In either case, OTP staff

members should monitor medication compliance

actively to prevent the emergence of multidrugresistant TB. Some patients may benefit from

receiving their TB medication under direct

observation along with their addiction treatment medication (Batki et al. 2002; Gourevitch

et al. 1996). However, directly observed treatment for eligible patients should be optional.

Addiction treatment medications should not be

withheld to ensure adherence to TB medications.

Isoniazid is effective in TB prevention but can

cause liver toxicity (Centers for Disease Control

and Prevention 2000). In view of the high

prevalence of liver disease and hepatitis among

patients in MAT, liver enzymes should be monitored during isoniazid therapy. A significant

increase (i.e., doubling or more) in one or more

liver enzymes (alanine aminotransferase or

serum pyruvic transaminase, aspartate aminotransferase, or lactate dehydrogenase) suggests

liver toxicity and warrants a thorough medical

evaluation.

If rifampin is used to treat TB in patients

receiving MAT, their addiction treatment medications should be adjusted carefully because

rifampin accelerates clearance of methadone

and other drugs metabolized by the liver (see

chapter 3). Rifabutin can be used as an alternative in patients receiving methadone. The

methadone dose may need to be increased,

split, or both. 

STDs

Syphilis

The consensus panel recommends that all

patients admitted to OTPs be tested at intake

for syphilis with one of the serologic blood tests

described by CDC (Centers for Disease Control

and Prevention 2002c), including the rapid

plasma reagent or the Venereal Disease

Reference Laboratory test. Because false 

positive results are common with nontreponemal serologic tests in people who inject drugs,

all positive tests should be confirmed with a 

treponemal antigen test such as fluorescent treponemal antibody absorption or Treponema

pallidum particle agglutination. Patients with a

confirmed positive serologic test for syphilis

[T]reatment

providers should

look for 

and question

patients about...

symptoms of active

TB...
Associated Medical Problems 167

need to receive treatment either on site or by

referral to a local clinic, hospital, physicianís

office, or health department. Treatment of

syphilis is particularly important because

syphilis has been shown to facilitate sexual

transmission of HIV.

Chlamydia and gonococcus

infections

Genital chlamydia and gonococcus infections

often go undetected and may facilitate the 

sexual transmission of HIV. One cross-sectional

study found that 7.9 percent of all adults

between ages 18 and 35 had untreated gonococcal or chlamydial infections (Turner et al.

2002). Although testing for sexually transmitted

genital infections is recommended in OTPs, it

often is ignored because it requires a full pelvic

and genital examination. Increased availability

of urine testing for STDs might enhance access

to their treatment in patients receiving MAT.

Additional information is available in TIP 6,

Screening for Infectious Diseases Among

Substance Abusers (CSAT 1993a).

Hepatitis

Hepatitis A

Hepatitis A is an important viral liver infection

that affects people who abuse drugs at higher

rates than rates found in the general population. Hepatitis A can cause serious morbidity

and mortality in patients already infected with

hepatitis B virus (HBV) or hepatitis C virus

(HCV). OTPs should screen for hepatitis A

virus (HAV) and provide vaccination services

or referral to such services for individuals who

are unexposed.

Hepatitis B

Fifty to seventy percent of people who begin

injecting drugs contract hepatitis B within 5

years, accounting for 17 percent of all new

cases in 2000 (Centers for Disease Control 

and Prevention 2003d). This prevalence is 

particularly disturbing because vaccination can

prevent HBV infection. In people with chronic

HBV infection, both active and carrier states

are marked by persistent surface antigen

expression. A chronic carrier is someone who

remains positive for serum hepatitis B surface

antigen for 6 months or more. Recovery is

marked by the disappearance of surface antigen, which is replaced by surface antibody.

Core antibody (antibody to HBV core proteins)

is present whenever patients are infected with

HBV, regardless of outcome. If patients are not

exposed to HBV, tests for the core antibody will

be negative, but these patients remain susceptible to infection if exposed.

Testing is important to identify individuals with

acute hepatitis B, those in chronic HBV carrier

states, and those who are untreated but symptomatic for chronic active hepatitis B, as well

as those unprotected from HBV infection who

can be immunized (Centers for Disease Control

and Prevention 2002c). All patients in MAT

should be tested on admission via blood tests

for both anti-HBV core antibody and HBV 

surface antigen. If patients are positive for the

surface antigen, further medical evaluation and

counseling about avoiding transmission to others is important. Medical evaluation, including

liver function testing, needs to be done on site

or by referral.

Patients who are negative for core antibody

and surface antigen should be advised of their

susceptibility to HBV infection and vaccinated

at the OTP if possible, although cost is a factor

in most OTPs. Patients who are positive for

HBV surface antibody either have been infected

or were vaccinated and probably are protected.

All staff members risk exposure to HBV 

infection, especially those who do physical

examinations or handle urine or blood 

specimens, and they should receive hepatitis

B vaccine, according to Occupational Safety

and Health Administration standards for

blood-borne pathogens (29 Code of Federal

Regulations [CFR], Part 1910 ß 1200).

Hepatitis C

An estimated 70 to 90 percent of people who

inject drugs have serologic evidence of 
168

exposure to HCV (National Institutes of Health

2002), which indicates that OTPs will treat

some patients with chronic HCV infection. 

The most appropriate intervention depends 

on HCV stereotype liver disease, alcohol 

consumption, and HIV status.

Testing for HCV. The consensus panel recommends that patients be tested by enzyme

immunoassay for exposure to HCV. Testing

should be simple and accessible on site. When

HCV antibody test results are negative, it is

important to educate patients about HCVís

high transmissibility. The main method of

transmission in this group is injection drug use

(National Institutes of Health 2002). Hepatitis

C is transmitted more than hepatitis A or B 

or HIV/AIDS. In one study, most subjects

became infected with HCV within the first 2

years of injection drug use (Thomas et al.

1995). Hepatitis C also can be acquired

through sexual transmission. However, this is

much less efficient than the parenteral route.

Sexual transmission of HCV occurs more frequently in HIV-infected individuals than in

other individuals.

Determination of HCV disease activity. A 

positive HCV antibody test indicates patient

exposure to HCV. Further evaluation should

determine whether HCV infection has selfresolved (cleared) or is chronic. Approximately

15 to 25 percent of patients exposed to HCV

clear their infections. To determine whether

HCV infection still is present, a test for HCV

ribonucleic acid is required. This test uses

polymerase chain reaction and is costly, presenting a significant barrier for patients without health insurance. Detection of liver

enzymes is a cheaper test but is insufficient to

detect the virus. Twenty-five to fifty percent of

people with HCV infection have normal liver

enzymes (Inglesby et al. 1999). Patients with

chronic hepatitis C infection may have few or

no symptoms, so they have little incentive to

incur further expense and visit their physicians.

The consensus panel recommends that OTPs

provide patients who are HCV positive with

advice on minimizing their risk of liver 

damage, as well as encouragement to be evaluated further. These patients should know that 

alcohol ingestion significantly worsens hepatitis

C (Regev and Jeffers 1999). They also should

be tested and receive vaccinations for HAV and

HBV infections if they have not been vaccinated.

Because acute hepatitis A can be severe among

HCV-infected patients, hepatitis A vaccination

is recommended for all persons who are HCV

infected. Many standard ìhepatitis panelî

blood tests include a test for HAV antibody. In

addition, patients who are HCV-antibody positive should avoid high doses of acetaminophen

because it can cause liver damage, and their

HCV antibody status should be communicated

to any physician prescribing medication so that

liver-toxic drugs are avoided (Thomas et al.

2000).

In contrast to HIV, the viral load of HCV does

not correlate with its liver disease severity. For

patients who have quantitative HCV, a complete

evaluation of liver disease includes determination of liver enzymes and a liver biopsy (Saadeh

et al. 2001). Virus genotyping is important if

pharmacotherapy is considered because the

results indicate the optimal length of treatment.

Treatment decisions are not based on patientsí

symptoms but on HCV genotype, level of liver

disease, co-occurring illnesses, and willingness

to undergo treatment. A decision flowchart for

evaluating patients for HCV exposure is given

in Exhibit 10-2.

Treatment of hepatitis C. The decision to treat

patients in MAT for chronic hepatitis C infection is complex because it must include many

factors, such as presence of co-occurring disorders, motivation to adhere to a 6- to 12-month

weekly injection schedule, and medication side

effects. Results of HCV genotyping (another

expensive blood test) and a liver biopsy also

must be considered. Counselors in OTPs can

support patients who are deciding whether to

undergo hepatitis C treatment. Patients with

HCV infection who do not need treatment

(minimal liver disease) may be concerned about

liver disease progression. They should be

informed that liver disease progresses to cirrhosis in 10 to 15 percent of cases and that its

Chapter 10
progression is more likely with alcohol consumption. Co-infection with HIV or other types

of hepatitis also may be associated with higher

risks of disease progression (National Institutes

of Health 2002).

The duration of hepatitis C treatment depends

on the virus genotype. Most patients are

infected with genotype 1 virus and require

approximately a year of treatment, consisting

of polyethylene glycol (PEG) interferon-alpha

combined with ribavirin. In genotype-2 and

Associated Medical Problems 169

Exhibit 10-2

Hepatitis C Evaluation Flowchart
genotype-3 patients, 6 months of treatment usually is sufficient. The most effective interferon at

this writing is pegylated interferon alpha-1 or

alpha-2a. Treatment combines one interferon

injection per week with ribavirin taken twice

daily in capsule form for up to 1 year depending on viral subtype. Side effects include flulike

symptoms and depression. Ribavirin also can

have numerous adverse effects, most notably

anemia and neutropenia. Therefore, cooccurring disorders and anemia should be 

evaluated carefully before initiating hepatitis C

treatment.

Pretreatment with

antidepressants can

be helpful to control

treatment-induced

depression. Some

selective serotonin

reuptake inhibitors

can increase plasma

levels of methadone

or levo-alpha acetyl

methadol (LAAM)

(see chapter 3);

therefore, patients

receiving these medications should be

observed for sedation or other effects

of overmedication.

Many treatment

providers are reluctant to treat patients

who are opioid

addicted for HCV

infection, but their

concerns are unsupported by evidence (Edlin et al. 2001).

Sylvestre (Sylvestre 2002a, 2002b) and

Sylvestre and Clements (2002) reported excellent treatment results for HCV in patients on

methadone maintenance, using a model that

included pretreatment with antidepressants

when necessary and weekly group support

meetings, a key element in treatment success.

Success in treatment did not require abstinence, although patients who used illicit drugs

daily did not respond well (Sylvestre 2002b;

Sylvestre and Clements 2002). Patients

required moderate increases in methadone during treatment, perhaps related to the discomfort of side effects (Sylvestre 2002a). Support

groups met twice per week, led by both a counselor and a peer; educated patients about HCV;

and provided a forum to share fears, crises,

problems, and successes (Sylvestre 2003). A

National Institutes of Health consensus statement (National Institutes of Health 2002) also

encouraged hepatitis C treatment for patients

who inject drugs:

Many patients with chronic hepatitis C

have been ineligible for trials because

of injection drug use, significant alcohol

use, age, and a number of comorbid

medical and neuropsychiatric conditions. Efforts should be made to

increase the availability of the best current treatments to these patients.

Treatment effectiveness is measured by absence

of detectable HCV after the treatment course

and at 24 weeks after completion of treatment

(sustained virologic response [SVR]). In one

study, combination treatment with pegylated

interferon and ribavirin produced an SVR in

more than 40 percent of patients (Manns et al.

2001). Most patients (75 percent or more) had

genotype 1 HCV infection, which is associated

with worse response (Manns et al. 2001). In

studies of all patients receiving these treatments

(i.e., not just patients who abused substances),

pegylated interferon and ribavirin produced

higher response rates for HCV genotypes 2 and

3 after only 6 months of treatment, whereas

regular interferon was less effective (Manns et

al. 2001). From approximately 50 (Lau et al.

1998) to more than 90 percent (Fontaine et al.

2000) of patients with an SVR in these studies

remained virus free. Treatment had partial

benefits for those who did not clear the virus,

such as reduced liver disease (Baffis et al. 1999;

Poynard et al. 2000).

Treatment choices are complex for patients who

have not responded to hepatitis C infection

treatment, have dropped out of treatment, or

have been judged too ill or behaviorally disturbed for treatment. There is no consensus 

170 Chapter 10

Treatment 

effectiveness is

measured by

absence of

detectable HCV

after the treatment

course and at 24

weeks after 

completion of

treatment... 
on whether treatment reinstatement might be

beneficial or medical maintenance should be

continued for partial responders.

Liver transplant. Transplantation is a last

recourse for patients with hepatitis C infection

with end-stage liver disease. The consensus

panel recommends that MAT providers become

familiar with the policies of regional transplant

centers and their acceptance requirements.

Success in obtaining a transplant may depend

on timeliness of action by a patientís extended

treatment team. Patients receiving methadone,

LAAM, or buprenorphine for opioid addiction

may be barred from transplant programs or

accepted only if they taper from their maintenance medication before transplantation (Koch

and Banys 2001). OTP medical staff members

can serve as advocates for patients needing

transplants. A common concern is that patients

will be unable to comply with complicated care

after their transplant. On the contrary, limited

reports on transplantation in patients receiving

MAT have shown excellent compliance with

aftercare, although their outcomes were not

compared with patients with no history of substance use (Kanchana et al. 2002; Koch and

Banys 2002).

HIV/AIDS

Since the early 1990s, the prevalence of HIV

infection has increased substantially in most of

the United States among people who inject

drugs (Hartel and Schoenbaum 1998). A 1998

survey by the American Methadone Treatment

Association (now the American Association for

the Treatment of Opioid Dependence) reported

that approximately 25 to 30 percent of patients

receiving methadone treatment in the United

States were infected with HIV (Gourevitch and

Friedland 2000). In practical terms, these

statistics mean that OTPs should be prepared

to care for many patients who are HIV positive

or have AIDS.

Relatively early in the AIDS epidemic, it was

shown that rates of needle use and conversion

to HIV seropositivity decreased in patients

receiving methadone maintenance compared

with untreated groups and that these rates 

continued to decrease with time in treatment

(e.g., Ball et al. 1988; Novick et al. 1990). These

lifesaving benefits of MAT have contributed significantly to the respect MAT is accorded within the medical community.

TIP 37, Substance Abuse Treatment for Persons

With HIV/AIDS (CSAT 2000e), provides information on the natural history or course of

HIV/AIDS and treatment for HIV/AIDS. A publication from the Center for Substance Abuse

Treatment (CSAT 2004b) provides information

on confidentiality issues related to substance

abuse treatment programs.

Testing for HIV infection

The U.S. Public Health Service and many State

health departments recommend that HIV counseling and testing be routinely offered in drug

or alcohol prevention and treatment programs,

especially where most patients have injected

drugs and therefore are at increased risk

(Centers for Disease Control and Prevention

2001a). ìRoutinely offeredî means providing

these services to all patients after informing

them that the test can be done either on site or

through referral. CDC also recommends that

pretest counseling be required for all patients

(Centers for Disease Control and Prevention

2001a) and that HIV testing be recommended

strongly and viewed as a routine procedure.

Individuals should be informed that they may

decline this testing without losing health care or

other services. Counseling and testing also

should be made available to patientsí acquaintances who might have been exposed to HIV. 

The consensus panel further recommends that

HIV counseling and testing be provided by the

OTP at no cost. Either a trained employee or

someone from an outside agency can provide

counseling and testing services. Some States

may have certification requirements. Many

State health departments, as well as CDC, provide training or training materials for HIV

counseling and testing. Standard tests include

enzyme immunoassay for antibodies to HIV-1

and HIV-2 and confirmation by Western blot

Associated Medical Problems 171
analysis (Centers for Disease Control and

Prevention 2001a). Several other tests are

approved by the U.S. Food and Drug

Administration (FDA), including tests using

urine and saliva and rapid tests that give

results in 10 to 60 minutes (see chapter 4).

These newer tests are for HIV-1 only, and positive tests are reconfirmed by Western blot.

OraQuick also tests for HIV-2. Although HIV-2

is rare in the United States, testing for it still is

recommended for blood bank donations and in

special populations, such as immigrants from

West Africa. There also is an FDA-approved

home collection kit that allows a sample to be

sent from home for testing (Branson 1998;

Centers for Disease Control and Prevention

2001a). TIP 37, Substance Abuse Treatment

for Persons With HIV/AIDS (CSAT 2000e),

provides additional information about patients

infected with HIV.

Prevention of HIV infection

Universal precautions to prevent the spread of

HIV through contaminated bodily fluids

(Centers for Disease Control 1988a) should be

followed in any OTP. The consensus panel recommends that staff members be educated about

how HIV is transmitted both to avoid exposure

and to reduce generally unfounded fears of

contamination during daily interactions with

patients such as counseling or shaking hands.

Prevention should include a factual understanding of the highly charged, often panicladen beliefs surrounding AIDS.

The panel believes that having an AIDS coordinator on staff as the resident expert, community liaison and educator, and patient resource is

optimal in areas with high HIV prevalence.

Education about HIV should be part of the

intake process for all patients and should

include a description of the modes of transmission (stressing sexual as well as needle-sharing

transmission), assessment of risk status, guidelines for prevention, and the importance of

HIV testing in prevention and intervention. 

HIV medications and

methadone

Gourevitch and Friedland (2000) summarized

interactions between methadone and commonly

used HIV medications. Some medications, such

as fluconazole, increase methadone levels, and

others, such as nevirapine, efavirenz, and

ritonavir, lower them. These authors pointed

out that decisions about raising or lowering

methadone dosages for patients in MAT who

are HIV positive should be based on observation during the first month of any treatment

change because some patients react differently

than indicated by published information

(Gourevitch and Friedland 2000). If necessary,

peak and trough blood levels can be drawn and

split dosing provided accordingly.

Neurologic complications of

AIDS and its treatment

Pain from neuropathy is difficult to control

with opioids alone, and some patients do better

with gabapentin or antidepressants instead of,

or in addition to, an increased methadone

dosage or the addition of another opioid for

breakthrough pain (see ìPain Managementî

below). Patients with AIDS-related dementia or

loss of balance may become erratic and difficult

to monitor in an OTP. For them, a referral for

neuropsychological evaluation may be helpful

to identify any cognitive deficits and effective

ways to provide supportive care. As dementia

worsens, patients with take-home privileges

may lose methadone bottles or mistakenly take

more than one daily dose. Patients who fall or

are unsteady might be assumed erroneously to

be intoxicated. Close cooperation between OTP

staff and providers treating these patients for

AIDS is key to managing patients with neurologic complications of AIDS.

Referral for treatment

Most OTPs offer no onsite treatment for HIV

because of its complexity and their limited

resources. Referral usually should be made for

medical assessment of patients who are HIV

positive. A standard assessment may include a

172 Chapter 10
baseline CD4 T-cell count, viral load, and

tuberculin skin test, along with updated immunizations. Based on the results, physicians

should discuss the potential utility of antiviral

therapy (Krambeer et al. 2001). Depending on

the availability of medical services, referrals

can be made to private physicians, infectious

disease specialists, HIV early-intervention

treatment programs, hospital-based clinics, or

community health centers. TIP 37, Substance

Abuse Treatment for Persons With HIV/AIDS

(CSAT 2000e), provides suggestions regarding

medical-care referrals.

Benefits of early intervention

The benefits of early intervention to control

HIV and opportunistic infections should be

stated clearly to patients. Patients and treatment staff, including drug counselors, should

discuss the importance of notifying patientsí

sex and needle-sharing partners, and staff

members should offer help in this. Encouragement to continue in MAT or another form of

addiction treatment is extremely important

because addiction treatment participation may

foster adherence to HIV treatment and lead to

reductions in the spread of HIV.

Patients With

Disabilities

OTPs increasingly must address the needs of

disabled patients. TIP 29, Substance Use

Disorder Treatment for People With Physical

and Cognitive Disabilities (CSAT 1998c), discusses the requirements of the Americans with

Disabilities Act of 1990. Many patients with

AIDS have disabilities such as visual impairment, or they lack the strength to visit an OTP.

Other patients may have hearing impairments

or other disabilities, some since birth and some

caused by trauma or other events. In one

study, prevalence of illicit drug use was higher

for persons with disabilities than for others.

The types of drugs used varied with age (Gilson

et al. 1996).

Home Dosing for Patients

With Disabilities in MAT

Home dosing is an important option for

patients whose disabilities preclude daily OTP

visits. However, some patients are ineligible.

For example, those with AIDS or other medical

problems that affect neurological functioning

may be unable to

manage their medication without supervision. Others who are

medically compromised and continue to

abuse substances usually are ineligible for

take-home dosing.

These patients pose

major challenges for

OTPs, and treating

them requires creative planning.

Solutions vary from

program to program

and in different

areas. For patients

with disabilities who

do not meet take-home eligibility criteria, home

dosing sometimes can be negotiated under the

emergency dosing provisions of Federal or

State regulations. For example, some OTPs

identify a responsible family member or significant support person to assist with dosing. With

patient permission, these individuals can be

educated about addiction treatment medications and made responsible for picking them up

from the OTP, ensuring safe storage (e.g.,

locked boxes, limited key access), and administering them daily to these patients. For patients

who cannot identify such people, OTPs might

negotiate medication support through the

Visiting Nurses Association or comparable 

programs that can assist in this process.

Some OTPs deliver medication directly to disabled patientsí homes, but such arrangements

may be impractical when patients live far from

their OTPs, and delivery often is expensive.

Associated Medical Problems 173

Patients in

methadone 

maintenance...

have high levels 

of tolerance for

the analgesic

effects of opioids.
Switching from methadone to LAAM might ease

the accessibility problem somewhat, but, as

indicated elsewhere

in this TIP, the

future availability of

LAAM is doubtful.

Buprenorphine, with

its longer duration of

action, also might be 

considered.

Regardless of the

strategy, meeting the

needs of homebound

patients is a challenge. Home dosing

can be time consuming and expensive,

and it introduces

safety and security

problems.

Consideration should be given to negotiating

with pharmacies or interested physicians who

can work directly with OTPs to provide home

dosing in geographically remote areas. The consensus panel encourages OTP administrators to

engage in discussions with their State agencies,

the U.S. Drug Enforcement Administration

(DEA), FDA, and other Federal and local 

agencies to develop creative solutions.

Pain Management

Patients in MAT have been shown to have high

rates of acute and chronic pain (Rosenblum et

al. 2003). Medical treatment providers, accrediting bodies, and the popular press have

focused considerable attention on the need for

adequate pain treatment, particularly to relieve

chronic, nonmalignant pain or pain at the end

of life, including palliative care with large doses

of opioids. Pain in MAT patients can sometimes

be managed with nonopioid medications, as

well as nonpharmacologic approaches, but

often the pain is severe and refractory to 

nonopioid analgesics or nonpharmacologic

treatments.

Increased attention to pain control has made

even physicians who are not addiction 

specialists more familiar with the use of

methadone in pain treatment, and they also 

are more likely to understand that methadone

should be continued if patients receiving MAT

are hospitalized. Reluctance to provide adequate pain treatment to patients in MAT 

usually is based on the mistaken belief that a

maintenance dose of opioid addiction treatment

medication also relieves acute pain. In fact,

long-term opioid pharmacotherapy produces

substantial tolerance for the analgesic effects 

of opioid treatment medications; therefore, a

usual maintenance dose affords little or no 

pain relief.

Patients receiving methadone maintenance

treatment were shown to be hyperalgesic,

meaning that they experienced pain more

severely than those not receiving methadone

(Doverty et al. 2001b). Patients in methadone

maintenance also were shown to have high 

levels of tolerance for the analgesic effects of

opioids, suggesting that conventional doses of

morphine may be ineffective in managing

episodes of acute pain in this patient group

(Doverty et al. 2001a).

Another common concern is that opioidcontaining analgesics aggravate addiction 

disorders. In fact, relapse to illicit opioid use

has occurred when opioid analgesics are given

to people in recovery. Such patients generally

should not be given the drugs they abused 

previously, and patients with current or past

opioid addiction should be monitored more

closely than those without these problems.

Relapse occurs most often when practitioners

are unaware of their patientsí opioid 

addiction history.

Occasionally some patients do not meet

Diagnostic and Statistical Manual of Mental

Disorders, Fourth Edition, Text Revision

(DSM-IV-TR) (American Psychiatric

Association 2000), criteria for addiction, but

they believe they are addicted to pain medication because they are dependent physically as a

result of chronic use of these medications. A

patient or physician who lacks education about

MAT might interpret physical dependence

alone (i.e., not psychological addiction) or drug

174 Chapter 10

Home dosing is an

important option

for patients whose

disabilities preclude daily OTP

visits.
Associated Medical Problems 175

seeking for poorly managed chronic pain as

addiction. Ideally, such patients should be

referred to pain management specialists.

However, the consensus panel recommends that

they also be accepted for MAT. Disadvantages

of this approach are that regulations and

requirements for observed dosing may be onerous and that these patients receive treatment

where most patients are opioid addicted, which

might not be therapeutic for patients not

addicted in the usual sense. If these patients

are treated in OTPs, the new regulatory framework allows for up to 1 month of take-home

medication, provided evidence of stability and

absence of unprescribed drug use exist (see

chapter 5). This option could reduce markedly

the burdens imposed by the earlier, more rigid

regulatory framework of OTPs. In smaller

communities with no OTPs, such patients might

be ostracized from pharmacies or from primary

care offices for insisting on proper pain control. Effort should be made to find physicians

who will help them manage their pain. Some

physicians are willing to accept patients after

they have been stabilized by the OTP.

Types of Pain

Examples of conditions, either foreseeable or

unplanned, that produce acute pain include

traumatic injury, dental procedures, and labor

and delivery. A dying patient with lung cancer

probably has chronic malignant pain. Patients

with arthritis or disc disease might have chronic

nonmalignant pain. In addition, patients in

MAT might have withdrawal-related pain, 

usually as aches in bones and joints along with

other withdrawal signs and symptoms. Various

types of pain are not mutually exclusive. For

example, withdrawal, anxiety, and depression

make chronic pain worse, and patients with

chronic pain may have acute exacerbations of

their pain. The most therapeutic intervention

for pain depends on its type, community

resources, patient preferences, and the extent

of services available.

Acute pain

Patients occasionally require medical, surgical,

and dental procedures that must be performed

away from the OTP. In their guidelines for

treating pain in patients receiving methadone,

Scimeca and colleagues noted that these

patients often required large doses of opioids at

relatively short intervals for pain control

because they had developed tolerance for 

opioids. One recommended approach to pain

management for this group was to prescribe

adequate doses of an alternative mu opioid 

agonist, such as morphine, hydromorphone, or

oxycodone, while maintaining the maintenance

dose of methadone or LAAM (Scimeca et al.

2000). Partial agonists such as buprenorphine,

butorphanol tartrate, and nalbuphine should

be avoided because they can cause opioid withdrawal in patients receiving MAT (Rao and

Schottenfeld 1999). Whenever possible, pain

management should be discussed with care

providers before surgery or dental procedures.

Several principles provide the basis for managing acute pain in hospitalized patients also

receiving opioid addiction pharmacotherapy

(Compton and McCaffery 1999; Savage 1998;

Scimeca et al. 2000):

ï Methadone should be continued at the same

daily dose, whether by oral or intramuscular

routes, although it can be divided. For example, 50 percent of the usual dose can be given

before surgery and 50 percent after. If

methadone must be given parenterally, the

injected dose should be 50 percent of the 

oral dose, because it is absorbed twice as 

efficiently by injection.

ï LAAM patients can be treated temporarily

with equivalent daily methadone doses (usually the 48-hour LAAM dose divided by 1.2),

taking into account the timing of the last

LAAM dose and its longer acting effects. 

ï Buprenorphine treatment may have to 

be suspended temporarily because it can

attenuate or block the effects of opioids.

ï Hospital physicians should be aware that

methadone can be prescribed by any physician with a DEA registration for treating
nonaddiction problems and that maintenance treatment can be continued without a

special registration throughout hospitalization, provided that a patient is being treated

in a certified and accredited program. For

example, when a patient in MAT is admitted

for treatment of any disorder other than

addiction, Federal regulations indicate that a

hospital physician may continue to prescribe

maintenance doses of methadone (21 CFR,

Part 1306 ß 07(c)).

ï Pain management should be discussed 

with affected patients, and they should

receive assurances that they will be afforded

adequate relief.

ï Patientsí levels of pain should be monitored

and, if increases are evident, pain should 

be treated promptly. Doses of short-acting

opioids might have to be administered in

addition to maintenance treatment, which is

preferable to increased methadone doses for

patients in MAT with acute pain. The doses

of opioid analgesic required to interrupt pain

in these patients can be larger and more frequent than for persons not in MAT because

of the higher tolerance of patients in MAT. A

patientís previous drug of abuse should not

be prescribed for pain treatment. Patientcontrolled analgesia can be successful to treat

postoperative pain in patients who are opioid

addicted, although the increments used

should be monitored to minimize the reinforcing properties of the medications 

(Savage 1998).

ï Partial agonist or agonist antagonist drugs

such as pentazocine, butorphanol tartrate,

nalbuphine hydrochloride, and buprenorphine should be avoided in methadonemaintained patients because these agents 

can precipitate withdrawal symptoms.

ï Changeover to nonopioid agents should occur

as soon as practical.

ï Take-home opioids should be monitored for

appropriate use and amounts limited.

Patients should be seen at shorter intervals

for refills, and prescriptions should specify a

fixed schedule rather than ìas needed.î The

actual time of day should be specified, rather

than ìtwice dailyî (or ìb.i.d.î) or ìthree

times dailyî (ìt.i.d.î) (Savage 1998).

Increasing the drug testing frequency also

may be advisable to verify that only prescribed medications are taken.

ï Hospital physicians should communicate

clearly with OTPs about discharge dates and

times and the amounts of final methadone

doses given in the hospital, to allow maintenance pharmacotherapy to be resumed 

effectively without interruption and to avoid

overmedication.

Chronic pain

Patients who complain of chronic pain first

need a thorough examination to determine and

treat the cause of the pain. Some patients may

need referral to specialists for testing and treatment. Several options should be tried before a

patient receives opioids for pain. Nonopioid

pain treatments may be tried, including 

medications, for example, nonsteroidal antiinflammatory drugs (which are not without

risksógastrointestinal bleeding is a well-known

side effect of chronic use), COX-2 inhibitors, or

other pharmacotherapies and physical therapy

or surgery. Exhibit 10-3 lists nonpharmacologic

approaches to managing chronic, nonmalignant

pain. Unfortunately, many pain centers that

provide these treatments hesitate to accept

patients taking opioid treatment medications.

Special consideration is needed to provide opioid therapy for patients in MAT who have

chronic, intractable, nonmalignant pain.

Studies of patients receiving methadone have

found that 37 to 60 percent have chronic pain

(Jamison et al. 2000; Rosenblum et al. 2003).

Use of opioids to treat chronic pain in this

group is controversial because of potential side

effects and hyperalgesia (Compton et al. 2001).

However, withdrawal of patients with chronic

pain from maintenance opioids is rarely appropriate and often results in failure to treat both

the addiction and the pain disorder. A pain

management expert and an addiction specialist

should coordinate treatment of patients in

MAT, following an extended team approach.

176 Chapter 10
Some OTPs restrict take-home dosing for

patients also receiving opioids for pain. The

consensus panel believes that such policies are

unfair and counterproductive. When a patient

in MAT uses opioid pain medications only as

prescribed, informs his pain treatment physician of his or her addiction history and participation in MAT, and refrains from abusing 

substances, long-term use of opioid pain medication should not disqualify the patient from

take-home dosing in MAT. Drug testing can be

useful in evaluating the degree to which such

patients are complying with treatment regimens

although it is not foolproof; urine drug tests,

for example, identify only the presence or

absence of substances, not the amount taken

(see chapter 9).

Adjustment of Methadone

Schedule

The methadone-dosing schedule to treat pain is

three or four times daily or every 6 to 8 hours.

Some patients in MAT with chronic pain might

benefit from having their daily methadone

dosage split for better pain control, which

necessitates a take-home schedule for the

remaining daily doses. When possible, program

guidelines should require that an OTP staff

member witness the first dose of the day.

Additional Opioids

Some patients with chronic pain have variable

levels of pain or bursts of acute pain as well.

For them, prescribing additional doses (or

ìrescueî doses) of opioid analgesics to manage

breakthrough pain may be indicated as part of

a comprehensive approach. If so, the amount

of rescue medication should be calculated

prospectively based on a patientís history

(Savage 1999). The rescue medication should

be monitored, and unannounced drug testing

may be indicated to prevent abuse or diversion. A primary care physician or a pain specialist can prescribe rescue medication. If a

patient needs frequent rescue medication, then

his or her substance abuse treatment medication probably should be increased in lieu of

prescribing increasingly higher doses of shortacting opioids. Certain types of pain respond

well to anticonvulsant adjuvant medications

Associated Medical Problems 177

Exhibit 10-3

Nonpharmacologic Approaches to Managing

Chronic Nonmalignant Pain

Physical Interventions Psychological Interventions

Cold and heat

Ultrasound

Counterstimulation (TENS*)

Massage and manipulation

Stretching and strengthening

Orthotics, splints, and braces

Positioning aids (pillows, supports)

Deep relaxation

Biofeedback

Guided imagery

Cognitive behavioral therapy

Mood disorder treatment

Posttraumatic stress disorder treatment

Family/relationship therapy

* Transcutaneous electrical nerve stimulation.

Source: Adapted with permission from Savage 1998.
such as carbamazepine or phenytoin, both of

which are potent CYP450 3A inducers that can

lead to a sharp reduction in serum methadone

levels. Gabapentin, which also is effective in

neuropathic pain, does not alter CYP450 3A

isoenzymes and therefore does not change

methadone levels.

Hospitalization of

Patients in MAT

During a medical crisis requiring hospitalization

of a patient in MAT, it is important that the

OTP physician communicate with the attending

physician and other members of the patientís

hospital health care team. The hospital team

should be informed of the patientís methadone

dosage, the date on which methadone was

last administered, and the patientís medical, cooccurring, or social problems.

During hospitalization, it is extremely important for the treating physician to understand

that a patient in MAT probably will require

larger doses of medication for anesthesia and

that adequate pain relief might require the

patient to receive a normal methadone dose 

(or its equivalent) plus additional medication,

as described earlier in this chapter. Communicating these facts to the hospital team ensures

appropriate care. Failure to provide sufficient

baseline opioid medication in accordance with

previous daily use plus additional medication

for anesthesia can lead to inadequate pain

relief, even with additional opioids.

In addition, the hospital team should be

advised to institute appropriate controls to prevent a patient from obtaining and using illicit

substances or abusing prescription drugs while

in the hospital. These controls are especially

important for unstable patients in the acute

phase of MAT. Such controls include limiting

visitors, preventing a patientís wandering

through the hospital, and conducting regular

drug tests. It usually is helpful to provide psychiatric consultation to medical or surgical staff

treating patients in MAT, especially for patients

with co-occurring disorders.

Some patients in MAT are hospitalized frequently. For example, a patient on dialysis

might require repeated shunt revisions, a

patient with chronic lung disease might have

pneumonia several times a year, or a patient

with cirrhosis might have episodes of variceal

bleeding. In such cases, OTP staff members

who dispense medications may be in a position

to monitor patients to facilitate early treatment.

General Medical

Conditions and MAT

As patients become engaged in MAT, they are

more likely to take better care of themselves,

modify their lifestyles, and participate in the

medical followup needed to manage common

chronic illnesses. In general, their medical care

for other conditions should be identical to that

given patients not in MAT. Primary care for

common medical conditions such as diabetes,

hypertension, and COPD can be provided easily in an OTP by nurse practitioners and other

staff members working in collaboration with

primary care physicians or internists. In some

cases, medications for these medical conditions

might need adjustment because of interactions

with opioid addiction treatment medications

(see chapter 3).

General advice on diet, exercise, smoking prevention, and stress management should be integrated into MAT, especially if nurse practitioners or physicianís assistants are on staff. A

comprehensive approach addressing all aspects

of patient health facilitates treatment of

neglected medical problems. Age- and riskappropriate medical screening, such as mammograms, sigmoidoscopy, prostate checks, or

exercise stress tests, should be discussed with

patients during regular examinations. The

counseling staff can use printed educational

material or videotapes to present this information. Some programs have developed healthrelated educational videotapes that are played

in the waiting room so patients can receive

information during daily OTP visits.

178 Chapter 10
179

11 Treatment of Multiple

Substance Use

In This

Chapter...

Prevalence of

Multiple Substance

Use in MAT

Common Drug

Combinations Used

by Patients in MAT

Effects of Other

Substance Use

Management of

Multiple Substance

Use in MAT

Inpatient

Detoxification and

Short-Term

Stabilization

Concurrent opioid and other substance use is a serious problem in opioid

treatment programs (OTPs). Patients in medication-assisted treatment for

opioid addiction (MAT) commonly use alcohol, amphetamines, benzodiazepines and other prescription sedatives, cocaine, and marijuana (THC

[delta-9-tetrahydrocannabinol]). Patterns of use range from occasional

low doses to regular high doses that meet dependence criteria. Central

nervous system (CNS) depressants such as alcohol, benzodiazepines, and

barbiturates are especially dangerous when used with opioids.

Except for naltrexone, which is used to treat alcohol dependence, the

treatment medications used in MAT do not address nonopioid substance

use directly, although patients stabilized on adequate treatment medication are less likely to abuse other substances than patients who are

undermedicated. Because multiple substance use during MAT may 

complicate treatment greatly, the consensus panel recommends that staff

members be trained to recognize the pharmacologic and psychosocial

effects of both opioid and nonopioid substances of abuse. OTPs should

have treatment options available to address multiple substance use either

directly or by referral.

An essential purpose of preliminary assessment is to determine whether

new patients are abusing or are dependent on substances other than opioids (see chapter 4). If one of these problems is identified, OTPs should

adjust treatment plans and the types of services provided accordingly.

OTPs should not exclude patients automatically from MAT who test positive for illicit drugs other than opioids. Treatment providers should treat

patients for their concurrent substance abuse aggressively or refer them

appropriately. Providers should try to understand and address the

underlying causes of concurrent substance use.
Prevalence of Multiple

Substance Use in MAT

Patients Entering OTPs Who

Abuse Other Substances

The Treatment Episode Data Set (TEDS) 

summarizes data on admissions to substance

abuse treatment programs in the United States.

According to TEDS, 42.7 percent of patients

entering substance abuse treatment in OTPs 

in 2000 reported using only heroin (Substance

Abuse and Mental Health Services

Administration 2002d). Exhibit 11-1 presents

TEDS data on heroin and other substances

used by people admitted to OTPs in 2000.

Proportions of patients using additional drugs

180 Chapter 11

Exhibit 11-1

Reported Use of Other Substances by Patients Admitted to OTPs

Primary Substance of Abuse

Heroin Other Opioids

Total number of admissions 243,523 25,839

Average number of substances used (per admission) 1.8 1.8

Substance Used in Addition to Primary Substance Percent Percent

None 42.7 44.4

Alcohol 23.3 24.4

Marijuana/hashish 12.1 14.2

Nonsmoked cocaine 22.2 7.2

Smoked cocaine 12.1 5.4

Methamphetamine/amphetamine 2.8 3.2

Other stimulants 0.2 0.3

Heroin NA 7.8

Other opioids 4.3 1.3

Hallucinogens 0.3 0.4

Tranquilizers 3.0 10.2

Sedatives 0.7 4.0

Phencyclidine 0.2 0.1

Inhalants <0.5 0.1

Other 0.7 1.5

Percentages sum to more than 100 because 1 patient could report more than 1 additional

substance. 

NA, not applicable.

Source: Substance Abuse and Mental Health Services Administration 2002d.
Treatment of Multiple Substance Use 181

and the types of drugs used varied by locality,

depending primarily on drug availability.

Although not shown in Exhibit 11-1, rates of

cigarette smoking in this population reportedly

range from 85 to 92 percent (Clarke, J.G., et

al. 2001; Clemmey et al. 1997).

Exhibit 11-2 summarizes results of a large-scale

study of co-dependence in 716 patients admitted to OTPs in Baltimore, Maryland, over a 

5-year period (1989 to 1994). Patients with 

co-occurring disorders had higher rates of substance co-dependence than patients without 

co-occurring disorders. Rates were substantially higher for lifetime co-dependence, even

among patients not co-dependent during the

study (Brooner et al. 1997).

Emergency Room Admissions

and Fatalities Involving

Concurrent Opioid and Other

Substance Use

The Drug Abuse Warning Network tracks data

from hospital emergency departments and

other institutions that report admissions for

substance use and drug-related deaths. In

2001, 93,064 nonfatal admissions mentioned

heroin use. Of these, 5 percent mentioned concurrent alcohol use only, 25 percent mentioned

concurrent use of another drug but not alcohol, and 15 percent mentioned concurrent use

of alcohol and another drug or other drugs as

well as heroin (Substance Abuse and Mental

Health Services Administration n.d.a). Nearly

90 percent of heroin-related deaths may

involve concurrent use of other substances

(Substance Abuse and Mental Health Services

Administration 2002b).

