CLINICAL GUIDANCE FOR 

TREATING PREGNANT AND 

PARENTING WOMEN WITH 

OPIOID USE DISORDER AND 

THEIR INFANTS
ii

Clinical Guidance for Treating 

Pregnant and Parenting Women With 

Opioid Use Disorder and Their Infants
Acknowledgments

This document was prepared for the Center for Substance Abuse Treatment (CSAT), Substance Abuse and 

Mental Health Services Administration (SAMHSA), U.S. Department of Health and Human Services (HHS), 

under contract numbers HHSS283200700003I/HHSS28342007T and HHSS283201200002I/HHSS28342009T. 

LCDR Brandon T. Johnson, MBA, served as the Contracting Officer’s Representative, and Melinda Campopiano, 

MD, served as the Chief Medical Advisor.

Disclaimer

The views, opinions, and content expressed herein are the views of the authors and do not necessarily 

reflect the official position of SAMHSA, other federal agencies or offices, or HHS. Nothing in this document 

constitutes an indirect or direct endorsement by SAMHSA, other federal agencies or offices, or HHS of any 

non-federal entity’s products, services, or policies, and any reference to a non-federal entity’s products, 

services, or policies should not be construed as such. No official support of or endorsement by SAMHSA, other 

federal agencies or offices, or HHS for the opinions, resources, and medications described is intended to be or 

should be inferred. The information presented in this document should not be considered medical advice and 

is not a substitute for individualized patient or client care and treatment decisions.

Public Domain Notice

All materials appearing in this document except those taken directly from copyrighted sources are in the 

public domain and may be reproduced or copied without permission from SAMHSA or the authors. Citation of 

the source is appreciated. However, this publication may not be reproduced or distributed for a fee without the 

specific, written authorization of the Office of Communications, SAMHSA, HHS.

Electronic Access and Copies of Publication

This publication may be downloaded from http://store.samhsa.gov. For more information call SAMHSA at 

1-877-SAMHSA-7 (1-877-726-4727) (English and Español).

Recommended Citation

Substance Abuse and Mental Health Services Administration. Clinical Guidance for Treating Pregnant and 

Parenting Women With Opioid Use Disorder and Their Infants. HHS Publication No. (SMA) 18-5054. Rockville, 

MD: Substance Abuse and Mental Health Services Administration, 2018.

Originating Office

Division of Pharmacologic Therapies, Center for Substance Abuse Treatment, Substance Abuse and Mental 

Health Services Administration, 5600 Fishers Lane, Rockville, MD 20857.

Nondiscrimination Notice 

SAMHSA complies with applicable federal civil rights laws and does not discriminate on the basis of race, color, 

national origin, age, disability, or sex. SAMHSA cumple con las leyes federales de derechos civiles aplicables y 

no discrimina por motivos de raza, color, nacionalidad, edad, discapacidad o sexo. 

HHS Publication No. (SMA) 18-5054

iii
iv

Part A: Introduction...................................................................................................................................................................................................... 1

Background ................................................................................................................................................................................................................. 2

Epidemiology.............................................................................................................................................................................................................. 2

Barriers to Treatment ............................................................................................................................................................................................. 2

Effective Interventions and Guidelines .........................................................................................................................................................3

Definition of Terms...................................................................................................................................................................................................4

Creation of the Guide.............................................................................................................................................................................................5

RAM Methodology...................................................................................................................................................................................................6

Limitations to the RAM Process and Gaps Identified in the Research........................................................................................6

How To Use the Clinical Guide........................................................................................................................................................................... 7

Introduction Web Resources..............................................................................................................................................................................9

References..................................................................................................................................................................................................................10

Part B: Factsheets........................................................................................................................................................................................................13

Section I: Prenatal Care............................................................................................................................................................................................14

FACTSHEET #1: PRENATAL SCREENINGS AND ASSESSMENTS................................................................................................17

FACTSHEET #2: INITIATING PHARMACOTHERAPY FOR OPIOID USE DISORDER.........................................................25

FACTSHEET #3: CHANGING PHARMACOTHERAPY DURING PREGNANCY.....................................................................34

FACTSHEET #4: MANAGING PHARMACOTHERAPY OVER THE COURSE OF PREGNANCY.................................. 39

FACTSHEET #5: PREGNANT WOMEN WITH OPIOID USE DISORDER AND COMORBID BEHAVIORAL ...............

