# Presentation: 663691

## Welcome

## Training CurriculumBased on TIP 43: Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs

**Module 1: TIP Chapters 1 and 2**

## What Is a TIP?

- Treatment Improvement Protocol
- Developed by CSAT
- Part of SAMHSA
- Within the DHHS
- Formation of best-practice guidelines

## What Is a TIP?

- A collaborative effort
- Experts in the field
- Federal agencies and national organizations
- Substance abuse treatment programs
- Hospitals
- Community health centers, counseling programs
- Criminal justice and child welfare agencies
- Private practitioners

## What Is the Purpose of TIP 43?

- A guide to medication-assisted treatment for opioid addiction in opioid treatment programs.

## Course Goals

- The goals of this training are to...
- Familiarize you with the content of TIP 43;
- Increase your awareness of the issues, research, and recommendations related to medication-assisted treatment of opioid addiction; and
- Attend 13 training sessions that cover the 14 chapters in the TIP.

## Course Curriculum

- Introduction and History of Treatment for Opioid Addiction
- Pharmacology
- Screening, Admission, and Assessment Techniques
- Clinical Pharmacotherapy
- Matching Patients to Treatment Options
- Phases of Treatment
- Approaches to Patient Care and Retention

## Course Curriculum

- Patient Care and Retention
- Drug Testing
- Associated Medical Problems
- Treatment of Multiple Substance Use
- Treatment During Pregnancy
- Administrative Considerations

## Module 1: Introduction and History

**During this module, you will:**
**Match terminology with definitions; **
**Describe how changing user populations, treatment approaches, and governmental responses have shaped the history of opiate addiction; **
**Explain recent changes in the field of medication-assisted treatment (MAT) for opiate addiction; and**
**Identify current challenges faced by treatment providers.**

## What Do You Know about Opioids?

**Write down as much as you know ****about opioids.**

## What Do These Key Terms Mean?

**Match the definition with each Key Term:**
**Dependence vs. Addiction**
**Detoxification**
**Tolerance**
**Withdrawal**
**MAT**
**OTP**
**Abstinence**
**Co-occurring Disorders**

## Dependence

**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.**** **

## Addiction

**A combination of the following that leads to compulsive use of a substance either for its positive effects or to avoid negative effects:                                           ****	**
**Physical dependence;**
**Behavioral manifestations of use; and **
**Subjective sense of need and craving.**

## Detoxification

**The treatment for addiction to an illicit substance involving the following:**
**The substance is gradually eliminated ****from a patient’s body; and **
**Reinforcing treatments are provided to alleviate adverse physical or psychological reactions.**

## Tolerance

**It involves the following:**
**Needing increased amounts of an opioid to achieve intoxication or a desired effect; and**
**Continued use of the same amount of a substance has a markedly diminished effect. **

## Withdrawal

**Reduction and elimination of substance use. **

## MAT: Medication-Assisted Treatment

**A type of addiction treatment that involves the following:**
**Provided in a certified, licensed opioid      treatment program or a physician’s office;**
**Provides maintenance pharmacotherapy using an opioid agonist, a partial agonist, or an antagonist medication; and**
**May be combined with other comprehensive treatment services, including medical and psychosocial services.**** **

## OTP: Opioid Treatment Program

**A SAMHSA-certified program that meets the following conditions:**
**Comprised of a facility, staff, administration, patients, and services; and**
**Engages in supervised assessment and treatment (using methadone, buprenorphine, LAAM, or naltrexone) of individuals who are addicted to opioids.**

## Abstinence

**Characterized by the non-use of alcohol, ****illicit drugs, or medications normally obtained by prescription or over the counter.  **
**In TIP 43*****, the term does not refer to nonuse of or withdrawal from maintenance medications (methadone, buprenorphine, LAAM, or naltrexone) when they are used in a medication-assisted treatment (MAT) program*****.**

## Co-occurring Disorders

**In TIP 43, a DSM-IV diagnosis of a mental disorder, present in an individual admitted to an opioid treatment program. (DSMIV 2000)**
*Diagnostic and Statistical Manual of Mental Disorders*, *Fourth Edition, Text Revision*
- (American Psychiatric Association 2000)

## A History of Medication-Assisted Treatment for Opioid Addiction

- Opioid use and addiction in the United States.
- Changes in the population groups affected by opioid addiction disorders.
- This country’s social, political, legal, and medical responses.