Common Drug

Combinations Used by

Patients in MAT

Exhibit 11-3 summarizes reasons patients in

MAT give for using particular combinations of

substances, based on the consensus panelís

experience. A common reason is that patients

have become dependent on the substance along

Exhibit 11-2

Current Substance Use Disorders in Patients Dependent on Another

Substance While Addicted to Opioids and Admitted to OTPs, With and

Without Co-Occurring Disorders (N=716)

Substance

With Co-Occurring

Disorders (%)

Without Co-Occurring

Disorders (%)

Cocaine 48.5 32.7

Marijuana 16.8 15.7

Alcohol 31.5 18.6

Sedatives 21.8 12.5

Percentages sum to more than 100 because 1 patient could report more than 1 additional

substance.

Adapted from Brooner et al. 1997.
182 Chapter 11

with their opioid addiction. Another common

reason is the need to self-medicate withdrawal

symptoms or uncomfortable affects (e.g., anxiety, depression, anger, loneliness) related to

nonñsubstance-induced mental disorders or

difficult life situations. Patientsí initial substance use experiences and continued attraction to drugs may indicate enhancementñ

avoidance reactions. That is, substances may

be used to enhance an experience (e.g., use of

alcohol as a social lubricant or cocaine to

heighten sexual pleasure) or to avoid or neutralize strong feelings (e.g., incest survivorsí

substance use before sex to numb their feelings

or adolescentsí substance use before sex to

avoid accepting responsibility for their

actions). Some patients develop unique drug

regimens that vary throughout the day, for

example, using stimulants in the morning, anxiolytics in the afternoon, and hypnotics at night.

Effects of Other

Substance Use

Alcohol

The acute effects of alcohol are well known,

including sedation, as well as impairment of

judgment, coordination, psychomotor activity,

reaction time, and night vision. Overdose

deaths can occur when alcohol is used alone in

high doses or in lower doses with opioid treatment medication or sedatives (Hardman et al.

Exhibit 11-3

Drug Combinations and Common Reasons for Use

Combination Reasons

Heroin plus alcohol Enhance a high; create euphoria or sedation

Heroin followed by alcohol Medicate opioid withdrawal; medicate cocaine 

overstimulation (e.g., anxiety, paranoia)

Heroin plus cocaine (ìspeedballî) Enhance or alter cocaine euphoria

Heroin followed by cocaine Medicate opioid withdrawal

Cocaine plus alcohol Enhance high; reduce cocaine overstimulation 

(e.g., anxiety, paranoia)

Cocaine followed by heroin Reduce cocaine overstimulation (e.g., anxiety, 

paranoia); modulate the cocaine crash

Methadone plus alcohol Create a high; sedate

Methadone plus cocaine Reduce cocaine overstimulation (e.g., anxiety, 

paranoia); moderate the cocaine ìcrashî

Methadone plus benzodiazepines Create a high; sedate

Any opioid plus any nonbenzodiazepine sedativeCreate a high; sedate

Any opioid followed by any 

nonbenzodiazepine sedative 

Medicate opioid withdrawal

Any opioid plus amphetamine Create a high
1996). The effects of concomitant alcohol and

methadone, levo-alpha acetyl methadol (LAAM),

or buprenorphine use are additive and more

sedating than either alcohol or treatment medication alone. Alcohol abuse can aggravate liver

damage from hepatitis C, which is common

among patients in MAT. Alcohol-related factors

are a major cause of death among patients in

MAT, both during and after treatment, and of

administrative discharges from OTPs (Appel et

al. 2000). On average, patients in MAT who are

alcohol dependent have more medical and mental disorders, greater criminality, and poorer

social and family functioning and peer relations

than patients who are not alcohol dependent

(Chatham et al. 1995b).

Alcohol abuse among patients in MAT can

affect treatment compliance (Bickel and Amass

1993) and outcomes adversely. Continuous use

may induce enzyme activity that increases the

metabolism of treatment medication, reducing

medication plasma levels and resulting in symptoms of undermedication that further complicate treatment.

Research is limited or conflicting on alcohol

disorder treatment for patients in MAT. Many

studies comparing alcohol use before OTP

admission and after 1 year have found little or

no improvement (e.g., Fairbank et al. 1993;

Hubbard et al. 1997). However, one study

found that short-term MAT reduced alcohol

consumption significantly in patients who did

not meet alcohol-dependence criteria (Caputo

et al. 2002), and a 10-year study found that less

than 6 percent of patients in MAT reported

alcohol problems in the previous 6 months

(Appel et al. 2001). 

Lubrano and colleagues (2002) found an association between inadequate methadone doses and

increased cravings for both heroin and alcohol.

Others noted that continued alcohol consumption among patients dependent on alcohol was

associated with smaller increases in methadone

doses during MAT (El-Bassel et al. 1993).

Stastny and Potter (1991) found that many

patients in MAT who abused alcohol also

abused benzodiazepines.

Treatment for alcohol dependence involves a

comprehensive approach combining detoxification if needed, counseling, medications such as

disulfiram, and participation in mutual-help

groups (Fuller and Hiller-Sturmhofel 1999).

Many groups do not support use of maintenance medication. Other interventions have

met with limited success. A pilot study provided intensive education for staff members at

OTPs in which 220 patients receiving

methadone also were treated for alcohol dependence. Eighty percent of these patients complied with treatment requirements and completed treatment (Kipnis et al. 2001). 

Benzodiazepines

Benzodiazepines such as diazepam (ValiumÆ)

and clonazepam (KlonopinÆ) have antianxiety

and sedative effects. They are schedule IV

drugs, signifying relatively low abuse liability.

However, people with other addiction disorders

are more likely to abuse benzodiazepines than

are members of the general population (Ross

and Darke 2000). In an early study, patients

receiving opioid treatment medication who also

abused benzodiazepines typically took the latter within 1 hour of the former and reported

that benzodiazepines increased the effects of

the medication (Stitzer et al. 1981). These

effects likely result from an interaction in

which each drug potentiates the sedative

aspects of the otheróknown on the street as

ìboosting.î When used in prescribed doses,

benzodiazepines are not dangerous for patients

in MAT, except when they cause patients to

seek other drugs with sedative effects. Highdose benzodiazepines can cause serious problems, including severe intoxication and higher

risk of injuries or fatal overdoses. These risks

are potentiated when high doses of benzodiazepines are mixed with methadone or other

drugs that produce sedation and respiratory

depression, even among patients in MAT who

have developed tolerance for the respiratorydepressant effects of opioids.

In the experience of the consensus panel,

patient use of benzodiazepines negatively

affects attendance at treatment sessions and

Treatment of Multiple Substance Use 183
progress in MAT. Regular benzodiazepine use

for 3 months or more may be associated with

physiologic dependence, even when benzodiazepines are taken in prescribed doses.

Patients who are abusing or dependent on benzodiazepines usually need detoxification and

more intensive treatment interventions to

remain safely in MAT.

Nonbenzodiazepine Sedatives

Nonbenzodiazepine sedatives such as intermediate- or short-acting barbiturates or

glutethimide are more likely than benzodiazepines to produce lethal overdose because

people who abuse them develop tolerance for

their sedative and euphoric effects but not for

their respiratory-depressant effects. Therefore,

as these people increase their dosages to get

high, they suddenly can overdose to respiratory depression. People who are opioid addicted

and abuse nonbenzodiazepine sedatives usually

need inpatient detoxification before starting

MAT or may do better with referral to a longterm, residential program such as a therapeutic

community. Nonbenzodiazepine sedatives

induce cytochrome P450 3A, an enzyme

involved in methadone, LAAM, and buprenorphine metabolism (see chapter 3), and can

make stabilization difficult.

The consensus panel recommends that OTPs

withhold treatment medication for patients who

appear intoxicated with a sedative-type drug

until intoxication has cleared and patients are

either detoxified from sedatives or confirmed

not to be sedative dependent. Nonbenzodiazepine sedative and barbiturate abuse is

rare in most areas. These medications are less

widely abused than in the past, because benzodiazepines are less dangerous and easier to

obtain in many areas.

Cocaine and Other Stimulants

Stimulant abuse, especially cocaine, is another

serious problem in many OTPs (see Exhibit 

11-1). Adverse effects of these substances

include cardiovascular effects (hypertension,

stroke, arrhythmias, myocardial infarction), 

respiratory effects (perforation of nasal septum,

bronchial irritation) if inhaled or smoked, or

mental effects (anxiety, depression, anger,

paranoia, psychotic symptoms). Patients in

MAT who abuse stimulants may be disruptive 

if the stimulants have severe mental effects,

and these patients may have problems with

mood swings and compliance with group or

individual therapy. TIP 33, Treatment for

Stimulant Use Disorders (CSAT 1999c), 

provides more information.

Another concern for patients in MAT who use

cocaine is concurrent alcohol use. The combination of alcohol and cocaine is popular

because it can create a more intense high and

less intense feelings of inebriation than either

substance alone. Individuals also use alcohol to

temper discomfort when they come down from

a cocaine-induced high. Patients in MAT who

abuse both alcohol and cocaine are significantly

more difficult to engage and retain in treatment

than patients who do not abuse all three substances (Rowan-Szal et al. 2000b). In addition,

cocaethylene, a psychoactive derivative of

cocaine formed exclusively during the combined

administration of cocaine and alcohol, can

increase the cardiotoxic effects of either substance alone. The combination of alcohol and

cocaine tends to have exponential effects on

heart rate and may increase violent thoughts

and tendencies (Pennings et al. 2002). The mixture of opioids, cocaine, and alcohol can be

lethal and has been identified as a leading cause

of accidental overdose (Coffin et al. 2003). 

Tennant and Shannon (1995) found that

cocaine use appeared to lower the methadone

concentration in blood. In addition, some

patients reduced their cocaine use when their

methadone dosages were increased. Borg and

colleagues (1999) found that adequate doses of

methadone seemed to reduce cocaine use even

though methadone does not target cocaine

directly. More focused treatments and research

on these interactions are needed.

Traditionally, disulfiram has been used to treat

alcohol dependence (chapter 3). Because

cocaine often is used with alcohol, Petrakis and

184 Chapter 11
colleagues (2000) evaluated disulfiram treatment

for cocaine dependence, with and without 

alcohol abuse, for patients in MAT. Patients

who were treated with disulfiram significantly

decreased the quantity and frequency of their

cocaine use, whereas those treated with a

placebo did not. Related studies found that the

positive effects of disulfiram on cocaine use

among patients in substance abuse treatment

remained evident after 1 year (Carroll et al.

2000) and that disulfiram also was promising

for patients treated with buprenorphine

(George et al. 2000). More research on the 

benefits of disulfiram therapy for cocaine

dependence during MAT is needed.

Marijuana 

In general, THC use is not as prevalent as

cocaine or amphetamine use among patients 

in MAT (see Exhibit 11-2). Some studies have

concluded that THC use in MAT does not 

affect MAT outcomes adversely. For example,

Epstein and Preston (2003) found that THC

was not associated with either poor treatment

retention or problem use of other substances

such as cocaine. One study (Wasserman et al.

1998) showed that, for patients committed to

opioid abstinence and doing well, positive tests

for THC could predict relapse, but this finding

has not been replicated (Epstein and Preston

2003).

OTPs vary in whether they require THC-free

drug tests before patients can qualify for or

continue take-home medication privileges. The

consensus panel recommends that OTPs

address patient THC use because, as with other

substances of abuse, THC increases the probability that patients will engage in activities that

put them at higher risk of relapse to opioid use,

other health problems, other related illicit

activities, and legal problems.

Patients in MAT sometimes use THC to selfmedicate for anxiety or insomnia. Approaches

to address THC use in these patients include

increased counseling, treatment of their anxiety

disorders with standard psychotropic medications and psychotherapy, and requirements

that drug tests be free of THC before patients

can qualify for take-home medication. Unlike

people addicted to nonopioid substances,

patients in MAT who are opioid addicted rarely

seek treatment for THC dependence. Therefore, it has received less attention in OTPs than

in other substance abuse treatment programs.

Nicotine

Tobaccoñsmoking-related illnesses are a major

cause of morbidity and mortality among

patients in MAT as they are in the general 

population. For example, 40 percent of deaths

over 15 years in one physicianís office-based

MAT program were related to cigarette smoking,

which was more than deaths from HIV/AIDS,

hepatitis C, and violence combined (Salsitz et

al. 2000). Frosch and

colleagues (2000)

found that patients in

MAT who smoked

heavily were more

likely to abuse cocaine

and opioids than were

patients who did not

smoke heavily, suggesting an association

between nicotine and

other substance use.

In other research,

patients receiving

methadone who

reduced their tobacco

use also reduced

cocaine use, although

cocaine was not addressed directly in treatment

(Shoptaw et al. 1996).

Many OTPs avoid addressing nicotine dependence because it may create additional stress

for patients. Research has shown that smoking

interventions neither detract from nor interfere

with addiction recovery and that patients who

attempt nicotine cessation are at the same risk

for relapse as other patients (Ellingstad et al.

1999; Hughes 1995). Furthermore, many

patients in MAT want to stop smoking

(Clemmey et al. 1997).

Treatment of Multiple Substance Use 185

[S]moking interventions neither

detract from 

nor interfere 

with addiction

recovery...
The consensus panel believes that OTPs should

address nicotine dependence routinely. In addition, because effective medications are available,

tobacco cessation should be a regular part of

patientsí treatment plans. The forthcoming TIP

Detoxification and Substance Abuse Treatment

(CSAT forthcoming a) contains information on

medications and other interventions for nicotine

cessation.

Management of

Multiple Substance

Use in MAT

Although some studies have indicated that

patients in MAT reduce other substance use significantly when they

receive adequate

doses of methadone,

LAAM, or

buprenorphine,

none of these medications reliably and

consistently stopped

nonopioid abuse in

studies reported by

Borg and colleagues

(1999) and by

Tennant and

Shannon (1995). A

major concern is

how to determine

what level of other

substance abuse by

patients indicates that MAT is insufficient and

other treatments should be tried or that MAT

should be stopped, perhaps against patient

wishes.

Some have argued for early treatment discharge if patients continue using multiple substances. In addition, some State regulations set

specific timetables for compliance, although the

requirement is unsupported by research. Some

OTP staff members may feel that patientsí continued use of alcohol and illicit drugs, despite

progress in recovery from opioid addiction,

reflects negatively on OTP credibility and that

these patients are taking the places of people

who would benefit more from MAT. Patients

who continue using illicit drugs sometimes

erode the morale of other patients, who may

conclude that treatment compliance and abstinence are optional.

Policies favoring treatment termination for

patients who use substances negate a fundamental principleóthat longer retention in

treatment is correlated highly with increased

treatment success (Hubbard et al. 1997, 2003).

In fact, substantial remission from all substance use is a common and positive outcome of

MAT, particularly when treatment includes regular drug counseling and other psychosocial

services (McLellan et al. 1993). Consensus

panel members have found that, if patients with

secondary substance use problems remain in

MAT and staff members address overall substance abuse patterns for these patients, many

patients stop using nonopioid and nonprescribed substances.

Changing staff attitudes can be helpful to both

patients and staff. Abuse of other substances

along with opioid addiction presents many

problems and challenges for treatment

providers and patients. Without treatment, a

person with these problems may continue criminal activity; remain obsessed with substance

use; experience severe financial, vocational,

and personal problems; and be at increased

risk for overdose death.

Given the importance of retention in MAT for

positive outcomes, the consensus panel agrees

that a policy of discharge for other substance

use is seldom appropriate. Instead of setting

standard timetables for discharge, limits should

be determined on a case-by-case basis. Patient

discharge should be done with great caution for

reasons stated elsewhere in this TIP (e.g.,

chapter 8) and only when staff members have

exhausted all reasonable alternatives. When

grappling with these difficult problems,

providers should keep in mind where patients

started, how far they have progressed, the

degree to which they are engaged in treatment,

whether all available interventions have been

186 Chapter 11

OTPs should have

clear policies

declaring the

desirability of 

cessation of all

substance use.
tried, the riskñbenefit ratio of keeping these

patients in treatment versus discharging them,

and a realistic expectation for patients, given

the resources available. If discharge must

occur, staff members should work with patients

to arrange transfer to another program where

a treatment slot is open and they can obtain

more benefit.

Other Procedures

A key element in treating multiple substance

use in an OTP is the need for intensified services and heightened structure and supervision

(see chapter 8). Because few chronic diseases

respond to a single care model, OTPs need a

variety of techniques for patients who abuse

multiple substances. These techniques should

incorporate available medical, mental health,

and social services. Usually patients who abuse

multiple substances require a more intensive

level of care for a limited period. Treatment

providers also should have referral agreements

with inpatient facilities for brief detoxification

from nonopioid substances, extended stabilization before reentry into an OTP, or admission

to a therapeutic community, residential treatment, or other long-term, more structured and

controlled environment. OTPs can enter into

agreements with residential treatment programs to allow continued MAT along with treatment for other substance dependence.

A common problem is that some OTP staff

members and patients assume that stopping

opioid and injection drug use is the sole objective of treatment. Use of cocaine and other substances should cause concern because it undermines patient stability. Nonetheless, use of

some substances such as THC may be viewed

as less serious unless clear evidence exists of

impaired functioning. Many people entering an

OTP regard alcohol use as acceptable because

it is legal. Changing such attitudes and behaviors requires patience and effort. OTPs should

have clear policies declaring the desirability of

cessation of all substance use. These policies

should clarify any ambiguity about abstinence

from nonprescribed medications but encourage

therapeutic use of medications that are 

effective to treat legitimate, diagnosed conditions. OTPs should encourage abstinence from

alcohol and nicotine, but it is difficult to

require it because these are legal substances.

However, OTPs may withhold medication if

patients have consumed alcohol shortly before

or are intoxicated during treatment and should

address alcohol problems.

The consensus panel believes it is helpful, both

when patients are admitted to an OTP and

throughout treatment, to maintain the position

that opioid use is only the most obvious part of

patientsí problems and that the role of all

intoxicants (both licit and illicit) in patientsí

lives and their overall substance-using lifestyle

are other important issues. Patients in MAT

should recognize that use of any intoxicant

undermines their progress.

Dosage Adjustments

During the dosing period (see chapter 5), OTPs

should ensure that patientsí dosages suppress

withdrawal and produce significant crosstolerance for opioids of abuse. Patients may be

abusing other drugs to self-medicate withdrawal symptoms caused by inadequate dosages or

other factors that affect medication

metabolism. In this case, raising the dosage or

splitting doses may lessen other substance use. 

Increased Counseling and

Other Psychosocial Services

Numerous studies have shown that regular

counseling is associated with a reduction in 

opioid and other substance use by patients in

MAT (Villano et al. 2002; see chapter 8 in this

TIP). In a study of patients who abused multiple substances and had co-occurring disorders

or criminal histories, those who received more

intensive cognitive behavioral treatments

reduced their cocaine use more than those in

less intensive treatment (Rosenblum et al.

1995). In another study of patients in MAT 

who received additional cognitive behavioral

therapy for cocaine abuse and patients who

received standard methadone treatment,

Treatment of Multiple Substance Use 187
188 Chapter 11

cocaine use declined significantly for both

groups (Magura et al. 2002). 

Increased Drug Testing

One obstacle to detecting other substance use

during MAT is that infrequent drug tests primarily identify only those patients who use

substances frequently, for example, daily.

Early detection and intervention requires occasional periods of more intensive, random drug

testing. OTPs, however, should have objective

policies that require combining increased drug

testing with more intensive counseling. Testing

frequency might be used as a contingency, with

more negative tests for illicit drugs resulting in

less frequent testing (see chapter 8).

Inpatient

Detoxification and

Short-Term

Stabilization

Use of alcohol or other CNS depressants with

opioids may cause depression of respiration, 

loss of consciousness, life-threatening withdrawal reactions, and increased risk of lethal

overdose (Baskin and Morgan 1997). This type

of withdrawal is not treatable with methadone

(Sporer 1999; White and Irvine 1999). Signs

and symptoms of withdrawal from CNS depressants include elevated body temperature,

hypertension, rapid pulse, confusion, hallucinations, and intractable seizures. When a

patient in MAT abuses a CNS depressant, the

depressant should be withdrawn medically

from the patientís system, and the opioid treatment medication should be continued with consideration of the need for a dosage increase.

The patient may require inpatient detoxification from CNS depressants and should continue MAT during the inpatient stay. In addition,

a history of seizures or toxic psychosis during

withdrawal from a sedative-hypnotic or anxiolytic drug or from alcohol is an absolute 

indication for inpatient detoxification. The

forthcoming TIP Detoxification and Substance

Abuse Treatment (CSAT forthcoming a) contains more information on detoxification from

substances of abuse.
12 Treatment of 

Co-Occurring

Disorders

In This

ChapterÖ

Prevalence of 

Co-Occurring

Disorders

Motivation for

Treatment and 

Co-Occurring

Disorders

Etiology of 

Co-Occurring

Disorders

Screening for 

Co-Occurring

Disorders

Making and

Confirming a

Psychiatric

Diagnosis

Prognosis for

Patients With 

Co-Occurring

Disorders

Treatment Issues

Many people who are opioid addicted have co-occurring mental disorders. However, mental health and addiction treatment systems often are

separated. This situation may result in patientsí being treated at one

location for addiction and at another for mental disorders. Some mental

health care facilities do not accept patients in medication-assisted treatment for opioid addiction (MAT), forcing these patients to choose which

disorder to treat. These problems, along with uncertainties about effective interventions for patients with both addiction and mental disorders,

have stimulated research in this area. This chapter summarizes current

thinking and consensus panel recommendations on screening, diagnosing, and treating these patients in opioid treatment programs (OTPs).

The term ìco-occurring disorderî in this TIP means a mental disorder

that coexists with at least one substance use disorder in an individual.

The consensus panel acknowledges that other types of disorders also

occur with substance use disorders, such as cognitive and medical disorders and physical disabilities. These conditions also require individualized treatment approaches, and, for patients who are opioid addicted,

other chapters in this TIP present discussions of treatments for other

types of disorders that occur with substance use disorders. Chapter 6

discusses patients with physical disabilities. Chapter 8 discusses patients

with cognitive disorders. Chapter 10 discusses patients with other 

medical disorders. 

TIP 42, Substance Abuse Treatment for Persons With Co-Occurring

Disorders (CSAT 2005b); Report to Congress on the Prevention and

Treatment of Co-Occurring Substance Abuse Disorders and Mental

Disorders (Substance Abuse and Mental Health Services Administration

2002c); and Strategies for Developing Treatment Programs for People

With Co-Occurring Substance Abuse and Mental Disorders (Substance

Abuse and Mental Health Services Administration 2003d) provide additional information on co-occurring disorders in substance abuse treatment. This chapter focuses on co-occurring disorders in patients with

opioid addiction.

189
Patients in MAT who have co-occurring disorders often exhibit behaviors or feelings that

interfere with treatment. These symptoms may

indicate either underlying co-occurring disorders

that would be present regardless of substance

use (i.e., independent or primary disorders) or

co-occurring disorders caused by substance use

(i.e., substance-induced or secondary disorders).

Symptoms may also indicate the presence of

both independent disorders and self-induced disorders along with substance use disorders.

Patients may have identifiable co-occurring disorders on admission to an OTP, or disorders

may emerge during MAT.

Unless MAT providers distinguish co-occurring

disorders accurately by type and address them

appropriately, these disorders likely will complicate patientsí recovery and reduce their

quality of life. Numerous studies have indicated

that rapid, accurate identification of patientsí

co-occurring disorders and immediate interventions with appropriate combinations of psychiatric and substance addiction therapies improve

MAT outcomes. The consensus panel for this

TIP endorses this view. Many standard treatments for mental disorders can be modified

readily for patients with co-occurring disorders

in MAT. 

Prevalence of 

Co-Occurring Disorders

Exhibit 12-1 lists the most common cooccurring disorders among patients in MAT,

based on representative studies (e.g., Brooner

et al. 1997; Mason et al. 1998). They are

grouped into Axis I and II disorders, as defined

in Diagnostic and Statistical Manual of Mental

Disorders, Fourth Edition, Text Revision

(DSM-IV-TR) (American Psychiatric

Association 2000).

Studies comparing patients in MAT with the

general population have confirmed higher rates

of co-occurring Axis I and II disorders in these

patients (e.g., Calsyn et al. 1996; Mason et al.

1998). In a study by Brooner and colleagues

(1997), nearly half of patients in MAT had 

co-occurring disorders during their lifetimes.

Factors Affecting Prevalence

of Co-Occurring Disorders

Some factors found to increase the prevalence

of co-occurring disorders among people with

substance use disorders include older age,

lower socioeconomic status, and residence in

urban areas (Kessler et al. 1994); homelessness

(North et al. 2001); and incarceration (Robins

et al. 1991). Certain mental disorders (e.g.,

antisocial personality disorder [APD],

schizophrenia) and some affective and anxiety

disorders (phobias, bipolar depression) have

been found to be more prevalent among persons with substance use disorders than in the

general population (Regier et al. 1990).

However, some of these studies did not 

determine whether symptoms of co-occurring

disorders were related to the pharmacological

effects of substances or to an underlying 

nonñsubstance-related disorder. TIP 42,

Substance Abuse Treatment for Persons 

With Co-Occurring Disorders (CSAT 2005b),

discusses factors affecting the prevalence of 

co-occurring disorders. 

Gender Differences in

Prevalence of Co-Occurring

Disorders

Rates of co-occurring disorders have been

found to differ between men and women. For

example, Ward and colleagues (1998b) found

that more women than men who were opioid

addicted had affective and anxiety disorders,

whereas more men than women who were opioid addicted had APD and were dependent on

alcohol. A study by Brooner and colleagues

(1997) found women were more likely than men

to have Axis I diagnoses, particularly major

depression; seven times more likely to have

borderline personality disorders; only half as

likely to be diagnosed with APD; and less likely

than men to manifest problems with other 

190 Chapter 12
substances, including alcohol. Another study

indicated that female patients receiving

methadone were more likely than male patients

to have psychotic and affective disorders

(Calsyn et al. 1996). Another study of patients

in MAT found that women were more likely

than men to have PTSD (Villagomez et al. 1995).

Motivation for

Treatment and 

Co-Occurring Disorders

Some studies have found that co-occurring disorders motivated people who were addicted to

seek treatment. Community surveys from both

the Epidemiologic Catchment Area study and

the National Comorbidity Study found that,

among respondents with substance use disorders, those with co-occurring disorders were

more likely to obtain treatment (Kessler et al.

1994, 1996; Regier et al. 1990).

Etiology of 

Co-Occurring Disorders

Mueser and colleagues (1998) identified four

common models to explain the relationship

between co-occurring and substance use 

disorders:

Treatment of Co-Occurring Disorders 191

Exhibit 12-1

Common Co-Occurring Disorders in Patients Who Are Opioid Addicted

Axis I Categories

(Clinical Disorders and Other Conditions)

Axis II Categories

(Personality Disorders and 

Mental Retardation)

ï Mood Disorders

Major depressive disorder 

Dysthymic disorder

Bipolar disorder

ï Personality Disorders

APD

Borderline personality disorder

Narcissistic personality disorder

ï Anxiety Disorders

Generalized anxiety disorder 

Posttraumatic stress disorder (PTSD)

Social phobia 

Obsessive-compulsive disorder

Panic disorders

ï Attention Deficit/Hyperactivity Disorder (AD/HD)

ï Schizophrenia and Other Psychotic Disorders

ï Cognitive Disorders 

ï Eating Disorders 

ï Impulse Control Disorders: Pathological Gambling

ï Sleep Disorders
192 Chapter 12

ï Primary substance use disorder and 

secondary co-occurring disorder. This 

ìdisease modelî holds that substance use disorders cause most co-occurring disorders in

patients. Appropriate treatment, by this theory, focuses on the underlying substance use.

ï Primary co-occurring disorder and secondary substance use disorder. This 

ìself-medicationî model, proposed by

Khantzian (1985), argues that preexisting

mental disorders are a significant cause of

substance use disorders. People who are drug

addicted choose drugs that lessen painful

feelings caused by their mental disorders, 

for example, opioids or alcohol to alleviate

anxiety or cocaine or other stimulants to

relieve depression. By extension of this view,

adequate treatment of the psychopathology

resolves the substance use disorder.

ï Common pathway. This model holds that

shared genetic or environmental factors may

cause both substance use and co-occurring

disorders. For example, accumulating evidence indicates that

childhood conduct 

disorders that persist to become adult

antisocial or borderline personality disorders are significant risk factors for

substance abuse

(e.g., Compton et al.

2000; Mueser et al.

1999). Other studies

(e.g., Ahmed et al.

1999; Nunes et al.

1998b) have found

that relatives of

patients who were

opioid addicted had

higher rates of major

depression, alcoholism, and substance use disorders, indicating that genetic factors increase susceptibility

to both addiction and co-occurring disorders.

ï Bidirectional model. This model emphasizes

that socioenvironmental and interpersonal

factors, such as poverty, social isolation, drug

availability, or lack of accountability by adult

caregivers, also contribute to both substance

use and co-occurring disorders through a

complex interaction between environment

and genetic susceptibility. The bidirectional

model has not been evaluated systematically.

Screening for 

Co-Occurring Disorders

The consensus panel believes that admission

and ongoing assessment routinely should incorporate screening for co-occurring disorders.

This screening should yield a simple positive or

negative result, depending on whether signs or

symptoms of co-occurring disorders exist. A

negative result generally should rule out immediate action, and a positive result should trigger

detailed assessment by a trained professional

(see chapter 4).

To identify patients in MAT with co-occurring

disorders, treatment providers must decide

ï When and how to screen patients

ï How to integrate psychological screening with

standard intake assessment

ï Which instruments to use for screening and

confirming co-occurring disorders

ï What qualifications are needed by staff who

conduct screenings

ï How to classify symptoms and other evidence

ï How to determine the most appropriate 

treatment methodology and level of care.

Specific Screening Procedures

OTPs should establish specific screening 

procedures for co-occurring disorders and

train counselors and intake workers to perform

these procedures, including how to recognize

the presenting symptoms of the most commonly

encountered co-occurring disorders. Few 

significant differences in symptoms of mental

disorders exist between patients who are

addicted to opioids and other people who are

not; therefore, the symptoms described in

[A]dmission and

ongoing assessment routinely

should incorporate

screening for 

co-occurring 

disorders.
Treatment of Co-Occurring Disorders 193

DSM-IV-TR are applicable during admission

screening. When possible, screening for cooccurring disorders should be linked with other

assessments to avoid duplicate efforts by staff

and unnecessary burdens on patientsí time. An

OTPís screening procedures for co-occurring

disorders should specify

ï Questions or instruments to be used

ï When and where to conduct screening 

segments (e.g., address all safety-related

questions during initial intake and defer

other questions until applicants are no longer

intoxicated or in withdrawalóbut wait no

longer than a specified period after admission)

ï Who conducts screenings

ï How to record results

ï Cutoff scores or other indicators of positive

results for co-occurring disorders

ï Exactly how to handle positive results (e.g.,

whom to inform, how, and when; what constitutes a psychiatric emergency and how to

address it)

ï How extensively a patientís self-reported

information must be corroborated with information from other sources (e.g., family and

friends, caseworkers, previous treatment

records)

ï Which staff members to consult if questions

arise about these procedures or the results.

Screening for co-occurring disorders usually

entails determining

ï An applicantís immediate safety and selfcontrol, including any suicide risk, aggression or violence toward others, or domestic

or other abuse or victimization and the 

ability to care for himself or herself (see

ìHandling Emergency Situationsî below).

ï Previous diagnosis, treatment, or hospitalization for a mental disorder and, if applicable,

why, when, and where, as well as the treatment received and its outcome. Questions

about the relationship of mental disorders 

to substance useófor example, whether a

mental disorder was present during abstinence or before the substance use disorderó

determine whether a co-occurring disorder is

substance induced or independent.

ï The applicantís current co-occurring disorder symptomatology based on DSM-IV-TR

criteria, including whether any psychotropic

medications have been prescribed or are

being used (usually included on a screening

questionnaire).

ï Trauma history (e.g., physical or sexual

abuse, living through a natural disaster or

war, witnessing death or tragedy). Questions

about trauma should be brief and general,

without evoking details that might precipitate

stress. Several screening instruments for

PTSD are described in other TIPs (see the

forthcoming TIP Substance Abuse and

Trauma [CSAT forthcoming d]; TIP 25,

Substance Abuse Treatment and Domestic

Violence [CSAT 1997b]; and the Modified

PTSD Symptom Scale: Self-Report in TIP

36, Substance Abuse Treatment for Persons

With Child Abuse and Neglect Issues [CSAT

2000d]).

ï Any history of mental disorder-related symptoms among immediate relatives and their

diagnoses, treatments, or hospitalization.

ï Any unusual aspects of an applicantís

appearance, behavior, and cognition. If 

indications of a cognitive impairment are 

present, a mental status examination should

be conducted.

Screening for cognitive

impairment

The accuracy of instruments to screen for 

co-occurring disorders may be compromised if

administered to patients with cognitive impairments. A brief preexamination of cognitive

functioning during a mental status examination

is recommended for individuals who are disoriented with respect to time, place, or person;

have memory problems; or have difficulty

understanding information in their first language. TIP 29, Substance Use Disorder

Treatment for People With Physical and

Cognitive Disabilities (CSAT 1998c), contains

an 18-item screening instrument for cognitive
194

impairment and functional limitations. TIP 33,

Treatment for Stimulant Use Disorders (CSAT

1999c), lists nine brief screening tools to determine cognitive impairment and reproduces the

Repeated Memory Test. Treatment providers

who prefer the familiar Mini-Mental State

Examination (Folstein et al. 1975) can order

either the standard or extended version via the

World Wide Web at www.minimental.com.

Screening Tools

Many States require specific screening or

assessment instruments, such as the Addiction

Severity Index (ASI), to document baseline

patient data. Other important considerations in

selecting a screening tool for co-occurring disorders include its psychometric properties and

cultural appropriateness and, if the test is selfadministered, the literacy level required. The

consensus panel believes that no instrument in

an OTP can identify co-occurring disorders

satisfactorily, and many of the most thoroughly

tested are not in the public domain. The ASI

records symptoms of mental disorders but does

not diagnose. More information on the ASI and

other screening instruments, including Mental

Health Screening Form III, the Mini International Neuropsychiatric Interview (M.I.N.I.),

and some proprietary instruments, is in TIP

42, Substance Abuse Treatment for Persons

With Co-Occurring Disorders (CSAT 2005b).

Other tools focusing on particular disorders 

or pathologies (e.g., suicide danger, PTSD,

AD/HD, depression) can be accessed through

the Web sites listed in Appendix 12-A.

Making and Confirming

a Psychiatric Diagnosis

After a possible co-occurring disorder is identified during screening, an experienced, licensed

mental health clinician (e.g., psychiatrist, 

psychologist, clinical social worker) should perform additional evaluation to make or confirm

a diagnosis. Ideally, this expertise is available

at the OTP. When it is not, appropriate consultants and referral resources must be substituted,

but procedures to use and reimburse these

resources should be well established.

The most widely used systems to classify mental

and substance use disorders are provided in

DSM-IV-TR and the International Classification

of Diseases, 10th Edition (ICD-10),

Classification of Mental and Behavioural

Disorders: Clinical Descriptions and

Diagnostic Guidelines (World Health

Organization 1992). Both systems present 

diagnosis criteria accepted by national (DSMIV-TR) or international (ICD-10) experts.

DSM-IV-TR Criteria 

Although many insurance companies require

International Classification of Diseases diagnostic codes for reimbursement purposes, 

clinicians and researchers in the United States

traditionally use the DSM classification system.

As this system has evolved over several editions, its authors have made important changes

in definitions for substance-related disorders.

Specifically, the DSM-IV-TR divides these disorders into two types: substance use disorders

and substance-induced co-occurring disorders.

Substance use disorders

DSM-IV-TR divides substance use disorders

into abuse and dependence with or without

physiological features such as tolerance or withdrawal. It also makes distinctions pertaining to

early or sustained remission; programs offering

agonist, partial agonist, or agonist/antagonist

therapy; and treatment while living in a controlled environment (e.g., jail).

Substance-induced 

co-occurring disorders

Substance-induced co-occurring disorders are

associated with intoxication, withdrawal, and

the persistent effects of substances of abuse.

Substance-induced persisting disorders are

those in which substance-related symptoms

continue long after a person stops using a drug

(e.g., prolonged flashbacks from hallucinogen

use, substance-induced persistent dementia,

Chapter 12
Treatment of Co-Occurring Disorders 195

substance-induced persistent amnesia). Exhibit

12-2 shows the association between substanceinduced co-occurring disorders and substances

of abuse. It is noteworthy that different drugs

have been associated with different types 

of co-occurring disorders and that some 

(such as opioids) have relatively few or no

reported psychotoxic effects, whereas others

have many.

Structured and Semistructured

Interview Formats for

Psychiatric Diagnoses 

A number of carefully designed and tested

instruments are available to determine DSM-IV

or ICD-10 diagnoses, although a careful clinical

interview usually can serve this purpose. Not

all instruments have been updated for DSMIV-TR diagnoses, but DSM-IV diagnoses are

similar. Examples include the

ï Structured Clinical Interview for DSM-IV

Axis I and II Disorders, Clinical Versions

ï Composite International Diagnostic

Interview, Core Version 2.1

ï Psychiatric Research Interview for Substance

Abuse and Mental Health Disorders

ï Diagnostic Interview Schedule, Version 4

ï Alcohol Use Disorder and Associated

Disabilities Interview Schedule.

TIP 42, Substance Abuse Treatment for

Persons With Co-Occurring Disorders (CSAT

2005b), discusses these and other screening and

assessment instruments and their sources at

greater length. 

Differential diagnosis

Careful assessment including a family history 

is critical to determine whether presenting

symptoms indicate independent co-occurring

disorders or disorders induced by substance

use or a general medical or neurological 

condition. In many cases, people who abuse

multiple substances have both an independent

co-occurring disorder and various substanceinduced symptoms precipitated by intoxication

or withdrawal. Substance use can magnify

symptoms of independent co-occurring 

disorders. For example, substance use can

heighten the mood

swings of bipolar disorder; intensify the 

hallucinations and 

paranoid delusions 

of schizophrenia; or

increase the risk of 

suicide, violence, and

impulsive behaviors

among individuals with

antisocial or borderline

personality disorders

(American Psychiatric

Association 2000).

The accuracy of differential diagnosis has

treatment implications because independent

and substance-induced co-occurring disorders

differ in their course. Independent disorders

tend to follow a typical course for each diagnosis and require specific, long-term treatment

(e.g., pharmacotherapy, psychotherapy).

Substance-induced disorders tend to follow 

the course of the substance use disorder and to

dissipate with abstinence, although persistent

disorders can deviate from this sequence.

Substance-induced symptoms can be disruptive

at the start of MAT, but they typically do not

require ongoing psychiatric treatment (Woody

et al. 1995a).

Timing for confirming a 

diagnosis 

Accurate diagnosis of independent co-occurring

disorders is difficult during the early phases of

MAT because substance-induced symptoms also

usually are present. A definitive diagnosis often

must wait until a patient is stabilized on treatment medication for a minimum of 5 to 7 days

(but preferably 2 to 4 weeks) and any continuing substance use is eliminated. Although 

several weeks of abstinence may improve the

accuracy of diagnoses, symptoms of severe 

co-occurring disorders (e.g., suicidality, 

psychotic reaction) need prompt attention and

might require more immediate pharmacological

[I]ndependent and

substance-induced

co-occurring 

disorders differ in

their course.
196 Chapter 12

Alcohol X X X X I W P P I/W I/W I/W I I/W

Amphetamines X X X X I I I/W I I I/W

Caffeine X I I

Cannabis X X X X I I I

Cocaine X X X X I I I/W I/W I I/W

Hallucinogens X X X I I* I I

Inhalants X X X I P I I I

Nicotine X X

Opioids X X X X I I I I I/W

Phencyclidine X X X I I I I

Sedatives, 

hypnotics, 

or anxiolytics X X X X I W P P I/W I/W W I I/W

Polysubstance X

Other X X X X I W P P I/W I/W I/W I I/W

Exhibit 12-2

DSM-IV-TR Classification of Diagnoses Associated With 

Different Classes of Substances 

*Also Hallucinogen Persisting Perception Disorder (flashbacks).

Note: X, I, W, I/W, or P indicates that the category is recognized in DSM-IV-TR. In addition,

I indicates that the specifier With Onset During Intoxication may be noted for the category; W

indicates that the specifier With Onset During Withdrawal may be noted for the category

(except for Withdrawal Delirium); and I/W indicates that either With Onset During

Intoxication or With Onset During Withdrawal may be noted for the category. P indicates that

the disorder is Persisting.

Source: Reprinted from DSM-IV-TR. Copyright 2000, American Psychiatric Association. Dependence Abuse Intoxication Withdrawal Intoxication Delirium Withdrawal Delirium Dementia Amnestic Disorder Psychotic Disorders Mood Disorders Anxiety Disorders Sexual Dysfunctions Sleep

Disorders
treatment or hospitalization (Woody et al.

1995a). OTPs should be aware that even symptoms of less severe co-occurring disorders can

prevent a patientís stabilization and should be

addressed quickly. 