HEALTH DISORDERS.......................................................................................................................................................................................... 42

FACTSHEET #6: ADDRESSING POLYSUBSTANCE USE DURING PREGNANCY ..............................................................45

FACTSHEET #7: PLANNING PRIOR TO LABOR AND DELIVERY...............................................................................................52

FACTSHEET #8: PERIPARTUM PAIN RELIEF ........................................................................................................................................ 58

SECTION I REFERENCES .................................................................................................................................................................................60

CONTENTS
v

Section II: Infant Care ...............................................................................................................................................................................................76

FACTSHEET #9: SCREENING AND ASSESSMENT FOR NEONATAL ABSTINENCE SYNDROME ...........................78

FACTSHEET #10: MANAGEMENT OF NEONATAL ABSTINENCE SYNDROME.................................................................84

FACTSHEET #11: BREASTFEEDING CONSIDERATIONS FOR INFANTS AT RISK FOR NEONATAL ............................

ABSTINENCE SYNDROME...............................................................................................................................................................................89

FACTSHEET #12: INFANT DISCHARGE PLANNING........................................................................................................................... 93

FACTSHEET #13: EARLY INTERVENTION STRATEGIES AND DEVELOPMENTAL ASSESSMENTS........................97

SECTION II REFERENCES..............................................................................................................................................................................100

Section III: Maternal Postnatal Care................................................................................................................................................................110

FACTSHEET #14: ADJUSTING PHARMACOTHERAPY DOSE POSTPARTUM..................................................................... 112

FACTSHEET #15: MATERNAL DISCHARGE PLANNING..................................................................................................................115

FACTSHEET #16: MATERNAL RETURN TO SUBSTANCE USE....................................................................................................119

SECTION III REFERENCES..............................................................................................................................................................................123

Part C: Conclusion ....................................................................................................................................................................................................126

Appendix A: Suitable Development Assessments for Opioid-Exposed Infants and Children ....................................130

Appendix B: Glossary and Acronyms............................................................................................................................................................133

GLOSSARY...............................................................................................................................................................................................................133

ACRONYMS.............................................................................................................................................................................................................139

APPENDIX B REFERENCES..........................................................................................................................................................................140

Appendix C: Master Reference List .................................................................................................................................................................141
Part A: Introduction

The introduction consists of 11 content areas: 

1. Background

2. Epidemiology

3. Barriers to Treatment

4. Effective Interventions and Guidelines

5. Definition of Terms

6. Creation of the Guide

7. RAM Methodology

8. Limitations to the RAM Process and Gaps Identified in the Research

9. How To Use the Clinical Guide

10. Introduction Web Resources

11. References

1
2

Background

The nation’s opioid epidemic continues to compromise the health and well-being of individuals, families, 

and communities. Federal policymakers and agencies are developing, implementing, and funding strategies 

focused on turning the tide (U.S. Department of Health and Human Services [HHS], 2016]) to address 

opioid misuse, opioid use disorder (OUD), fatal and non-fatal drug overdoses, prenatal substance exposure, 

dissolution or breakup of families, and financial ruin experienced in communities nationwide. 

Epidemiology

In 2015, more than 27 million people in the United States reported current use of an illicit drug or misuse of 

prescription drugs in the past 30 days (Center for Behavioral Health Statistics and Quality [CBHSQ], 2016). The 

number of women of childbearing age, defined as ages 15–44, who reported past-month heroin use increased 

to 109,000 in 2013–2014, an increase of 31 percent from 2011–2012 (CBHSQ, 2015, Table 6.71A). The number 

of women ages 15–44 who reported past-month misuse of prescription pain relievers such as OxyContin© 

increased to 98,000 in the same period, an increase of 5.3 percent (CBHSQ, 2015, Table 6.71A). The Centers for 

Disease Control and Prevention (CDC) estimates that one-third of reproductive-age women enrolled in Medicaid 

and more than one-quarter of those with private insurance filled a prescription for an opioid pain medication 

each year between 2008 and 2012 (Ailes et al., 2015). The prevalence of OUD during pregnancy more than 

doubled between 1998 and 2011 to 4 per 1,000 deliveries (Maeda, Bateman, Clancy, Creanga, & Leffert, 2014).

Neonatal abstinence syndrome (NAS) is a group of physiologic and neurobehavioral signs of withdrawal that 

may occur in a newborn who was exposed to psychotropic substances (e.g., opioids) in utero. Opioid use, 

whether resulting from prescription misuse or from illicit use, has consequences for the mother–infant dyad, with 

anywhere from 50 to 80 percent of opioid-exposed infants developing NAS (Jones, Chisolm, Jansson, & Terplan, 

2012; Patrick, Dudley, et al., 2015). 