## The Emergence of Opioid Addiction

**Opioid usage ranges from legal (medicinal) to illegal (recreational).**

## Two Views of Opioid Dependence

**View 1**
- Opioid addiction is an incurable disease.  Treatment requires long term medical maintenance.

**View 2**
- Opioid addiction is caused by weak will, moral failing, other psychodynamic factors, or is predetermined.  Treatment is criminalizationof use and distribution,and promotion of abstinence.

## The Changing Face of Opioid Addiction

- Opioid addiction became a serious problem during and after the Civil War.
- By 1900, an estimated 300,000 persons were opioid addicted in the U.S.
- By end of the 19th century, doctors became more cautious about prescribing opioids.

## The Changing Face of Opioid Addiction

- Early 20th century:  size and composition of addict population changes.
- Early treatment response involved prescriptive administration of opioids.
- Addiction causing increasing concern as tolerance for addicts wanes.
- By the end of the 1990s, an estimated 898,000 Americans used heroin.

## Society’s Changing Response

**The Pure Food and Drug Act of 1906.**
**The Harrison Narcotic Act of 1914.**
**Prohibition against prescribing opioids to persons with an addiction.**

## Early Treatment Efforts

**Early opioid treatment programs before 1919.**
**The Treasury closes opioid treatment clinics in the 1920s.**
**The U.S. Public Health Service introduces two prison-like treatment facilities.**

## The Need for a Solution

## The Need for a Solution

## Development of Medications to Treat Opioid Addiction

- Dr. Vincent P. Dole
- Dr. Marie E. Nyswander - *The Drug Addict as a Patient *
- Dr. Mary Jeanne Kreek

## Development of Medications to Treat Opioid Addiction:  Methadone

- Methadone research demonstrated:
- Normal patient functioning;
- No euphoric, tranquilizing, or analgesic effects;
- Blocking euphoric and tranquilizing effects of opioid drugs;
- No change in tolerance levels over time;
- Effective when orally administered;
- Relieved opioid craving;
- Minimal side effects; and
- Medically safe and nontoxic.

## Methadone Maintenance: From Research to Public Health Program

**In 1965, the initial research project on methadone safety and efficacy transferred to General Hospital in NYC.**
**Dr. Frances Rowe Gearing formed team.**
**Patients’ social functioning improved with time.**
**Patients stabilized on 80-120 mg per day.**
**Patients who remained in treatment typically eliminated illicit-opioid use.**
**Dr. Jerome Jaffe led a major public health initiative to treat opioid addiction.**

## Development of LAAM

- 1948: Developed by German chemists as an analgesic.
- 1960: Interest in *Levo-alpha acetyl methadol (*LAAM) as alternative to methadone.
- 1969-1981: Twenty-seven separate studies established safety and efficacy.
- 1993: Food and Drug Administration (FDA) approved LAAM for use in OTPs.
- 2004: Roxane Laboratories ceases production of LAAM production.

## Development of Buprenorphine

**2002: Drug Enforcement Agency (DEA) classified as Schedule III drug.**
**First drug approved for treatment of opioid addiction in physicians’ offices.**

## Development of Naltrexone

- Naltrexone only pure opioid antagonist.
- Approved for opioid addiction treatment in 1984.
- Most useful for motivated patients who have undergone detoxification and need support to avoid relapse.
- Helps some patients in beginning stages of opioid use and addiction.
- Some patients demonstrate poor compliance with long-term naltrexone therapy.

## Public Policy Studies and Reports

**California Drug and Alcohol Treatment Assessment.**
**Institute of Medicine.**
**National Institutes of Health.**

## California Drug and Alcohol Treatment Assessment

- 1994 study:
- Treatment cost averaged $7 returned for every dollar invested.
- Methadone among most cost effective, yielding savings $3-$4 for every dollar spent.
- Methadone maintenance patients showed greatest reduction in heroin use, criminal activity reduction and drug selling.
- Health care use decrease for all treatment modalities.

## Institute of Medicine

- 1995 Institute of Medicine study recommendations:
- Encourage programs to provide comprehensive services;
- Emphasize need for continuing clinical assessment throughout treatment; and
- End arbitrary restrictions for OTP practices.

## National Institutes of Health Recommendations

- Public education:  opioid addiction is a medical disorder that can be treated.
- Methadone treatment should be available for persons under legal supervision.
- Increased funding for maintenance treatment.
- Improve treatment through accreditation.
- DEA regulation revisions.
- Faster approval of new medications.
- Expansion of pharmacotherapy.