Guidelines for distinguishing

nonñsubstance-induced 

from substance-induced 

co-occurring disorders 

To assist with a differential diagnosis, the 

following information (Woody et al. 1995a)

should be collected and reviewed:

ï Previous history of mental disorders and

treatment, focusing on temporal relationship

of symptoms to substance use and response

to previous treatment

ï Type, quantity and frequency, and time of

last use of illicit substances or prescribed psychotropic drugs (each substance class produces specific physiological and behavioral

effects, especially during acute intoxication or

withdrawal after prolonged, high-dosage use)

ï Family history of mental disorders.

DSM-IV-TR (American Psychiatric Association

2000) offers the following procedures to ascertain whether a co-occurring disorder is primary

or secondary:

ï Label the disorder according to predominant

symptom pattern and specified criteria (e.g.,

mood, anxiety, psychotic disorder)

ï Consider the co-occurring disorder primary

(not substance induced) if

ñ Symptoms developed before the substance

use disorder

ñ Symptoms have persisted during 30 days 

or more of abstinence (depending on the

characteristic withdrawal course for each

substance)

ñ Symptoms are inconsistent with or exceed

those produced by the abused substance at

the dosage used (e.g., hallucinations after

opioid withdrawal, paranoid delusions

after low-dose marijuana use)

ñ Substance use or another medical disorder

cannot account better for the symptoms

ï Consider the mental disorder secondary

(substance induced) if

ñ Symptoms developed only during periods

of active substance use or within 1 month

of intoxication or withdrawal

ñ Symptoms are consistent with intoxication

or withdrawal from substances used 

ñ Other features (e.g., age at onset) are atypical for primary co-occurring disorder

ñ Another co-occurring or medical disorder

does not account better for the symptoms.

Prognosis for Patients

With Co-Occurring

Disorders

Patients with co-occurring disorders generally

have been found to have poorer prognoses and

to be more difficult to treat than those with

diagnoses of either a substance use or mental

disorder (Dausey and Desai 2003; Kessler

1995). Research has suggested that persons

with co-occurring disorders are at higher risk

of suicide, psychiatric hospitalization, legal 

difficulties and incarceration, homelessness,

life-threatening infectious diseases, domestic

violence, abuse or neglect of their children,

unemployment, and other interpersonal 

problems (e.g., Dausey and Desai 2003; 

Room 1998). 

Effects of Co-Occurring

Disorders on Treatment

Outcomes

The conventional view, which has considerable

empirical support, is that unidentified, untreated co-occurring disorders impede progress for

patients in MAT and lead to difficulties in

engaging patients in treatment, establishing a

Treatment of Co-Occurring Disorders 197
198

therapeutic alliance between patients and 

treatment providers, maintaining adherence 

to treatment regimens, eliminating substance

abuse and other risky behaviors, and preventing premature dropout or early relapse.

Conversely, a review by Drake and Brunette

(1998) concluded that substance abuse complicates co-occurring disorders, often precipitating relapse to psychopathological symptoms,

hospitalization, disruptive behavior, familial

problems, residential instability, decreased

functional status, HIV infection, or medication

noncompliance.

Because research on treatment outcomes for

patients with opioid addiction and co-occurring

disorders usually examines small groups of subjects and because patients in these groups are

not homogeneous, the general applicability of

current findings is limited. Many confounding

factors exist (Room 1998). Despite these limitations, numerous studies have found that many

patients with co-occurring disorders did well

when appropriate psychiatric and substance

abuse treatments were delivered. The consensus panel recommends more intensive and 

psychiatrically specific treatment for these

patients.

Effects of Symptom Severity

Studies disagree on whether the severity of cooccurring disorder symptoms in patients who

are addicted is a useful predictor of treatment

outcomes. Early studies found that the severity

of co-occurring disorder symptoms, particularly in patients with anxiety or depression,

strongly predicted treatment outcomes and that

the most severely symptomatic patients had the

heaviest substance use and most impaired

adjustment, whereas the least symptomatic did

best in addiction treatment (McLellan et al.

1993; Rounsaville et al. 1986). However, later

studies have found that higher symptom severity, although associated with higher levels of

substance use and worse overall adjustment,

did not predict treatment response. In one

study, drug test results for patients with severe

psychopathology improved significantly over

time (Belding et al. 1998). In another study,

patients in MAT for at least 90 days who had

co-occurring disorders and high levels of symptom severity had positive treatment responses

(Joe et al. 1995). Patients with more than one

co-occurring disorder engaged in treatment

more readily than those who were addicted

only, and both groups were similar in average

incidence of drug use or criminal activity.

Patients with depression, anxiety, suicidal

ideation, and other pathologies at intake were

twice as likely to attend individualóbut not

groupócounseling sessions and significantly

more likely to discuss psychological problems

than those reporting none of these symptoms.

Consequently, caution is advised in predicting a

simple, stable correlation between symptom

severity of co-occurring disorders and treatment outcomes. However, the consensus panel

believes that co-occurring disorders can

improve substantially but that outcomes

depend heavily on additional treatment being

provided for these disorders and that patients

with severe symptoms may require longer,

more intensive treatment.

Prognosis for Specific 

Co-Occurring Disorders

Effects of co-occurring APD

on progress in MAT

APD has been estimated to affect 24 to 39 percent of people seeking treatment for opioid

addiction (Brooner et al. 1997; Darke et al.

1996; King et al. 2001). Some studies have

found that people with APD and opioid addiction had more criminal activity, more history of

early violent and aggressive behaviors, greater

likelihood of engaging in activities that risked

HIV transmission, more extensive and severe

polydrug abuse, and earlier onset of opioid use

than persons who were opioid addicted without

APD (Brooner et al. 1997; Darke et al. 1996). 

However, agreement is lacking on the 

significance of a diagnosis of APD in MAT.

Some studies have found that patients with

Chapter 12
Treatment of Co-Occurring Disorders 199

co-occurring APD had less favorable outcomes

than those without this disorder, even if the

former group received additional psychotherapy (e.g., Alterman et al. 1998; Galen et al.

2000). Others have found that patients with

APD in MAT improved to the same extent, on

average, as those without APD (e.g., Cacciola

et al. 1995; Darke et al. 1996), although the

former group had more severe symptoms at

both entry and followup. This lack of consistent findings has led some researchers to 

question the clinical utility, reliability, or validity of DSM-IV-derived APD diagnoses in MAT

patients (Alterman et al. 1998; Cacciola et al.

1995). Darke and colleagues (1998) expressed

concern that people addicted to opioids might

be diagnosed with APD as a reflection of their

risk-taking and drug-dealing lifestyles rather

than actual existence of their underlying 

personality disorders.

Patients with APD can improve in MAT, and

OTPs should be prepared to manage and limit

aggressive, impulsive, or criminal behaviors by

patients, regardless of whether the behaviors

are related to a DSM-based diagnosis of APD.

Effects of co-occurring PTSD

on progress in MAT

Increasing attention has been paid to the high

prevalence and negative effects of PTSD on

patients in MAT, especially women (Villagomez

et al. 1995). Hien and colleagues (2000) found

that women with symptoms of PTSD at admission were significantly less likely than those

without such symptoms to adhere to treatment

requirements, including abstinence from substances during the first 3 months of MAT. In

another study, patients with current PTSD

symptoms had greater drug abuse severity

(Clark et al. 2001). These patients may need

special attention paid to depression and suicidal ideation (Villagomez et al. 1995). TIP 36,

Substance Abuse Treatment for Persons With

Child Abuse and Neglect Issues (CSAT 2000d),

and TIP 42, Substance Abuse Treatment for

Persons With Co-Occurring Disorders (CSAT

2005b), provide more information on PTSD

and substance abuse treatment.

Effects of co-occurring AD/HD

on progress in MAT

King and associates (1999) studied 125 people

admitted to OTPs over a 1-year period to

determine the relationship of AD/HD to current attention problems, other co-occurring

and substance use 

disorders, and other

outcome variables.

Nineteen percent of

patients had a history

of AD/HD, and 88

percent with lifetime

AD/HD diagnoses 

had current symptoms of AD/HD.

Although patients

with AD/HD showed

poorer attention 

during continuous

performance testing

and more concurrent

Axis I and II disorders (e.g., dysthymia,

anxiety disorders

including social phobia, APD) than those 

without AD/HD, the AD/HD diagnosis was not

a significant predictor of decreased treatment

retention, poor treatment compliance, or 

continuing substance abuse. 

Treatment Issues

General Treatment

Considerations for Patients

With Co-Occurring Disorders

Clearly, co-occurring disorders should not

exclude people with opioid addiction from

admission to an OTP. The consensus panel

believes that the best strategy is to stabilize

these patientsí opioid addiction with

methadone, buprenorphine, or levo-alpha

acetyl methadol (LAAM) while assessing their

co-occurring disorder symptoms and choosing

the most appropriate treatment course.

Although OTP staff members often focus on

[P]atients with

severe symptoms

may require

longer, more 

intensive 

treatment.
200 Chapter 12

the condition that is most severe and threatening, it usually is best to address all of a patientís

disorders simultaneously because each

can influence the

others. TIP 42,

Substance Abuse

Treatment for

Persons With CoOccurring Disorders

(CSAT 2005b), provides information

about treatment

planning and implementation for this

group.

The consensus panel

believes that the following principles are

essential to manage patients with co-occurring

disorders in an OTP:

ï Treatment of co-occurring disorders should

be integrated or closely coordinated with substance abuse treatment when the former is

not available on site.

ï Staff members, whether primarily from the

substance abuse treatment or mental health

fields, should be knowledgeable about treatments for both disorders.

ï Psychotropic medications should be prescribed only after patients are stabilized on

the treatment medication (which in the

panelís experience takes an average of 3 to 7

days for buprenorphine and 3 weeks to a

month for methadone), unless an independent co-occurring disorder is evident from

past records or clinical examination or significant impairment associated with the symptoms of a co-occurring disorder exists.

ï All medications used by patients and patientsí

adherence to medication regimens should be

monitored carefully, for example, via drug

testing. Physicians should be careful about

prescribing substances with abuse potential,

such as benzodiazepines. If such medications

are prescribed, the less abusable drugs in a

class should be chosen, for example,

oxazepam (SeraxÆ) rather than lorazepam,

clonazepam, alprazolam or diazepam.

ï Patients resistant to being psychiatrically

diagnosed should be assured that it is not

shameful but is likely to provide a better

understanding of their problems and aid in

treatment. Educating patients about cooccurring disorders helps. 

ï Therapy for patients with co-occurring 

disorders should be more intensive, on average, than for patients without co-occurring 

disorders. The primary goal is abstinence

from substances. Remission of co-occurring

disorder symptoms should be an important

secondary goal.

Co-Occurring Disorders and

Treatment Planning 

Because patients in MAT exhibit a wide range

of co-occurring disorders, the consensus panel

believes that early treatment planning and

resource management should include classifying

patients, at least tentatively, into categories

based on types and severity of co-occurring 

disorders, although treatment always should be

tailored individually.

Patients in acute psychiatric

danger

Patients presenting with suicidal or homicidal

ideation or threatsówhether resulting from

acute intoxication or withdrawal or from an

independent co-occurring disorderóor those

manifesting psychotic symptoms (e.g., hallucinations, paranoia) that may interfere with their

safety and ability to function should be assessed

and treated immediately. Although their symptoms may be short lived, admission to a psychiatric unit for brief treatment may be necessary

if outpatient care is too risky or problematic.

Immediate administration of antipsychotic

drugs, benzodiazepines, or other sedatives may

be required to establish behavioral control

(Minkoff 2000). A physician, physicianís assistant, or nurse practitioner on staff can prescribe medications at the OTP. Otherwise,

[C]o-occurring 

disorders should

not exclude people

with opioid addiction from admission to an OTP.
Treatment of Co-Occurring Disorders 201

referral is warranted. In emergencies, OTPs

should send patients to affiliated hospital emergency rooms (see ìHandling Emergency

Situationsî below).

Patients with established,

severe co-occurring disorders

Patients in MAT who are not in acute danger

but have been diagnosed or treated for severe

co-occurring disorders (e.g., schizophrenia,

bipolar disorder) should receive medication

with the lowest abuse potential for their condition. If an OTP is staffed appropriately and

prepared to treat patients with severe cooccurring disorders, these patients can be treated on site. Otherwise, they should be referred to

an OTP with these qualifications. If there is no

such OTP, patients may need to remain in a less

optimal OTP but receive psychiatric treatment

at another facility. For referrals, effective communication between OTPs and mental health

providers is necessary to coordinate treatment.

Patients with less severe,

persisting or emerging 

symptoms of co-occurring

disorders

Patients in MAT with nondisabling symptoms

of less severe co-occurring disorders (e.g.,

mood, anxiety, and personality disorders), 

psychiatric treatment histories, or verified

diagnoses and current prescriptions for medications to treat such disorders (regardless of

whether they are used) should continue or

begin medication, psychotherapy, or both for

their co-occurring disorders. These patients

should continue in MAT if the OTP is staffed to

treat them. Although it is desirable for patients

to be stabilized on methadone, buprenorphine,

or LAAM before other pharmacotherapy is initiated, newer medications with relatively benign

side effects can be initiated sooner (e.g., selective serotonin reuptake inhibitors [SSRIs]) if a

primary mental disorder is indicated. Such

medications may facilitate engagement in MAT

and addiction recovery (Minkoff 2000).

Patients with less severe, presumptively substance-induced

co-occurring disorders

The consensus panel recommends that patients

in MAT with symptoms of Axis I disorders but

no history of primary co-occurring disorders

receive no new psychotropic medications until

they are stabilized on MAT because their symptoms might remit or significantly diminish after

a period of substance abuse treatment (Joe et

al. 1995). Exceptions include patients who have

acute, substance-induced disorders such as

extreme anxiety or paranoia that are likely to

be transitory but require temporary sedation

or antianxiety medication.

Effects of Co-Occurring

Disorders on HIV Risk

Behaviors and Comorbidity 

King and colleagues (2000) found that patients

with co-occurring disorders in MAT were at

higher risk for contracting and transmitting

HIV than those without these disorders. In

another study, patients who were HIV seropositive and had co-occurring disorders were more

likely than those without co-occurring disorders to continue using drugs, less likely to be

prescribed HIV medications or to adhere to

medication regimens, and more likely to develop AIDS (Ferrando et al. 1996). People with

co-occurring disorders, particularly depression

or dysthymia, were more likely than those without Axis I disorders to continue needle sharing

and other high-risk behaviors (Camacho et al.

1996). Patients in MAT who injected drugs and

had APD were at higher risk for contracting

and spreading HIV (Brooner et al. 1993). To

decrease the spread of HIV, it is important to

treat both substance use and co-occurring disorders and provide education and support for

patients who inject drugs. More information on

HIV/AIDS and substance abuse treatment,

including the combined treatment of HIV/AIDS,

substance abuse, and mental illness, can be

found in TIP 37, Substance Abuse Treatment

for Persons With HIV/AIDS (CSAT 2000e).
202 Chapter 12

Models of Care

Although it is not always feasible to provide

more specialized services on site, patient adherence to medical treatment was found to drop

dramatically when such services were provided

through offsite referral (Batki et al. 2002). Even

when referrals are to services near an OTP,

noncompliance may have significant consequences for personal, social, and public health.

If a program cannot provide onsite ancillary

services, it is important that staff members

identify co-occurring disorders early so that

they can refer patients to appropriate

resources. It is essential to monitor patient

progress and compliance with offsite treatment,

which can be done by a counselor, case manager, nurse, or physicianís assistant or by assigning one staff member to coordinate and monitor all referrals. Offsite referrals also may be

necessary to obtain psychotropic medications

and evaluate patientsí reactions to them. 

Handling Emergency

Situations 

A high percentage of patients with co-occurring

disorders in MAT have reported suicide

attempts or difficulty controlling violent behavior during their lifetimes (Cacciola et al. 2001).

Patients who present an acute danger to themselves or others or have psychotic symptoms or

disordered thinking that could interfere with

their safety or that of others should receive

immediate, aggressive intervention on admission and throughout treatment. Staff members

should be trained to notice indications of 

suicidal or homicidal risks. These observations

should be documented and communicated to

designated staff members who can take necessary action, including appropriate medication,

notification of family members and involved

agencies (e.g., probation office, childrenís 

protective services), or transfer of patients to

more secure or protective settings. Staff members should understand thoroughly and be 

prepared to act on an OTPís ìduty to warnî

(CSAT 2004b) about potentially violent 

behavior by patients.

Risk factors and predictors for

suicidal ideation and threats 

People who are opioid addicted have high rates

of suicide and attempted suicide, ranging from

8 to 17 percent in some studies with even higher

rates among certain groups (Krausz et al.

1996). Substance intoxication or withdrawal

can cause or exacerbate suicidal ideation or

threats, and the presence of co-occurring disorders further increases the risk. Chapter 4 discusses risk factors for suicide and recommended treatment responses. Risk factors do not

predict individual behavior, but a high-risk

profile merits immediate and ongoing attention

(Chatham et al. 1995a; Hall et al. 1999). In one

study of suicidality among patients in an OTP,

the strongest predictors of suicide risk were

psychosocial dysfunction (e.g., depression,

social withdrawal, hostility toward friends and

family), help-seeking behaviors (e.g., previous

treatment episodes, attendance at mutual-help

meetings, self-referral), and perceived lack of

support from others (Chatham et al. 1995a).

At least two studies of patients in MAT who

overdosed on opioids concluded that overdoses

usually were accidental and not predictive of

subsequent suicide attempts. In an early work,

Kosten and Rounsaville (1988) found that accidental overdoses were three times more likely

than suicidal ones. More recently, Darke and

Ross (2001) reported that 92 percent of

patients who overdosed characterized the 

overdose as accidental. In that study, of the 40

percent who acknowledged a previous suicide

attempt, only 10 percent deliberately overdosed

with heroin compared, for example, with 21

percent who deliberately overdosed with 

benzodiazepines.

Protocol for identifying 

and handling suicide and

homicide risk

All intake workers, certified addiction counselors, and clinicians should be alert to risk

factors for suicide and homicide and should

question at-risk patients routinely about suicidal or homicidal thoughts or plans. This is
Treatment of Co-Occurring Disorders 203

important for patients who appear withdrawn,

depressed, angry, or agitated or are known to

have experienced a recent significant loss or

other source of stressóespecially if a cooccurring disorder is suspected or diagnosed or

if a patient still is intoxicated or withdrawing

from a psychoactive substance. Although the

consensus panel believes such screening is helpful, the research evidence supporting its effectiveness is limited (Kachur and DiGuiseppi

1996).

To aid in screening and referral for suicidality

and homicidality, all programs should have

protocols in place that specify

ï Who asks what questions or uses what 

specific tool to identify these types of risk

ï How identified risks are documented

ï Who is informed about risks and is responsible for taking actions and what resources he

or she can use (e.g., medications,

referral/transfer, family involvement).

Any patient suspected of suicide or homicide

risk should be referred immediately to a mental

health clinician for further evaluation. If the

OTP has no psychologist, clinical social worker, or psychiatrist on staff, it should have

arrangements for rapid consultations.

Decisions should be made about using antipsychotic medications, benzodiazepines, or other

sedatives to establish behavioral control rapidly (Minkoff 2000). Such medications may be

needed to alleviate or control symptoms until

other mood stabilizers or antidepressants take

hold, which can take several weeks. Medicationassisted treatment of acute suicidality should be

on an inpatient basis unless family members or

friends are willing to be responsible for administering the drugs regularly, keeping the at-risk

patient safe, and monitoring his or her reactions. 

Patients identified as being at imminent risk 

of committing suicide or homicide might need

hospitalization for short-term observation.

Some key factors in this decision are clearly

expressed intent, specific and lethal plans,

accessible means, limited social or familial

resources, severe symptoms of mental illness or

psychosis, command hallucinations, hopelessness, and previous suicide or homicide attempts.

If a referral is made, the patient should not be

left alone until responsibility for monitoring

safety is transferred to the referred facility.

Counseling, Psychotherapy,

and Mutual-Help Groups for

People With Co-Occurring

Disorders in MAT

Chapter 8 discusses counseling, case management, and psychotherapy for patients in MAT.

Programs should encourage participation in

mutual-help groups that focus on the needs of

people with co-occurring disorders. Exhibit 12-

3 lists some of the best known of these groups,

along with contact information.

Exhibit 12-3

Mutual-Help Groups for People With Co-Occurring Disorders

ï Double Trouble in Recovery (www.doubletroubleinrecovery.org)

ï Dual Recovery Anonymous (www.draonline.org)

ï Dual Disorders Anonymous (847-781-1553 or P.O. Box 681268, Schaumburg, IL 60168)

ï Dual Diagnosis Recovery Network (www.dualdiagnosis.org) (active mostly in California)
204 Chapter 12

Psychoeducation for Patients

With Co-Occurring Disorders

in MAT

Group sessions presenting information about

topical issues can help patients with co-occurring

disorders and their families. Patients can

explore relevant themes by emphasizing positive

coping strategies and sharing experiences.

Possible topics for psychoeductional groups are

presented in Exhibit 12-4.

Pharmacotherapy for Patients

With Co-Occurring Disorders

in MAT

Several pharmacological treatments for cooccurring disorders are available and should be

used when indicated. Most medications are

more effective when used with counseling or

psychotherapy in comprehensive MAT.

In many ways, an OTP is an optimal setting 

to initiate and monitor psychiatric pharmacotherapy for co-occurring disorders because

patients attend daily (at least in the early stages

of treatment) and onsite physicians and other

staff can observe their reactions to psychotropic

medications as well as to methadone or other

addiction treatment medications.

When psychotropic medications are used in an

OTP, they should be prescribed

ï In a comprehensive program that integrates

medical, psychiatric, and social interventions

and supports patient compliance with 

medication dosing schedules.

Exhibit 12-4

Topics for Psychoeducational Groups for People 

With Co-Occurring Disorders 

ï Causes, symptoms, and treatment for substance use and co-occurring disorders

ï Medical and mental effects of co-occurring disorders

ï Psychosocial effects of co-occurring disorders

ï The recovery process for co-occurring disorders

ï Medications to treat co-occurring disorders, their side effects, and medication management

ï Coping with cravings, anger, anxiety, boredom, and depression

ï Changing negative or maladaptive thinking

ï Developing a sober support system 

ï Addressing family issues

ï Learning to use leisure time constructively

ï Spirituality in recovery

ï Joining 12-Step and co-occurring disorder recovery mutual-help groups

ï Risk factors in ongoing recovery 

ï Understanding and getting maximum benefits from psychotherapy and counseling

Adapted from Daley 2000.
ï In the context of a multidisciplinary-team

approach in which regularly scheduled team

meetings ensure that all members are aware

of the patientís progress in treatment.

ï With careful selection of medications because

some patients may attempt to get high on any

medication prescribed. Some medications

(e.g., amitriptyline, tramadol, benzodiazepines) have little abuse potential in other

populations but pose a significant risk of

abuse in this population (Cicero et al. 1999).

If patients in an OTP are prescribed other

medications in addition to addiction treatment

medications, the consensus panel recommends

the following procedures:

ï All prescribed psychotropic medications

should be to treat suspected or confirmed 

co-occurring disorders, not to alleviate normal discomfort (Minkoff 2000).

ï Fixed, rather than ìprnî or ìas needed,î

doses of psychotropic medications should be

prescribed because, especially early in MAT,

patients addicted to opioids have difficulty

regulating medications of any kind (Minkoff

2000). Whenever possible, given resource

availability, potentially abusable medications

should be dispensed by OTP staff along with

addiction treatment medication.

ï Patients receiving psychotropic medications

should be educated about each drugís

expected benefits, potential disadvantages

and limitations, side effects, implications for

pregnancy and breast-feeding, length of time

before full effects should begin, and potential

to cause tolerance and withdrawal. This 

education can be done individually or in a

group, but all information should be communicated both in writing and orally. 

ï An onsite (full- or part-time) physician or

psychiatrist should have regular contact with

each patient with a co-occurring disorder to

review medication response and compliance.

This professional also should supervise counselor interactions with these patients and

participate in team meetings to discuss 

treatment plans.

OTPs should consider a hierarchical approach

to treating patients with co-occurring disorders,

starting with psychosocial interventions such as

increased counseling or psychotherapy (unless

the patient has a disorder clearly needing medication). Depending on severity and acuity of

symptoms, treatment providers may be able to

use nonpharmacological approaches such as

psychotherapy, either alone or with psychiatric

medications. If these psychosocial approaches

are ineffective or of limited benefit, providers

should select psychiatric medications with the

lowest abuse potential that are likely to be

effective. TIP 37, Substance Abuse Treatment

for Persons With HIV/AIDS (CSAT 2000e, pp.

83ñ84), provides a summary of abuse potential

for psychiatric medications. The psychiatric

medications should be, in most instances,

adjunctive to other ongoing interventions, not a

substitute for them. However, other factors to

consider include 

ï The potential effect of medication side effects

on compliance

ï Potential negative interactions with addiction

treatment medication or other drugs

ï Lethality if the drug is used impulsively or

intentionally for suicide

ï Potential effects on a patientís physical conditionófor example, whether the drug might

injure an already damaged liver or increase

blood pressure in a hypertensive patient.

Some studies have found that methadone may,

by itself, relieve some symptoms of mood and

anxiety disorders but not Axis II personality

disorders (Calsyn et al. 2000a; Musselman and

Kell 1995). From a practical viewpoint and

assuming sufficient time to observe patients

before further intervention, the consensus

panel believes that the best approach is careful

observation during the first weeks of MAT to

determine whether symptoms of co-occurring

disorders diminish before psychiatric medications are considered.

Treatment of Co-Occurring Disorders 205
Medications for major depression and bipolar disorder

The hierarchical approach described in the

previous two paragraphs for treating patients

in MAT with co-occurring disorders should be

used to determine which patients diagnosed

with major depression or bipolar disorder may

benefit from antidepressant medication.

Exhibit 12-5 summarizes interactions of some

206 Chapter 12

Exhibit 12-5

Interactions of Some Medications for Depression and Bipolar Disorder

With Methadone and Recommended Treatment Response in MAT

Medication Type 

and Examples Action With Methadone

Recommended Treatment

Response

SSRIs

fluvoxamine

(LuvoxÆ), 

fluoxetine

(ProzacÆ),

sertraline

(ZoloftÆ)

Some SSRIs inhibit metabolism of

methadone and increase

methadone blood levels (Eap et al.

1997). Fluoxetine and sertraline 

do not increase methadone levels

significantly. Fluvoxamine is the

most dangerous SSRI and should

be avoided for patients in MAT.

Observe patients carefully for

signs of methadone overmedication

during the first weeks of treatment

with SSRIs. Methadone withdrawal

symptoms may occur after discontinuation of fluvoxamine.

Carbamazepine

(TegretolÆ)

Carbamazepine speeds production

of liver enzymes that metabolize

methadone and can cause severe

opioid withdrawal symptoms (Eap

et al. 2002).

Avoid carbamazepine and use

alternatives such as valproate

(DepakoteÆ). Increase and/or split

the methadone dosage to increase

its blood levels.

Tricyclics

desipramine,

nortriptyline,

imipramine,

doxepin

Methadone impairs the metabolism

of tricyclics and can cause

increased tricyclic medication

blood levels (Maany et al. 1989).

Adjust doses of tricyclic 

medications as needed; monitor

blood levels if clinically indicated.

Monoamine 

oxidase (MAO)

inhibitors

MAO inhibitors may have 

dangerous interactions with 

certain foods and substances of

abuse (Kleber 1983).

Use extreme caution in prescribing these medications in MAT.

Lithium None. Monitor closely because window

between therapeutic and toxic

dose is narrow.
antidepressant medications with methadone

and recommended treatment response.

Antidepressants have been used successfully 

to treat depression in patients in MAT. One

example is a study of patients with chronic

depression who were treated with the tricyclic

imipramine or a placebo. Fifty-seven percent of

imipramine-treated patients showed both significant improvement in mood and some decreases

in illicit drug use according to self-reports, compared with only 7 percent of placebo patients

who reported results (Nunes et al. 1998a).

However, no significant reductions in substance

use were found between the two groups based

on drug testing. There is no theoretical reason

to presume that tricyclic medications are

unique among antidepressants improving

mood, and SSRIs are much safer and may be

the preferred treatment. Antidepressants also

may be helpful for anxiety disorders.

Bipolar disorder in patients in MAT can be

treated with antipsychotic or mood-stabilizing

medications. Mood stabilizers shown to be

effective include lithium, valproate, and 

carbamazepine (Hellewell 2002). Lamotrigine

(LamictalÆ) also has been shown to be effective. 

Anxiety disorders

Anxiety disorders, including panic disorder,

PTSD, and others, can be treated with 

psychotherapy, pharmacotherapy, or both.

These disorders can be treated effectively with

antidepressant medications such as the SSRIs,

venlafaxine (EffexorÆ), and the tricyclics.

Patients sometimes respond better to one drug

class or a specific drug in a class. Therefore,

another antidepressant should be considered if

patients do not respond to their first one after a

4- to 8-week trial. Some antidepressants also

have sedative effects (e.g., mirtazapine

[RemeronÆ], trazodone, and some tricyclic

antidepressants), which might be beneficial for

patients with insomnia when these drugs are

taken before bedtime, or for patients with high

levels of anxiety. Nonsedating antidepressants

might be especially useful for patients with 

psychomotor inhibition.

The well-documented abuse potential of 

benzodiazepines has led to a common belief

that they are contraindicated in patients 

receiving methadone. However, evidence suggests major differences in the abuse liability of

benzodiazepines. Those with a slower onset of

action such as oxazepam rarely are mentioned

as substances of abuse, have a wide margin of

safety, and are effective in reducing anxiety,

even over extended periods (Sellers et al. 1993).

Several case reports have indicated that benzodiazepines, particularly those with low abuse 

liability, may be used safely for patients with

substance use disorders (Adinoff 1992; Sellers

et al. 1993). Sellers and colleagues also found a

ìserious pattern of nontherapeutic benzodiazepine use . . . among opiate-dependent 

persons, particularly those in methadone maintenance treatment programsî (1993, p. 72),

leading these authors to recommend that ìif

benzodiazepine is used [with this group], those

with an apparently low abuse potential are 

generally preferable.î

The consensus panel believes that patients who

have a history of benzodiazepine abuse should

not be disallowed from receiving previously

prescribed benzodiazepines, provided that they

are monitored carefully and have stopped the

earlier abuse. They may be attempting to

reduce symptoms of co-occurring disorders,

and, when they receive a prescribed medication

with low abuse liability and are monitored for

their co-occurring anxiety and substance use

disorders, improvement and cessation of other

benzodiazepine use may occur naturally. Some

drug-testing laboratories can determine specific

types of benzodiazepines used. If such a

resource is available, testing can determine

whether patients are using only their prescribed

benzodiazepines or supplementing them with

others obtained illicitly. The latter would indicate a need to change patientsí treatment plans.

AD/HD

Stimulants such as methylphenidate (RitalinÆ)

are the treatment of choice for childhood

AD/HD. Stimulant treatment in adulthood also

is potentially effective but carries the obvious

Treatment of Co-Occurring Disorders 207
risk of abuse by patients in MAT. Use of cocaine

could be an attempt to control symptoms of

AD/HD (Levin et al. 1998). If AD/HD is severe,

treatment providers should consider treatment

with medications such as methylphenidate,

amphetamine, or atomoxetine (StratteraÆ)

because these medications reduce AD/HD

symptoms and address cocaine or other stimulant use. However, they should be monitored

carefully because some patients have abused

them by injection, and medical complications

can result from long-term injection use.

Tricyclic antidepressants also are effective for

some patients in MAT with co-occurring AD/HD

and depression (Higgins 1999), and these drugs

carry no addiction liability. Recently, the nonstimulant atomoxetine was approved to treat

AD/HD and may prove advantageous for

patients in MAT with co-occurring AD/HD.

However, because atomoxetine is metabolized

by the cytochrome P450 system of liver

enzymes, the potential for interaction with

methadone exists, and it should be used cautiously until more information is available.

Schizophrenia

Patients in MAT who have schizophrenia often

have profound impairment in thinking and

behavior and are unlikely to fit in well in many

OTPs. Antipsychotic medication, along with

psychosocial intervention, is the mainstay of

treatment. Newer atypical antipsychotic medications for schizophrenia are preferred over

older ìtypicalî agents, which carry a risk of

movement disorders such as tardive dyskinesia,

a neurological syndrome caused by long-term

use of neuroleptic medications (National

Institute of Neurological Disorders and 

Stroke 2001).

Newer antipsychotic medications (clozapine

[ClozarilÆ, olanzapine [ZyprexaÆ], risperidone

[RisperdalÆ]), quetiapine, ziprasidone

[GeodonÆ], and aripiprazole [AbilifyÆ]) have

fewer side effects, are more effective in many

cases, and should be considered as the initial

treatment for some patients or as a second

option for those not responding to more traditional medications. TIP 42, Substance Abuse

Treatment for Persons With Co-Occurring

Disorders (CSAT 2005b), provides more 

information.

Collaboration Between

Counselors and Physicians

Many counselors have little or no psychiatric

background and need training in 

ï Working with patients who may have cooccurring disorders but who resist evaluation

or respond only partially to treatment

ï Exploring stereotypes and feelings about what

it means to have a co-occurring disorder

ï Helping patients keep physician appointments, understand information, and follow

physician recommendations

ï Supporting patients to try medication if 

recommended

ï Supporting patients to tolerate side 

effects long enough to determine whether

medications help

ï Providing guidance about when to contact a

physician to report side effects or lack of

relief from or worsening symptoms 

ï Supporting patients to continue taking 

medication, even when they feel better.

Physicians need training or guidance in

ï Providing education to OTP staff about cooccurring disorders and medications

ï Recognizing common misunderstandings

about and resistances to medication in 

addiction treatment

ï Creating protocols that make good use

of counselor ability to provide detailed 

observations and ongoing feedback on

patientsí conditions (Zweben 2003).

208 Chapter 12
ï Comorbidity and Addictions Center: George

Warren Brown School of Social Work

(www.gwbweb.wustl.edu/Users/cac/

measurescollection.htm). Lists 175 instruments for measuring aspects of substance use

and psychopathology with hyperlinks to

descriptions. Information for each measure

or scale includes purpose, authors, key 

references, target populations, variables,

administration and scoring options, and time

estimates as well as copyright, cost, and

ordering information. 

ï Medical Outcomes Systems, Inc.

(www.medical-outcomes.com). Contains a

description of the Mini International

Neuropsychiatric Interview as well as downloadable versions of all M.I.N.I. instruments,

including the screen version and standard

and expanded (Plus) 5.0.0 editions (January

2002). Although materials are protected by

copyright, researchers and clinicians working

in nonprofit or publicly owned settings (e.g.,

universities, teaching hospitals, government

institutions) may make copies for clinical or

research purposes.

ï National Institute on Alcohol Abuse and

Alcoholism (www.niaaa.nih.gov/

publications). Provides access to information

first published in Assessing Alcohol

Problems: A Guide for Clinicians and

Researchers (Allen and Columbus 1995). The

site specifies useful measures for screening,

diagnosing, and planning treatment for 

alcohol-related and other psychoactive substance use disorders, as well as co-occurring

disorders. The site also includes information

on administration and scoring options, 

estimated times for administration, key 

variables, groups on which normative data

for the instrument were based, psychometric 

properties, and ordering costs.

ï University of Adelaide (Australia) Library

Guide (www.library.adelaide.edu.au/guide/

med/menthealth/scales.html). Contains a list

of psychiatric rating scales and information

about where copies and descriptions of these

instruments can be obtained, hyperlinks to

electronic versions, and references on developmental history and psychometric properties

of each instrument. 

Treatment of Co-Occurring Disorders 209

Appendix 12-A. Internet Resources for

Accessing Psychiatric Instruments

13 Medication-Assisted

Treatment for Opioid

Addiction During

Pregnancy

211

In This

Chapter...

Acceptance of

Methadone

Maintenance as the

Standard of Care

Diagnosing Opioid

Addiction in Pregnant

Patients

Medical and Obstetrical

Concerns and

Complications

Methadone Dosage and

Management

Postpartum Treatment

of Mothers in MAT

Breast-Feeding

Effects on Neonatal

Outcome

Use of Buprenorphine

During Pregnancy

Importance of

Integrated,

Comprehensive Services

Nutrition Assessment,

Counseling, and

Assistance

Little information exists on the prevalence of opioid use by pregnant

women, but there is some information about opioid use by pregnant

women entering substance abuse treatment programs. Of the 400,000

women admitted to programs in 1999, 4 percent were pregnant when

admitted. Opioids were the primary substance of abuse for 19 percent of

both pregnant and nonpregnant women who entered these programs

(Office of Applied Studies 2002).

Acceptance of Methadone

Maintenance as the 

Standard of Care

Methadone has been accepted since the late 1970s to treat opioid addiction during pregnancy (Kaltenbach et al. 1998; Kandall et al. 1999). In

1998, a National Institutes of Health consensus panel recommended

methadone maintenance as the standard of care for pregnant women

with opioid addiction (National Institutes of Health Consensus

Development Panel 1998). Methadone currently is the only opioid medication approved by the U.S. Food and Drug Administration (FDA) for

medication-assisted treatment for opioid addiction (MAT) in pregnant

patients. Buprenorphine is classified as a category C drug by FDA (i.e.,

one lacking adequate, well-controlled studies in pregnant women) and, at

this writing, is not FDA approved to treat pregnant women, although

several studies have found it safe and effective in this group (e.g.,

Fischer et al. 2000; Lacroix et al. 2004). Even though it is a category C

drug, buprenorphine may be used with pregnant patients in the United

States under certain circumstances (see ìUse of Buprenorphine During

Pregnancyî later in this chapter).

Effective medical maintenance treatment with methadone has the same

benefits for pregnant patients as for patients in general. In addition,

methadone substantially reduces fluctuations in maternal serum opioid

levels, so it protects a fetus from repeated withdrawal episodes
(Kaltenbach et al. 1998). Comprehensive

methadone maintenance treatment that

includes prenatal care reduces the risk of

obstetrical and fetal complications, in utero

growth retardation, and neonatal morbidity

and mortality (Finnegan 1991).

Diagnosing Opioid

Addiction in Pregnant

Patients 

In the consensus panelís experience, some

women who are opioid addicted do not

acknowledge pregnancy readily, or they misinterpret early signs of pregnancy, for example,

fatigue, headaches, nausea and vomiting, and

cramps, as opioid withdrawal symptoms.

Consequently, onset of pregnancy may cause

these patients to increase their use of illicit 

opioids or other substances that do not alleviate

their perceived withdrawal symptoms but

expose their fetuses to increased serum levels 

of these substances. 

Many women who are opioid addicted confuse

the amenorrhea caused by their stressful,

unhealthful lifestyles with infertility. They

might have been sexually active for years 

without using contraceptives and becoming

pregnant. The consensus panel has noted that,

because methadone normalizes endocrine functions, it is not unusual for women in the early

phases of MAT to become pregnant unintentionally, especially if they receive no counseling

for this possibility.

Procedures for diagnosing opioid and other

addictions in pregnant women should incorporate information from their medical and substance use histories, physical examinations, drug

test reports, and observed signs or symptoms of

withdrawal. Other indications of addiction may

include evidence of diseases associated with

drug use (e.g., hepatitis, bacterial endocarditis,

cellulitis), poor attendance for prenatal care,

and unexplained fetal growth abnormalities

(e.g., intrauterine growth retardation). Using an

opioid antagonist to diagnose addiction in pregnant women is absolutely contraindicated

(Finnegan 1991); inducing even mild withdrawal

can cause premature labor or other adverse

fetal effects.

Medical and

Obstetrical Concerns

and Complications

Pregnant women who abuse substances, 

including alcohol and nicotine, have a greaterthan-normal risk of medical complications.

These women should be monitored regularly

for signs of anemia, poor nutrition, increased

blood pressure, hyperglycemia, sexually transmitted diseases (STDs), hepatitis, preeclampsia,

and other complications of pregnancy or health

problems related to addiction. Good nutrition,

including vitamin supplements, should be

encouraged. Pregnant women should be educated about the potential adverse effects of 

substance use on their fetuses, such as fetal

alcohol syndrome and premature labor associated with opioid withdrawal or stimulant use.

Patient use of prescribed medications other than

methadone should be monitored for compliance

with usage directions and for adverse effects.

Chronic substance use in pregnancy can cause

medical complications (some are listed in

Exhibit 13-1), depending on how substances are

administered and when or whether problems

are identified and treated. Infections account

for a high percentage of these complications in

pregnant women who are opioid addicted, as

they do in all people who abuse opioids (see

chapter 10). Infections can be profoundly

harmful to both women and their fetuses, particularly if infections remain unrecognized and

untreated during gestation. Hepatitis B and C,

bacterial endocarditis, septicemia, tetanus, 

cellulitis, and STDs are especially frequent

(Finnegan 1991).

The rate of vertical perinatal transmission of

hepatitis B virus (HBV) is high (ranging from

70 to more than 90 percent [Centers for Disease

Control 1988b; Ranger-Rogez et al. 2002]),

especially if a pregnant woman has active 

infection (determined by a positive 

212 Chapter 13
hepatitis B antigen test) in the third trimester

or within 5 weeks postpartum. If a new motherís

hepatitis B antigen test is positive, the neonate

should receive both hepatitis B vaccine and

hepatitis B immune globulin (Kaltenbach et al.