From 2009 to 2012, the number of infants diagnosed with NAS increased from 3.4 to 5.8 per 1,000 hospital births, 

with more than 20,000 infants diagnosed with NAS in 2012 (Patrick, Davis, Lehmann, & Cooper, 2015). The rate of 

NAS per 1,000 hospital births is not uniform across the nation; rates in rural regions are generally higher than those 

in urban regions (Villapiano, Winkelman, Kozhimannil, Davis, & Patrick, 2017). The increase in numbers of infants with 

NAS, along with other complications, and approach the hospital takes to treating NAS contributes to substantially 

increased hospital costs, with an average mean charge of $93,400 in 2012 dollars (Patrick, Davis, et al., 2015). 

Barriers to Treatment

Women with OUD and their infants face critical barriers to optimal care such as legal consequences in several 

states with statutes that sanction pregnant women with OUD. The goal of these efforts is to protect the fetus 

or infant from opioid exposure (Guttmacher Institute, 2017; House, 

Coker, & Stowe, 2016) but these legal consequences may drive women 

away from available care, seeking care or continuing to engage in 

care thereby potentially leading to worse outcomes for both the fetus 

and mother (Angelotta, Weiss, Angelotta & Friedman, 2016). The 

dichotomy between such policies and recommendations of healthcare 

professionals (e.g., American Academy of Addiction Psychiatry, 2015; 

American Society of Addiction Medicine [ASAM], 2015; Committee 

on Healthcare for Underserved Women, ASAM, & American College 

of Obstetricians and Gynecologists [ACOG], 2011; Patrick, Schiff, & 

American Academy of Pediatrics [AAP] Committee on Substance Use 

and Prevention, 2017) with regard to substance use disorder (SUD) 

screening and treatment, reporting of substance use during pregnancy 

and the postpartum period, and involvement of child protection 

services can be confusing (House et al., 2016). The shame associated 

with OUD during pregnancy and motherhood and the misinformation 
3

among healthcare professionals and systems that results in reluctance to provide care 

for such women, are also significant barriers. Together, these barriers can prevent 

women from receiving essential prenatal care or treatment for their OUD until they are 

close to delivery or in labor. Barriers can also prevent the woman from receiving essential 

care during the postpartum period. Without treatment, pregnant women with OUD face 

increased risks of preterm delivery, low infant birth weight, and transmitting HIV to their 

infants (Binder & Vavrinková, 2008). 

Effective Interventions and Guidelines

Effective interventions for OUD, including medication-assisted treatment (MAT), do 

exist, and healthy outcomes can occur for both the mother and the infant, but only 

when healthcare professionals can recognize and treat SUDs, which include OUD, 

and substance exposure in infants. The Substance Abuse and Mental Health Services 

Administration (SAMHSA) developed the clinical guidance in this document to meet 

an urgent need among professionals who care for women with OUD and substanceexposed infants for reliable, useful, and accurate information that can be applied in clinical practice to 

optimize the outcome for both mother and infant.

Currently, guidelines for treatment of pregnant women with OUD are available at global, country, and 

state levels (e.g., Commonwealth of Pennsylvania, 2016; Council of the Society of Obstetricians and 

Gynaecologists of Canada, 2011; New South Wales Ministry of Health, Australia, 2006; Norwegian Directorate 

of Health, 2011; Vermont Department of Health, Division of Alcohol and Substance Abuse Programs, & 

Department of Vermont Health Access, 2010; World Health Organization [WHO], 2014). SAMHSA has 

published two guides specifically for pregnant women with OUD in recent years: Methadone Treatment for 

Pregnant Women (SAMHSA, 2014) and A Collaborative Approach to the Treatment of Pregnant Women 

With Opioid Use Disorders: Practice and Policy Considerations for Child Welfare, Collaborating Medical, 

and Service Providers (SAMHSA, 2016a). A recent CDC guideline (Dowell, Haegerich, & Chou, 2016) addresses 

issues in opioid prescribing, focusing on nonpharmacologic therapy and nonopioid pharmacologic therapy 

in the treatment of chronic pain in the general population. The CDC guideline recommends that, if opioids 

must be prescribed for acute pain, the effective dosage should be used for 3 or fewer days and rarely more 

than 7 days (Dowell et al., 2016, Box 1, Item #6). The CDC guideline does not specifically address the issue of 

OUD in pregnant women. ASAM National Practice Guideline for the Use of Medications in the Treatment of 

Addiction Involving Opioid Use devotes a chapter to special pharmacotherapy concerns for pregnant and 

parenting women (ASAM, 2015). 