## Regulation History

- Controlled Substances Act.
- Narcotic Addict Treatment Act.
- Drug Addiction Treatment Act.

## Controlled Substance Act

- Enacted in 1970.
- All manufacturers, distributors and practitioners who prescribe, dispense or administer controlled substances must register with the DEA.

## Narcotic Addict Treatment Act

- Enacted in 1974
- Defined maintenance treatment.
- Medical practitioners required to register with the DEA.
- Increased coordination between U.S. Dept. of Health and Human Services and the DEA.
- Established National Institute on Drug Abuse (NIDA) as an institute separate from National Institute on Mental Health (NIMH).
- Split regulation authority between NIDA and FDA.

## Drug Addiction Treatment Act

- Enacted in 2000; amended the Controlled Substances Act.
- Allows practitioners who meet qualifying criteria to dispense or prescribe schedule III, IV or V controlled substances approved by FDA for MAT.

## History of Federal Methadone Regulation

**1972:  FDA issued regulations; modified in 1980s.**
**2001:  oversight shifted from FDA to Substance Abuse Mental Health Services Administration (SAMHSA).**
**Regulations set forth general certification requirements and treatment standards.**
**Accreditation: a peer-review process.**
**Once accredited, SAMHSA uses accreditation results and other data to determine whether a program is qualified to provide treatment under new standards.**

## History of State Methadone Regulation

- New federal regulations preserve States’ authority to regulate OTPs.
- Treatment oversight is tripartite system involving States, Department of Health and Human Services (DHHS)/SAMHSA and U.S. Department of Justice.
- States monitor same areas as federal agencies, but regulations are not always the same.

## Transformation of Medication-Assisted Treatment

- Accreditation.
- Medication choices.
- Changes in healthcare system.
- Acceptance of opioid addiction as a medical disorder.
- New accreditation oversight system.

## MAT—Accepted Form of Treatment

- Opioid addiction viewed as medical disorder.

## Similarities to Other Medical Disorders

- Substance addiction comparable to asthma, hypertension and diabetes.
- Risk of relapse highest during first 3-6 months.
- Patients respond best to a combination of pharmacological and behavioral interventions.
- Treatment of severe cases improves outcomes.

## Treatment Options

- Medical maintenance treatment:
- Medication choices: Methadone, buprenorphine and naltrexone;
- Pharmacotherapy with assessment,  psychosocial intervention and support services; and
- Detoxification from short-acting opioids.
- Medically supervised withdrawal treatment.

## Remaining Challenges

- Dosage levels.
- Patients with complex problems.
- Expansion of treatment.
- Access for Criminal Justice populations:
- Few correctional systems offer MAT; and
- Perception that MAT “...is substitution of one drug for another.”
- Promoting comprehensive treatment.
- Combating stigma.

## Appropriate Dose Levels

- Therapeutic dosages.
- Dosage appropriate to each patient.

## Patients with Complex Problems

- Untreated co-occurring disorders complicate treatment of opioid addiction.
- 60-90 % of people who inject drugs have Hepatitis C Virus (HCV) infection.
- Patients addicted to pain management medication.
- Since mid-1990s prevalence of lifetime heroin use has increased.

## Expansion of Treatment

- Number of patients in OTPs almost doubled since 1993.
- Estimated 898,000 heroin users; only 20 percent treated.

## Promoting Comprehensive Treatment

- National Institute on Drug Abuse (NIDA) - *Principles of Effective Drug Addiction Treatment: A Research-Based Guide.*
- Effective treatment attends to multiple needs of individual.
- Counseling and other behavioral therapies are critical components of effective treatment.
- Medications are an important element of treatment for many patients, especially combined with other behavioral therapies.
- Source: National Institute on Drug Abuse 1999.

## Combating Stigma

- Opioid addiction and stigma:
- Predominant view and self-induced condition resulting from a character disorder or moral failing.
- Results:
- Stigma associated with MAT affects social policies, programs, and attitudes;
- Limits funding and space for OTPs;
- Discourages patients from entering or remaining in treatment.
- Eliminating Stigma in OTPs:
- Patients should be treated with respect.
- Verbiage used with regard to patients and treatment should be more clinical.

## Training CurriculumBased on TIP 43: Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs

- Module 1: TIP Chapters 1 and 2