1998). The rate of perinatal transmission of

hepatitis C virus (HCV) is lower than that of

HBV, as discussed below; however, vaccines

exist for hepatitis A virus and HBV but not 

for HCV. Recommended laboratory tests for

pregnant women who are opioid addicted are

listed in Exhibit 13-2.

HCV 

Pregnant women with a history of injection

drug use are at high risk for HCV infection and

should be screened for anti-HCV antibody.

HCV ribonucleic acid (RNA) testing should be

performed if an anti-HCV antibody test is positive. The results facilitate referral for further

evaluation, staging, and treatment of liver disease after delivery. Infants whose mothers have

hepatitis C should receive HCV RNA testing

along with antibody testing for HCV between

ages 2 and 6 months and again between 18 and

24 months (Roberts and Yeung 2002).

During pregnancy, HCV can be transmitted

vertically from mother to fetus. However, 

multiple studies have shown low overall HCV

vertical transmission risk and greater risk from

factors such as HIV co-infection or high HCV

viral load (Roberts and Yeung 2002). Vaginal

delivery and breast-feeding do not appear to

increase the risk of neonatal HCV infection significantly (Dinsmoor 2001; Roberts and Yeung

2002). Available treatments to prevent vertical

MAT During Pregnancy 213

Exhibit 13-1

Common Medical Complications Among 

Pregnant Women Who Are Opioid Addicted

Anemia 

Bacteremia/septicemia

Cardiac disease, especially endocarditis

Cellulitis

Depression and other mental disorders

Edema

Gestational diabetes

Hepatitis (acute and chronic)

Hypertension/tachycardia

Phlebitis

Pneumonia

Poor dental hygiene

STDs

Chlamydia

Condyloma acuminatum

Gonorrhea

Herpes 

HIV/AIDS

Syphilis 

Tetanus 

Tuberculosis

Urinary tract infections

Cystitis 

Pyelonephritis 

Urethritis

Adapted from Finnegan 1979.
214 Chapter 13

transmission, however, are limited by the fetal

toxicity of the medications currently available

for HCV infection.

HIV/AIDS 

Pregnant women who are opioid addicted 

and HIV positive present a unique treatment

problem. A limited number of studies with

small numbers of patients have examined the

relationship of HIV, methadone, and immune

function (e.g., Beck et al. 2002; Siddiqui et al.

1993). These studies have not been replicated

widely. Therefore, it is difficult to conclude any

significant relationship involving HIV,

methadone, and immune function until 

additional studies are completed. Studies on

the combined effects of HIV antiretroviral

treatment and methadone especially are 

needed. 

During the early 1990s, before effective prevention treatments were available, studies in

North America and Europe found mother-tochild or perinatal HIV transmission rates of 16

to 25 percent. However, between 1996 and 2000,

after the implementation of new guidelines,

studies in the United States found transmission

rates of 5 to 6 percent, and more recent studies

have found rates below 2 percent when antenatal antiretroviral drugs or zidovudine (AZT) is

combined with cesarean section (Centers for

Exhibit 13-2

Laboratory Tests for Pregnant Women Who Are Opioid Addicted

ï Complete blood count with differential and

platelets

ï Chemistry screen (K, Na, Cl, Ca, P, CO2,

creatinine, blood glucose, blood urea

nitrogen, total bilirubin, total serum 

protein albumin)

ï Hepatic panel (liver function tests)

ï Hepatitis B surface antigen (full panel if

positive)

ï Hepatitis C antibody

ï Rubella titer

ï Serology (Venereal Disease Research

Laboratory or Rapid Plasma Reagin tests)

ï Sickle prep (if appropriate)

ï Blood type; Rh and indirect Coombs

Varicella (if unsure of history)

ï HIV (with counseling)

ï Urine tests

Urinalysisóroutine and microscopic

Urine culture and sensitivity

Urine drug screen

ï Tuberculin skin test (Mantoux)

ï Alpha-fetoprotein between 15 and 21

weeksí gestation (optimal, 16 to 18 weeks)

ï 1-hour, 50 mg glucose challenge test at 

24 to 28 weeksí gestation (at initial visit if

risk factors)

ï Repeat complete blood count and serology

at 24 to 28 weeksí gestation

ï Group B Strep vaginal-rectal culture at

35 to 37 weeksí gestation

Reprinted from Obstetrics and Gynecology Clinics of North America, 25(1), Kaltenbach et

al., Opioid dependence during pregnancy. Effects and management, pp. 139ñ151, 1998,

with permission from Elsevier.
Disease Control and Prevention 2001b).

Although AZT prophylaxis reduces the risk of

perinatal HIV infection, monotherapy often is

inadequate to treat a motherís HIV disease.

Combination antiretroviral therapy is now the

standard of care (Paul et al. 2001).

Studies in the United States and Europe have

found that pregnancy has no effect on HIV

progression (Burns et al. 1998; Saada et al.

2000). Studies before the availability of

antiretroviral therapy showed no increase in

prematurity, low birth weight, or intrauterine

growth restriction associated with HIV infection. These data are difficult to interpret

because of relatively high rates of adverse

events in the control groups attributed to 

other conditions such as substance abuse

(Brocklehurst and French 1998; Bucceri et al.

1997). Studies have not found increases in

birth defects or fetal malformation related to

HIV infection (Brocklehurst and French 1998).

The consensus panel recommends that women

who are opioid addicted and HIV infected

receive additional counseling and support during the postpartum period to improve their

adherence to antiretroviral therapy and to

meet the demands of caring for a newborn.

Breast-feeding by HIV-infected women has

been associated with an increased risk of HIV

transmission and should be discouraged

(Nduati et al. 2000).

Obstetrical Complications 

Obstetrical complications in pregnant women

who are opioid addicted are the same as those

seen at increased rates in all women who lack

prenatal care (see Exhibit 13-3). These complications may be difficult to diagnose in patients

who are opioid addicted because they often

deny the existence of complications or avoid

medical settings. When obstetrical complications are confirmed, standard treatments,

including use of medications to arrest preterm

labor, can be initiated safely.

Methadone Dosage

and Management

The pharmacology of methadone in pregnant

women has been evaluated thoroughly.

Methadone is distributed widely throughout 

MAT During Pregnancy 215

Exhibit 13-3

Common Obstetrical Complications Among Women Addicted to Opioids

Abruptio placentae

Chorioamnionitis

Intrauterine death

Intrauterine growth retardation

Intrauterine passage of meconium

Low Apgar scores

Placental insufficiency

Postpartum hemorrhage

Preeclampsia

Premature labor/delivery

Premature rupture of membranes

Septic thrombophlebitis

Spontaneous abortion

Reprinted from Obstetrics and Gynecology Clinics of North America, 25(1), Kaltenbach et

al., Opioid dependence during pregnancy. Effects and management, pp. 139ñ151, 1998,

with permission from Elsevier.
the body after oral ingestion, with extensive

nonspecific tissue binding creating reservoirs

that release unchanged methadone back into

the blood, contributing to methadoneís long

duration of action (Dole and Kreek 1973).

Peak plasma levels occur between 2 and 6

hours after a maintenance dose of methadone is

ingested, with less than 6 percent of the ingested dose in the total blood volume at this time.

Lower sustained plasma concentrations are

present during the remainder of a 24-hour

period (Stine et al. 2003).

As pregnancy progresses, the same methadone

dosage produces lower blood methadone levels,

owing to increased

fluid volume, a larger tissue reservoir

for methadone, and

altered opioid

metabolism in both

the placenta and

fetus (Weaver 2003).

Women who are

methadone maintained often experience symptoms of

withdrawal in later

stages of pregnancy

and require dosage

increases to maintain

blood levels of

methadone and

avoid withdrawal

symptoms (Jarvis et

al. 1999; Kaltenbach

et al. 1998). The

daily dose can be increased and administered

singly or split into twice-daily doses

(Kaltenbach et al. 1998).

Historically, treatment providers have based

dosing decisions on the need to avoid or reduce

the incidence of neonatal abstinence syndrome

(NAS) (Kaltenbach et al. 1998; Kandall et al.

1999) rather than to achieve an effective therapeutic dosage. This low-dose approach, which

emerged from several 1970s studies (e.g.,

Harper et al. 1977; Madden et al. 1977), has

been contradicted by more recent studies (e.g.,

Brown et al. 1998; Kaltenbach and Comfort

1997). The consensus panel knows of no compelling evidence supporting reduced maternal

methadone dosages to avoid NAS. On the contrary, higher dosages have been associated with

increased weight gain, decreased illegal drug

use, and improved compliance with prenatal

care by pregnant women in MAT and with

increased birth weight and head circumference,

prolonged gestation, and improved growth of

infants born to women in MAT (De Petrillo and

Rice 1995; Hagopian et al. 1996). Moreover,

reduced methadone dosages may result in continued substance use and increase risks to both

expectant mothers and their fetuses (Archie

1998; Kaltenbach et al. 1998). The consensus

panel recommends that methadone dosages for

pregnant women be determined individually to

achieve an effective therapeutic level.

Induction and Stabilization

Methadone dosages for pregnant women should

be based on the same criteria as those for

women who are not pregnant. Women who

received methadone before pregnancy should

be maintained initially at their prepregnancy

dosage. However, if pregnant women have not

been maintained on methadone, the consensus

panel recommends that they either be inducted

in an outpatient setting by standard procedures

or be admitted to a hospital (for an average

stay of 3 days) to evaluate their prenatal health

status, document physiologic dependence, and

initiate methadone maintenance if possible.

For pregnant women being inducted in an outpatient setting, a widely accepted protocol is to

give initial methadone doses of 10 to 20 mg per

day, with exact dosage based on a patientís opioid use history. A patient should be asked to

return at the end of the day for followup evaluation, and the initial dose may be followed by

regular adjustments of 5 to 10 mg based on

therapeutic response (Archie 1998). Twice 

daily observation should continue until the

patient is stabilized. If evidence of intoxication

or withdrawal emerges, treatment providers

should adjust the patientís dosage immediately.

Most pregnant women can be stabilized within

216 Chapter 13

[M]ethadone

dosages for 

pregnant women

[should] be determined individually

to achieve an

effective therapeutic level.
48 to 72 hours (Kaltenbach et al. 1998). In 

outpatient settings, where fetal monitors 

usually are unavailable, it is crucial that

patients record measures of fetal movement at

set intervals (Jarvis and Schnoll 1995).

Split Dosing 

Split-dosing methadone regimens are accepted

widely for pregnant patients, but little empirical

investigation has been done of its effects on

fetuses or maternal plasma levels (Jarvis et al.

1999). Although split dosing may improve

maternal compliance with treatment and

decrease cocaine use (De Petrillo and Rice

1995), traveling to an opioid treatment program

(OTP) twice a day or, for unstable or newly

admitted patients, qualifying for take-home

medication doses may be difficult.

Managing Polysubstance Use 

A large percentage of pregnant women in

MATóup to 88 percent in one studyócontinue

to use other substances including alcohol, nicotine, heroin, cocaine, barbiturates, and tranquilizers (Edelin et al. 1988). The risks of other

substance use for both maternal and fetal

health are well documented (Reid 1996). It is

essential that patients be monitored for use of

both licit and illicit drugs and alcohol to manage appropriately the perinatal care of both

mothers and infants (Kaltenbach et al. 1998). 

Polysubstance use is a special concern during

pregnancy because of the adverse effects of

cross-tolerance, drug interactions, and potentiation (Kaltenbach et al. 1998) and the serious

maternal and fetal health risks from continued

substance use and lack of adequate prenatal

care (Svikis et al. 1997a). Chapter 11 provides

more information about treatment of multiple

substance abuse in MAT; the forthcoming TIP

Substance Abuse Treatment: Addressing the

Specific Needs of Women (CSAT forthcoming f)

contains additional information on the effects

of different substances on pregnant women.

Management of Acute Opioid

Overdose in Pregnancy

Opioid overdose in pregnancy threatens both

pregnant women and their fetuses. Naloxone, a

short-acting, pure opioid antagonist, is the

pharmacological treatment of choice for opioid

overdose but should be given to pregnant

patients only as a last resort (Weaver 2003).

Patients should receive naloxone (0.01 mg/kg

of body weight) intravenously after an airway

is established to ensure adequate respiration.

Patients can receive additional naloxone doses

every 5 minutes after they regain consciousness. Naloxoneís duration of action is from 30

minutes to 2 hours, depending on the dose and

type of substance that was used, whereas that

of most opioids is from 6 to 8 hours and that 

of methadone or other long-acting opioids 

(e.g., morphine sulfate contin, OxyContinÆ) is

from 12 to 48 hours (or more for levo-alpha

acetyl methadol). Therefore, symptoms are

likely to recur within 30 minutes to 2 hours 

of naloxone treatment, and treatment

providers should continue administering 

naloxone intravenously or intramuscularly 

at intervals until the effects of illicit opioids

markedly diminish, which may take 2 to 3

days. Special care is needed to avoid acute 

opioid withdrawal that can harm a fetus.

Treatment providers should titrate the naloxone dose against withdrawal symptoms and 

use a short-acting opioid to reverse acute 

withdrawal symptoms (Archie 1998).

Managing Withdrawal From

Methadone 

Withdrawal from methadone, called medically

supervised withdrawal (MSW) or dose tapering, is not recommended for pregnant women.

When MSW is considered, however, a thorough

assessment is important to determine whether a

woman is an appropriate candidate for MSW

because the procedure frequently results in

relapse to opioid use. Appropriate patients for

MSW during pregnancy include those who

MAT During Pregnancy 217
ï Live where methadone maintenance is

unavailable

ï Have been stable in MAT and request MSW

before delivery

ï Refuse to be maintained on methadone

ï Plan to undergo MSW through a structured

treatment program (Archie 1998; Kaltenbach

et al. 1998).

A patient who elects to withdraw from

methadone should do so only under supervision

by a physician experienced in perinatal addiction treatment, and the patient should receive

fetal monitoring. MSW usually is conducted in

the second trimester because the danger of miscarriage may increase in the first trimester and

the danger of premature delivery or fetal death

may increase in the third trimester (Kaltenbach

et al. 1998; Ward et al. 1998a). However, the

consensus panel has found no systematic studies on whether withdrawal should be initiated

only during the second trimester. If MSW is

undertaken, methadone should be decreased by

1.0 to 2.5 mg per day for inpatients and by 2.5

to 10.0 mg per week for outpatients. Fetal

movement should be monitored twice daily in

outpatients, and stress tests should be performed at least twice a week; MSW should be

discontinued if it causes fetal stress or threatens

to cause preterm labor (Archie 1998;

Kaltenbach et al. 1998). 

Postpartum Treatment

of Mothers in MAT

Current treatment practices include continuing

methadone after delivery either at dosages similar to those before pregnancy or, for women who

began methadone maintenance during pregnancy, at approximately half the dosages they

received in the third trimester. However, no

empirical data support these approaches, and

any decrease should be based on signs of overmedication, withdrawal symptoms, or patient

blood plasma levels (Kaltenbach et al. 1998). 

Breast-Feeding 

Mothers maintained on methadone can breastfeed if they are not HIV positive, are not 

abusing substances, and do not have a disease

or infection in which breast-feeding is contraindicated (Kaltenbach et al. 1993). Hepatitis

C is no longer considered a contraindication for

breast-feeding. 

The American Academy of Pediatrics has a

longstanding recommendation (1983) that

methadone is compatible with breast-feeding

only if mothers receive no more than 20 mg in

24 hours. However, studies have found minimal

transmission of methadone in breast milk

regardless of maternal dose (Geraghty et al.

1997; Wojnar-Horton et al. 1997). McCarthy

and Posey (2000) found only small amounts of

methadone in breast milk of women maintained

on daily doses up to 180 mg and argued that

available scientific evidence does not support

dosage limits of 20 mg a day for nursing

women.

Effects on Neonatal

Outcome 

NAS

Infants prenatally exposed to opioids have a

high incidence of NAS, characterized by hyperactivity of the central and autonomic nervous

systems that is reflected in changes in the gastrointestinal tract and respiratory system.

Infants with NAS often suck frantically on their

fists or thumbs but may have extreme difficulty

feeding because their sucking reflex is uncoordinated (Kaltenbach et al. 1998). Withdrawal

symptoms may begin from minutes or hours

after birth to 2 weeks later, but most appear

within 72 hours. Preterm infants usually have

milder symptoms and delayed onset. Many factors influence NAS onset, including the types 

of substances used by mothers, timing and

dosage of methadone before delivery, characteristics of labor, type and amount of anesthesia

or analgesic during labor, infant maturity and

218 Chapter 13
nutrition, metabolic rate of the infantís liver,

and presence of intrinsic disease in infants.

NAS may be mild and transient, delayed in

onset or incremental in severity, or biphasic in

its course, including acute neonatal withdrawal

signs followed by improvement and then onset

of subacute withdrawal (Kaltenbach et al.

1998). Although NAS can be more severe or

prolonged with methadone than heroin because

of methadoneís longer half-life, with appropriate pharmacotherapy, NAS can be treated satisfactorily without any severe neonatal effects.

Onset of NAS may be delayed by other neonatal

illnesses. In addition, various other conditions

may mimic NAS, such as hypoglycemia,

hypocalcemia, sepsis, and neurological illnesses. To rule out such conditions, infants suspected of having NAS should have a complete blood

cell count with differential, electrolyte and 

calcium levels, comprehensive neurological

consultation, and head ultrasound if indicated.

An abstinence scoring system should be used to

monitor opioid-exposed newborns to assess the

onset, progression, and diminution of symptoms (Kaltenbach et al. 1998). The Neonatal

Abstinence Score (Finnegan and Kaltenbach

1992) is used widely to estimate NAS severity,

determine whether pharmacotherapy is needed, and monitor the optimum response to therapy. All infants of mothers with an opioid use

history should be scored every 4 hours.

Control is achieved when the average Neonatal

Abstinence Score is less than 8, infants exhibit

rhythmic feeding and sleep cycles, and infants

have optimal weight gains.

If pharmacological management is indicated,

infants should be treated with neonatal opioid

solution (0.4 mg/mL of morphine-equivalent

solution; starting dosage, 0.4 mg/kg/dose given

orally in six to eight divided doses [timed with

the feeding schedule]). Dosage should be

increased by 0.4 mg/kg/dose as needed until

control is achieved or a maximum dosage of 2.0

mg/kg/day is reached. If Neonatal Abstinence

Scores remain high but daily doses approach

the maximum, the infantís symptoms should be

reassessed and concurrent pharmacotherapy

with phenobarbital considered (American

Academy of Pediatrics Committee on Drugs

1998).

When control is achieved, the dosage should be

continued for 72 hours before pharmacological

weaning begins, in which dosage is decreased

10 percent daily or as tolerated until 0.2

mg/kg/day is reached, when medication may be

discontinued. Decisions about dosage decrease

rate during pharmacological weaning should be

based on Neonatal Abstinence Scores and daily

weight and physical exams.

Maternal Methadone Dosage

and Extent of NAS

The relationship between maternal methadone

dosage and NAS has been difficult to establish,

and the consensus panel believes no compelling

evidence shows that methadone reduction

avoids NAS. Although a number of investigators have reported significant relationships

between neonatal withdrawal and maternal

methadone dosage (e.g., Malpas et al. 1995;

Mayes and Carroll 1996), most have found no

such relationship (e.g., Berghella et al. 2003;

Brown et al. 1998). 

Perinatal Outcomes

Another area of concern is the intrauterine

growth of infants born to women maintained on

methadone. Early research yielded somewhat

inconsistent findings,

and not much new has

been added since the

1980s. Studies comparing infants born to

women addicted to

heroin but not receiving methadone with

infants born to

women receiving

methadone found differential effects, with

reduced fetal mortality and greater birth

weights indicated for

MAT During Pregnancy 219

...NAS can be

treated satisfactorily without any

severe neonatal

effects.
infants of women maintained on methadone

(Connaughton et al. 1977; Kandall et al. 1977).

Some studies comparing infants born to women

not using opioids with infants of women in

methadone treatment found lower birth weights

in the latter group (Chasnoff et al. 1982;

Lifschitz et al. 1983), whereas others found no

differences in birth weights (Rosen and

Johnson 1982; Strauss et al. 1976).

A study by Kaltenbach and Finnegan (1987)

with 268 infants found that those exposed to

methadone had lower birth weights and smaller

head circumferences than those not exposed to

drugs. However, the infants exposed to

methadone were not small for their gestational

age, and there was a positive correlation

between head circumference and birth weight

in both groups. These data suggested that

infants born to women who are opioid addicted

and maintained on methadone may have lower

birth weights and smaller head circumferences

than nonñdrug-exposed comparison infants,

but the former are not growth restricted.

Researchers (e.g., Chasnoff et al. 1984; Jeremy

and Hans 1985) who used the Brazelton

Neonatal Behavioral

Assessment Scale

(Brazelton 1984) to

investigate neurobehavioral characteristics in newborns

undergoing opioid

withdrawal have

found differences

consistently in

behavior between

these infants and

infants born to

women not opioid

addicted. Infants

exposed to opioids

were more irritable,

exhibited more

tremors, and had

increased muscle

tone. Several studies

have reported less

responsiveness to

visual stimuli and reduced alertness among

infants exposed to opioids (Strauss et al. 1975).

Important aspects of these behavioral characteristics are their implications for motherñ 

infant interactions. In the consensus panelís

experience, these infants are frequently difficult to nurture, causing poor motherñinfant

bonding, which Hoegerman and colleagues

(1990) suggested might be the most devastating

legacy of perinatal addiction.

Developmental Sequelae 

Research on developmental sequelae associated

with in utero methadone exposure has found

that infants through 2-year-olds function well

within the normal developmental range (e.g.,

Kaltenbach and Finnegan 1986; Rosen and

Johnson 1982). Lifschitz and associates (1985)

found no significant developmental differences

between children of mothers maintained on

methadone and children of mothers still using

heroin or using no opioids, when sociodemographic, biological, and other health factors

were considered. Other data have suggested

that maternal drug use is not the most important factor in how opioid-exposed infants and

children develop but that family characteristics

and functioning play a significant role (Johnson

et al. 1987). More information is needed to

update or extend these findings from the 1970s

and 1980s.

Use of Buprenorphine

During Pregnancy 

Buprenorphine use for pregnant women has

not been approved in the United States,

although it may be used with pregnant patients

under certain circumstances (see below). It

may be a safe and effective treatment for some

pregnant women who are opioid addicted, but

more research is needed. Several animal studies have been conducted. However, only limited

prospective and open-label studies using sublingual buprenorphine tablets in pregnant

women have been reported, and these represent the most closely controlled data (e.g.,

220 Chapter 13

[I]nfants born to

women who are

opioid addicted

and maintained on

methadone may

have lower birth

weights and 

smaller head 

circumferences...
Johnson et al. 2001; Lejeune et al. 2002).

Several case studies have been reported, mainly in France, of buprenorphine use during

pregnancy (e.g., Marquet et al. 1997, 1998).

Johnson and colleagues (2003a) provided a

complete review of these reports. The studies

all found that buprenorphine was well accepted

by mothers and infants during the early neonatal stage and appeared useful to treat pregnant

women who were opioid addicted.

In view of incomplete data and the absence of

FDA approval for use of buprenorphine in

pregnant patients, the consensus panel recommends that buprenorphine be used only when

the prescribing physician believes that the

potential benefits justify the risks. For example, patients already maintained and stable on

buprenorphine who become pregnant probably

should continue on buprenorphine with careful

monitoring. Pregnant women who are opioid

addicted but cannot tolerate methadone, those

for whom program compliance has been difficult, or those who are adamant about avoiding

methadone may be good candidates for

buprenorphine. In such circumstances, it

should be clearly documented in the patientís

medical record that she has refused methadone

maintenance treatment or that such services

are unavailable; that she was informed of the

risks of using buprenorphine, a medication

that has not been thoroughly studied in pregnancy; and that she understands these risks.

When treating pregnant patients, treatment

providers should use buprenorphine monotherapy tablets (SubutexÆ) because no work has

been done on the effects of fetal exposure to

sublingual naloxone in buprenorphinenaloxone combination tablets (SuboxoneÆ) 

during pregnancy. Consensus panelists have

found that a patient already maintained on

buprenorphine-naloxone combination tablets

who becomes pregnant can be transferred

directly to buprenorphine monotherapy tablets.

A more detailed discussion on buprenorphine

use in the treatment and management of 

pregnant patients and its effects in newborns

can be found in TIP 40, Clinical Guidelines 

for the Use of Buprenorphine in the Treatment

of Opioid Addiction (CSAT 2004a). For a comprehensive review of buprenorphine use in

pregnant patients and its effects on the

neonate, see the article by Johnson and colleagues (2003a). Current data indicate that

buprenorphine probably is safe and effective

for some women who are pregnant and opioid

addicted, but more research is needed.

Buprenorphine Effects on NAS

Johnson and colleagues (2003a) reviewed 21

reports of buprenorphine use during pregnancy, most from Europe, and found that NAS was

reported in 62 percent of approximately 309

infants exposed to buprenorphine, with 48 

percent requiring treatment and 40 percent

confounded by other drug use. Another study

of 100 infants of mothers maintained on

buprenorphine found NAS in approximately 67

percent (Johnson et al. 2001). Of these, 53 percent required treatment for withdrawal, and

approximately 7 percent were admitted to a

neonatal intensive care unit. Similar to infants

born to women receiving methadone, infants of

women receiving comprehensive prenatal care

plus buprenorphine had improved birth outcomes compared with those whose mothers

received no comprehensive prenatal care.

Buprenorphine-associated NAS generally

appears within 12 to 48 hours, peaks at 72 to

96 hours, and lasts 120 to 168 hours, although

some reports have indicated buprenorphinerelated NAS lasting 6 to 10 weeks.

Buprenorphine-associated NAS was found to

be less intense than that associated with

methadone (Johnson et al. 2003a). If controlled

randomized trials confirm that newborns of

mothers treated with buprenorphine have less

NAS than those of mothers treated with

methadone, it may be appropriate to switch

patients from methadone to buprenorphine

during early pregnancy to reduce chances for

marked withdrawal syndromes in newborns.

MAT During Pregnancy 221
Breast-Feeding During

Buprenorphine Treatment

Research has indicated that only small amounts

of buprenorphine and buprenorphine-naloxone

pass into breast milk, with little or no effect on

infants (Johnson et al. 2001; Schindler et al.

2003; CSAT 2004a). These data are inconsistent with product labeling, which advises

against breast-feeding in mothers treated with

buprenorphine or the buprenorphine-naloxone

combination. Based on research data, particularly findings that buprenorphine is likely to be

poorly absorbed by infants via the oral route,

the consensus panel recommends that women

maintained on buprenorphine be encouraged to

breast-feed because of the benefits to infants

and motherñchild interaction. The panel recommends more research, particularly to confirm that infants absorb little buprenorphine

during breast-feeding.

Importance of

Integrated,

Comprehensive

Services 

Pregnant women who are opioid addicted need

comprehensive treatment services, including

individual, group, and family therapy to

address both the physiological and psychological effects of substance use and psychosocial

factors. Psychosocial complications may

include disruption of the motherñchild relationship, guilt over the adverse effects of addiction

on the family, and family adjustment when a

newborn is retained in the hospital. Problems

associated with domestic violence, financial

support, food, housing, and childcare issues

can be overwhelming to women in recovery and

should be addressed. AIDS prevention, counseling, testing, and educational services should

be available during prenatal and parenting

classes. Services should be aimed at eliminating

substance use, developing personal resources,

improving family and interpersonal relationships, eliminating socially destructive behavior,

and helping new parents cope with their 

environment. 

Integrated services, whether on site or through

linkages to other community-based agencies,

encourage prospective patients to enter a 

treatment program and continue treatment.

Services should be woman centered and 

directly address traumatic events. The array of

services may include

ï Special groups to address problems of pregnant women who are opioid addicted

ï Available treatments for women addicted to

opioids, including pharmacotherapies

ï Education and discussion groups on parenting and childcare

ï Special groups and services for children and

other family members

ï Couples counseling

ï Case management and assistance in locating

safe, affordable housing.

The forthcoming TIP Substance Abuse

Treatment: Addressing the Specific Needs of

Women (CSAT forthcoming f) has more

detailed information on the psychosocial 

components of women-centered treatment. 

Psychosocial Barriers 

Women addicted to opioids typically face financial, social, and psychological difficulties that

affect their options and treatment progress.

Many have histories of negative experiences

with the legal system or childrenís protective

services that may cause them to be resistant to

or noncompliant with treatment. Guilt and

shame coupled with low self-esteem and selfefficacy can produce behaviors difficult for

some staff members to tolerate, such as lateness, missed appointments, continued illegal

drug use, and demanding or provocative

behaviors. For successful treatment, care

should be provided in a gender-specific, nonpunitive, nonjudgmental, nurturing manner,

with attention to each patientís fears and cultural beliefs (Kaltenbach et al. 1998; Ward et

al. 1998a).

222 Chapter 13
Contingency Management

Treatment Strategies

As discussed in chapter 8, contingency management strategies offering positive reinforcement

for behavioral change have been effective in

treating a range of substance use disorders.

Voucher-based reinforcement therapy (VBRT)

has been particularly effective in increasing

abstinence from substances and strengthening

behaviors such as compliance with treatment

plans and participation in vocational training

(Kidorf et al. 1998; Petry 2000; Silverman et

al. 1996). These and other studies also have

suggested that VBRT may help manage polysubstance abuse and improve retention for

pregnant women in MAT.

Although few systematic studies have been done

with pregnant women who are opioid addicted,

available evidence has indicated that positivecontingency rewards for abstinence or treatment

attendance can improve pregnancy outcomes

(Chang et al. 1992; Jones et al. 2001).

Contingency management incentives for this

population have ranged from cash (Carroll et

al. 1995; Chang et al. 1992) to vouchers

exchangeable for goods and services (Jones et

al. 2000, 2001; Svikis et al. 1997b).

Carroll and colleagues (1995) compared the

effectiveness of an enhanced treatment program

for pregnant patients that included a contingency management component, in which clients

could earn $15 weekly for three consecutive

negative drug tests, with an unenhanced treatment program. The group receiving enhanced

treatment had better neonatal outcomes, but

the two groups did not differ in percentages of

positive drug tests. The authors attributed

these results primarily to more frequent prenatal care in the contingency management group.

However, results of the study were limited by

the small sample size (seven women in each

group), the inability to discern which components contributed to improved outcomes, and

use of a demanding contingency procedure that

reinforced continuous abstinence (e.g., three

consecutive negative drug tests) but not discrete

abstinence (each negative drug test). 

Many pregnant women who receive MAT discontinue treatment prematurely, with the highest dropout rates occurring on transfer from

residential to outpatient treatment. A related

series of controlled, randomized studies (Jones

et al. 2000, 2001; Svikis et al. 1997b) examined

whether brief voucher incentives improved

patient participation and decreased substance

use during this transition phase. In pregnant

women maintained on methadone, low-value

incentives did not influence substance use

(Jones et al. 2000). However, greater incentives,

using an escalating

reinforcement procedure, both decreased

substance use and

increased full-day

outpatient treatment

attendance (Jones et

al. 2001). 

Overall, these studies

have suggested that

contingency management using positive

rewards for desired

behaviors may be an

important adjunct to

MAT for pregnant

women. It is noteworthy that interventions

such as VBRT not

only are compatible

with MAT but

address both continued substance abuse and

poor program attendance.

Nutrition Assessment,

Counseling, and

Assistance

People with substance use disorders often are

poorly nourished. Substances themselves may

impair usersí metabolism, interfere with nutrient availability, and affect appetite. However,

other lifestyle factors associated with substance

use play a significant role, including poverty,

poor eating and exercise habits, lack of concern

MAT During Pregnancy 223

Integrated 

services... 

encourage

prospective

patients to enter a

treatment program

and continue 

treatment.
about nutrition and health, and diets restricted

by physiological conditions. 

Pregnancy is an opportune time to help women

improve their health-related attitudes and

behaviors. The consensus panel recommends

that all pregnant patients in MAT receive

ï An assessment of nutritional status, eating

habits, and weight

ï Education on appropriate diet and weight to

meet optimal targets for the pregnancy

ï Counseling to ensure that special nutritionrelated medical and psychosocial problems

are addressedówith high priority given to

stopping or substantially reducing cigarette,

alcohol, and other substance use with known

adverse effects on fetuses

ï Supplemental nutrients when nutritional

needs cannot be met by diet changes

ï Information about and referral to food assistance programs. 

Nutritional Education for

Pregnant Patients in MAT 

Most pregnant women in MAT can benefit from

nutritional guidance that encourages them to

have wholesome, well-balanced diets consistent

with their ethnic or cultural backgrounds and

financial situations. Such guidance helps them

understand how diet and substance use affect

the fetus, pregnancy, labor and delivery, and

breast-feeding. 

Some OTPs have trained nurses or other staff

members who facilitate a nutrition education

program. In addition, the National Center for

Nutrition and Dietetics of the American Dietetic

Association (800-366-1655 or www.eatright.org)

refers inquirers to registered dietitians in the

local area who provide individual or group

counseling or program information about diet

during pregnancy. Another useful resource,

Pregnancy and Nutrition, a seven-page pamphlet developed by the National Womenís

Health Information Center (www.4women.gov/

faq/preg-nutr.htm), covers recommended

dietary allowances for pregnant women, diet

changes and weight gain, cravings, exercise,

dietary supplements, diabetes, morning 

sickness, and nausea. 

OTPs wishing to assess patientsí knowledge

about nutrition might be interested in the U.S.

Department of Agricultureís 22-page survey

forms (www.barc.usda.gov/bhnrc/foodsurvey)

to ascertain respondentsí knowledge of nutrition, food composition, labeling requirements,

and serving sizes, as well as eating habits and

attitudes. 

Food Program Assistance for

Pregnant Patients in MAT

Pregnant women in MAT who are nutritionally

at risk or financially needy may be eligible for

supplemental food assistance. Their school-age

children also might qualify for school breakfast

and lunch programs, as well as summer food

programs. OTP counselors should be familiar

with the services and requirements of each type

of program and make appropriate referrals.

Facts about food stamps can be found at

www.fns.usda.gov/fns. Information about the

Federal Women, Infants, and Children program can be accessed at www.fns.usda.gov/wic

or www.nal.usda.gov/wicworks.

224 Chapter 13
14 Administrative

Considerations

In This

ChapterÖ

Staffing

Medication

Diversion Control

Plans

The Community

Effort

OTPs and National

Community

Education

Initiatives

Evaluating

Program and Staff

Performance

This chapter describes policies, procedures, and considerations that

make opioid treatment program (OTP) administrators and managers

more effective, therefore contributing to improved treatment outcomes.

OTPs are complex, dynamic environments, and their staffing and 

management are challenging. OTP directors influence patient outcomes

positively by providing sound leadership and staff management (Magura

et al. 1999). Managers are responsible for keeping staff members focused

on patient care and improved treatment outcomes. Conflict or misunderstanding about treatment goals can increase the stress of working in an

OTP (Bell 1998). Managers should set clear staff guidelines, supply the

needed resources, and create a culture that nurtures professional growth

and staff retention.

Staffing

How . . . interactions [between OTP staff and patients] are 

conducted, and particularly the attitude of staff members, is

probably the next most important determinant of treatment

effectiveness after an adequate dose of methadone. (Bell 1998, 

p. 168)

Successful treatment outcomes depend on staff competence, values, and

attitudes. To develop a stable group of competent personnel, OTP

administrators should recruit qualified, capable, culturally competent

people; offer competitive benefit packages; and provide careful supervision and ongoing training. Employees then can increase their understanding of medication-assisted treatment for opioid addiction (MAT).

Qualifications

Licensing, certification, and credentialing

The complexities of treating patients who are opioid addicted demand

highly trained caregivers who can provide direct patient care and 

coordinate access to other services that their OTP cannot provide. To

ensure these qualifications, OTPs should hire individuals who are

225
licensed or credentialed under State regulations

and have a record of working effectively with

the types of patients served by the OTP.

Licensed and credentialed staff members also

may be viewed as having more legitimacy by

State regulators, community members, and

third-party payers.

Staff interpersonal 

characteristics

In addition to hiring licensed or credentialed

staff, administrators should employ people with

empathy, sensitivity, and flexibility, particularly regarding patients in MAT. Empathic staff

members create a

therapeutic milieu

(Joe et al. 2001). In

addition, staff members should maintain appropriate

professional boundaries with patients.

Transference and

countertransference. Some patients

with addictions 

project feelings or

emotions onto their

treatment providers

or cast providers in

unintended roles, a

phenomenon known

as transference.

Countertransference

occurs when treatment providers project their feelings

onto patients, which

can interfere with

treatment and be destructive to therapeutic

relationships. OTP supervisors should ensure

that staff members avoid countertransference

(e.g., displaying anger toward patients or disappointment with them). TIP 36, Substance

Abuse Treatment for Persons With Child Abuse

and Neglect Issues (CSAT 2000d), contains a

detailed discussion of these topics.

Sensitivity to cultural, gender, and age issues.

In a review of the literature on culturally relevant health care interventions and their effect

on treatment outcomes, Kehoe and colleagues

(2003) found that treatment provider knowledge of cross-cultural principles significantly

improved outcomes for patients with drug

addictions. OTP staff members should be 

willing to work with people from diverse backgrounds, explore and accept other value systems, and understand how culture and values

can relate to patientsí behavior. Support staff

should be accepting and understanding of

patients from diverse groups because these staff

members often are the first people a new

patient sees at the OTP and those with whom

the patient interacts most. If possible, management should recruit employees who reflect

patient demographics and should consider 

hiring people who are recovering from addiction (see below).

People working with diverse groups should

remember that diversity also exists within cultures. It is important to be sensitive to cultural

differences but to avoid acting on cultural

assumptions. Understanding both a patientís

cultural influences and his or her individuality

requires taking time to know the patient.

Treatment staff should be sensitive to other 

factors that can affect recovery, such as

patientsí sexual orientations or ages, but should

avoid generalizing about patients based on

these factors. Correctly identifying such factors

requires an effort to see the world through each

patientís eyes. Information on cultural competence and diversity is available at Web sites of

the National Association of Social Workers

(www.socialworkers.org/diversity) and

Substance Abuse and Mental Health Services

Administration (SAMHSA) (www.samhsa.gov/

search/search.html) and in ìCultural

Competence for Social Workersî (Center for

Substance Abuse Prevention 1995) and the

forthcoming TIP Improving Cultural

Competence in Substance Abuse Treatment

(CSAT forthcoming b).

Multicultural and multilingual representation.

The consensus panel is aware of no published

226 Chapter 14

[A]dministrators

should recruit

qualified,...culturally competent 

people; offer 

competitive benefit

packages; and 

provide careful

supervision and

ongoing training.
data demonstrating improved outcomes from

ethnic matching of patients and substance

abuse treatment providers. Sterling and colleagues (2001) noted the existence of ìequivocal

findings of the effect that therapist and patient

similarity plays in treatment outcomeî (p.

1015) in substance abuse treatment programs

and concluded that more research is needed.

However, the panel believes that, when program staff generally reflects the demographics 

of the population served, patients are more

likely to feel comfortable in the OTP. When

multicultural representation among staff is 

limited, OTPs should find ways to communicate acceptance of diverse cultures and groups.

Programs with nonñEnglish-speaking patients

should provide information in patientsí first

languages by employing staff members or interpreters who can communicate with patients.

Federal and State resources are available for

programs seeking literature in languages other

than English. Community colleges, universities,

and other institutions or agencies might assist

in translating forms and pamphlets. Information

about translation services is available via the

Internet (visit www.atanet.org/bin/view.fpl/

52076.html).

Flexibility in thinking, behavior, and attitudes.

Staff attitudes about MAT and opioid addiction

can affect patient outcomes. Administrators

should seek staff members who are free of rigid

biases, are not judgmental, and do not have

punitive attitudes toward patients (Bell 2000). 

OTP staff members sometimes hold negative

attitudes toward patients (Caplehorn et al.

1997) or MAT (Forman et al. 2001). At least

one study has associated such attitudes with

lower rates of patient retention and poorer

patient outcomes (Caplehorn et al. 1998). OTP

managers should be vigilant about monitoring

staff attitudes and conduct inservice training to

create or sustain appropriate attitudes about

patients and MAT.

The verbal expressions used by OTP staff

members can reflect how they feel toward

patients. Treatment staff members, who might

have absorbed societyís antipathy toward 

people in MAT, sometimes use countertherapeutic language, for example, the phrase ìdirty

urineî to describe an unsatisfactory urine drug

test (ìpositive testî is less judgmental). Staff

should avoid terms suggesting the criminal 

justice system, such as ìprobationî or ìprobationary,î to refer to the status of patients doing

poorly in treatment. ìTerminationî should be

avoided in reference to patient discharge.

Other preferred expressions in MAT include

ìpatientsî not ìclientsî and ìdose taperingî or

ìmedically supervised withdrawalî not ìdetoxî

in reference to withdrawal from treatment

medication. Applying words derived from

ìtoxinî to treatment medication suggests that

the medication is a toxin; ìdetoxificationî

should refer only to withdrawal from substances

of abuse.