The urgent need for clinical guidance supporting the individualized management of pregnant and 

parenting women with OUD was reinforced during the development of this Guide by audience responses to 

presentations of preliminary recommendations at the 2016 annual conferences of ASAM and the American 

Association for the Treatment of Opioid Dependence. At these conferences, SAMHSA staff and expert panel 

members (Exhibit A.1) provided updates on the completion of the RAND/UCLA Appropriateness Method 

(RAM) report and the development of this Guide. Conference attendees reaffirmed the need for resources 

such as this Guide to provide information on the most current pharmaceutical treatments, specifically MAT, to 

support recovery from opioid use in pregnant women and treatment for infants exposed to opioids in utero.

This Guide provides comprehensive, national guidance for the optimal management of pregnant and 

parenting women with OUD and their infants based on the recommendations of experts reviewing the limited 

evidence available for this population as of 2017. In the past, only one option was available for OUD treatment 

in pregnant women. Today, more options are available, so healthcare professionals need to provide more 

education to their patients and obtain their detailed informed consent to ensure decision-making is shared 

between the pregnant woman or new mother and the healthcare professional. This Guide will help healthcare 

professionals and patients determine the most clinically appropriate action for a particular circumstance, with 
4

Name, Degree Affiliation

Shahid Ali, MD, MBBS Meharry Medical College Rainbow Program

Diana Coffa, MD Department of Family and Community Medicine, University of California San Francisco, School of Medicine

Deborah Finnell, DNS, PMHNP-BC, 

CARN-AP, FAAN

Department of Acute and Chronic Care, Johns Hopkins University School of Nursing

Lauren Jansson, MD Department of Pediatrics, Johns Hopkins University School of Medicine, and Center for Addiction and 

Pregnancy, Johns Hopkins Bayview Medical Center

Hendrée E. Jones, PhD, Chair University of North Carolina at Chapel Hill School of Medicine, Department of Obstetrics and Gynecology, 

and the UNC Horizons Program

Marjorie Meyer, MD, FACOG Maternal–Fetal Medicine Division, University of Vermont College of Medicine

Charles Schauberger, MD, MS, FACOG, CPE Gundersen Health System, La Crosse, Wisconsin

Mishka Terplan, MD, MPH, FACOG Department of Obstetrics and Gynecology, Virginia Commonwealth University School of Medicine

*The expert panel comprised health professionals and scientists representing diverse geographic areas and disciplines, 

including family practice, neonatology, nursing, obstetrics/gynecology, pediatrics, psychology, and psychiatry.

Exhibit A.1: Expert Panelists* 

the expectation that the healthcare professionals will make individualized treatment decisions. A cornerstone 

of the Guide is that a healthy pregnancy results in a healthy infant and mother. The Guide recognizes the 

mother and infant as a dyad, and the recommendations are provided in light of what actions will optimize 

the outcomes for the mother–infant dyad as a whole, with guidance provided from preconception to several 

months postpartum and for the first few years of infant development. 

Definition of Terms 

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, defines OUD as “a problematic 

pattern of opioid use leading to clinically significant impairment or distress” (American Psychiatric Association, 

2013). People with OUD typically experience a strong desire for opioids, inability to control or reduce use, 

continued use despite interference with major obligations or social functioning, use of larger amounts over 

time, development of tolerance, spending a great deal of time to obtain and use opioids, and withdrawal 

symptoms that occur after stopping or reducing use, such as negative mood, nausea or vomiting, muscle 

aches, diarrhea, fever, and insomnia (SAMHSA, 2015). The term infant is used in this document for infants at 

birth to the first 12 months, and the majority of the postnatal materials are focused on infants younger than 12 

months, although there are some recommendations for developmental assessments in young children.

Fetuses exposed to tobacco, alcohol, prescription medications (e.g., benzodiazepines), and illicit substances 

may exhibit signs of physiologic withdrawal from these substances after birth. NAS is a nonspecific term 

assigned to this type of presentation in the newborn. It is widely applied clinically and in the published 

literature to infants withdrawing from opioids. However, the more specific term neonatal opioid withdrawal 

syndrome (NOWS) is becoming more widely used. The utility of the more specific NOWS term is to 

more accurately identify the numbers of infants experiencing withdrawal from opioid exposure in 

utero. This distinction is important because specific screening and treatment protocols 

can be used to promote the best outcomes for these infants whereas infants not 

exposed to opioids may require different assessment (e.g., Neonatal Intensive 

Care Unit Network Neurobehavioral Scale) and management (e.g., other 

medication to treat withdrawal).
5

However, the published literature uses the more general NAS term, and, in clinical practice, prenatally 

substance-exposed infants are typically exposed to multiple substances. The research publications relied on 

to support this Guide almost universally studied pregnant women with SUD, rather than OUD only. As such, 

this Guide uses the term NAS when referring to the withdrawal symptoms expressed by infants delivered to 

mothers with SUD, including OUD. 