Inclusion of recovering patients. The consensus panel believes that employing treatment

professionals and support staff who are in

recovery also adds valuable perspectives to

treatment and provides role models for

patients. OTP policies on hiring people who are

in addiction recovery should be in writing and

include procedures for addressing staff members who relapse. State regulations may establish a minimum abstinence period before an

OTP can hire someone in recovery. Policies

also must comply with Federal and many State

laws prohibiting discrimination against people

who are addicted (CSAT forthcoming b). Staff

members who are in recovery and their colleagues who have no addiction history should

be treated similarly. 

Staff Retention

Retaining staff is important for several reasons: 

ï Stability of treatment staff may affect 

treatment outcomes.

ï High staff turnover can undermine relations

with the community, funders, and others.

ï Investment in recruitment and training is lost

when staff members leave.

ï Unfilled staff positions result in longer

patient waiting lists.

Administrative Considerations 227
ï Reducing staff turnover minimizes disruption

to patientsí treatment.

ï Accreditation standards place importance on

the stability of OTP staff.

Factors that may contribute to high staff

turnover include low salaries and benefits, 

negative stereotypes of MAT and its patients,

job stress, excessive counselor workload,

unreasonable operating hours, and unsafe OTP

locations. Staff members can experience

burnout when they work in isolation with 

difficult patients and inadequate support or

feedback. Managers should take concrete steps

to retain staff, including the following:

ï Establish and maintain clear policies and 

procedures, and apply them consistently.

ï Avoid excessive caseloads. Even the most 

professional, committed counselor struggles

when the caseload is too large. Managers can

use a monitoring system that focuses on the

number of counseling hours a caseload

requires, which can differ dramatically from

the number of cases assigned per counselor,

depending on the requirements of individual

patients.

ï Encourage a team approach. Staff members

usually feel less isolated and overwhelmed

when a team makes treatment decisions.

When a lack of cohesion exists, staff members

risk burnout, disillusionment, or cynicism. A

well-coordinated team also reduces the level

of intrastaff disagreements about patient care

and decreases the likelihood of ìstaff splitting,î when patients pit staff members against

one another.

ï Encourage a culture of mutual respect

through team cooperation, clear and effective

communication, and inclusive, interdepartmental decisionmaking. Managers should

hold regular staff meetings. Staff cooperation

also can be fostered through training and

retreats. The program director or manager

should mediate disputes among staff members.

ï Establish job descriptions that clearly 

delineate roles, responsibilities, and lines of

communication (Bell 1998), and review them

annually with personnel.

ï Establish objective performance standards

derived from job descriptions, and conduct

regular performance evaluations that include

feedback based on patient outcomes.

ï Establish regular consulting sessions among

counselors, their supervisors, and other staff

members. Supervisors should be well trained

and supported.

ï Provide opportunities for professional 

training, either by onsite training or by 

permitting staff members to attend offsite

training during work hours.

ï Encourage professional development by 

supporting staff certifications.

ï Establish personnel policies that demonstrate

concern for staff well-being, including flexible

work schedules to reduce stress.

ï Offer routine praise and recognition for staff

contributions and achievements.

The forthcoming TIP Substance Abuse:

Administrative Issues in Outpatient Treatment

(CSAT forthcoming c) provides more information on supervision, and Newman (1997) provides information on the therapeutic alliance

between patients and treatment providers.

Training

Training should be offered for all staff members, including secretaries, nurses, counselors,

supervisors, and managers, to ensure a strong

knowledge base so that staff members do their

best and to affirm that all staff members are

valued members of the treatment team. The

importance of training has increased because

accreditation standards require OTPs to provide continuing staff education, with many

States requiring such education for OTPs to

maintain licensure. OTPs should help professional staff members acquire education credits

to maintain their licensure by offering onsite

training, collaborating with other agencies for

reciprocal training, or paying for educational

leave or tuition.

At minimum, training should focus on the 

following areas:

228 Chapter 14
ï Facts about MAT and the health effects of

treatment medications. Educating OTP staff

about the health effects of MAT medications

and the value of remaining in treatment is

essential. Some studies have revealed a high

level of misinformation among OTP staff

members about the health effects of maintenance medications (e.g., Kang et al. 1997).

Other studies have shown that many staff

members hold negative attitudes about MAT

(e.g., Caplehorn et al. 1997), which negatively affect patient outcomes (Caplehorn et al.

1998). One way to address negative staff 

attitudes is to include successful patients in

training (Bell 2000).

ï Up-to-date information about medications.

Staff should be able to discuss medications

with patients. Medical staff members should

be able to assess patients and determine, with

input from other treatment team members,

which medication is most appropriate.

ï Up-to-date information about drugs of

abuse. Training should ensure that staff

members are knowledgeable about drug

abuse trends in the community. 

ï Up-to-date information about communicable

diseases. Training should focus on both 

diseases commonly experienced by patients 

in MAT, such as hepatitis C, and emerging

diseases in the community, possibly including

tuberculosis or HIV/AIDS.

ï Skills training. Staff members should have

access to generic skills training such as crisis

management, communications, and problemsolving, as well as new evidence-based MAT

treatments. They should have access to 

training about the populations the OTP

serves, including cultural information and

information about specific disorders.

ï Patient sensitivity training. The importance

of emphasizing sensitivity to patient needs

should be reviewed periodically. No matter

how creative and naturally sensitive a staff

member may be, factors such as burnout can

affect how he or she responds.

A large OTP can tap into its own staff to 

provide training. A program physician might

educate staff members about the etiology 

of addiction and effects of medications. A 

psychiatrist might distinguish primary mental

disorders from those that are substance related

and provide information on psychotropic medications. Therapists and social workers might

teach behavior management techniques, parenting, and resource allocation. Nurses might

provide training on gender and wellness, as

well as the side effects of pharmacologic regimens. Consistent inservice training can help

staff members understand the programís 

mission and the effects of MAT. 

Federal and State

agencies and professional associations

offer seminars, 

courses, and workshops. SAMHSAís

Addiction Technology

Transfer Centers

(ATTCs) offer an

array of training

events and resource

materials

(www.nattc.org).

Some States offer

training leading to

certification for

addiction specialists

and counselors.

Hospitals and large

OTPs sometimes

allow staff from

smaller programs to attend their sessions.

Professional societies, such as the American

Society of Addiction Medicine, American

Academy of Addiction Psychiatry, and

Osteopathic Academy of Addiction Medicine,

offer training for medical personnel in various therapeutic techniques. National counseling organizations, such as the Association for

Addiction Professionals, and professional

nursing societies also offer treatment courses.

OTP administrative, financial, clerical, 

maintenance, and custodial staff may lack

direct treatment responsibilities, but they are

very much part of the team. Reception staff

members, often the first to speak with patients,

play an important role. They should receive an

Administrative Considerations 229

The importance of

training has

increased because

accreditation standards require

OTPs to provide

continuing staff

education...
230 Chapter 14

orientation about MAT to ensure that they

understand how the OTP operates so that they

develop favorable attitudes about patients. If

possible, all staff members should receive

annual training in such areas as confidentiality

requirements, cultural competence, prevention

of workplace violence, and patient rights.

Medication Diversion

Control Plans

Federal opioid treatment standards state that

an OTP must maintain a current diversion 

control plan (DCP) that includes measures to

reduce the possibility of medication diversion

and assigns responsibility for control measures

to medical and administrative staff members

(42 Code of Federal Regulations [CFR], 

Part 8 ß 12(c)(2)).

A DCP should address diversion of medication

both by patients, who might sell or give their

take-home medication to others, and by staff,

who might steal medication or spill or otherwise

waste it.

Reducing the Possibility of

Diversion by Patients

Patients considered for take-home medication

must meet Federal criteria. The medical director makes decisions

about take-home

medications (42

CFR, Part 8 ß

12(i)(2)), and these

decisions and their

basis must be documented (42 CFR,

Part 8 ß 12(i)(3)).

Staff should ensure

that patients can

store medications

safely in their homes

(42 CFR, Part 8 ß

12(i)(2)(vii)). All

take-home medication must be labeled

with the OTP ìname, address, and telephone

number andÖpackaged in a manner that is

designed to reduce the risk of accidental ingestion, including child-proof containersî(42 CFR,

Part 8 ß 12(i)(5)).

Callbacks (see chapter 5) help prevent patient

diversion of take-home medication. Callbacks

require OTPs to select patients at random to

return to the OTP with their remaining takehome medication. A random-callback policy

avoids patient complaints of being unfairly

ìpicked onî by staff members. Programs also

can require patients to undergo drug tests when

they bring in their medications. OTPs should 

document that patients have been informed 

of their responsibilities regarding callbacks

(e.g., how much notice they will receive beforehand) and about the consequences of failure to

respond or of discrepancies in medication

amounts. The OTP callback policy should be

stated clearly in the program DCP.

A no-loitering policy is part of an effective

DCP. The policy should be clarified at the

beginning of treatment and enforced consistently. Extending OTP hours helps eliminate 

overcrowding and loitering. The OTP should

include routine meetings with community leaders, attendance at neighborhood civic association meetings, and open communications with

local law enforcement officials to help resolve

community concerns.

Reducing the Possibility of

Diversion by Staff Members

OTPs rely on the integrity of employees who

handle U.S. Drug Enforcement Administration

(DEA)-scheduled substances. Even so, protocols should be in place to reduce the risk that

staff will divert medications. All scheduled 

substances should be accounted for rigorously

and inventoried continuously. Receipt and 

dispensing should be noted in logbooks.

Working stocks should be logged and tracked

from receipt through dispensing and measured

at the beginning and end of each workday.

Measurements and daily reconciliations should

be monitored by supervisors and checked 

[A]n OTP must

maintain a 

diversion control

plan...to reduce

the possibility of

medication 

diversion...
Administrative Considerations 231

periodically by dispensary managers. Any 

significant discrepancy should prompt an investigation. The dispensary manager, executive

director, and medical director should follow up

on investigation findings. The security of computerized records and systems also should be

ensured to prevent employee theft of medication. Spills and other accidents should be

reported immediately. Within the dispensary,

employees should open the safe or work with

scheduled substances only in the presence of

other staff members. In matters of medication

dispensing, OTPs must consult and comply

with DEA regulations (Drug Enforcement

Administration 2000).

The Community Effort

Community Opposition,

Stigma, and the Importance

of Community Relations

Community resistance to MAT has been chronicled for decades (e.g., Genevie et al. 1988;

Joseph et al. 2000; Lewis 1999; Lowinson and

Langrod 1975). The consensus panel believes

that this resistance has been reduced since TIP

1, State Methadone Treatment Guidelines

(CSAT 1993b), was published, particularly

through efforts to improve scientific clarity

about opioid addiction, to affirm the efficacy

and benefits of MAT, and to educate professionals and the public about MAT. The expanding patient advocacy movement effectively may

be countering some stereotypes and misunderstandings about MAT. Some treatment

providers have overcome community oppositionósometimes called not-in-my-backyard

(NIMBY) syndromeóthrough outreach and

educational efforts (e.g., Weber and Cowie

1995). Many prevention and treatment programs are becoming increasingly responsive to

the needs of cultural and ethnic groups (i.e.,

more culturally competent). These successes

provide models for effective community 

relations in other settings.

Despite progress, MAT remains stigmatized and

controversial in many U.S. communities

(Joseph et al. 2000). The association of MAT

with substantial improvements in individual

health and employment and with reductions in

HIV risk and criminal behavior has been validated by research (e.g., Krantz and Mehler

2004; Mueller and Wyman 1997), but MAT

remains misunderstood even among some

health care professionals.

Sensationalized media coverage and successful

NIMBY-type opposition have continued to

delay or preempt the siting of new facilities

(Lawmakers may restrict 2000; Shepard 2001;

Sissenwein 2000; Zoning fight over Michigan

1998). Introducing MAT into communities is

difficult without community support. However,

the consensus panel believes that, since the

early 1990s, the willingness of treatment professionals and patients; government officials;

agencies representing health, mental health,

addiction treatment, research, and criminal

justice; and the general public to learn more

about MAT and opioid addiction has increased.

Organizations appear more willing to include

OTPs in community health planning as wellregarded community services, but this effort

remains a work in progress.

Good Community Relations

Good community relations are part of good

treatment. When TIP 1 was published in 1993,

Federal regulations guiding the operation of

OTPs did not mandate efforts to improve 

community relations or educate the community.

Transition in Federal oversight of substance

abuse treatment from the U.S. Food and Drug

Administration (FDA) to SAMHSA altered the

Federal regulatory perspective, as reflected in

SAMHSA regulations guiding OTPs (21 CFR,

Part 291, and 42 CFR, Part 8 [Federal

Register 66:4076ñ4102]). In the panelís view,

this change in oversight is bringing OTPs into

the medical mainstream, under the purview of

SAMHSA, by establishing an OTP accreditation system similar to the requirements of other

medical services. Furthermore, the new rules

have codified SAMHSAís earlier guidelines for
OTP accreditation (CSAT 1999b), which 

recognize community relations, education, and

stigma reduction as necessary operational elements. SAMHSAís approved OTP-accrediting

organizationsóincluding at this writing the

Commission on Accreditation of Rehabilitation

Facilities, Council on Accreditation for

Children and Family Services, Joint

Commission on Accreditation of Healthcare

Organizations, National Commission for

Correctional Health Care, State of Missouri

Department of Mental Health Division of

Alcohol and Drug Abuse, and Washington

State Department of Social and Health Services

Division of Alcohol and Substance Abuseó

require that MAT providers demonstrate 

effective community relations and stigmareduction efforts.

OTPs serve both patients and the community.

They affect public health, education, and 

citizensí sense of well-being. Publicly funded

OTPs often rely on community support.

Moreover, MATís placement within the medical

and behavioral spectrum of health care affects

relations with the payer community (Edmunds

et al. 1997), including government and private

insurers and managed care organizations. These

connections increase the need for effective outreach to other community services and entities.

Overcoming Negative

Community Reactions to OTPs

Joseph and colleagues (2000) reported that

most community resistance involves concern

about patient loitering, drug sales, and the

diversion of methadone (see ìMedication

Diversion Control Plansî above). Adding 

alternative care models and longer acting 

pharmacotherapies to the services continuum

can decrease loitering, illicit transactions, illegal parking, and other activities that increase

community concerns. These options enable

highly functioning patients who meet specific

criteria to receive ongoing medical care and

pharmacotherapy with fewer visits to the OTP.

In the view of the consensus panel, incorporation of primary medical care, day treatment,

and short-stay residential models into 

treatment options can affect community 

perceptions positively because patients

involved in MAT are less likely to loiter near

the OTP.

Facilities for onsite patient activities to limit

outside loitering are beneficial. Having adequate onsite staff is equally important in avoiding and resolving community problems. Glezen

and Lowery (1999) provide other practical

guidelines for addressing community concerns

about substance abuse treatment facilities.

Community opposition can be triggered when

community groups believe that they have been

informed or consulted insufficiently. OTP

administrators should meet regularly with 

community leaders to ensure that all parties

are heard. The physical appearance of facilities

should be conceived carefully. The OTP should

be clean and orderly to distinguish it as a professional, responsible facility. Surrounding

property (e.g., entrances, sidewalks, fencing,

trash receptacles, signs) and OTP hours should

not impede pedestrian or vehicle traffic. The

availability of public transportation is important when considering an OTPís location

(Glezen and Lowery 1999).

Some communities have found mobile treatment facilities more acceptable than fixed-site

OTPs. Mobile services allow more people

addicted to opioids to be treated without confronting NIMBY reactions. Pilot studies have

confirmed their success (e.g., Gleghorn 2002;

Ho 1999). 

Whether institution or community based, fixed

site or mobile, OTPs should be situated,

designed, and operated in accordance with

accreditation standards, Federal guidelines,

and State and local licensing, approval, and

operating requirements. The consensus panel

recommends that MAT providers thoroughly

know and understand their communities and

provide the levels of input and support

requested by community leaders, representatives, and constituents to site a facility and

develop services that are responsive to 

community needs.

232 Chapter 14
Administrative Considerations 233

Community Relations and

Education Plan

Each OTP should develop a community relations and education plan that extends from its

general mission statement. Staff and patients

should be part of a multifaceted, proactive effort

to educate community entities affected by OTP

operations, including the medical community,

neighbors, and agencies and individuals 

providing support services. Although program

activities differ in specificity and scope, a 

community relations plan should address the 

following:

ï Learning about the community, its structures,

and directly affected constituents

ï Delineating the community relations mission,

goals, protocols, and staff roles

ï Initiating and maintaining contact with community liaisons

ï Educating and serving the community

ï Establishing effective media relations

ï Developing policies and procedures to

address community concerns about the OTP

ï Documenting community contacts and community relations activities.

The forthcoming TIP Substance Abuse:

Administrative Issues in Outpatient Treatment

(CSAT forthcoming c) provides additional

information on developing a community 

relations and education plan.

Delineating the community

relations, mission, goals, 

protocols, and staff roles

In the opinion of the consensus panel, community relations and education should be an

inherent function of OTP staff. OTPs with 

sufficient resources might employ or retain a

community relations professional to establish

links with local leaders, coordinate staff and

patient participation in community activities,

determine who will represent the OTP at local

events and when, and arrange speaking and

other community education activities. If 

funding for dedicated community relations staff

is unavailable, the OTP should develop an 

internal plan for community relations and 

education. If the OTP is affiliated with a larger

institution, it should ensure full cooperation

from the parent organizationís community 

relations department.

Initiating and maintaining

contacts with community 

Personal contact with community leaders permits open dialog, information sharing, and discussion of community developments, needs,

and problems. Members of the consensus panel

agree that such communication fosters trust 

in the OTP. Moreover, personal contact with

community representatives

ï Encourages leaders to use the OTP as a

resource on addiction and related health

issues

ï Promotes MATís public health benefits

ï Highlights the value of the OTP for community

members with addiction- and other healthrelated problems.

Regular contact with key liaisons should

include onsite and offsite meetings. Demystification of MAT

occurs when treatment is viewed firsthand. Community

members who visit

OTPs can observe

operations and speak

with staff and consenting patients, assuming

OTP operation is

unimpaired and

patient confidentiality

is maintained.

Educating and serving the

community

Information about MAT and the OTP can be

presented through various media. Brochures

and factsheets can be developed that cover the

programís mission, its board membership, the

OTP administrators should meet

regularly with

community 

leadersÖ
234 Chapter 14

types of services

offered, and data on

patients. Occasional

press releases can

notify the public

about specific 

services, activities,

accomplishments,

announcements,

improvements, or

events. Highlights of

an OTPís annual

report can be shared

with community 

officials, liaisons,

and the general 

public. A program

newsletter highlighting health and 

addiction issues 

and containing 

OTP information

and patient and staff articles can be distributed. The Internet has enabled the public to view

more information about opioid addiction and

MAT. Government and private organizations,

professional journals, sponsoring or research

institutions, provider coalitions, advocacy

organizations, and individual OTPs and

patients offer Web sites that discuss MAT

options, policies, services, and developments

and frequently link to related Internet sites.

Some examples are the following:

ï American Association for the Treatment of

Opioid Dependence, Inc. (AATOD;

www.aatod.org)

ï National Institute on Drug Abuse (NIDA;

www.nida.nih.gov)

ï SAMHSA (www.samhsa.gov)

ï SAMHSAís National Help Line

(www.ncadi.samhsa.gov) and Treatment

Improvement Exchange 

ï White House Office of National Drug Control

Policy (www.whitehousedrugpolicy.gov).

Some OTPs have developed speakersí bureaus

for local events. Interested, successful patients,

patient advisory committees, patient family

groups, and OTP alumni can be promoted as

potential speakers. Advocacy groups are

becoming increasingly instrumental in empowering patients as active participants in public

relations, community outreach, and program

support initiatives and in local, State, and

national community education efforts.

OTPs should take an aggressive, proactive

stance in community projects and events,

including some not directly tied to MAT.

Sponsoring conferences, forums, exhibits, 

and awareness events establishes an OTP as a

leader, resource, and participant in the 

community. Staff members with community

development expertise can support other 

organizations in advocacy, promotional, and

support efforts. OTPs can provide noninvasive

medical-screening services (e.g., blood 

pressure, pulse, and weight checks; nutritional

advice) to community members. Hospital-based

OTPs and those licensed to provide primary

medical services can furnish immunizations to

community residents. OTPs can donate surplus

office items or other products to organizations

or groups. Consenting patients and staff can

organize projects such as community cleanups

and neighborhood patrols. Highly visible 

community services demonstrate an OTPís

commitment to community improvement and

counter negative stereotypes.

OTPs also serve communities by providing

addiction treatment for community residents

and offering jobs for qualified residents. The

panel recommends that efforts be made to

recruit and hire responsible, qualified 

personnel from the local community.

OTP administrators and staff can be active 

as representatives, speakers, or planners at

professional conferences and as members or

leaders in professional and community coalitions, including advisory councils. Such affiliations augment community relations efforts

through increased professional education and

public awareness, providing an opportunity 

to exchange information with and counter 

MAT stigmatization among other treatment

professionals. These forums also may present

Highly visible

community 

services demonstrate an OTPís

commitment to

community

improvement and

counter negative

stereotypes.
community relations models that can be adapted effectively by OTPs. Staff participation on

local planning or development bodies can 

contribute to community improvement, 

particularly in social and health services.

OTPs are encouraged to participate in national

SAMHSA campaigns, for instance, by supporting National Alcohol and Drug Addiction

Recovery Month or sponsoring events to

emphasize that addiction recovery is possible

and facilitating MAT as compassionate and a

sound investment.

Establishing effective media

relations

Print, broadcast, and Internet media play critical roles in reporting and educating, as well as

influencing public opinion. Local and national

media differ widely in their portrayals of opioid

addiction, MAT, and people addicted to opioids.

These differences reflect a combination of factors including journalistic integrity, reporting

style and philosophy, political leanings, regional

influences, and business considerations. News

accounts and other depictions of MAT often

seem limited, misinformed, and negative.

Nevertheless, many noteworthy, responsible

features have been produced, providing important, accurate information to the public about

the science and policy of opioid addiction and

treatment (e.g., Barry 2002; Hammack 2002;

Moyers and Moyers 1998). Although treatment

providers sometimes are disciplined to resist

media exposure in order to protect patient 

confidentiality and avoid misrepresentation,

the consensus panel believes that successful

media outreach enhances an OTPís image,

improves understanding of a programís mission

and methods, and generates supportive public

policies. Media outreach can demystify treatment, counteract stigma, and improve fairness

of coverage.

OTPs operating in larger institutions can work

with institutional public affairs professionals.

Administrators should respond to or address

members of the local press when necessary, as

an outgrowth of providing service to the public.

The panel believes that providing quality treatment and operating OTPs responsibly position

programs to interact openly and confidently

with the media.

The forthcoming TIP Substance Abuse:

Administrative Issues in Outpatient Treatment

(CSAT forthcoming c) provides additional

details for establishing media relations.

Developing policies and 

procedures to address and

resolve community concerns

The best intentions to educate and serve the

community are undermined if they are not 

followed up to resolve problems and concerns

about OTPs. The panel recommends that

detailed strategies and procedures be in place

to respond to sources of community anxiety

and hostility. 

It is essential for OTPs to take stepsópossibly

including staff or security patrols of the community, visits with local merchants or representatives, and establishment of a community hot

lineóto curtail loitering, drug sales, and the

diversion of methadone before they prompt

community complaints. These patrols should

emphasize observation, not intervention. Logs

summarizing observations should be maintained. Staff visibility reminds patients of the

negative effect of loitering and similar behavior

and demonstrates to neighbors that OTPs

actively are committed to community safety

and improving quality of life.

Patients observed loitering should be counseled, and their treatment plan should be

revised to address this behavior. OTPs with 

loitering problems should investigate day treatment programs to provide increased treatment

intensity. Discharge should be considered for

patients observed in illegal transactions or

medication diversion. Although discharge is

counter to the mandates of voluntary treatment, patients who are unconcerned about an

OTPís community acceptance might be better

Administrative Considerations 235
served by a facility equipped to handle their

behaviors.

Decisions to discharge patients for loitering

should balance consequences for the individual

patient and public health against the need to

ensure a stable OTP environment and maintain

community-based services open to all patients.

The panel recommends that loitering policies

that culminate in patient discharge should first

provide for progressive discipline and intervention and incorporate patient rights to a fair

hearing and treatment (see discussion in

Appendix D).

Community representatives should have OTP

contact information to report problems involving patients. However, OTPs should clarify 

that they cannot assume a police role; in 

emergency and criminal matters, the police

should be contacted first, not the OTP.

Effective liaison with local law enforcement

personnel is critical to OTP relations with the

community. Although police officers are generally supportive, OTPs should correct any misconceptions police personnel have about OTPs.

Patients should be differentiated from people

actively using illicit drugs or abusing prescription drugs, and law enforcement personnel

should be informed about OTP operations,

with the understanding that police and OTPs

share a purposeóaddressing substance abuse

in the community. Other community problems

(e.g., drug sales, unsafe community conditions)

identified during staff tours can be reported to

law enforcement authorities. Local officers

should be encouraged to contact the OTP about

problems involving patients. Confidentiality

remains paramount, so this relationship should

be delineated carefully.

Documenting community

contacts and community 

relations activities

Programs should document their efforts to

establish productive community contacts and

resolve community concerns. A database

should be developed and updated (e.g., the

number and nature of community complaints

received and the programís response).

Communications should be logged, and staff

participation in community events should be

summarized. Letters and communications 

substantiating community complaints and the

programís followup should be on file. Records

should be kept of staff participation in professional and community conferences, articles

published in professional journals, and 

contributions to local news organizations.

Using this information, OTP administrators

regularly should evaluate community relations

efforts. Such reviews can identify organizations

excluded from previous efforts or problems

requiring revision of program policies or 

practices.

OTPs and National

Community Education

Initiatives

OTPs should be aware of and involved in the

national dialog and efforts to promote MAT,

improve and disseminate information about

opioid addiction, and partner with other

national organizations and agencies in public

relations and community education efforts. 

In addition, OTPs should build on and contribute to these national initiatives within 

their communities.

Numerous resources are available to educate

the public about MAT and assist OTPs with

public relations. National organizations such as

AATOD and the American Society of Addiction

Medicine hold national and regional conferences that bring together treatment providers,

policymakers, researchers, and advocates to

share knowledge and discuss how to advance

national drug policy and expand effective treatment models, including strategies to improve

public relations and reduce stigma. Focused

training sessions also provide critical information, for example, to encourage physicians not

associated with OTPs to enter into MAT or

explain how to improve their current treatment

of patients who are opioid addicted. Other 

sessions may focus on improving staff attitudes

236 Chapter 14
and the treatment system regarding implementation of accreditation (Parrino 2001). 

NIDA has invited professionals, practitioners,

policymakers, and the public to sessions

focused on merging research with everyday

clinical practices in community-based drug

treatment programs. For example, one

conference, Blending Clinical Practice and

ResearchóForging Partnerships To Enhance

Drug Addiction Treatment, held in April 2002

(National Institute on Drug Abuse 2002), 

incorporated a special forum focused on the

mediaís role in presenting addiction treatment

and research issues in the context of science

reporting.

Publications and other information resources,

often available without charge or at low cost,

highlight stories about the life-changing effects

of MAT (e.g., American Methadone Treatment

Association, Inc. 2000; CSAT 2000a). To educate drug court judges and practitioners,

AATOD has produced Drug Court Practitioner

Fact Sheet (Parrino 2002). DEA and AATOD

developed the first DEA-specific guidelines for

OTPs, Narcotic Treatment Programs: Best

Practice Guideline (Drug Enforcement

Administration 2000), which is distributed

nationally to MAT providers and addresses the

safekeeping of and proper accountability for

controlled opioid treatment medications. The

Center for Substance Abuse Treatmentís

(CSATís) Siting Drug and Alcohol Programs:

Legal Challenges to the ìNIMBYî Syndrome

(Weber and Cowie 1995) provides assistance

with problems related to siting treatment 

facilities including OTPs. 

In 1999, SAMHSA convened expert panels and

hearings to examine critical issues affecting the

National Treatment Plan Initiative to improve

and extend alcohol and drug treatment to all

communities and people in need in the United

States (CSAT 2000b). This extensive exploration

documented widespread stigma and bias and its

effect on public support and policy, such as

delaying the acknowledgment of addiction as a

disease; inhibiting prevention, care, treatment,

and research efforts; and diminishing the life

opportunities of those stigmatized. Changing

the ConversationóImproving Substance Abuse

Treatment: The National Treatment Plan

Initiative (CSAT 2000b) affirmed the value of

mass media public health education campaigns,

comprehensive community-based health 

communications, media advocacy, and the

application of commercial marketing 

technologies to programs to change social attitudes. This publication proposed a unique

national approach to reducing stigma that

incorporates science-based marketing research,

a social marketing plan, facilitation and support of grassroots efforts by the recovery 

community, and promotion of the dignity of

people in treatment.

NIDAís Community Epidemiology Surveillance

Networksómultiagency work groups with a

public health orientationóstudy the growth

and development of

drug abuse and related problems in communities nationwide.

The primary objectives are to describe

drug abuse patterns

in defined geographic

areas, identify

changes in these 

patterns, detect

emerging substances

of abuse, and communicate and disseminate information so

that appropriate 

community agencies

and organizations can

develop prevention

and treatment 

strategies. 

As government and

provider-based organizations mobilize

national efforts,

patients in and

providers of MAT,

along with other interested citizens, have been

encouraged to unite and organize, educate

Administrative Considerations 237

OTPs should be...

involved inÖ

efforts to promote

MAT, improve and 

disseminate 

information about 

opioid addiction,

and partner with

other national

organizations and

agenciesÖ
health providers and their communities, and

actively engage in public relations initiatives

and other advocacy efforts that advance knowledge and change attitudes about MAT. CSATís

Recovery Community Support Program assists

advocacy organizations in promoting their 

messages (www.samhsa.gov/search/search.html).

Evaluating Program

and Staff Performance

Why Program Evaluation and

Performance Improvement

Are Important

Recent developments lend urgency to the 

development of good program evaluation and

performance improvement procedures in

OTPs. Federal regulations (42 CFR, Part 8 ß

12(c)) and guidelines (Guidelines for the

Accreditation of Opioid Treatment Programs

[CSAT 1999b], Section III, Part C) require

OTPs to establish performance improvement

programs based on ongoing assessment of

patient outcomes. SAMHSA-approved accrediting bodies (listed above) require performance

improvement objectives in their guidelines.

Many Single State Agencies and managed care

organizations also require programs to collect

and analyze outcome data. OTPs are pressed

increasingly to

demonstrate their

effectiveness and

efficiency. Administrators and staff

must implement program evaluation processes that help meet

these demands.

Program evaluation

contributes to

improved treatment

by enabling administrators to base

changes in services

on evidence of what

works.

Beyond the general information below about

program and staff evaluation in an OTP, readers who want to know more about the specific

questions to ask and the considerations that

should be made during evaluation should refer

to Demystifying Evaluation: A Manual for

Evaluating Your Substance Abuse Treatment

ProgramóVolume 1 (CSAT 1997a).

Background

MAT is one of the most frequently studied

addiction therapies, but evaluating program

performance based on patient outcomes is 

relatively new to OTPs. Previous regulations

(21 CFR, Part 291), which gave regulatory

oversight to FDA, stressed process evaluation

based on compliance with recommended 

treatment procedures. Process evaluation does

not ask whether a recommended process has

worked, only whether it has been followed.

The Institute of Medicine (IOM) was among the

first organizations to recommend an outcome

evaluation system for OTPs based on ìdirect

and valid measures of reduction in opiate and

non-opiate drug use and improvement in positive social functionî (Institute of Medicine

1995, p. 228), which could be used by OTPs,

regulatory and funding agencies, and

researchers. IOM looked to the Methadone

Treatment Quality Assurance System

(MTQAS)óa NIDA-funded effort lasting 

from 1989 to 1998óto develop a performancebased reporting and feedback system as the

foundation for a formal performance improvement system in OTPs. MTQAS was never fully

adopted because most OTPs lacked the

ìfocused technical assistanceî (Ducharme 

and Luckey 2000, p. 87) required to translate

feedback into action. Eight States participated

in the MTQAS study, but only Massachusetts

and North Carolina are using elements of the

system at this writing. Many OTPs appear to be

on their own in conducting program evaluations that comply with accreditation and State

mandates.

238 Chapter 14

OTPs are pressed

increasingly to

demonstrate their

effectiveness and

efficiency.
Outcome and Process

Evaluation

Both performance outcome and process 

evaluations have value, but they answer 

different questions and require different

approaches. Performance outcome evaluation

focuses on results, for example, patient

progress. Process evaluation focuses on how

results were achievedóthe active ingredients

of treatment. The forthcoming TIP Substance

Abuse: Administrative Issues in Outpatient

Treatment (CSAT forthcoming c) and

Demystifying Evaluation: A Manual for

Evaluating Your Substance Abuse Treatment

ProgramóVolume 1 (CSAT 1997a) describe

and contrast these two types of evaluations.

Outcome evaluation in OTPs

Outcome evaluation in OTPs focuses on

patients and their progress during or after participation in MAT. It should focus on progress

markers (see chapter 7) and behavioral

improvements as guideposts and avoid terms

such as ìsuccessî and ìfailure.î Even small

improvements may be significant. For example,

an outcome evaluation might measure drug use

(as quantified by drug testing) in patients who

have spent various times in treatment. Such a

study can set a baseline and provide a benchmark to evaluate the effects of changes in program practices, for example, prescribing individually appropriate dosages for patients.

Researchers measure many variables to assess

MAT treatment outcomes, including drug use,

criminal activity, medical problems, vocational

skills, employment, family relationships, and

social activities. The measures selected by an

OTP should agree with the target behaviors

specified in program goals and objectives. For

example, evaluation of a treatment initiative

designed to reduce substance use, decrease

criminal involvement, and increase job skills

should be based on data in those areas. An

OTP can measure other outcomes (such as

patientsí use of emergency rooms for medical

care) to assess whether it has had other effects

on patient behaviors or the community. 

SAMHSAís accreditation guidelines list the 

following treatment outcomes as examples of

what might be measured by OTPs:

ï ìreducing or eliminating the use of illicit 

opioids, other illicit-drugs, and the problematic use of prescription drugs 

ï reducing or eliminating associated criminal

activities

ï reducing behaviors contributing to the spread

of infectious diseases

ï improving quality of life by restoration of

physical and mental health and functional

status.î (CSAT 1999b, p. 7)

Outcome evaluation also can be focused narrowly; it can assess the results of particular

treatment approaches on patient behavior. For

example, an OTP might provide patients with

bus tokens to defray transportation costs to

and from treatment (some cities fund this kind

of intervention). After a certain period, the

OTP could evaluate whether providing bus

tokens improved program attendance. This

simple evaluation would require only attendance data. The most reliable evaluation uses a

control group for comparison (e.g., a group of

patients who must purchase their bus tokens),

but this is not always practical or ethical.

Process evaluation

Process evaluation describes what is happening

in the treatment program: what kind of treatment, who conducts the sessions, how many

and how long the sessions are, and where the

sessions occur. A process evaluation documents

what actually happens during an intervention,

how a new program or initiative is put into

operation, who the players are and what steps

they take, specific problems and barriers

encountered, strategies used to overcome these

problems and barriers, and necessary modifications to the original plan. Process evaluation

also may describe what is happening within the

ìblack boxî of the treatment program. Black

box, a commonly used term in this context (Ball

and Ross 1991, p. 5), refers to the unknown

quality of some treatment programsóthat is,

the fact that patients go into a program as

Administrative Considerations 239
known entities and come out with certain 

measurable outcomes, but what actually occurs

in treatment is not readily apparent. Process

evaluation permits others to replicate methods

that achieve their goals by evaluating the factors

responsible for those achievements. A process

evaluation can lead to development of a manual

describing the theories and practices of an OTP

to guide others. Implementation analysis should

document a process fully. It is well suited to

documenting an OTPís efforts in community

relations, which is required in the accreditation

process. 

A process evaluation can serve as a management tool for program development if it is used

to assess the strengths and weaknesses of a program and suggest ways to improve operations.

A process evaluation helps administrators

understand how program resources, including

both staff and time, are used and can lead to

improved resource allocation. Process evaluation is useful for examining whether OTP procedures are congruent with its stated goals. For

example, if a goal is to facilitate patientsí use of

peer support groups, the OTP could measure

how often meetings of such groups are held on

site, how often counselors provide patients with

lists of local meetings, or whether patients actually receive interventions as intended. For

example, an OTP intending to individualize

care and match services to patientsí needs may

decide to use the Addiction Severity Index

(ASI) as a guide to treatment planning because

research shows that the ASI indicates effective

patientñservice matches (McLellan et al. 1997).

A process evaluation might examine the degree

to which treatment plans and service delivery

were congruent with the needs identified by the

ASI. If the program finds a lack of congruence,

it can make corrections through training and

supervision. The process evaluation also can

measure the intensity and duration of services

received by patients.

Resources for Program

Evaluation and Performance

Improvement

CSAT has published a comprehensive, detailed

guide to program evaluation that provides a

modularized learning approach, including 

exercises, for designing and conducting 

evaluations. Demystifying Evaluation: A

Manual for Evaluating Your Substance Abuse

Treatment ProgramóVolume 1 (CSAT 1997a)

is available from SAMHSAís National

Clearinghouse for Alcohol and Drug Abuse

Information at 800-729-6686 or

www.ncadi.samhsa.gov.

For OTPs that want to use cost accounting as 

a form of program evaluation, NIDA has 

developed a manual based on a cost-procedureprocess-outcome analysis model that has been

well researched and tested in substance abuse

treatment programs. Measuring and Improving

Costs, Cost-Effectiveness, and Cost-Benefit for

Substance Abuse Treatment ProgramsóA

Manual is available at www.nida.nih.gov/

IMPCOST/IMPCOSTIndex.html.

The Institute of Behavioral Research at Texas

Christian University has carried out a substantial body of research on treatment process and

outcomes (Simpson, D.D., et al. 1997a, 2000).

The instituteís findings and experience in

adapting assessments to field settings have 

guided development of a set of core instruments

that are available at www.ibr.tcu.edu/pubs/

datacoll/coresetforms.html. The Web site also

contains useful program evaluation forms for

gathering OTP data, including the organizationís readiness to change and patient satisfaction with treatment.

United Way of America has developed an

Outcome Measurement Resource Network that

is available through national.unitedway.org/ 

outcomes.

The Change Book, a guidebook for organizational change in OTPs, is produced and distributed by the National ATTC, which can be

reached at 877-652-2882 or

www.nattc.org/resPubs/cbResources.html#cb.

240 Chapter 14
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Appendix B:

Abbreviations and

Acronyms

AA Alcoholics Anonymous

AAS American Association of Suicidology

AATOD American Association for the Treatment of Opioid

Dependence (formerly American Methadone Treatment

Association [AMTA])

ADA Americans with Disabilities Act of 1990

AD/HD attention deficit/hyperactivity disorder

AMA American Medical Association

APA American Psychiatric Association

APD antisocial personality disorder

ASAM American Society of Addiction Medicine

ASI Addiction Severity Index

ATTC Addiction Technology Transfer Center

AZT zidovudine

CA Cocaine Anonymous

CALDATA California Drug and Alcohol Treatment Assessment

CARF Commission on Accreditation of Rehabilitation Facilities

CBT cognitive behavioral therapy

CDC Centers for Disease Control and Prevention

CFR Code of Federal Regulations

CJS criminal justice system

279
CNS central nervous system

COPD chronic obstructive pulmonary

disease

CPS childrenís protective services

CRA community reinforcement

approach

CSA Controlled Substances Act

CSAT Center for Substance Abuse

Treatment

CYP3A4 cytochrome P3A4

CYP450 cytochrome P450

DASIS Drug and Alcohol Services

Information System

DATA Drug Abuse Treatment Act 

of 2000

DAWN Drug Abuse Warning Network

DCP diversion control plan

DEA U.S. Drug Enforcement

Administration

DHHS U.S. Department of Health and

Human Services

DSM-IV-TR Diagnostic and Statistical

Manual of Mental Disorders, 

Fourth Edition, Text Revision

ECA Epidemiological Catchment

Area

ECG electrocardiogram

EEG electroencephalogram

EIA enzyme immunoassay

EMIT Enzyme Multiplied

Immunoassay Technique

FDA U.S. Food and Drug

Administration

GC/MS gas chromatography/mass 

spectrometry

HAV hepatitis A virus

HBV hepatitis B virus

HCV hepatitis C virus

HIPAA Health Insurance Portability

and Accountability Act of 1996

HIV human immunodeficiency virus

ICD-10 International Statistical

Classification of Diseases and

Related Health Problems, 

10th Edition

IND investigational new drug

IOM Institute of Medicine

JCAHO Joint Commission on the

Accreditation of Healthcare

Organizations

LAAM levo-alpha acetyl methadol

LGB lesbian, gay, and bisexual

MA Methadone Anonymous

MAT medication-assisted treatment

for opioid addiction

MDI Bayley Mental Development

Index

MSW medically supervised 

withdrawal

MTQAS Methadone Treatment Quality

Assurance System

NA Narcotics Anonymous

NAPAN National Association for the

Prevention of Addiction to

Narcotics

NAS neonatal abstinence syndrome

NASADAD National Association of 

State Alcohol and Drug 

Abuse Directors

280 Appendix B
NCADI SAMHSAís National

Clearinghouse for Alcohol and

Drug Abuse Information

NIDA National Institute on Drug

Abuse

NIH National Institutes of Health

NIMBY not in my back yard

NIMH National Institute of 

Mental Health

OBOT office-based opioid treatment

ONDCP Office of National Drug 

Control Policy

OTP opioid treatment program

PCR polymerase chain reaction

PEG polyethylene glycol

PPD purified protein derivative

PTSD posttraumatic stress disorder

QSOA Qualified Service Organization

Agreement

RIA radioimmunoassay

RNA ribonucleic acid

RTSH Recovery Training and 

Self-Help

SAMHSA Substance Abuse and Mental

Health Services Administration

SAPT Substance Abuse Prevention

and Treatment (name of block

grant)

SMA State Methadone Authority

SML serum methadone level

SSA Single State Agency

SSRI selective serotonin reuptake

inhibitor

STD sexually transmitted disease

SVR sustained virologic response

TB tuberculosis

TC therapeutic community

THC tetra-hydrocannabinol

TIP Treatment Improvement

Protocol

TLC thin layer chromatography

TMA transcription mediated 

amplification

VBRT voucher-based reinforcement

therapy

Abbreviations and Acronyms 281

Appendix C:

Glossary

-Aabstinence. Nonuse of alcohol or any illicit drugs, as well as nonabuse

of medications normally obtained by prescription or over the

counter. Abstinence in this TIP does not refer to nonuse of or withdrawal from maintenance medications (methadone, buprenorphine,

LAAM, or naltrexone) when they are used in MAT. Compare medically supervised withdrawal.

accreditation. Process of periodic review of an OTP for conformance

with accrediting-body standards. Accrediting bodies and their standards are approved by SAMHSA. See 42 CFR, Part 8 ß 2, for other

accreditation-related terms and definitions.

acute phase. Initial and usually the most symptomatic intensivetreatment phase of MAT.

addiction. Combination of the physical dependence on, behavioral

manifestations of the use of, and subjective sense of need and 

craving for a psychoactive substance, leading to compulsive use 

of the substance either for its positive effects or to avoid negative

effects associated with abstinence from that substance. 

Compare dependence.

administrative discharge. Release or discharge of a patient from an

OTP, often against the patientís wishes. See involuntary discharge.

admission. Formal process of enrolling patients in an OTP, carried

out by qualified personnel who determine that the patient meets

acceptable medical criteria for treatment. Admission can include orientation to the program and an introduction to peer support, patient

rights, services, rules, and treatment requirements related to MAT.

agonist. See opioid agonist.

analgesic. A compound that alleviates pain without causing loss of consciousness. Opioid analgesics are a class of compounds that bind to

283
specific receptors in the central nervous

system to block the perception of pain or

affect the emotional response to pain. Such

compounds include opium and its derivatives, as well as a number of synthetic compounds. Chronic administration or abuse

of opioid analgesics may lead to addiction.

antagonist. See opioid antagonist.

assessment. Process of identifying the precise nature and extent of a patientís substance use disorder and other medical,

mental health, and social problems as a

basis for treatment planning. Assessment

usually begins during program admission

and continues throughout treatment. It

includes a personal substance abuse history, physical examination, laboratory evaluation, and determination of disease morbidity. Severity of disease often is assessed

further in terms of physiologic dependence,

organ system damage, and psychosocial

morbidity. Assessment also may involve

determining patient motivation and readiness for change.

assessment tools. Instruments (e.g., questionnaires) used to capture the range of

patient variables affecting treatment planning, methods, and outcomes. Valid assessment tools contain quantifiable indicators

to measure patient progress and to track

patients through treatment.

Axis I. DSM-IV-TR disorder classification

comprising definitions and descriptions of

major disorders (i.e., psychotic, mood, and

substance use disorders) that may require

clinical attention.

-Bbenzodiazepines. Group of medications

having a common molecular structure and

similar pharmacological activity, including

antianxiety, sedative, hypnotic, amnestic,

anticonvulsant, and muscle-relaxing

effects. Benzodiazepines are among the

most widely prescribed medications (e.g.,

diazepam, chlordiazepoxide, clonazepam,

alprazolam, lorazepam).

best-treatment practices. Methods determined, often by a consensus of experts, to

be optimal for defined therapeutic situations. Such guidelines usually are based on

both an analysis of published research

findings and the experience of experts.

blood testing. Identifying evidence of opioid

and other psychoactive substance use and

measuring the levels of substances or medications in the body by examining patient

blood specimens for the presence and concentrations of identifiable drugs and their

metabolites.

buprenorphine. Partial opioid agonist

approved by FDA for use in detoxification

or maintenance treatment of opioid addiction and marketed under the trade names

SubutexÆand SuboxoneÆ(the latter also

containing naloxone).

-Ccertification. Process by which SAMHSA

determines that an OTP is qualified to provide opioid addiction treatment under the

Federal opioid treatment standards.

civil commitment. Legal process that permits individuals to be confined against their

will in psychiatric or other treatment facilities, which usually is justified by determining that a patient is a threat to himself or

herself or others. Although statutes permitting involuntary civil commitment may

remain in some States, such laws rarely

have been used to commit people who

abuse substances and are not under criminal justice jurisdiction.

Commission on Accreditation of

Rehabilitation Facilities (CARF). One

of several SAMHSA-approved accreditation organizations charged with ensuring

that OTPs meet the standards set forth in

Federal regulations and SAMHSA guidelines. Also known as CARF. . . The

Rehabilitation Accreditation Commission.

284 Appendix C
comprehensive maintenance 

treatment. Continuous therapy with

medication in conjunction with a wide

range of medical, psychiatric, and psychosocial services. Compare medical 

maintenance.

comprehensive treatment assessment.

Evaluation made after formal admission to

an OTP, in which trained staff members

determine the range and severity of a

patientís problems and the patientís service

needs. These determinations are used to

establish short- and long-term treatment

goals in the patientís treatment plan.

confidentiality regulations. Rules established by Federal and State agencies to

limit disclosure of information about a

patientís substance use disorder and treatment (described in 42 CFR, Part 2 ß 16).

Programs must notify patients of their

rights to confidentiality, provide a written

summary of these rights, and establish

written procedures regulating access to and

use of patient records.

consent to treatment. Form completed

with and signed by an applicant for MAT

and by designated treatment program staff

members, which verifies that the applicant

has been informed of and understands program procedures and his or her rights and

treatment goals, risks, and performance

expectations.

contingency contracting. Use of preestablished, mutually agreed-on privileges (e.g.,

take-home dosing) or consequences (e.g.,

loss of privileges) to motivate improvements

in treatment outcomes. Many experts agree

that negative contingencies in MAT (e.g.,

reduction in medication) are neither effective nor ethical and should be avoided.

continuing-care phase. Optional phase of

MAT in which patients who have completed

medically supervised withdrawal from

treatment medication and are leading

socially productive lives continue to 

maintain regular contact with their

treatment program.

co-occurring disorder. In this TIP, a mental disorder, according to DSM-IV diagnosis, that is present in an individual who is

admitted to an OTP.

counseling. In MAT, a treatment service in

which a trained counselor and a case manager evaluate both a patientís external 

circumstances and immediate treatment

progress and offer appropriate advice and

assistance or referral to other experts and

services as needed. A major objective in

MAT is to provide skills and support for a

substance-free lifestyle and encourage

abstinence from alcohol and other 

psychoactive substances. Compare 

psychotherapy.

craving. Urgent, seemingly overpowering

desire to use a substance, which often is

associated with tension, anxiety, or other

dysphoric, depressive, or negative affective

states.

cross-tolerance. Condition in which repeated administration of a drug results in

diminished effects not only for that drug

but also for one or more drugs from a similar class to which the individual has not

been exposed recently.

cultural competence. Capacity of a service

provider or organization to understand and

work effectively in accord with the beliefs

and practices of persons from a given 

ethnic/racial/religious/social group or sexual orientation. It includes the holding of

knowledge, skills, and attitudes that allow

the treatment provider and program to

understand the full context of a patientís

current and past socioenvironmental 

situation.

cultural diversity. Differences in backgrounds and beliefs that may affect the way

groups of patients in OTPs and individuals

within these groups view the world and

Glossary 285
their place in it, their substance use, and

treatment.

-Ddependence. State of physical adaptation

that is manifested by a drug class-specific

withdrawal syndrome that can be produced

by abrupt cessation, rapid dose reduction,

and/or decreasing blood level of a substance and/or administration of an antagonist. Compare addiction.

detoxification. In this TIP, treatment for

addiction to an illicit substance in which

the substance is eliminated gradually from

a patientís body while various types and

levels of reinforcing treatment are provided

to alleviate adverse physical or psychological reactions to the withdrawal process.

This TIP avoids the term ìdetoxificationî

to designate the process of dose tapering

from maintenance medication because that

term incorrectly suggests that opioid treatment medications are toxic. Compare medically supervised withdrawal.

diagnosis. Classification of the nature and

severity of the substance use, medical,

mental health, or other problems present in

a patient who is addicted to opioids. DSMIV-TR and ICD-10 classifications commonly are used to classify substance use and

mental disorders.

discharge. Release from or discontinuation of

enrollment in treatment when maximum

benefit has been achieved or when a patient

is deemed no longer suitable for treatment.

See administrative discharge, involuntary

discharge.

diversion. Sale or other unauthorized distribution of a controlled substance, usually

for a purpose other than the prescribed

and legitimate treatment of a medical or

mental disorder.

diversion control plan. Documented procedures to reduce the possibility that controlled substances are used for other than

their legitimate use. Federal opioid 

treatment standards (42 CFR, Part 8 ß

12(c)(2)) require a diversion control plan in

an OTP as part of its quality assurance

program.

dosage determination. Process of identifying the amount of medication that will minimize withdrawal symptoms and craving in

patients in MAT and eliminate their opioid

abuse. Much evidence supports a linear

relationship among the amount of medication provided, the timeframe over which it

is allowed to act before another dose is

administered (dose frequency), and treatment response.

dose tapering. See medically supervised

withdrawal.

drug interaction. Action of one drug on the

effectiveness or toxicity of another drug.

drug testing. Examination of an individual

to determine the presence or absence of

illicit or nonprescribed drugs or alcohol or

to confirm maintenance levels of treatment

medications, usually by a methodology that

has been approved by the OTP medical

director based on informed medical judgment. OTPs also must conform to State

laws and regulations in this area. See blood

testing, oral-fluid drug testing, urine 

testing.

duration of action. Length of time that a

treatment medication effectively prevents

withdrawal symptoms or craving. Duration

of action can be affected by many factors,

including drug interactions, certain diseases and medical conditions, patient crosstolerance, and the relative affinity of a

medication for its targeted cell receptor.

-Eeligibility. See treatment eligibility.

elimination half-life. Time required after

administration of a substance (e.g.,

methadone) for one-half the dose to leave

the body. Elimination half-life affects the

duration of action of a substance or 

286 Appendix C
Glossary 287

medication and can be influenced by

patient factors such as absorption rate,

variable metabolism and protein binding,

changes in urinary pH, concomitant 

medications, diet, physical condition, age,

pregnancy, and even use of vitamins and

herbal products. 

-Hhalf-life. See elimination half-life.

hepatitis C. Viral disease of the liver that is

the leading cause of cirrhosis in the United

States and a particular concern in MAT

because of the high incidence of the disease

and spread of the infection among people

who inject drugs.

high-risk behavior. Activity that increases

the likelihood that a recovering patient in

substance abuse treatment will relapse to

substance use or contract a substance 

use-related disorder, such as an infectious

disease.

hospital-based treatment. Treatment of

opioid addiction and related complications

that requires patient residency for some

period in a hospital setting or outpatient

treatment in a hospital-linked facility to

ensure that necessary services and levels of

care are available.

-Iiatrogenic opioid addiction. Addiction

resulting from medical use of an opioid

(i.e., under physician supervision), usually

for pain management.

induction. Initial treatment process of adjusting maintenance medication dosage levels

until a patient attains stabilization.

induction stage. The period of opioid pharmacotherapy, usually during the acute

phase of treatment, in which steady-state

blood levels of a medication are achieved.

intake. Initial screening of applicants for

admission to an OTP.

intensity of treatment. Frequency and

method of delivery for therapeutic services.

In this TIP and in American Society of

Addiction Medicine Patient Placement

Criteria, intensity of treatment is one component, along with treatment setting, that

determines the level of care for a patient.

Levels of care are adjusted during MAT

based on patient needs and the treatment

plan. See, for example, intensive inpatient

treatment and intensive outpatient 

treatment.

intensive inpatient treatment. Level of

care in which addiction professionals and

clinicians provide a regimen of around-theclock evaluation, care, and therapy in an

inpatient setting. Involvement of physicians

can range from monitoring multidisciplinary staff members to direct management of cases, depending on the severity of

patientsí problems.

intensive outpatient treatment. Level of

care (possibly including partial hospitalization) in which addiction professionals and

clinicians provide therapeutic services to

clients who live at home or in special residences. Treatment is delivered in two to

five regularly scheduled sessions per week

totaling 6 to 24 hours per week. Many

treatment services and levels of care are

compatible with intensive outpatient 

treatment, but most programs include

structured psychoeducation and group

counseling.

interim maintenance treatment. Timelimited pharmacotherapeutic regimen in

conjunction with appropriate medical services while a patient awaits transfer to an

OTP that provides comprehensive maintenance treatment (42 CFR, Part 8 ß 2).

intervention. The process of providing care

to a patient or taking action to modify a

symptom, an effect, or a behavior. Also the

process of interacting after assessment with

a patient who is substance addicted to present a diagnosis and recommend and negotiate a treatment plan. Also frequently used
as a synonym for treatment. Types of 

intervention can include crisis intervention, brief intervention, and long-term 

intervention.

involuntary discharge. Formal discontinuation of a patientís enrollment in an OTP

without patient consent, usually for reasons related to program operations, safety,

or treatment complianceófor example,

violence or threats of violence; buying and

selling drugs; repeated loitering; flagrant

noncompliance with program rules resulting in an observable, negative impact on

the program, staff, and other patients;

nonpayment of fees; and incarceration or

other confinement. See administrative 

discharge.

-JJoint Commission on Accreditation of

Healthcare Organizations (JCAHO).

One of several SAMHSA-approved accreditation organizations charged with ensuring

that OTPs meet the standards set forth in

Federal regulations and SAMHSA 

guidelines.

-LLAAM. See levo-alpha acetyl methadol.

level of care. The setting or combination of

settings in which the appropriate intensities

and types of treatment services can be provided for individual patients.

levo-alpha acetyl methadol (LAAM;

trade name ORLAAM). An opioid agonist medication derived from methadone

that is effective for up to 72 hours. Reports

in 2000 and 2001 of potential arrhythmogenic cardiac effects of LAAM led to tightening of guidelines, including recommendations that LAAM no longer be used for

first-line therapy but only for treatment of

patients who already have used it successfully or do not show an acceptable response

to other addiction treatments. At this writing, LAAMís future availability for opioid

pharmacotherapy is doubtful.

-Mmaintenance dosage. Amount of medication that is adequate to achieve desired

therapeutic effects for 24 hours or more,

with allowance for day-to-day fluctuations.

maintenance medication. Medication

used for ongoing treatment of opioid 

addiction.

maintenance treatment. Dispensing of 

an opioid addiction medication at stable

dosage levels for a period in excess of 21

days in the supervised treatment of an 

individual for opioid addiction 

(42 CFR, Part 8 ß 2).

medical maintenance. (1) Phase of MAT

and type of treatment by an OTP, medication unit, or physician affiliated with an

OTP in which a person who has achieved a

stable lifestyle and has remained abstinent

from illicit drugs for at least 2 years (longer

in some States) receives ongoing pharmacotherapy with methadone, buprenorphine, or LAAM but no longer requires the

structure or frequency of psychosocial

treatment services provided in an OTP, as

determined by the OTP medical director.

(2) Medical maintenance also can be provided by physicians using buprenorphine

or naltrexone (42 CFR, Part 8 ß

12(i)(3)(vi); 42 CFR, Part 8 ß 11(h)).

medically supervised withdrawal.

Dispensing of a maintenance medication in

gradually decreasing doses to alleviate

adverse physical or psychological effects

incident to withdrawal from the continuous

or sustained use of opioid drugs. The purpose of medically supervised withdrawal is

to bring a patient maintained on maintenance medication to a medication-free state

within a target period. 

medication-assisted treatment for 

opioid addiction (MAT). Type of 

addiction treatment, usually provided in 

a certified, licensed OTP or a physicianís

office-based treatment setting, that provides 

288 Appendix C
maintenance pharmacotherapy using an

opioid agonist, a partial agonist, or an

antagonist medication, which may be 

combined with other comprehensive

treatment services, including medical and

psychosocial services.

medication unit. Facility established as part

of, but geographically separate from, an

opioid treatment program, from which certified private practitioners or community

pharmacists may dispense or administer

opioid agonist medications for observed

ingestion (42 CFR, Part 8 ß 11(i)(1)).

methadone. The most frequently used opioid

agonist medication. Methadone is a synthetic opioid that binds to mu opiate receptors

and produces a range of mu agonist effects

similar to those of short-acting opioids such

as morphine and heroin.

methadone maintenance treatment.

Dispensing of methadone at stable dosage

levels for more than 21 days in the supervised treatment of an individual for opioid

addiction (42 CFR, Part 8 ß 2).

mobile treatment services. Substance use

treatment provided directly to patients

from traveling units or vans, ranging from

comprehensive maintenance services (with

medication and counseling in one or several

mobile units) to more limited care, usually

medication maintenance therapy, in conjunction with a fixed-site program offering

counseling and other psychosocial services.

multiple substance abuse. Concurrent

opioid and other substance useóa serious

problem in OTPs. Other substances commonly used by people addicted to opioids

include alcohol, amphetamines, benzodiazepines (particularly alprazolam and

diazepam), other prescription sedatives,

cocaine, marijuana, and nicotine. Patterns

of use range from periodic low doses to regular high doses that also can meet criteria

for addiction. Some drugsóin particular,

high-dose barbituratesóused in 

combination with opioids are immediately

life threatening.

mutual-help program. Program offering

the benefits of peer support to people who

are substance addicted, through attendance

at group meetings and other activities.

Twelve-Step programs are one type of

mutual-help program.

-Nnaloxone. Short-acting opioid antagonist.

Because of its higher affinity than that of

opioids for mu opiate receptors, naloxone

displaces opioids from these receptors and

can precipitate withdrawal, but it does not

activate the mu receptors, nor does it cause

the euphoria and other effects associated

with opioid drugs. Naloxone is not FDA

approved for long-term therapy for opioid

addiction, except in the combination

buprenorphine-naloxone tablet. Some programs use naloxone to evaluate an individualís level of opioid dependence. See naloxone challenge test.

naloxone challenge test. Test in which

naloxone is administered to verify an applicantís current opioid dependence and eligibility for admission to an OTP. Withdrawal

symptoms evoked by naloxoneís antagonist

interaction with opioids confirm an individualís current dependence. 

naltrexone. Derivative of naloxone and the

only opioid antagonist approved for use

alone in long-term treatment of people with

opioid addiction. Naltrexone is used primarily after medically supervised withdrawal from opioids to prevent drug

relapse in selected, well-motivated patients. 

narcotic. See opioid (preferred usage).

not-in-my-backyard (NIMBY) syndrome. Informal name used to label

opposition to the placement of OTPs in

communities.

Glossary 289
-Ooffice-based opioid treatment (OBOT).

MAT provided in a physicianís office or

health care setting other than an OTP (42

CFR, Part 8 ß 11(i)(1)). See medication

unit.

opiate receptors. Areas on cell surfaces in

the central nervous system that are activated by opioid molecules to produce the

effects associated with opioid use, such as

euphoria and analgesia. Opiate receptors

are activated or blocked by opioid agonist

or antagonist medications, respectively, to

mediate the effects of opioids on the body.

Mu and kappa opiate receptor groups principally are involved in this activity.

opioid. Natural derivative of opium or synthetic psychoactive substance that has

effects similar to morphine or is capable of

conversion into a drug having such effects.

One effect of opioid drugs is their 

addiction-forming or addiction-sustaining

liability.

opioid addiction. Cluster of cognitive,

behavioral, and physiological symptoms

resulting from continuation of opioid use

despite significant related problems. Opioid

addiction is characterized by repeated selfadministration that usually results in 

opioid tolerance, withdrawal symptoms,

and compulsive drug taking.

opioid addiction treatment. Dispensing

of approved medication to prevent withdrawal and craving during the elimination

of opioid use by a patient in MAT, with or

without a comprehensive range of medical

and rehabilitation services or medication

prescribed when necessary to alleviate the

adverse medical, psychological, or physical

effects. This term encompasses medically

supervised withdrawal, maintenance treatment, comprehensive maintenance treatment, and, under restricted timeframes,

interim maintenance treatment (adapted

from 42 CFR, Part 8 ß 2).

opioid agonist. Drug that has an affinity for

and stimulates physiologic activity at cell

receptors in the central nervous system

normally stimulated by opioids. Methadone

and LAAM are opioid agonists. 

opioid antagonist. Drug that binds to cell

receptors in the central nervous system

that normally are bound by opioid psychoactive substances and that blocks the

activity of opioids at these receptors without producing the physiologic activity produced by opioid agonists. Naltrexone is an

opioid antagonist.

opioid partial agonist. Drug that binds to,

but incompletely activates, opiate receptors

in the central nervous system, producing

effects similar to those of a full opioid agonist but, at increasing doses, does not produce as great an agonist effect as do

increased doses of a full agonist.

Buprenorphine is a partial opioid agonist.

opioid treatment program (OTP).

SAMHSA-certified program, usually comprising a facility, staff, administration,

patients, and services, that engages in

supervised assessment and treatment, using

methadone, buprenorphine, LAAM, or naltrexone, of individuals who are addicted to

opioids. An OTP can exist in a number of

settings, including, but not limited to,

intensive outpatient, residential, and hospital settings. Services may include medically

supervised withdrawal and/or maintenance

treatment, along with various levels of

medical, psychiatric, psychosocial, and

other types of supportive care.

oral-fluid drug testing. Method of identifying evidence of opioid and other psychoactive substance use and measuring the levels

of substances or medications in the body by

examining patient saliva for the presence

and concentrations of identifiable drugs

and their metabolites. Oral-fluid testing

must be approved for drug testing by the

OTP medical director for patient and program needs.

290 Appendix C
orientation. See patient orientation.

outcome-based evaluation. Measurement

of program effectiveness based on patient

response to treatment, such as measures of

reduction in opioid and nonopioid drug use

and improvement in social function. An

outcome-based evaluation system requires

that the measures and instruments that are

used reflect a consensus of the field, provide incentives to programs to submit data,

and include ways to validate and aggregate

clinic-level data for national and regional

evaluation purposes. Compare processbased evaluation.

outpatient psychosocial program. In

this TIP, an approach to MAT that may

involve the use of opioid addiction treatment medication for medically supervised

withdrawal but not for ongoing maintenance pharmacotherapy. Counseling and

other psychosocial interventions are the

primary features of outpatient psychosocial

treatment programs.

OxyContinÆ. Long-acting class II opioid drug

usually obtained by prescription for treatment of pain. OxyContin is one of several

prescription opioids increasingly obtained

by illicit means and abused by people

addicted to opioids.

-Ppain management. Treatment of acute or

chronic pain by various treatment methods, often including administration of opioid medications.

patient. Any individual undergoing MAT in

an opioid treatment program (42 CFR,

Part 8 ß 2).

patient advocacy. Term applied to two levels of activity in addiction treatment: (1) a

social or political movement working for

changes in legislation, policy, and funding

to reflect patient concerns and protect their

rights (i.e., advocacy for patients) and (2) a

philosophy of substance abuse treatment

practice maintaining that patients should

be involved actively in their own treatment

and have rights in its planning and implementation (i.e., advocacy by patients).

Much of advocacy is about shifting the system from the directive model to one in

which the patient is an empowered,

involved participant in treatment decisions.

This fits with the growing emphasis on individualized treatment.

patient exception. Special permission

requested from and decided by SAMHSA

for a substance abuse treatment program to

dispense or arrange for the offsite delivery

of maintenance medication to a patient in

an emergency or hardship situation when

the patient does not meet regulatory

requirements for such services. Patient

exceptions are requested on SAMHSA form

SMA-168. In most States, patient exceptions are contingent on the approval of the

appropriate State Methadone Authority.

patient handbook. Document provided to a

patient in an OTP that contains the information he or she should know to understand MAT, program offerings, program

structure, and patient limits and privileges,

as well as rights and responsibilities of

patients and treatment providers.

patient matching. See patientñtreatment

matching.

patient motivation for change. Relative

readiness to modify oneís lifestyle and the

sincerity and purposefulness of a patient in

an OTP toward achieving the goals of MAT.

patient orientation. Planned introduction

to the structure, services, offerings, and

methods used in an OTP and to patientsí

and treatment providersí rights and

responsibilities within the program.

patient referral. Alternative to providing all

necessary treatment services and levels of

care at the program site by collaboratively

outsourcing some services to other settings

and providers. When a patient must obtain

comprehensive services in multiple settings,

Glossary 291
treatment program staff members should

arrange the referrals, monitor patient

progress, and coordinate care.

patientñtreatment matching. Process of

individualizing therapeutic resources to

patient needs and preferences, ideally by a

participatory process involving both the

treatment provider and patient. Because

many people addicted to opioids have multiple needs, effective patientñtreatment

matching in an OTP is a three-step process:

(1) assessing, (2) selecting the most suitable

treatment modality and site, and (3) identifying the most appropriate services.

pharmacology. Science that addresses the

origin, nature, chemistry, effects, and uses

of medications and drugs.

pharmacotherapy. Treatment of disease

with prescribed medications.

preliminary assessment. Basic assessment

occurring before admission to a treatment

program, in which an individualís eligibility

for entry and level of any psychosocial 

crisis are determined.

prevalence. Number of cases of a disease in a

population, either at a point in time (point

prevalence) or over a period (period 

prevalence). Prevalence rate is the fraction

of people in a population who have a 

disease or condition at one time (the

numerator of the rate is the number of

existing cases of the condition at a specified

time and the denominator is the total 

population).

process-based evaluation. Evaluation of

program effectiveness based on compliance

with procedural standards. Compare 

outcome-based evaluation.

psychiatric comorbidity. See co-occurring

disorder.

psychoactive drug. A substance that affects

the mind, thoughts, feelings, and sometimes

behaviors.

psychotherapy. Treatment service provided

to patients in a comprehensive opioid treatment program, either directly or by referral, in which a trained therapist evaluates

and treats patients for diagnosed psychiatric problems. Compare counseling.

-Rreadmission. Reenrollment of a patient who

previously left an opioid treatment program. Readmission usually is preceded by a

review of the patientís records to determine

whether and how the individualís treatment

plan should be modified.

referral. See patient referral.

rehabilitative phase. Phase of MAT in

which patients who are stabilized on opioid

treatment medication continue to eliminate

addictive substances from their lives while

gaining control of other major life domains

(e.g., medical problems, co-occurring disorders, vocational and educational needs,

family circumstances, legal issues).

relapse. Breakdown or setback in a personís

attempt to change or modify a particular

behavior; an unfolding process in which the

resumption of compulsive substance use is

the last event in a series of maladaptive

responses to internal or external stressors

or stimuli. 

remission. State in which a mental or physical disorder has been overcome or a disease

process halted.

residential treatment. Therapy received

within the context of a cooperative living

arrangement. Residential treatment programs vary in duration and intensity of 

services and general philosophy.

retention in treatment. Period during

which a patient is able and willing to

remain in therapy, which is influenced by a

combination of patient and program characteristics. Retention in treatment should

be considered the product of a continuing

292 Appendix C
therapeutic relationship between recovering patients and their treatment providers.

-Ssaliva testing. See oral-fluid drug testing.

screening. Process of determining whether a

prospective patient has a substance use disorder before admission to treatment.

Screening usually involves use of one or

more standardized techniques, most of

which include a questionnaire or a structured interview. Screening also may include

observation of known presenting complaints and symptoms that are indicators of

substance use disorders.

sedative. Medication with central nervous

system sedating and tranquilizing properties. An example is any of the benzodiazepines. Most sedatives also promote

sleep. Overdoses of sedatives can lead to

dangerous respiratory depression (slowed

breathing).

self-help program. See mutual-help 

program.

self-medication. Medically unsanctioned use

of drugs by a person to relieve any of a

variety of problems (e.g., pain, 

depression).

serum half-life. Time required for the

amount of a compound (e.g., an opioid) in

blood serum to be halved through

metabolism or excretion.

side effect. Consequence (especially an

adverse result) other than that for which a

drug is usedóespecially the result produced on a tissue or organ system other

than that being targeted.

stabilization (stability). Process of providing immediate assistance (as with an opioid

agonist) to eliminate withdrawal symptoms

and drug craving.

stand-alone clinic. Facility that generally

offers a comprehensive range of medication

and psychosocial services for patients who

are opioid addicted, including all levels of

care and phases of treatment. Compare

hospital-based treatment.

State Authority. Agency (sometimes

referred to as a ìSingle State Agencyî) designated by the governor or another official

assigned by the governor to exercise the

responsibility and authority within a State

or territory for governing the treatment of

addiction to opioid drugs (adapted from 42

CFR, Part 8 ß 2).

stigma. Negative association attached to an

activity or condition; a cause of shame or

embarrassment. Stigma commonly is associated with opioid addiction and MAT.

stimulant. Agent, drug, or medication that

produces stimulation. In this TIP, stimulant usually refers to drugs that stimulate

the central nervous system (e.g.,

amphetamines, cocaine). 

substance addiction. See opioid addiction.

substance dependence. See dependence.

substance use disorder (frequently

referred to as substance abuse or

dependence). Maladaptive pattern of

drug or alcohol use manifested by recurrent, significant adverse consequences

related to the repeated use of these drugs

or alcohol. The substance-related problem

must have persisted and occurred repeatedly during a 12-month period. It can

occur sporadically and mainly be associated with social or interpersonal problems,

or it can occur regularly and be associated

with medical and mental problems, often

including tolerance and withdrawal.

supportive-care phase. Phase of MAT in

which patients maintain abstinence from

substances and continue on maintenance

medication while receiving other types of

intervention as needed to resume primary

responsibility for other aspects of their

lives.

Glossary 293
-Ttake-home medication. Opioid addiction

treatment medication dispensed to patients

for unsupervised self-administration.

tapering phase. Phase of MAT in which

patients receiving medication maintenance

attempt gradually to eliminate their treatment medication (e.g., methadone) while

remaining abstinent from illicit substances.

therapeutic alliance. Joining of patients

and their treatment providers in an effective collaboration to assess and treat

patientsí substance use disorders.

therapeutic community (TC). Consciously

designed social environment or residential

treatment setting in which social and group

processes are harnessed with treatment

intent. A TC promotes abstinence from

substance use and seeks to decrease antisocial behavior and effect a global change in

lifestyle, including attitudes and values. A

TC views substance abuse as a disorder of

the whole person, reflecting problems in

conduct, attitudes, moods, values, and

emotional management. Treatment focuses

on drug abstinence, coupled with social and

psychological change requiring a multidimensional effort along with intensive mutual help and support.

therapeutic dosage. Combination of

amount of medication and frequency and

timing of administration that is determined

by laboratory analysis, professional observation, or patient self-report to be beneficial to control and ameliorate symptoms of

withdrawal from addiction and drugseeking behavior. Therapeutic dosage levels

should be determined by what each patient

needs to remain stable.

tolerance. Condition of needing increased

amounts of an opioid to achieve intoxication or a desired effect; condition in which

continued use of the same amount of a substance has a markedly diminished effect.

treatment barrier. Anything that hinders

treatment. Examples include financial

problems, language difficulties, ethnic and

social attitudes, logistics (caring for children, transportation), and unhelpful

patient behaviors (tardiness, missed

appointments).

treatment efficacy. Ability of an intervention or medication in expert hands and

under ideal circumstances to produce the

desired therapeutic effect.

treatment eligibility. Relative qualification

of a prospective patient for admission to an

OTP according to Federal, State, or thirdparty payer requirements. In general,

Federal guidelines are minimum requirements and restrict admission to individuals

who have been demonstrably dependent on

opioids for 1 year; however, certain highrisk populations including pregnant women

are admitted more quickly.

treatment intensity. Frequency and methods for delivery of therapeutic services.

OTPs aim to establish levels of treatment

intensity that match patientsí needs.

treatment outcomes. Observable results of

therapy, including decreased use of illicit

psychoactive substances, improved physical

and emotional health, decreased antisocial

activities, and improved social functioning;

considered the best indicator of treatment

program effectiveness.

treatment plan. Documented therapeutic

approach for each patient that outlines

attainable short-term goals mutually

acceptable to the patient and the OTP and

that specifies the services to be provided

and their frequency and schedule (adapted

from 42 CFR, Part 8 ß 2).

treatment retention. See retention in

treatment.

12-Step program. Self-help program requiring mastery of a set of steps to achieve and

maintain abstinence, based on the program

294 Appendix C
Glossary 295

of Alcoholics Anonymous. Many addiction

treatment programs use a 12-Step structure

or philosophy as a construct for treatment

design.

-Uurine drug testing. Most common laboratory assessment technique in addiction treatment, which involves analysis of urine samples from patients for the presence or

absence of specific drugs. Originally used

as a measure of program effectiveness,

urine testing now is used to make programmatic decisions, monitor psychoactive substance use, adjust medication dosage, and

decide whether a patient is responsible

enough to receive take-home medication.

Methods of urine testing vary widely.

-Vvoluntary discharge. Departure from an

OTP that is initiated by the patient.

Tapering from medication is negotiated

among the patient, program physician, and

treatment providers.

-Wwithdrawal. Reduction and elimination of

substance use. See medically supervised

withdrawal, withdrawal syndrome.

withdrawal syndrome (or withdrawal). 

Predictable constellation of signs and

symptoms after abrupt discontinuation of

or rapid decrease in use of a substance that

has been used consistently for a period.

Signs and symptoms of withdrawal are usually opposite to the direct pharmacological

effects of a psychoactive substance.

Appendix D:

Ethical Considerations

in MAT

Medication-assisted treatment for opioid addiction (MAT) is firmly 

rooted in medical treatment models. Treatment decisions by MAT

providers should be based on four accepted principles of medical ethics,

which can be listed briefly as beneficence, autonomy, nonmalfeasance,

and justice (Beauchamp and Childress 2001).

Fundamental Ethical Principles

Beneficence (Benefit)

According to Beauchamp and Childress (2001), the medical principle 

of beneficence emphasizes that treatment providers should act for the

benefit of patients by providing competent, timely care within the

bounds of accepted treatment practice. The principle of beneficence is

satisfied when treatment providers make proper diagnoses and offer 

evidence-based treatments, that is, treatments drawn from research that

provides statistical data about outcomes or from consensus-based standards of care. Beneficence is compromised when diagnoses are questionable or when outcome data do not validate a diagnosis or treatment.

When MAT is carried out according to best-practice standards, the 

principle of beneficence is satisfied (Bell and Zador 2000).

Autonomy

Autonomy, like beneficence, springs from the ideal of promoting

patientsí best interests. However, whereas beneficence emphasizes the

application of provider knowledge and skills to improve patient health,

autonomy emphasizes respect for patientsí rights to decide what treatment is in their best interests (Beauchamp and Childress 2001).

Standard medical practice places great value on patient autonomy.

Usually, patientsí and physiciansí goals for treatment are identical, but,

when they differ, physicians generally accord patients the right to make

297
their own choices and accept the fact that

patientsí values may differ from physiciansí

values. For example, a physician might focus

on extending a patientís life, whereas the

patient might be more concerned with the 

quality of that life.

Exceptions to the principle of autonomy in

standard medical practice are limited to circumstances in which patientsí decisions might

endanger themselves or others or in which

patients may lack the capacity (because of

physical or mental impairment) to make rational choices. Normally, standard medical practice does not permit an exception when patients

make the ìwrongî choice and the physician

ìknows better.î The physician may educate or

perhaps attempt to persuade a patient but may

not make decisions for the patient.

NonmalfeasanceóìFirst, Do

No Harm î

The principle of nonmalfeasance emphasizes

that health care providers should not harm or

injure patients (Beauchamp and Childress

2001). Opioid treatment programs (OTPs) are

on strong footing in terms of this principle.

Before entering MAT, patients have been

ingesting illicit opioids (and often other substances) and exposing themselves to serious

health risks. Patients entering MAT are also at

risk of arrest and imprisonment for illegal

activities to support their addictions.

Once enrolled in OTPs, patients begin ingesting

medications that have been manufactured in a

regulated setting. The risks associated with

injecting or otherwise ingesting substances of

abuse produced under unknown conditions are

gradually eliminated. Patients come under the

care of professionals who monitor adverse drug

reactions and attend to other health care needs.

However, MAT carries risks of its own, including an increased risk of death in the induction

phase of pharmacotherapy if medication dosage

is not adjusted carefully (see chapter 5).

Justice

The principle of justice emphasizes that treatment providers should act with fairness

(Beauchamp and Childress 2001). Sometimes

this principle is expressed as the duty of

providers to treat patients in similar circumstances equally and to use resources equitably.

When treatment resources are limited, it may

be unclear how to apply this principle in MAT.

The principle of justice also applies when treatment providers consider the involuntary discharge of patients.

Besides emphasizing that clinicians should act

fairly toward patients, the principle of justice

imposes a responsibility to advocate politically

and socially for resources (including adequate

funding and better treatment by other medical

providers) to meet the needs of patients in MAT.

Ethics in Practice

Conflict Between Beneficence

and Autonomy

A conflict arises between the principles of

beneficence and autonomy when a treatment

provider and a patient disagree about what is

in the patientís best interest and how treatment

should progress. Exhibit D-1 describes such a

clash in which a provider believes that stopping

all illicit drug use is feasible and in the patientís

best interest but the patient disagrees or cannot

comply. One or both of the following questions

express the source of controversy:

ï What is the proper balance between respect

for a patientís autonomy and a providerís

responsibility for that patientís health?

ï Should the patient or the clinician decide

what is in a patientís best interests?

Patients in MAT who stop their opioid abuse

but not their abuse of other substances (i.e.,

ìnoncompliantî or ìnonrespondingî patients)

are a major research focus. The literature is

replete with studies of strategies, such as contingency contracting (see chapter 8), that use

patientsí dependence on their treatment 

298 Appendix D
medication to compel their compliance with 

treatment-related mandates. These strategies

ìare based on the assumption that patients

have the necessary skills to produce drug-free

urine samples but often lack sufficient motivationî (Iguchi et al. 1996, p. 315). Examples of

mandates enforced by contingency contracting

include adoption of and adherence to a drugfree lifestyle (Iguchi et al. 1997), attendance at

additional therapy-related sessions (with or

without a significant other) (Iguchi et al. 1996;

Kidorf et al. 1997), and performance of

employment-related tasks (Kidorf et al. 1998).

Training in substance abuse treatment provides

treatment providers with an awareness and

understanding of patientsí tendencies toward

denial, minimization, and rationalization of

their substance use. A working familiarity with

such studies provides treatment providers with

a reasonable basis to choose beneficence over

autonomy when they conclude that they know

better than patients what is in patientsí best

interest.

The conflict between beneficence and autonomy

is not unique to MAT, but it is especially acute

in MAT because of the fundamental power

imbalance between treatment providers and

patients. Patients in OTPs depend on their

medication and may fear the effects of withdrawal from it. That dependence gives

providers (and the principle of beneficence) the

upper hand. Patients who refuse to comply

with provider views of what is in their best

interests risk administrative discharge or other

sanctions. Until recently, only an OTP could

provide patients with medication, ensuring the

OTPís hold over patients. Often no other facility exists from which to obtain MAT.

Why do treatment providers in OTPs lean

toward the principle of beneficence and away

from the principle of autonomy in their

approach to patients? The following factors

may apply:

ï A longstanding, complex regulatory system

that favors a rule-governed perspective in

OTPs

ï Belief that patients in denial cannot act in

their best interests

ï Disagreement about goals between patients

and treatment providers

ï Attention to community concerns

ï Effects of noncompliant patients on staff,

patients in compliance, and new patients

ï Discomfort with the disease model (see below)

ï View of patients in MAT as failures

ï Limited research examining the precept 

that complete abstinence is in patientsí best

interests.

Ethical Considerations in MAT 299

Exhibit D-1

Case Example

R.S., a 35-year-old man who has been in MAT for 18 months, is in his second

MAT episode. The first ended when he was arrested and imprisoned for armed

robbery. R.S. has not missed medication appointments but is less attentive to

counseling sessions. He regularly uses alcohol and marijuana and occasionally

cocaine. R.S. is unwilling to stop using alcohol and drugs. His position is that he

has stopped his use of illicit opioids entirely, which was his goal entering treatment. His other drug use is his choice, and the clinic should ìget off his back.î
Clinicians Who Are Uneasy

With the Disease Model 

MAT providers generally embrace the concept

of addiction as a chronic relapsing disease;

however, unlike medical professionals treating

other chronic illnesses, some providers appear

uncomfortable with the idea of alleviation of

symptoms without cure (Hunt and Rosenbaum

1998, p. 202). These providers might draw on

lessons from physicians caring for patients with

other chronic diseases. How do they deal with

noncompliant patients who fail to alter their

diets or lifestyles, for example? Based on the

disease model underlying comprehensive maintenance treatment, total abstinence may be

unrealistic in the short run for some patients.

When OTPs refuse to recognize that immediate

abstinence is unrealistic and punish patients for

the continuing but reduced presence of symptoms, they are not defining addiction as a disease. The long-term goal is always reducing or

eliminating the use of illicit opioids and other

illicit drugs and the problematic use of prescription drugs; but, in the short run, patients

should be supported as they reduce their substance use.

Research suggests that many patients are aware

that they may relinquish their autonomy when

they enter MAT. A study about the attitudes 

of patients receiving methadone found that

many see OTPs as institutions that control 

and punish more than they helpóOTPs are

agents of conventional society (Hunt and

Rosenbaum 1998).

In the opinion of Bell (2000, p. 1741), ìPatients

need protection because many are reluctant to

complain because they have a sense of powerlessness and do not want to jeopardize their

treatment.î Providers at OTPs should be

aware of any bias toward the principle of

beneficence and away from the principle of

autonomy. Rather than assuming that the tilt

toward beneficence is always correct, treatment

providers and administrators should ask themselves in each case whether they are striking 

a proper balance between these two fundamental principles.

300 Appendix D

Some Patientsí Perspectives

ì[C]lients often felt that the relationship between themselves and their counselors was less focused on therapy than power; less about psychological growth,

getting help and a sense of well-being than about social control, conforming to

rules and regulations, and punishment.î (Hunt and Rosenbaum 1998, p. 209)

ì[Study participants] were also aware and fearful that having once adopted the

culture of the clinic they would become dependent on it, and more significantly

on the goodwill of individual counselors. This dependence was particularly

troubling to them because of the increasing insecurity of subsidized slots. Many

users expressed concern about once having entered the system and accepting its

lifestyle with little or no warning they would be ejected from it. . . . [M]any

study participants felt, precisely because of the asymmetrical relationship

between the client and the clinic, the staff used this as a way of exacting compliance.î (Hunt and Rosenbaum 1998, pp. 200ñ201)
Other Conflicts Among the

Four Principles of Medical

Ethics

Involuntary discharge 

An OTPís decision to discharge a patient

against his or her wishes calls into question all

four ethical principles. Involuntary discharge

appears to breach practitionersí duties to put

patient health first, do no harm, and respect

patientsí wishes, as well as to avoid harm to the

community from reintroducing the effects of

untreated opioid use (especially criminal

behavior and potential disease transmission).

Yet an OTP often must balance the interests of

individuals facing discharge with those of other

patients, staff, future patients, and the larger

community and society.

Threats to safety

When a patient commits or threatens an act of

violence against another patient (on OTP

premises) or against staff (on or off OTP

premises), comes to treatment armed with a

weapon, or deals drugs at or near an OTP, that

patient poses a threat to the safety of the program, its staff, and its patients. Involuntary

discharge of such a patient, although not in his

or her best interests, takes into account the

OTPís ethical responsibility to the rest of its

patients (current and future), its staff, and others. The consensus panel believes that patient

behavior threatening the safety of patients and

staff or the status of the program in the community is grounds for patient discharge. OTP

administrators may need to make difficult judgments about what constitutes threatening

behavior (especially in light of deficits in interpersonal skills and possible untreated cooccurring disorders) and evidence of drug dealing. But an OTPís responsibility to provide

good treatment for its other patientsóindeed,

its responsibility to remain a viable resource in

the communityórequires that these limits be

set and enforced.

Failure to pay

Involuntary discharge for failure to pay treatment fees presents a more difficult ethical issue

involving the limited financial resources of

many patients and the uneven public funding of

MAT. Patients discharged for inability to pay

or because their OTPs have lost funding might

have been doing well, and terminating treatment, in most cases, will halt their recovery or

precipitate relapse (Knight et al. 1996a).

Although involuntary discharge for failure to

pay fees appears to violate the principles of

autonomy, beneficence, and nonmalfeasance,

the unfortunate reality is that OTPs must operate within fiscal constraints. If OTPs continue

to deliver uncompensated care, they may face

financial ruinóa consequence that would jeopardize treatment for all patients (including

those who continue to pay). Nonetheless, OTPs

considering patient discharge for nonpayment

should address the principle of nonmalfeasance, at least in part, by mitigating harm to

patients, for example, by working out payment

schedules, assisting with access to insurance or

other funding sources, or facilitating transfer to

lower cost facilities. In 2003, the American

Association for the Treatment of Opioid

Dependence (AATOD) released new recommendations addressing involuntary withdrawal

from treatment for nonpayment of fees

(www.dmhas.state.ct.us/opioid/

withdrawal.htm).

Failure to respond

Another difficult ethical issue occurs when an

OTP proposes to discharge a patient involuntarily for failure to respond to treatment. No

matter which principle the OTP follows, it will

fail to uphold anotheróperhaps even the very

principle it is seeking to uphold. An OTP has at

least two choices, and all four ethical principles

are implicated.

ï To discharge. When an OTP discharges a

noncompliant patient, it risks violating the

principle of beneficence because discharge

might lead to a poorer health outcome for

Ethical Considerations in MAT 301
that patient and perhaps repercussions for

the community. Indeed, because research has

shown that discharge from MAT leads to poor

outcomes, by pursuing the principle of beneficence to its logical conclusion of involuntary

discharge, the OTP may be putting a

patientís health at greater risk. The OTP

may be violating the principle of nonmalfeasance as well, especially if it is unaware 

of the possible consequences of involuntary

discharge.

Involuntary discharge of noncompliant

patients often occurs when OTPs have waiting lists. When limited slots existóbecause of

the limits of public sector funding or regulatory caps on slotsóand applicants are waiting for treatment, pressure mounts to discharge patients who are not fully compliant

with treatment regimens. Concerns about the

fairness of continuing to treat a patient who is

unwilling or unable to take full advantage of

treatment appeal to the principle of justice.

ï Not to discharge. Arguably, when treatment

providers do not discharge noncompliant

patients but continue treating them, they risk

violating the principle of beneficence because

they are not providing care they believe will

promote patient health. By ignoring the effect

noncompliant patients have on the therapeutic milieu for other patients, providers are

violating the principle of beneficence for those

other patients. Treatment providers who continue to treat noncompliant patients also violate the principle of justice by denying treatment to potential patients on the waiting list.

OTPs should decide how to respond to 

treatment noncompliance based on factors

and principles discussed above and patientsí

specific circumstances. No single decision is

correct in all cases. The OTP has an ethical

responsibility to consider these principles 

and the effect of discharge on patients and

the program.

Take-home privileges

The decisions a medical director makes about

take-home privileges, although not as stark as

those related to involuntary termination, also

require that all four ethical principles be

weighed. Patients are usually interested in

increasing their autonomy and ability to carry

out normal daily activities by reducing visits to

their OTP for medication, but the medical

director must consider what is safest for

patients. Take-home medication privileges

might benefit a patient by reducing his or her

exposure to an OTPís less stable patients and

making it easier for the patient to lead a normal

life, by providing an incentive to further

enhance recovery, and by expressing a programís confidence in the patientís progress.

However, increased take-home privileges may

pose a risk to a patient of overmedication and

lethal use and to people in the community of

drug diversion or accidental life-threatening

ingestion by intolerant individuals (e.g., children). Federal regulations governing OTPs

require that a medical director deciding

whether to allow or increase patient take-home

privileges consult the principle of nonmalfeasance by considering the risk of harm to

patients or others (42 Code of Federal

Regulations, Part 8 ß 12(i)(2)).

The longstanding concern with methadone

diversion also is rooted in the principle of 

justice. OTPs are under considerable public

scrutiny. If an OTP gives take-home privileges

to irresponsible patients and those patients,

their family members, or others in the community are harmed, the OTPís operations may be

restricted or the OTP might be shut down.

When an OTP closes its doors, its responsible

patientsóand the staff and ultimately the 

communityósuffer. Therefore, it is important

to consider a patientís behavior carefullyónot

just the time in treatmentóbefore allowing

take-home medication.

A word about due process

The decision to discharge a patient involuntarily or adjust take-home privileges might require

that a treatment provider or administrator

resolve factual disputes or differences in interpretation between a staff member and a patient

or between two patients. It is important that an

OTP provide a forum so that patients can

302 Appendix D
receive a fair hearing on their versions of disputed events, including a review of the evidence

and proposed sanctions. Some States require

additional due-process procedures.

Ethics: Conclusion

OTP staff members can avoid or minimize

some ethical dilemmas by remaining aware of

sources of potential conflict, keeping ethical

principles in mind, familiarizing themselves

with the ethical standards of their profession,

and discussing potential conflicts with patients

and other staff members. The goal always is

reducing or eliminating the use of illicit opioids

and other illicit drugs and the problematic use

of prescription drugs. Exhibit D-2 presents the

canon of ethics adopted by AATOD. Exhibit D3 provides Internet links to the ethical guidelines of other treatment-centered organizations.

Ethical Considerations in MAT 303

Exhibit D-2

AATOD Canon of Ethics

ï Ensure that patients are treated with compassion, respect, and dignity

regardless of race, creed, age, sex, handicaps, or sexual orientation.

ï Retain competent and responsible personnel who adhere to a strict code of

ethics, including but not limited to prohibiting of fraternization with patients,

exploitation of patients, and criminal behavior.

ï Subscribe to the treatment principles published in TIP 43, MedicationAssisted Treatment for Opioid Addiction in Opioid Treatment Programs,

which serves as a resource in making therapeutic decisions.

ï Provide patients with accurate and complete information regarding

methadone treatment, the nature of available services, and the availability of

alternative treatment modalities before admission and throughout the treatment process.

ï Ensure that discharge from treatment is conducted in accordance with sound

and medically acceptable practice. The patient is assured of due process if the

discharge is administrative in nature.

ï Provide a safe and clean environment for patients and staff that is conducive

to the therapeutic process.

ï Remain in compliance with the required Federal, State, and local operating

standards.

ï Take all necessary and appropriate measures to maintain individual patient

records and information in a confidential and professional manner.

ï Strive to maintain good relations with the surrounding community, and pursue every reasonable action to encourage responsible patient behavior and

community safety.
304 Appendix D

Exhibit D-3

Ethical Codes of Selected Treatment-Oriented Organizations

and Their Web Sites

American Medical Association’s Code of Ethics

www.ama-assn.org/ama/pub/category/8600.html 

American Nurses Association’s Code of Ethics 

nursingworld.org/ethics/chcode.htm 

American Psychological Association’s Code of Ethics

www.apa.org/ethics 

Mental Health Counselors’ Code of Ethics

www.counseling.org

National Association of Alcohol and Drug Abuse Counselors’ Code of Ethics

www.naadac.org

National Association of Social Workers’ Code of Ethics

www.socialworkers.org/pubs/code/code.asp

Public Policy of the American Society of Addiction Medicine, Principles 

of Medical Ethics

www.asam.org/ppol/Principles%20of%20Medical%20Ethics.htm 
Appendix E:

Resource Panel

Nancy Bateman, LCSW-C, CAC

Senior Staff Associate

Behavioral Health Care

National Association of Social Workers

Washington, D.C.

Shirley Beckett

Certification Administrator

National Association of Alcoholism &

Drug Abuse Counselors

Alexandria, Virginia

Brent Bowman

Clinical Director

Metwork Health Services, Inc.

Eldersburg, Maryland

Kurt Brandt, M.D.

Medical Supervisor

Alexandria Substance Abuse Services

Alexandria, Virginia

Carol Butler

Program Director

R.E.A.C.H. Mobile Health Services

Baltimore, Maryland

James F. Callahan, D.P.A.

Executive Vice President

American Society of Addiction Medicine

Chevy Chase, Maryland

Cynthia Cohen, R.N., CS-P

Clinical Coordinator

Addiction & Mental Health Center

Montgomery General Hospital

Olney, Maryland

Fred C. Cristofuri, M.D.

Medical Director

We Care Methadone Clinic

Laurel, Maryland

James Dorsey, M.D.

Medical Director

Adult Addiction Services

Anne Arundel County Department 

of Health

Annapolis, Maryland

Joel A. Egertson

Drug Policy Advisor

U.S. Department of Health and Human

Services

Washington, D.C.

Irene Gainer

Executive Director

National TASC

Washington, D.C.

Janis Gold

Director

Outpatient Services

Alexandria Mental Health, Mental

Retardation, and Substance Abuse

Services

Alexandria, Virginia

Janice Ford Griffin

Deputy Director

Join Together

Boston University SPH

Boston, Massachusetts

305
Michael G. Hayes, M.D.

Center for Addiction Medicine

Baltimore, Maryland

Vladimire Herard

Editor

Substance Abuse Funding News

Silver Spring, Maryland

James G. Hill

Director

Office of Substance Abuse

American Psychological Association

Washington, D.C.

Hendree Jones, Ph.D.

Assistant Professor of Psychiatry/

Director of Cornerstone/Research 

Director of Center for 

Addiction & Pregnancy

Johns Hopkins University

Baltimore, Maryland

Jennifer Kasten

Policy Analyst

Research Triangle Institute

Research Triangle Park, North Carolina

Chris Kelly, M.P.H., M.P.A.

Advocates for Recovery Through Medicine

Washington, D.C.

Joseph G. Liberto, M.D.

Clinical Manager

Substance Abuse Treatment Program

VA Maryland Health Care System

American Academy of Addiction 

Psychiatry

Baltimore, Maryland

James J. Manlandro, D.O., FAOAA

American Osteopathic Academy for

Addiction Medicine

Somerspoint, New Jersey

David Monosson

N.A.M.A. Washington Chapter

N.A.M.A./W.A.M.A.

Washington, D.C.

Dennis Scurry, Jr., M.D.

Chief Medical Officer

D.C. Department of Health

Addiction Prevention and 

Recovery Administration

Washington, D.C.

Suzan Swanton, LCSW-C

Clinical Director

Analyze Research, Inc.

Baltimore, Maryland

Susan Tatum

Therapist Supervisor

MHMRSA/SAóCity of Alexandria

Alexandria, Virginia

Annie Umbricht, M.D.

Medical Director

SHARP

Baltimore, Maryland

Diane Wood, LPN

LPN/Nursing Supervisor

Metwork Health Services, Inc.

Eldersburg, Maryland

306 Appendix E
Appendix F:

Field Reviewers

Cynthia E. Aiken

Executive Director/Clinical Consultant

Narcotic Drug Treatment Center, Inc.

Anchorage, Alaska

Janet Aiyeku, M.P.A., CASAC

Associate Director

Kings County Hospital Center

Brooklyn, New York

Norma E. Alexander, CMA

Board of Directors

Dora Weiner Foundation

Staten Island, New York

Marsha Althoff

Nursing Supervisor

Operation PAR

Clearwater, Florida

John J. Appeldorn, CAC, LPC, NCC, MAC

Director of Social Services

Tadiso, Inc.

Pittsburgh, Pennsylvania

G. Dean Austin, M.A.

Bureau Chief

Bureau of Substance Abuse Services and 

Licensure

Iowa Department of Public Health

Des Moines, Iowa

Doug Baker, M.S., CCAS

North Carolina State Opioid Treatment 

Authority

North Carolina Division of Mental Health, 

Developmental Disabilities, and 

Substance Abuse Services

Raleigh, North Carolina

Cynthia Banfield-Weir, LICSW, BCD

Clinical Director

Community Substance Abuse Center

Chicopee, Massachusetts

Mac R. Bell

SAN-Administrator

Kentucky Division of Substance Abuse 

Services

Frankfort, Kentucky

Bert Bennett, Ph.D.

Best Practice Team

North Carolina Division of Mental Health, 

Developmental Disabilities, and 

Substance Abuse Services

Raleigh, North Carolina

Richard Bilangi, M.S.

Executive Director

Connecticut Counseling Centers, Inc.

Middlebury, Connecticut

Dona C. Blair, R.N., CHCQM

Administrator

The Life Center of Galax

Galax, Virginia

307
Gary Blanchard, M.A., CAC-AD

Director

Center for Positive Path Recovery

Crownsville, Maryland

Cynthia H. Bolger, R.Ph., FASCP

Pharmacist Consultant

Richmond, Virginia

Jean J.E. Bonhomme, M.D., M.P.H.

Medical Director

Alliance Recovery Center

Decatur, Georgia

Susan Mayo Bosarge

State Methadone Authority

Behavioral Health Services Division

New Mexico Department of Health

Santa Fe, New Mexico

Daniel Brown

President

Brown Consulting, Ltd.

Toledo, Ohio

Marylee Burns, M.Ed., M.A., CRC

Assistant Director

Office of Behavioral Health

NYC Health and Hospitals Corporation

New York, New York

Denise Calcagnino, CSW, CASAC, ADS

Program Supervisor

Methadone Maintenance Treatment 

Program

Crouse Hospital, Inc.

Syracuse, New York

Donald Calsyn, Ph.D.

Psychologist/Director of Outpatient Services

Addiction Treatment Center

Veterans Affairs Puget Sound Health Care 

System

Seattle, Washington

James C. Carleton, M.S.

Director of Opioid Treatment Services

CODAC Behavioral Health

Cranston, Rhode Island

Matthew Cassidy

Director of Administration

Mount Sinai Medical Centerís Narcotics 

Rehabilitation Center

New York, New York

Patricia A. Champ, LMHC, LADC

Clinical Director

Habit Management Incorporated 

South Yarmouth, Massachusetts

Steven J. Chen, Ph.D.

Assistant Director

Division of Substance Abuse and 

Mental Health

Department of Human Services

Salt Lake City, Utah

George K. Clarke

Director

Southeastern CT Advocates for Recovery 

Through Medicine

New London, Connecticut

Peter Coleman, M.S., CASAC

Senior Director, Substance Abuse

NYC Health and Hospitals Corporation

New York, New York

Carol Colleran, CAP, ICADC

National Director

Older Adult Services

Hazelden Foundation

West Palm Beach, Florida

James P. Connolly, CMA

Regional Director

PA-NAMA

Newtown, Pennsylvania

Glen J. Cooper, M.A.

President

Pennsylvania Association of Methadone 

Providers

Allentown, Pennsylvania

308 Appendix F
Nancy L. Culver, R.N., CD

Head Nurse/Unit Manager

Methadone Program

Kent County Counseling Services

Dover, Delaware

Eugenia Curet, M.S.W.

Administrative Director

Adult Services Clinic

Cornell Medical College

Department of Public Health

New York, New York

Julie DíAscenzo

Community Education Coordinator

PA-NAMA

Philadelphia, Pennsylvania

Joy Davidoff, M.P.A.

Coordinator of Addiction Medicine

New York State Office of Alcoholism and 

Substance Abuse Services

Albany, New York

Carol Davidson, M.S.W.

Treatment Director

Evergreen Treatment Services

Seattle, Washington

M. Brooke Dawson, M.S.W., LCSW

Program Specialist II

Division of Alcohol and Drug Abuse

Missouri Department of Mental Health

Jefferson City, Missouri

Melissa DeFilippi, M.S.W., LICSW

Quality Management Manager

Health and Addictions Research, Inc.

Boston, Massachusetts

Peter A. DeMaria, Jr., M.D., FASAM

Coordinator of Psychiatric Services

Tuttleman Counseling Services

Philadelphia, Pennsylvania

John de Miranda, Ed.M.

Executive Director

National Association on Alcohol, Drugs 

and Disability

San Mateo, California

Mairead Desmond, M.A.

Program Director

New Directions Treatment Services

West Reading, Pennsylvania

Kay M. Doughty

Director

Family Centered Substance Abuse Services

Drug Abuse Comprehensive Coordinating 

Office, Inc.

Tampa, Florida

Sharon R. Dow, M.S.

Project Director

Joint Commission on Accreditation of 

Healthcare Organizations

Washington, D.C.

Marilyn Dubin, R.N.

Nurse Coordinator

Sinai Hospital Addictions Recovery 

Program

Baltimore, Maryland

Eric Ennis, LCSW, CAC III

Instructor of Psychiatry/Director of 

Outpatient Services

Addiction Research and Treatment Services

University of Colorado School of Medicine

Denver, Colorado

Beth Epstein

Practice Improvement Director

TASC, Inc.

Chicago, Illinois

Michael Fingerhood, M.D.

Associate Professor of Medicine

Johns Hopkins Bayview Medical Center

Baltimore, Maryland

Loretta P. Finnegan, M.D.

Medical Advisor

Office of Research on Womenís Health

National Institutes of Health

Bethesda, Maryland

Field Reviewers 309
Michael T. Flaherty, Ph.D.

Executive Director

Institute for Research, Education and 

Training in Addictions

Northeast Addiction Technology Transfer 

Center

Pittsburgh, Pennsylvania

Beth E. Francisco

Vice President/Director

Advocates for Recovery Through Medicine

Burton, Michigan

Michael C. Freeman, M.S., LADC, CCS

Program Director

Connecticut Counseling Centers, Inc.

Waterbury, Connecticut

Michael Galer, D.B.A., M.B.A., M.F.A.

Chairman of the Graduate School of 

Business

University of PhoenixóGreater Boston 

Campus

Braintree, Massachusetts

Devang H. Gandhi, M.D.

Assistant Professor of Psychiatry

University of Maryland School of Medicine

Baltimore, Maryland

Lynn Gerard

Quality Improvement Coordinator

Addiction Research and Treatment

San Francisco, California

Karen K. Gilmore-Thomas, LPN

ADA Liaison/LPN Clinic Administrator

Substance Abuse Treatment Clinic

University of Arkansas for Medical Sciences

Little Rock, Arkansas

Paolo Giudici, LPCC, LADAC

Clinical Director

Ayudantes, Inc.

Santa Fe, New Mexico

Alice Gleghorn, Ph.D.

Project Director

Community Substance Abuse Services

San Francisco Department of Public Health

San Francisco, California

Janis Gold, LPC, LMFT

Director

Outpatient Services

Alexandria Mental Health, Mental 

Retardation, and Substance Abuse 

Services

Alexandria, Virginia

Marc N. Gourevitch, M.D., M.P.H.

Director of Addiction Medicine

Associate Professor

Albert Einstein College of Medicine

Montefiore Medical Center

Bronx, New York

Douglas Gourlay, M.D., FRCP, FASAM

Medical Consultant

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Diane M. Grieder, M.Ed.

Owner/Consultant

AliPar, Inc.

Suffolk, Virginia

Therese E. Gruble, M.A., NCC

Therapist/Project Manager

Middle Tennessee Treatment Center

Nashville, Tennessee

Hildi Hagedorn, Ph.D., LP

Staff Psychologist

Minneapolis VA Medical Center

Minneapolis, Minnesota

Dana Harlow, LISW, CCDCIII-E

Manager

Quality Management Unit

Ohio Department of Alcohol and Drug 

Addiction Services

Columbus, Ohio

310 Appendix F
John Haywood, Jr., CSAC, ADS

Program Manager

Hampton-Newport News Community 

Services Board

Hampton, Virginia

Laurel Heiser, M.S.W., CSAC

Assistant Program Director

Sellati & Co., Inc./Cardinal Group, Inc.

Richmond, Virginia

Michael Pierre Henson, LAC

PIDARC

Washington, D.C.

James Herrera, M.A., NCC, LPCC

Clinical Counselor

University of New Mexico Hospital

Albuquerque, New Mexico

Robert Holden

Director

PIDARC

Washington, D.C.

Beatrice Huey

Director

Program Compliance and Outcome 

Monitoring

Arkansas Department of Health, Alcohol 

and Drug Abuse Prevention

Little Rock, Arkansas

Kimberly Johnson

Director

Maine Office of Substance Abuse

Augusta, Maine

Nora R. Johnson, M.A., CAP

Program Coordinator

DACCO Methadone Maintenance 

Treatment Program

Tampa, Florida

Herman Joseph, Ph.D.

Social Science Research in the Addictions

Social Research in OASAS

New York, New York

Patti Juliana, ACSN

Associate Executive Director

Division of Substance Abuse

Albert Einstein College of Medicine

Bronx, New York

David Kalman, Ph.D.

Assistant Professor

Department of Psychiatry

Boston University

Bedford, Massachusetts

Linda Kaplan, M.A.

Executive Director

Danya Institute/Central East ATTC

Silver Spring, Maryland

Jennifer Kasten

Policy Analyst

Research Triangle Institute

Research Triangle Park, North Carolina

Chris Kelly, M.P.H., M.P.A.

Advocates for Recovery Through Medicine

Washington, D.C.

Van L. King, M.D.

Associate Professor

Johns Hopkins University School of 

Medicine

Baltimore, Maryland

Suzanne A. Kinkle, R.N., CARN

Risk Reduction Coordinator

Southern New Jersey Perinatal Cooperative

Registered Nurse

Kennedy Health System

Pennsauken, New Jersey

Steven Kipnis, M.D., FACP, FASAM

Medical Director

New York State Office of Alcoholism and 

Substance Abuse Services

Orangeburg, New York

Field Reviewers 311
Daniel Kivlahan, Ph.D.

Director

Center of Excellence in Substance Abuse 

Treatment and Education

VA Puget Sound Health Care System

Seattle, Washington

Marc H. Kleinman, Ph.D.

Regional Administrator 

Methadone Services

Operation PAR/PAR Clinical Services

Port Richey, Florida

Thomas Kosten, M.D.

Professor of Psychiatry

Yale University School of Medicine

New Haven, Connecticut

Robert C. Lambert, M.A.

Program Director

Connecticut Counseling Centers, Inc.

Norwalk, Connecticut

John Langrod, Ph.D., CASAC, CSW-R

Director of Admissions/Evaluation

Division of Substance Abuse

Albert Einstein College of Medicine

Bronx, New York

Shirley Linzy, R.N., M.S.

Program Director

Dr. Miriam & Sheldon G. Adelson Clinic 

for Drug Abuse Treatment 

and Research

Las Vegas, Nevada

Sheera Lipshitz, M.H.S., CADC

Director

Community Support Programs

Brandywine Counseling

Wilmington, Delaware

Howard S. Lotsof, CMA

President

Dora Weiner Foundation

Staten Island, New York

Thomas Magaraci, M.Ed., M.B.A.

CEO

Habit Management

Boston, Massachusetts

Terri Martinez

Director/Consultant

Addiction Treatment Watchdog

Platte City, Missouri

Megan Marx, M.P.A.

Administrator

State Controlled Substance

Alcohol and Drug Abuse Division

Colorado Department of Human Services

Denver, Colorado

Arlene F. Mayotte, R.N., M.S.

Nurse Manager

Habit Management

Fitchburg, Massachusetts

Elinore F. McCance-Katz, M.D., Ph.D.

Professor of Psychiatry

Chair of the Division of Addiction 

Psychiatry

Medical College of Virginia

Virginia Commonwealth University

Richmond, Virginia

Brian A. McCarroll, M.S., D.O.

Medical Director

Biomed Behavioral Healthcare, Inc.

Clinton Township, Michigan

Sarah S. McHugh

Vice President, Performance Improvement

Family Guidance Centers, Inc.

Chicago, Illinois

Paul McLaughlin, M.A.

Executive Director

Hartford Dispensary

Hartford, Connecticut

Don McNamee, M.A., LPC, LAODC

Clinical Supervisor

Montgomery County Medication Assisted 

Treatment Program

Rockville, Maryland

312 Appendix F
Ray Miller, M.A., LCADC

Chief, Treatment Services

Maryland Alcohol and Drug Abuse 

Administration

Catonsville, Maryland

Carolyn J. Miranda, CMA

President

NAMA SOCAL

Fountain Valley, California

Richard Moldenhauer, M.S., LADC, ICADC

State Methadone Authority

Chemical Health Division

State of Minnesota

St. Paul, Minnesota

Nancy A. Murray, M.A., CAGS, LDCP

Vice President of Operations

Discovery House

Providence, Rhode Island

Maureen E. Neville

Certified Methadone (Patient) Advocate

NAMA

Haverhill, Massachusetts

James Nolan, CAS, CPP

Administrator, Addiction Medicine

Prison Health Services, Inc.

Rikers Island

East Elmhurst, New York

Jeanne L. Obert, M.F.T., M.S.M.

Executive Director

Matrix Institute on Addictions

Playa Vista, California

Beth OíNeal, LPC, LMFT

Clinical Supervisor

Austin Travis County Mental HealthMental Retardation

Austin, Texas

Carmen Pearman-Arlt, CADAC II

Director

Chemical Dependency and Addictions

Porter Starke Services

Valparaiso, Indiana

Luc R. Pelletier, R.N., M.S.N., BC, CPHQ

Project Director

Danya International, Inc.

Silver Spring, Maryland

Cheryl Petty, R.N., M.S.N., NP

Coordinator, OSC

RLR Veterans Affairs Medical Center

Indianapolis, Indiana

Mary Planthaber, LPN

Nursing Manager

Operation PAR

Pasco, Pinellas, Manatee, and Lee Counties

Clearwater, Florida

Deborah Podus, Ph.D.

Assistant Research Sociologist

UCLA Integrated Substance Abuse 

Programs

Los Angeles, California

Deborah J. Powers

State Methadone Authority

Department of Health and Family Services

Madison, Wisconsin

Michelle R. Rawls, RCAC

Substance Abuse Counselor

PIDARC

Washington, D.C.

Philip F. Richmond, M.S., LADC

Associate Director

Hartford Dispensary

Hartford, Connecticut

Kimber P. Richter, Ph.D., M.P.H.

Assistant Professor

University of Kansas Medical Center

Kansas City, Kansas

Deborah S. Rienhimer, M.S., LCADC

Treatment Systems Administrator

Maryland Alcohol and Drug Abuse 

Administration

Catonsville, Maryland

Field Reviewers 313
Michael Rizzi

President/CEO

CODAC Behavioral Healthcare

Cranston, Rhode Island

Elias Robles, Ph.D.

Research Assistant Professor

University of Arkansas for Medical Sciences

Little Rock, Arkansas

Aaron Rolnick

Executive Vice President

Detroit Organizational Needs in Treatment

Detroit, Michigan

Andrew J. Saxon, M.D.

Professor

Department of Psychiatry and Behavioral 

Sciences

University of Washington/VA Puget Sound 

Healthcare System

Seattle, Washington

Brent Scobie, LCSW

Clinical Supervisor

The Acadia Hospital

Bangor, Maine

Anthony Scro

Technical Assistance Unit Manager/Board 

Member

New York State OASAS/National Alliance of

Methadone Advocates

New York, New York

Audrey Sellers, M.D.

Medical Director

Bay Area Addiction Research and 

Treatment

San Francisco, California

Edward C. Senay, M.D.

Professor Emeritus, Psychiatry

University of Chicago

Naperville, Illinois

Diane Sevening, Ed.D.

Assistant Professor

Alcohol and Drug Abuse Studies 

Department

University of South Dakota

Vermillion, South Dakota

Stephen Shearer, CPHQ, CCM, CADC, CEAP

Healthcare Consultant

Stephen Shearer, Inc.

Redwood City, California

Karl G. Sieg, M.D.

Medical Director of Addiction Psychiatry

Hampton Roads Clinic

Hampton, Virginia

Susan Simon

CEO/President

Hepatitis C Association

Scotch Plains, New Jersey

Genie Skypek, Ph.D.

President

The Skypek Group, Inc.

Tampa, Florida

Lisa M. Soderlund

ACI/OTP Program Supervisor

CODAC Behavioral Healthcare

Cranston, Rhode Island

Jim Soward, CPC, CSAC

Alcohol and Substance Abuse Program 

Manager

Pascua Yaqui Tribe of Arizona

Tucson, Arizona

Shannon Staggers, BRPS

Senior Substance Abuse Counselor

Hartford Dispensary

Hartford, Connecticut

Deborah Stephenson, M.D.

Central Valley Clinic

San Jose, California

314 Appendix F
Eric C. Strain, M.D.

Professor

Department of Psychiatry and Behavioral 

Sciences

Johns Hopkins University School of 

Medicine

Baltimore, Maryland

William B. Swafford, M.D.

Medical Director

Addiction Research and Treatment Services

Division of Substance Dependence

University of Colorado Health Sciences 

Center

Denver, Colorado

James Szabo, LICSW

Manager

Family Outpatient Services

Gateway Healthcare

Pawtucket, Rhode Island

Charlotte L. Thomas, M.S.W., CACIII

Retired Addiction Treatment Provider

Colorado Springs, Colorado

Elaine Tophia

Executive Director

National Opioid Treatment Clinicians 

Association

Decatur, Georgia

Sari Trachtenberg, M.A., CCS, LPC

Program Coordinator

Narcotic Addict Rehabilitation Program

Thomas Jefferson University

Philadelphia, Pennsylvania

Ernest J. Vasti, M.D.

Medical Director

San Joaquin County 

Office of Substance Abuse

Stockton, California

Winifred Verse-Barry, Ph.D., R.N.

CTP Nursing Coordinator

Dayton Veterans Affairs Medical Center

Dayton, Ohio

Gary Wenner

Vice President of Methadone and 

Laboratory Services

Operation PAR

Clearwater, Florida

Carol Wertheimer, Psy.D.

Director of Clinical Services

Habit Management

Boston, Massachusetts

Melvin H. Wilson

HIDTA Coordinator

WB/HIDTA-Maryland Division of Parole 

and Probation

Baltimore, Maryland

Diane Wood, LPN

LPN/Nurse Supervisor

Metwork Health Services

Eldersburg, Maryland

Johanna Esmus York, M.P.H., CAP

Program Director, NATC-B

Operation PAR

Bradenton, Florida

Field Reviewers 315

Index

Notes: Because the entire volume is about medication-assisted treatment for opioid addiction, the

use of these terms as entry points has been minimized in this index. Commonly known acronyms

are listed as main headings. Page references for information contained in exhibits appear in italics.

317

12-Step programs. See mutual-help programs

42 CFR, Part 8, 3, 22, 46, 103, 121, 134, 154

A

About Methadone (patient handbook), 132

abstinence, 187

definition, 2

violation effect, 138

accreditation, and movement from compliance

orientation, 22

acupuncture, 136

acute phase of treatment, 102ñ103, 104ñ105

and co-occurring disorders, 106

goals of, 103ñ105

and hospitalization, 178

and legal problems, 106ñ107

and medical and dental problems, 106

and therapeutic relationships, 107

and transition to rehabilitative phase, 108

addiction

definition, 2

disease versus moral view of, 12

iatrogenic, 12

and pain management, 7, 12

perinatal, 219ñ220

as a social issue, 14

Addiction Severity Index, 43, 139, 194, 240

Addiction Technology Transfer Center

Network, 7

administrative discharge, 138ñ139, 186

alternatives to, 140

for continued substance abuse, 139

guidelines for, 140

for incarceration, 140

for nonpayment, 139ñ140

prevention of, 140

and principles of medical ethics, 301

procedures for, 141

review and appeals processes, 141

admission process, 46

denial of, 47

adolescents, 92ñ93

parental consent to treatment, 48, 50

Advisory Commission on Narcotic and Drug

Abuse, 1963, 16

advocacy, patient, 142

Advocates for Recovery Through Medicine, 84,

142

aging patients, 95

alcohol

effects of, 182

and overdose risk, 188

treatment for dependence, 183

and use of stimulants, 184

American Association for the Treatment of

Opioid Dependence, 18, 171

Canon of Ethics, 303

American Society of Addiction Medicine,

patient placement criteria, 87

Americans with Disabilities Act, 112, 173

antisocial personality disorder, 191, 198ñ199

anxiety disorders, medications for, 207

appropriate language, 9

arrythmia, cardiac, 35, 41

ASI. See Addiction Severity Index

assessment

Brazelton Neonatal Behavioral Assessment

Scale, 220

of children, 134

comprehensive, 53

cultural, 54ñ55

of financial status, 60

induction, 53

of insurance status, 58

medical, 49, 65

and patient-treatment matching, 88
318 Index

of peer relations and support, 58

psychosocial, 55

of recreation activities, 60

of spirituality, 59

of substance use, 54

ATTC. See Addiction Technology Transfer

Center Network

attention deficit/hyperactivity disorder, 199

medications for, 207ñ208

autonomy

and conflict with beneficence, 298

principle of medical ethics, 297

B

barriers to treatment, 44, 222

basic-care services, 107, 121

behavioral problems, remedial approaches to,

140

beneficence

and conflict with autonomy, 298

principle of medical ethics, 297

benzodiazepines

and ìboostingî, 183

effects of, 183ñ184

bidirectional model of co-occurring disorders,

192

bipolar disorder, medications for, 206ñ207

Blending Clinical Practice and Research:

Forging Partnerships To Enhance Drug

Addiction Treatment (2002 conference), 237

blind withdrawal, 141

blood drug testing, 147

botulism, wound, 164

breast-feeding, 218

during buprenorphine treatment, 222

and methadone, 218

buprenorphine, 4, 5, 8

and compliance testing, 144

DEA classification of, 22

development of, 19

dosage forms, 32

dose levels, 71

efficacy of, 33

FDA approval for use, 25

and induction stage of pharmacotherapy, 68

metabolization of, 30

and mu receptors, 30

and naloxone combination, 26, 30ñ36, 69,

221

overdose, 30, 42

pharmacology and pharmacotherapy of, 30

and physician waivers, 26, 27

and pregnancy, 220

safety of, 42

side effects of, 36

and youth, 93

C

California Drug and Alcohol Treatment

Assessment, 19ñ20

cardiac arrhythmia, 35

cardiovascular effects, 35

case management, 124, 127

case studies

conflict between beneficence and autonomy,

299

patient-treatment planning in MAT, 97ñ99

Changing the Conversation: Improving

Substance Abuse Treatment: The National

Treatment Plan Initiative, 237

childrenís issues

assessment, 134

child abuse, 56

childcare, onsite, 94

childrenís protective services, 94, 134

Chinese immigrants, and opium smoking, 12

chromatographic analyses, 151

civil commitment, 15ñ16

definition, 15

Civil War veterans, and opioid addiction, 12

CLIA. See Clinical Laboratory Improvement

Amendments

Clinical Laboratory Improvement

Amendments, 154, 155

cocaine

and concurrent alcohol use, 184

effects of, 184

cognitive behavioral therapies, 127ñ128

community reinforcement approach, 128

contingency management, 128ñ129

motivational enhancement, 130

node-link mapping, 128

cognitive impairment, screening for, 193

common pathway model of co-occurring 

disorders, 192

Community Epidemiology Surveillance

Network (NIDA), 237
Index 319

community issues

community relations and education plan,

232ñ233

documenting community activities, 236

and media relations, 235

national community education initiatives, 236

overcoming negative reactions, 232, 235

community reinforcement approach, 128

complementary medicine, 136

comprehensive treatment assessment, 53

comprehensive treatment services, 8

concurrent medical disorder, 82, 111, 122, 178

confidentiality, 47ñ48, 60, 91, 149

consent to treatment, written, 48, 61, 107

contingency management, 128ñ129

and pregnancy, 223

strategy for, 129

continuing-care phase of treatment, 119

Controlled Substances Act of 1970, 21

co-occurring disorders

classification of diagnoses, 194, 196

definition, 2, 189

diagnostic instruments, 195, 209

differential diagnosis, 106, 196

DSM-IV-TR criteria, 194

etiology of, 191ñ192

and gender differences, 190ñ191

history of, 55

and HIV risk, 201

and homicidality, 202

identification of, 190

models of care, 192

mutual-help programs for, 203

and pharmacotherapy, 204

prevalence of, 190

prognosis for, 197

psychiatric diagnosis, 194

and psychoeducation, 204

screening for, 192

substance-induced versus non-substanceinduced, 194, 197

and symptom severity, 198

treatment issues, 199ñ200

and treatment motivation, 191

and treatment outcomes, 197ñ198

and treatment planning, 200

cost benefits of treatment, 19ñ20

counseling

and case management, 124ñ125

group, 126

individual, 125ñ126

resistance to, 132

resources for, 127

criminal history, 58

criminal justice

populations, 8

treatment settings, 90ñ91

cross-tolerance, 28ñ29, 70ñ71

cultural assessment, 54ñ55

cultural sensitivity, 226

and language use, 227

custody, 134

cytochrome P3A4 enzyme system, 28, 36, 41,

184, 208

inducers and inhibitors of, 40

D

DATA. See Drug Addiction Treatment Act of

2000

deemed status, 22

definitions

abstinence, 2

addiction, 2

civil commitment, 15

co-occurring disorders, 2, 189

dependence, 2

level of care, 87

medication-assisted treatment for opioid

addiction, 2

opioid agonist, 28

opioid treatment programs, 2

QT interval, 35

steady state, 66

tolerance, 12

Demystifying Evaluation: A Manual for

Evaluating Your Substance Abuse Treatment

Program, 238, 239

dental problems, 106

and acute pain, 175

dependence, definition, 2

dependence duration rule, SAMHSA, 49

depression, medications for, 206ñ207

detoxification

in acute phase of treatment, 103

inpatient, 188

and medically supervised withdrawal, 79ñ80

types of, 80
320 Index

diagnosis

of HIV infection, 52

of substance use, DSM-IV-TR classifications,

195

differential diagnosis of co-occurring disorders,

195

disabilities

patients with, 92, 173

physical, 92

and take-home medications, 84

discharging patients, 235ñ236

disease model of co-occurring disorders, 192

and clinicians uneasy with the concept, 300

diversion control, 9, 83, 115, 159, 230, 302

Dole, Dr. Vincent P., 17, 18

domestic violence, 56, 57, 135

dosage determination, 70

dosage forms

of buprenorphine, 32

of LAAM, 32

of methadone, 31

of naltrexone, 32

dosage reduction, 78

blind, 79

and incarceration, 81

involuntary, 80

dosing

contigency, 77

determination of, 70

dose levels, 6, 71, 75

home dosing, 173

missed doses, 85

optimal, 67ñ68

and overmedicating and undermedicating,

70, 76

split, 67, 76, 217

studies of, 72ñ75

and vomiting, 76ñ77

Drug Abuse Warning Network, 83, 181

Drug Addict as a Patient, The, 17

Drug Addiction Treatment Act of 2000, 6, 21,

26, 27, 68

drug combinations

common, 181ñ182

reasons for use, 182

drug interactions, 36

for depression and bipolar disorder, 206

with methadone, 37ñ39

preventing harmful, 40ñ42

drug testing, 52ñ53

accuracy of, 158

benefits and limitations of, 144

blood, 147

components and methods, 148

and false-positive results, 144ñ145

frequency of, 111, 154, 188

hair, 148

immunoassays in, 150

interpretation of, 155ñ156

laboratory selection, 154

minimum concentrations of substances of

abuse, 145

and multiple substance use, 188

onsite test analysis, 155, 156

oral-fluid, 147

patient falsification of, 157

and patient self-reports, 146

reliability, 158

results, 143, 156, 159

specimen collection, 148

for substance abuse, 144

sweat, 147ñ148

for treatment compliance, 144

of urine, 146

validity, 158

and written procedures, 151

due process, and principles of medical ethics,

302ñ303

duration of action

buprenorphine, 30, 174

LAAM, 28, 67

methadone, 216

E

early intervention, 173

education

formal, 112

patient, 41, 44, 106, 132

Effective Treatment of Opiate Addiction (1997

conference), 22

efficacy

of buprenorphine, 33

of LAAM, 33

of methadone, 32

of naltrexone, 33

EIA. See immunoassay

elderly, 95
Index 321

eligibility for treatment, 115

and Federal regulations, 49, 89

emergency room admissions, 181

emergency situations, 82, 84, 202

endocarditis, 163

Enzyme Multiplied Immunoassay Technique,

150

ethics, 298, 304

etiology, of co-occurring disorders, 191ñ192

European immigrants, 13

evaluation

outcome, 238ñ239

process, 239

program, 238

resources for, 240

staff, 238

evidence-based practices, 7

extended-care services, 122

extinction therapy, 138

F

false-positive drug tests, 144ñ145, 158

family background, 56ñ57

family involvement, benefits of, 133

Federal Regulation of Methadone Treatment,

Institute of Medicine study, 20

financial issues, patient, 123ñ124, 139

and principles of medical ethics, 301

forms of dosage. See dosage forms

funding issues, 7ñ8

G

gateway drugs, 1, 14

Gearing, Dr. Frances Rowe, 18

gender differences and co-occurring disorders,

190ñ191

Goodman and Gilmanís Pharmacological Basis

of Therapeutics, 28

group counseling, 126

Guidelines for the Accreditation of Opioid

Treatment Programs, 238

H

hair drug testing, 148

Harrison Narcotic Act of 1914, 14

HCV. See hepatitis C infection

Health Insurance Portability and

Accountability Act, 3, 154

hepatitis, A and B, 167, 213

testing, 51, 167

hepatitis C infection, 7

and alcohol use, 183

counseling for, 126, 131

determination of disease activity, 168

evaluation, 169

and liver disease, 168

liver transplant, 171

and pregnancy, 213ñ214

sustained virologic response, 170

testing for, 51, 168

treatment of, 168, 169

heroin

blockade of effects, 70

and cross-tolerance, 72

immune system effects, 35

introduction, 12

prevalence, 7, 12ñ16, 180ñ181

route of administration, 122

and suicide, 202

use and cost to criminal justice system, 1

use, and methadone maintenance, 73

HIPAA. See Health Insurance Portability and

Accountability Act

history

of co-occurring disorders, 55

criminal, 58

drug and medication, 40

employment, 59

medical, 50

military, 59

of nonopioid substance use, 50

of opioid addiction, 11

physical or sexual abuse, 57ñ58

psychosocial, 53

sexual, 60

sociodemographic, 55

substance abuse, 47

HIV/AIDS

and co-occurring disorders, 201

counseling for, 131ñ132

interactions of medications and methadone,

172

neurologic complications of, 172

and pregnancy, 214ñ215

prevention of, 172

rapid tests for, 52, 172

referral for treatment, 172ñ173
322 Index

testing for, 171

HIV testing, 52

Western blot analysis, 171ñ172

homelessness, 58

homicidality, 44ñ46

hospitalization, 84ñ85, 178

housing status, 58

and referrals, 92

hydrocodone, 83

hypodermic drug administration, 12

I

iatrogenic addiction, 12

immigrants, 12, 13

immune system effects, 35

immunoassay, 149, 150, 168, 171

impulse control disorders, 48

incarceration

and dosage reduction, 81

failure of, 16

and involuntary withdrawal, 81

treatment discharge for, 140

individual counseling, 125ñ126

induction stage of MAT, 68ñ69

assessment during, 53

induction stage of pharmacotherapy, 65

with buprenorphine, 68

and dosing, 65ñ66, 67

with methadone and LAAM, 67ñ68

with naltrexone, 70

and pregnancy, 216

and steady state, 66ñ67

infections, acute, life-threatening, 163

endocarditis, 163

necrotizing fasciitis, 163ñ164

soft-tissue, 163

tuberculosis, 164, 165

wound botulism, 164

infectious diseases, 164

chlamydia and gonococcus, 167

hepatitis, 167

syphilis, 166

tuberculosis, 164

Venereal Disease Reference Laboratory test,

166

information collection, 47

informed consent. See written consent to 

treatment

initial dosing, 69

initial screening, 43

and admission, 46

goals of, 44

inner-city populations, 13ñ14

insurance status, 58ñ59

intake. See screening process

integrated services, versus referral services,

162

integrative approaches to MAT, peer support,

135

interim maintenance treatment, 46ñ47

International Center for Advancement of

Addiction Treatment, 142

involuntary discharge, 138ñ139, 186

alternatives to, 140

for continued substance abuse, 139

guidelines for, 140

for incarceration, 140

for nonpayment, 139ñ140

prevention of, 140

and principles of medical ethics, 301

procedures for, 141

review and appeals processes, 141

isoniazid treatment of tuberculosis, 166

J

Jaffe, Dr. Jerome, 18

justice, principle of medical ethics, 298

K

Kreek, Dr. Mary Jeanne, 17

L

LAAM, 5

cessation of production, 25

clinical guidelines for, 18ñ19

and compliance testing, 144

development of, 18ñ19

dosage forms, 32

dose levels, 72

efficacy of, 33

equivalency dosing tables for methadone, 72

overdose, 67

pharmacology and pharmacotherapy of,

28ñ29

safety of, 42

side effects, 35

withdrawal and termination from, 79
Index 323

laboratory

selection, 154

testing, 51

legal problems, 58, 106ñ107

leisure activities, 60

lesbian, gay, and bisexual patients, 94

level of care, 87

levo-alpha acetyl methadol. See LAAM

LGB. See lesbian, gay, and bisexual patients

liver

effects on, 35ñ36

toxicity, 166

liver disease

and hepatitis C, 168

and liver transplant, 171

M

maintenance medication, 4

maintenance stage of pharmacotherapy, 77

and dose reduction, 78ñ81

origins of, 17

and relapse prevention, 78

maintenance treatment, 5

major depression, medications for, 206ñ207

Manhattan County Jail for Men, 16

marijuana, effects of, 185

MAT

and conflict with mutual-help programs, 135

definition, 2

eligibility for, 49

information resources for, 237

involuntary discharge from, 138ñ139

orientation to, 47ñ48

phases of. See phases of treatment

rationale for phased-treatment approach,

101

reduction in unnecessary regulation of, 20

media

relations, 235

reports about MAT, 9

Medicaid, 7ñ8

medical assessment, 49, 65

medical ethics, principles of, 297

medically supervised withdrawal treatment, 6,

78, 141, 217ñ218

medical maintenance phase of treatment, 5, 116

eligibility for, 114ñ115

and OBOT, 115ñ116

and random drug testing, 115

medical problems

acute, life-threatening infections, 163

disability, 173

followup for, 163

HIV/AIDS, 171

and hospitalization of patients in MAT, 178

and pregnancy, 212, 213

medication

diversion of, 159

over-the-counter, 48

for patients with co-occurring disorders, 205

prescription, 48

take-home, 81ñ82

medication-assisted treatment for opioid 

addiction. See MAT

medication dosages, individualized, 123

medication unit, 2, 115

methadone, 4, 8

access to by people in the criminal justice

system, 5

cardiovascular effects, 35

development of, 17ñ18

dosage forms, 31ñ32

dosage reduction, 78ñ79

dose levels, 6, 71, 74ñ75

and dose tapering, 79

drug interactions with, 37ñ39, 206

efficacy of, 32ñ33

equivalency dosing tables for LAAM, 72

and HIV medications, 172

metabolization of, 29

optimal levels, 68

overdose, 67, 202

pharmacology and pharmacotherapy of,

28ñ29

and pregnancy, 219

regulation, 22

safety of, 42

side effects, 35

States not available in, 5

and use of stimulants, 184

methadone maintenance treatment, 63

efficacy of, 17

origins of, 17

and pain management, 174ñ175

and pregnancy, 215ñ216

as public health program, 18

split dosing in pregnancy, 217

methadone regulation, history of, 22ñ23
324 Index

missed doses, 85

mobile treatment units, 90

models of care, 202

money management, 60

monotherapy tablets, 69

morphine, 12ñ17

duration of action, 217

and neonatal abstinence syndrome, 219

and pain management, 174ñ175

motivational enhancement, 130

motivational interviewing, 53

Motivational Interviewing: Preparing People

for Change, 130

motivation for seeking treatment, 54, 96, 107,

191

multidisciplinary treatment team, 100

multiple substance use, 48, 106, 111

and co-occurring disorders, 181

and dosage adjustments, 187

and increased drug testing, 188

management of, 186

and morbidity and mortality, 181

and pregnancy, 217

prevalence of, 180, 181

and psychosocial treatment services, 187ñ188

mu opiate receptors, 28, 29

and buprenorphine, 30

and methadone, 29

and naltrexone, 30

mutual-help programs

and conflict with MAT, 135

and patientñtreatment matching, 88

for people with co-occurring disorders, 203

Web sites for, 136, 203

N

naloxone-buprenorphine combination. See

buprenorphine, SuboxoneÆ

naloxone challenge test, 50, 70

naltrexone, 5

development of, 19

dosage forms, 32

dose levels, 72

efficacy of, 33

induction stage of pharmacotherapy, 70

and overdose, 42

pharmacology and pharmacotherapy of, 30ñ31

safety of, 42

side effects of, 35

Narcan challenge. See naloxone challenge test

Narcotic Addict Treatment Act of 1974, 21, 25

narcotics farms, 15

Narcotics Register, New York City, 16

Narcotic Treatment Programs: Best Practice

Guideline, 237

National Institutes of Health consensus panel

recommendations, 4, 20

necrotizing fasciitis, 163ñ164

Neonatal Abstinence Score, 219

neonatal abstinence syndrome, 216, 218ñ219

and buprenorphine, 220ñ221

and methadone, 219

nicotine, effects of, 185

and pregnancy, 212

node-link mapping, 128

nonmalfeasance, principle of medical ethics,

298

nutrition, and pregnancy, 223ñ224

Nyswander, Dr. Marie E., 17

O

OBOT. See office-based opioid treatment

observed dosing, 65ñ66

office-based opioid treatment, 6, 63, 85, 90

with methadone, 115

opioid addiction

diagnosing in pregnant patients, 212

history of, 11ñ12

as a medical disorder, 3ñ5

opioid agonist, 64

definition, 28

side effects of, 34

opioid analgesic abuse, 14

opioid antagonist, 5, 19

and diagnosing addiction in pregnant

women, 212

side effects of, 34

opioid overdose, 50

opioid pharmacotherapy

contraindications to, 64ñ65

stages of, 65

opioid treatment programs

administrative considerations, 225

attendance requirements, 124

and co-occurring medical and mental 

disorders, 91

definition, 2

and duty to warn, 202
Index 325

early OTPs, 14ñ15

evaluation, 238

Federal regulation of, 6

managing to meet service needs, 122

offsite treatment options for, 122

outpatient, 89

readmission to, 120

who should not be admitted, 64, 199

opioid use

abuse patterns, 7, 48

additional doses for acute pain, 177

methods of, 48

opium smoking, among Chinese immigrants, 12

optimal dosing, 67ñ68, 71

oral-fluid drug testing, 147

orientation to MAT, 47ñ48

OTP. See opioid treatment programs

outcome predictors, 3

overdose in pregnancy, 217

overdose risk, 65, 202

oxycodone, 17, 83, 122, 151, 175

OxyContinÆ, 151, 217

P

pain management, 95, 112

for acute pain, 175

and addiction, 7

for chronic pain, 176ñ177

and methadone dosing, 177

nonpharmacologic, 177

and relapse, 174

parenting groups, 134

parenting issues, 94

custody, 134

partial response to maintenance medication, 4

Partners for Recovery (national educational

campaign), 9

patient exception, 49, 82, 104, 116

patient handbook, 47

patient issues

advocacy, 142

aging, 95

disabilities, 92

education, 41, 44, 132

failure to respond to MAT, 301

family, 92

followup, 138

housing, 92

motivation, 54

pain, 95

patient placement criteria, 87

retention, steps to improving, 123ñ124

social problems, 92

special needs, 91

patientñtreatment matching, steps in, 88ñ91, 97

patterns of opioid abuse, 48

pharmacotherapeutic medications, 26

buprenorphine, 30

and co-occurring disorders, 204

LAAM, 28

methadone, 28

naltrexone, 30

pharmacotherapy

maintenance, 77ñ78

methadone, 28

stages of, 65

phases of treatment, 101

acute, 102ñ108

continuing-care, 119

medical maintenance, 114ñ116

rehabilitative, 108ñ113

supportive-care, 113ñ114

tapering and readjustment, 116ñ119

transition between, 108, 119

physical examination, 50ñ51

physicianís waiver. See waiver, physicanís, to

dispense buprenorphine

polysubstance abuse. See multiple substance

use

population shifts, 13

postpartum treatment of women in MAT, 218

posttraumatic stress disorder, 56, 93, 199

pregnancy, 93

barriers to treatment, 222

breast-feeding, 218

buprenorphine, 211

comprehensive treatment services, 222

diagnosing opioid addiction, 212, 214

medical problems, 212, 213

methadone maintenance, 211

neonatal abstinence syndrome, 216

nutrition, 212, 223ñ224

obstetrical complications, 212, 215

and opioid antagonists, 212

overdose, 217

postpartum treatment, 218

testing, 51, 53

withdrawal from methadone, 217ñ218
326 Index

prescription opioids

and blockade of effects, 70

prevalence, 83

Principles of Addiction Treatment: A ResearchBased Guide, 8

principles of effective drug addiction treatment, 8

principles of medical ethics, conflicts among the

principles, 301

program

administration, 225

evaluation, 238

goals, 123

management, 10

proprietary programs, 5

psychiatric instruments, 209

psychoeducation, 132

for people with co-occurring disorders, 204

strategies for, 133

psychosocial assessment, 55

psychosocial history, 53

psychosocial treatment services

and multiple substance use, 187

and patient-treatment matching, 88

psychotherapy

group, 130ñ131

and staff qualifications, 130

strategies for, 131

PTSD. See posttraumatic stress disorder

public relations, 9ñ10, 237

Pure Food and Drug Act of 1906, 14

Q

QT interval, 64

definition, 35

R

Rapid HIV Testing Initiative, SAMHSA, 52

recovery resources, patient, 49

Recovery Training and Self-Help, 136

Recovery Training and Self-Help: Relapse

Prevention and Aftercare for Drug Addicts,

132

referral, 46, 88, 111, 122, 141, 162, 187

for co-occurring disorders, 194, 202

for HIV treatment, 172

and lesbian, gay, and bisexual patients, 94

for pregnant women, 93

and sexual or physical abuse, 93

to social services, 138

referral services, versus integrated services,

162

regulations

history of, 21ñ23

reduction of unnecessary, 20

rehabilitative phase of treatment, 109ñ110

and continued alcohol and prescription drug

abuse, 111

and co-occurring disorders, 113

and income-related issues, 112

and legal problems, 112ñ113

and social supports, 112

relapse

after tapering, 117

risk, 4

warning signs of, 138

relapse prevention, 33, 64, 78, 136

and abstinence violation effect, 138

building relapse prevention skills, 137

and extinction therapy, 138

Relapse Prevention Workbook, 137

strategies for multiple substance use,

137ñ138

remedial approaches to behavioral problems,

140

Report to Congress on the Prevention and

Treatment of Co-Occurring Substance Abuse

Disorders and Mental Disorders, 189

residential treatment programs, 89ñ90

resources

for counseling, 127

for evaluation, 240

for MAT, 237

restrictions on treatment, State mandated, 5

retaining patients, 122ñ124

retention, patient, 123

RIA. See immunoassay

Rikers Island, New York City, 91

Riverside Hospital for adolescents with 

addiction disorders, 15

Roxane Laboratories, Inc., 18, 35

S

safety, 42, 65, 193

of patients and employees, 139

and principles of medical ethics, 301

staff, 149

saliva drug testing. See oral-fluid drug testing
Index 327

sanatoriums for opioid addiction, 12

schedule II controlled substance, 18, 20

scheduling, 49

schizophrenia, medications for, 208

screening process

admission process, 46

for cognitive impairment, 193

for co-occurring disorders, 192

and emergency situations, 44

initial screening, 43

instruments, 196

for suicidality, 203

tools for, 194

sedatives, nonbenzodiazepine, effects of, 184

selective serotonin reuptake inhibitors. See

SSRIs

self-help programs. See mutual-help programs

self-medication model of co-occurring 

disorders, 192

serious medical disorders, 91

serum methadone level, 28ñ29, 73ñ75, 76

and SSRIs, 37

sexual abuse, 57, 93, 131

sexually transmitted diseases, 52

chlamydia and gonococcus, 167

syphilis, 166

and youth, 93

sexual orientation, 60, 126, 226

side effects, 33ñ36

Siting Drug and Alcohol Programs: Legal

Challenges to the ìNIMBYî Syndrome, 237

SML. See serum methadone level

social services

case management, 127

referral to, 138

social supports, 112

Special Action Office for Drug Abuse

Prevention, 18

specimen collection, 148, 151ñ152

spirituality, 59ñ60

split dosing, 67, 76

SSRIs, 37, 170

stabilization

and pregnancy, 216

versus steady state, 70

staffing issues

cultural sensitivity, 226

and inclusion of recovering patients, 227

knowledge and attitudes, 9, 124, 227

qualifications, 130, 225

staff evaluation, 238

staff needs, 122

staff retention, 227ñ228

training, 144, 208, 228

transference and countertransference, 226

stages of change, 96

Statesí authority to regulate OTPs, 23

steady state, 66, 68

versus stabilization, 70

stigma, 4, 6, 8ñ10, 13, 92, 231

stimulants. See cocaine

Strategies for Developing Treatment Programs

for People With Co-Occurring Substance

Abuse and Mental Disorders, 189

SuboxoneÆ, 6, 32

Substance Abuse and Mental Health Services

Administration, and MAT approval and 

monitoring, 22ñ23

substance use, testing for, 144

SubutexÆ, 6, 32

suicidality, 44

and co-occurring disorders, 200, 202

risk factors, 45, 202

supportive-care phase of treatment, 114

and treatment compliance, 114

support systems, patient, 58

sweat drug testing, 147ñ148

syphilis testing, 166

T

take-home medications, 81, 129

for acute pain, 176

and callbacks, 230

and concurrent medical disorders, 82

and contingency contracting, 77

decisions about, 159

and disability or illness, 84, 92, 173

and emergency situations, 82

Federal criteria for, 81, 90, 230

medical exceptions for, 82

in medical maintenance phase of treatment,

115

monitoring patients, 83ñ84

and positive drug tests, 82ñ83

and principles of medical ethics, 302

tapering, 123

involuntary, 80ñ81

medically supervised, 141

voluntary, 78
328 Index

tapering and readjustment phase of treatment,

118

versus detoxification, 116

and patient stage of change, 117

reasons for, 117

and relapse, 117

and reversion to MAT, 119

testing

hepatitis, 51, 213

HIV, 52

laboratory, 51

medical, 163

onsite test analysis, 155ñ156

for pregnant women, 214

STD, 52

tuberculosis, 51

therapeutic relationships, 107

TIPs cited

Assessment and Treatment of CocaineAbusing Methadone-Maintained Patients

(TIP 10), 1

Clinical Guidelines for the Use of

Buprenorphine in the Treatment of Opioid

Addiction (TIP 40), 19, 25, 63, 70, 221

Detoxification and Substance Abuse

Treatment (forthcoming), 186

Enhancing Motivation for Change in

Substance Abuse Treatment (TIP 35), 54,

96, 130

Improving Cultural Competence in

Substance Abuse Treatment (forthcoming),

55, 226

Integrating Substance Abuse Treatment and

Vocational Services (TIP 38), 112

LAAM in the Treatment of Opiate Addiction

(TIP 22), 1

Matching Treatment to Patient Needs in

Opioid Substitution Therapy (TIP 20), 1

Screening for Infectious Diseases Among

Substance Abusers (TIP 6), 167

State Methadone Treatment Guidelines (TIP

1), 1, 143, 231

Substance Abuse: Administrative Issues in

Outpatient Treatment (forthcoming), 228,

233, 235, 239

Substance Abuse and Trauma (forthcoming),

193

Substance Abuse Treatment: Addressing the

Specific Needs of Women (forthcoming), 53,

94, 217, 222

Substance Abuse Treatment and Domestic

Violence (TIP 25), 56, 135, 193

Substance Abuse Treatment and Family

Therapy (TIP 39), 134

Substance Abuse Treatment for Adults in the

Criminal Justice System (TIP 44), 91, 107

Substance Abuse Treatment for People With

Physical and Cognitive Disabilities (TIP

29), 173

Substance Abuse Treatment for Persons

With Child Abuse and Neglect Issues (TIP

36), 56, 93, 131, 193, 226

Substance Abuse Treatment for Persons

With Co-Occurring Disorders (TIP 42), 2,

189, 190, 194, 196, 200, 206

Substance Abuse Treatment for Persons

With HIV/AIDS (TIP 37), 131, 163, 171,

201, 205

Substance Abuse Treatment: Group Therapy

(TIP 41), 126

Substance Use Disorder Treatment for

People With Physical and Cognitive

Disabilities (TIP 29), 173, 193

Treatment for Stimulant Use Disorders (TIP

33), 184, 194

Treatment of Adolescents With Substance

Use Disorders (TIP 32), 93

tobacco. See nicotine, effects of

tolerance to opioids, 12, 71

Tombs, the. See Manhattan County Jail for

Men

torsade de pointes, 35

transference and countertransference, 226

trauma, 193

treatment

cost benefits of, 19ñ20

duration, 102

interruptions, 84

offsite, 122

options, 5ñ6

treatment compliance, testing for, 144

treatment history, 47

treatment outcomes for people with co-occurring disorders, 197ñ198

treatment, phases of. See phases of treatment

treatment planning, 95ñ96

case study, 97ñ99

and co-occurring disorders, 200
Index 329

elements of, 96ñ97

and multidisciplinary team approach, 100

and role of counselor and patient, 96

treatment program types

and criminal justice settings, 90ñ91

mobile treatment units, 90

office-based opioid treatment, 90

outpatient OTPs, 89

residential treatment programs, 89ñ90

tuberculosis

classification of, 165

and isoniazid treatment, 166

prevention of, 166

treatment of, 166

tuberculosis testing, 51

Bacillus Calmette-Guerin vaccination, 165

Mantoux test, 164

purified protein derivative, 164

types and frequency of, 164ñ165

U

urine drug testing, 146

chromatographic analyses, 151

cutoff concentrations, 145

direct observation, 149

Enzyme Multiplied Immunoassay Technique,

150

and patient privacy, 149

sample guidelines for monitoring, 151ñ153

U.S. Public Health Service Narcotics Hospital,

15

V

vaccination

Bacillus Calmette-Guerin, 165

against hepatitis B infection, 167

Vietnam, 13

violence, 44ñ46, 139, 202, 301

domestic, 56, 57

Violence Against Women Act, 56

vomiting, 76ñ77

voucher-based reinforcement therapy, 223

W

waiting lists for treatment, 46

waiver, physicianís, to dispense buprenorphine, 26, 27

Web sites cited, 227

Addiction Technology Transfer Center

Network, 7, 229

Advocates for Recovery Through Medicine,

84

American Association for the Treatment of

Opioid Dependence, 140, 234

Centers for Disease Control and Prevention,

164

The Change Book (ATTC), 240

Comorbidity and Addictions Center, 209

DATA, 26

Double Trouble in Recovery, 203

Dual Diagnosis Recovery Network, 203

Dual Recovery Anonymous, 203

ethical codes, 304

Exception Request and Record of

Justification form, 82

Federal Women, Infants, and Children 

program, 224

food stamps, 224

International Center for Advancement of

Addiction Treatment, 142

medication interactions with methadone, 42

Mini International Neuropsychiatric

Interview, 209

Mini-Mental State Examination, 194

mutual-help programs, 136

National Alliance of Methadone Advocates,

135, 142

National Association of Social Workers, 226

National Center for Nutrition and Dietetics,

224

National Clearinghouse for Alcohol and

Drug Abuse Information, 240

National Institute on Alcohol Abuse and

Alcoholism, 209

National Institute on Drug Abuse, 234

National Womenís Health Information

Center, 224

NIDA cost analysis manual, 240

Outcome Measurement Resource Network,

240

pharmacokinetics of methadone and HIV

medications, 146

Rapid HIV Testing Initiative, SAMHSA, 52

recommendations on involuntary withdrawal

from treatment, 301

Recovery Community Support Program

(CSAT), 237ñ238
330 Index

Substance Abuse and Mental Health Services

Administration, 226, 234

Texas Christian University core instruments,

240

translation services, 227

University of Adelaide Library Guide, 209

U.S. Department of Agriculture survey

forms, 224

Violence Against Women Act, 56

White House Office of National Drug

Control Policy, 234

Western blot analysis, 171ñ172

withdrawal, 64, 188

after detoxification, 79ñ80

blind, 141

fetal, 211

and incarceration, 81

medically supervised, 5, 78ñ79, 141,

217ñ218

and pregnancy, 217ñ218

severity of, 12

triggered, 77

womenís issues, 53, 93

written consent to treatment, 48, 61, 143

Y

youth, 92ñ93
331

TIP 1 State Methadone Treatment Guidelines—Replaced

by TIP 43

TIP 2* Pregnant, Substance-Using Women—BKD107

Quick Guide for Clinicians QGCT02

KAP Keys for Clinicians KAPT02

TIP 3 Screening and Assessment of Alcohol- and Other

Drug-Abusing Adolescents—Replaced by TIP 31

TIP 4 Guidelines for the Treatment of Alcohol- and Other

Drug-Abusing Adolescents—Replaced by TIP 32

TIP 5 Improving Treatment for Drug-Exposed Infants—

BKD110

TIP 6 Screening for Infectious Diseases Among Substance 

Abusers—BKD131

Quick Guide for Clinicians QGCT06

KAP Keys for Clinicians KAPT06

TIP 7 Screening and Assessment for Alcohol and Other

Drug Abuse Among Adults in the Criminal Justice

System—Replaced by TIP 44

TIP 8* Intensive Outpatient Treatment for Alcohol and

Other Drug Abuse—BKD139

TIP 9 Assessment and Treatment of Patients With

Coexisting Mental Illness and Alcohol and Other

Drug Abuse—Replaced by TIP 42

TIP 10 Assessment and Treatment of Cocaine-Abusing

Methadone-Maintained Patients—Replaced by TIP 43

TIP 11 Simple Screening Instruments for Outreach for

Alcohol and Other Drug Abuse and Infectious

Diseases— BKD143

Quick Guide for Clinicians QGCT11

KAP Keys for Clinicians KAPT11

TIP 12 Combining Substance Abuse Treatment With

Intermediate Sanctions for Adults in the Criminal

Justice System—Replaced by TIP 44

TIP 13 Role and Current Status of Patient Placement

Criteria in the Treatment of Substance Use

Disorders—BKD161

Quick Guide for Clinicians QGCT13

Quick Guide for Administrators QGAT13

KAP Keys for Clinicians KAPT13

TIP 14 Developing State Outcomes Monitoring Systems for

Alcohol and Other Drug Abuse Treatment—BKD162

TIP 15 Treatment for HIV-Infected Alcohol and Other

Drug Abusers—Replaced by TIP 37

TIP 16 Alcohol and Other Drug Screening of Hospitalized

Trauma Patients—BKD164

Quick Guide for Clinicians QGCT16

KAP Keys for Clinicians KAPT16

TIP 17 Planning for Alcohol and Other Drug Abuse

Treatment for Adults in the Criminal Justice

System—Replaced by TIP 44

TIP 18 The Tuberculosis Epidemic: Legal and Ethical

Issues for Alcohol and Other Drug Abuse Treatment

Providers—BKD173

Quick Guide for Clinicians QGCT18

KAP Keys for Clinicians KAPT18

TIP 19* Detoxification From Alcohol and Other Drugs—

BKD172

Quick Guide for Clinicians QGCT19

KAP Keys for Clinicians KAPT19

TIP 20 Matching Treatment to Patient Needs in Opioid

Substitution Therapy—Replaced by TIP 43

TIP 21 Combining Alcohol and Other Drug Abuse

Treatment With Diversion for Juveniles in the

Justice System—BKD169

Quick Guide for Clinicians and Administrators

QGCA21

TIP 22 LAAM in the Treatment of Opiate Addiction—

Replaced by TIP 43

TIP 23 Treatment Drug Courts: Integrating Substance

Abuse Treatment With Legal Case Processing—

BKD205

Quick Guide for Administrators QGAT23

TIP 24 A Guide to Substance Abuse Services for Primary

Care Clinicians—BKD234

Concise Desk Reference Guide BKD123

Quick Guide for Clinicians QGCT24

KAP Keys for Clinicians KAPT24

CSAT TIPs and Publications Based on TIPs

What Is a TIP?

Treatment Improvement Protocols (TIPs) are the products of a systematic and innovative process that brings together clinicians,

researchers, program managers, policymakers, and other Federal and non-Federal experts to reach consensus on state-of-the-art 

treatment practices. TIPs are developed under CSAT’s Knowledge Application Program to improve the treatment capabilities of

the Nation’s alcohol and drug abuse treatment service system.

What Is a Quick Guide?

A Quick Guide clearly and concisely presents the primary information from a TIP in a pocket-sized booklet. Each Quick Guide is

divided into sections to help readers quickly locate relevant material. Some contain glossaries of terms or lists of resources. Page

numbers from the original TIP are referenced so providers can refer back to the source document for more information.

What Are KAP Keys?

Also based on TIPs, KAP Keys are handy, durable tools. Keys may include assessment or screening instruments, checklists, and

summaries of treatment phases. Printed on coated paper, each KAP Keys set is fastened together with a key ring and can be kept

within a treatment provider’s reach and consulted frequently. The Keys allow you—the busy clinician or program administrator—

to locate information easily and to use this information to enhance treatment services.

*Under revision
TIP 25 Substance Abuse Treatment and Domestic

Violence—BKD239

Linking Substance Abuse Treatment and Domestic

Violence Services: A Guide for Treatment

Providers MS668

Linking Substance Abuse Treatment and Domestic

Violence Services: A Guide for Administrators

MS667

Quick Guide for Clinicians QGCT25

KAP Keys for Clinicians KAPT25

TIP 26 Substance Abuse Among Older Adults—BKD250

Substance Abuse Among Older Adults: A Guide for 

Treatment Providers MS669

Substance Abuse Among Older Adults: A Guide for

Social Service Providers MS670

Substance Abuse Among Older Adults: Physician’s 

Guide MS671

Quick Guide for Clinicians QGCT26

KAP Keys for Clinicians KAPT26

TIP 27 Comprehensive Case Management for Substance

Abuse Treatment—BKD251

Case Management for Substance Abuse Treatment: 

A Guide for Treatment Providers MS673

Case Management for Substance Abuse Treatment: 

A Guide for Administrators MS672

Quick Guide for Clinicians QGCT27

Quick Guide for Administrators QGAT27

TIP 28 Naltrexone and Alcoholism Treatment—BKD268

Naltrexone and Alcoholism Treatment: Physician’s 

Guide MS674

Quick Guide for Clinicians QGCT28

KAP Keys for Clinicians KAPT28

TIP 29 Substance Use Disorder Treatment for People With

Physical and Cognitive Disabilities—BKD288

Quick Guide for Clinicians QGCT29

Quick Guide for Administrators QGAT29

KAP Keys for Clinicians KAPT29

TIP 30 Continuity of Offender Treatment for Substance

Use Disorders From Institution to Community—

BKD304

Quick Guide for Clinicians QGCT30

KAP Keys for Clinicians KAPT30

TIP 31 Screening and Assessing Adolescents for Substance

Use Disorders—BKD306

See companion products for TIP 32.

TIP 32 Treatment of Adolescents With Substance Use 

Disorders—BKD307

Quick Guide for Clinicians QGC312

KAP Keys for Clinicians KAP312

TIP 33 Treatment for Stimulant Use Disorders—BKD289

Quick Guide for Clinicians QGCT33

KAP Keys for Clinicians KAPT33

TIP 34 Brief Interventions and Brief Therapies for

Substance 

Abuse—BKD341

Quick Guide for Clinicians QGCT34

KAP Keys for Clinicians KAPT34

TIP 35 Enhancing Motivation for Change in Substance

Abuse Treatment—BKD342

Quick Guide for Clinicians QGCT35

KAP Keys for Clinicians KAPT35

TIP 36 Substance Abuse Treatment for Persons With Child

Abuse and Neglect Issues—BKD343

Quick Guide for Clinicians QGCT36

KAP Keys for Clinicians KAPT36

Helping Yourself Heal: A Recovering Woman’s

Guide to Coping With Childhood Abuse Issues—

PHD981

Also available in Spanish: PHD981S

Helping Yourself Heal: A Recovering Man’s Guide

to Coping With the Effects of Childhood Abuse—

PHD1059

Also available in Spanish: PHD1059S

TIP 37 Substance Abuse Treatment for Persons With

HIV/AIDS—BKD359

Fact Sheet MS676

Quick Guide for Clinicians MS678

KAP Keys for Clinicians KAPT37

TIP 38 Integrating Substance Abuse Treatment and

Vocational Services—BKD381

Quick Guide for Clinicians QGCT38

Quick Guide for Administrators QGAT38

KAP Keys for Clinicians KAPT38

TIP 39 Substance Abuse Treatment and Family Therapy—

BKD504

Quick Guide for Clinicians QGCT39

Quick Guide for Administrators QGAT39

TIP 40 Clinical Guidelines for the Use of Buprenorphine in

the Treatment of Opioid Addiction—BKD500

TIP 41 Substance Abuse Treatment: Group Therapy—

BKD507

Quick Guide for Clinicians QGCT41

TIP 42 Substance Abuse Treatment for Persons With CoOccurring Disorders—BKD515

Quick Guide for Clinicians QGCT42

Quick Guide for Administrators QGAT42

KAP Keys for Clinicians KAPT42

TIP 43 Medication-Assisted Treatment for Opioid

Addiction in Opioid Treatment Programs—BKD524

TIP 44 Substance Abuse Treatment for Adults in the

Criminal Justice System—BKD526

*Under revision

332
Treatment Improvement Protocols (TIPs) from the Substance Abuse and Mental Health Services

Administrationís (SAMHSAís) Center for Substance Abuse Treatment (CSAT)

Place the quantity (up to 5) next to the publications you would like to receive and print your mailing address below.

___TIP 2* BKD107

___QG+ for Clinicians QGCT02

___KK+ for Clinicians KAPT02

___TIP 5 BKD110

___TIP 6 BKD131

___QG for Clinicians QGCT06

___KK for Clinicians KAPT06

___TIP 8* BKD139

___TIP 11 BKD143

___QG for Clinicians QGCT11

___KK for Clinicians KAPT11

___TIP 13 BKD161

___QG for Clinicians QGCT13

___QG for Administrators QGAT13

___KK for Clinicians KAPT13

___TIP 14 BKD162

___TIP 16 BKD164

___QG for Clinicians QGCT16

___KK for Clinicians KAPT16

___TIP 18 BKD173

___QG for Clinicians QGCT18

___KK for Clinicians KAPT18

___TIP 19* BKD172

___QG for Clinicians QGCT19

___KK for Clinicians KAPT19

___TIP 21 BKD169

___QG for Clinicians & Administrators

QGCA21

___TIP 23 BKD205

___QG for Administrators QGAT23

___TIP 24 BKD234

___Desk Reference BKD123

___QG for Clinicians QGCT24

___KK for Clinicians KAPT24

___TIP 25 BKD239

___Guide for Treatment Providers MS668

___Guide for Administrators MS667

___QG for Clinicians QGCT25

___KK for Clinicians KAPT25

___TIP 26 BKD250

___Guide for Treatment Providers MS669

___Guide for Social Service Providers

MS670

___Physician’s Guide MS671

___QG for Clinicians QGCT26

___KK for Clinicians KAPT26

___TIP 27 BKD251

___Guide for Treatment Providers MS673

___Guide for Administrators MS672

___QG for Clinicians QGCT27

___QG for Administrators QGAT27

___TIP 28 BKD268

___Physician’s Guide MS674

___QG for Clinicians QGCT28

___KK for Clinicians KAPT28

___TIP 29 BKD288

___QG for Clinicians QGCT29

___QG for Administrators QGAT29

___KK for Clinicians KAPT29

___TIP 30 BKD304

___QG for Clinicians QGCT30

___KK for Clinicians KAPT30

___TIP 31 BKD306

(see products under TIP 32)

___TIP 32 BKD307

___QG for Clinicians QGC312

___KK for Clinicians KAP312

___TIP 33 BKD289

___QG for Clinicians QGCT33

___KK for Clinicians KAPT33

___TIP 34 BKD341

___QG for Clinicians QGCT34

___KK for Clinicians KAPT34

___TIP 35 BKD342

___QG for Clinicians QGCT35

___KK for Clinicians KAPT35

___TIP 36 BKD343

___QG for Clinicians QGCT36

___KK for Clinicians KAPT36

___Brochure for Women (English)

PHD981

___Brochure for Women (Spanish)

PHD981S

___Brochure for Men PHD1059

___Brochure for Men (Spanish)

PHD1059

___TIP 37 BKD359

___Fact Sheet MS676

___QG for Clinicians MS678

___KK for Clinicians KAPT37

___TIP 38 BKD381

___QG for Clinicians QGCT38

___QG for Administrators QGAT38

___KK for Clinicians KAPT38

___TIP 39 BKD504

___QG for Clinicians QGCT39

___QG for Administrators QGAT39

___TIP 40 BKD500

___TIP 41 BKD507

___QG for Clinicians QGCT41

___TIP 42 BKD515

___QG for Clinicians QGCT42

___QG for Administrators QGAT42

___KK for Clinicians KAPT42

___TIP 43 BKD524

___TIP 44 BKD526

*Under revision

+QG = Quick Guide; KK = KAP Keys

Name:

Address:

City, State, Zip:

Phone and e-mail: 

You can either mail this form or fax it to (301) 468-6433. Publications also can be ordered by calling SAMHSA’s NCADI at

(800) 729-6686 or (301) 468-2600; TDD (for hearing impaired), (800) 487-4889.

TIPs can also be accessed online at www.kap.samhsa.gov.
SAMHSA’s National Clearinghouse for Alcohol and Drug Information

P.O. Box 2345

Rockville, MD 20847-2345

STAMP

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This TIP, Medication-Assisted Treatment for Opioid Addiction in Opioid

Treatment Programs, incorporates the many changes in medicationassisted treatment for opioid addiction (MAT) that have occurred over

the most active decade of change since the inception of this treatment

modality approximately 40 years ago. The TIP describes the nature and

dimensions of opioid use disorders and their treatment in the United

States, including basic principles of MAT and historical and regulatory

developments. It presents consensus panel recommendations and 

evidence-based best practices for treatment of opioid addiction in opioid

treatment programs (OTPs). It also examines related medical, psychiatric,

sociological, and substance use disorders and their treatment as part of 

a comprehensive maintenance treatment program. The TIP includes a 

discussion of the ethical considerations that arise in most OTPs, and it

provides a useful summary of areas for emphasis in successfully 

administering MAT in OTPs.

Quick Guide for Clinicians

KAP Keys for Clinicians

Collateral Products

Based on TIP 43

Medication-Assisted Treatment

for Opioid Addiction 

in Opioid Treatment Programs

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Treatment

DHHS Publication No. (SMA) 05-4048

Printed 2005