Creation of the Guide 

This Guide recommends feasible, standard approaches to the care of pregnant and parenting women with 

OUD and their infants that can be adopted in care settings throughout the United States.

 It also provides clinical guidance for healthcare professionals seeking to optimize 

outcomes for women and infants in their care. The following sections briefly describe 

the rationale for selecting the RAND/UCLA Appropriateness Method ([RAM]; Fitch et al., 

2001) to accomplish these goals and how RAM results were clinically translated into this 

Guide. Healthcare professionals may need to adjust their approaches and processes as 

higher quality evidence and new information about OUD treatments become available. 

The rationale for applying RAM to the creation of this Guide is twofold. First, randomized 

clinical trials—the “gold standard” for evidence-based medicine—are generally not 

conducted with this population. Second, even when such trials do exist, they may not 

provide direct evidence at a sufficient level of detail to apply to the range of patients that 

healthcare professionals see in their daily practice. Where there was no robust evidence 

for a particular practice or treatment approach, RAM reviewers rated the treatment 

options based on their expertise and clinical experience with the patient population. 

Exhibit A.2: Guidelines Used To Inform the RAM Process

• Clinical Protocol #21: Guidelines for Breastfeeding and Substance Use or Substance Use Disorder, 

Revised 2015 (Reece-Stremtan, Marinelli, & Academy of Breastfeeding Medicine, 2015) 

• Clinical Report: Neonatal Drug Withdrawal (revised)—Guidance for the Clinician in Rendering 

Pediatric Care (Hudak, Tan, AAP Committee on Drugs, & AAP Committee on Fetus and Newborn, 

2012) 

• Committee Opinion No. 524: Opioid abuse, dependence, and addiction in pregnancy. Committee on 

Healthcare for Underserved Women, American Society of Addiction Medicine, & American College 

of Obstetricians and Gynecologists. (2012, reaffirmed 2016). 

• Guidelines for the Identification and Management of Substance Use and Substance Use Disorders 

in Pregnancy (WHO, 2014) 

• National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving 

Opioid Use (ASAM, 2015)

The expert panelists and Federal Steering Committee 

did not review the use of the long-acting forms of 

buprenorphine because they had not been approved 

by FDA at the time of the RAM review.
6

Name, Degree Affiliation

Sonia Hernandez-Diaz, MD, DrPH Pharmacoepidemiology Program, Harvard School of Public Health

Karol Kaltenbach, PhD, Emeritus Pediatrics, Sidney Kimmel Medical College Thomas Jefferson University

Walter Ling, MD Psychiatry and Biobehavioral Sciences and Integrated Substance Abuse Program, University of California 

Los Angeles, David Geffen School of Medicine

Exhibit A.3: Scientific Advisors for the Expert Panel

Assistant Secretary for Planning and Evaluation, HHS National Institutes of Health, HHS

Centers for Disease Control and Prevention, HHS Office of National Drug Control Policy, The White House

Centers for Medicare & Medicaid Services, HHS Office of the Assistant Secretary for Health, HHS

Federal Bureau of Prisons, U.S. Department of Justice Office on Women’s Health, HHS

Food and Drug Administration, HHS Substance Abuse and Mental Health Services Administration, HHS

Health Resources and Services Administration, HHS U.S. Department of Defense

Indian Health Service, HHS U.S. Department of Veterans Affairs

Exhibit A.4: Agencies and Offices Participating in the FSC

RAM Methodology 

The expert panelists’ evidence review and rating processes were informed by an extensive literature review 

(Klaman et al., 2017), evidence from 5 published guidelines (Exhibit A.2), expertise of 3 scientific advisors 

(Exhibit A.3) who participated in discussions during the in-person expert panel work session but did not rate 

the items under consideration, and input from the Federal Steering Committee (FSC) representing 14 agencies, 

including SAMHSA (Exhibit A.4).

The members of the FSC oversaw the entire RAM process and development of the RAM report and provided 

agency perspectives when needed. 

The expert panel and FSC considered the use of methadone, buprenorphine, buprenorphine/naloxone, and 

naltrexone in pregnant and parenting women with OUD as well as the option of medically-supervised withdrawal. 

They did not review the use of the long-acting buprenorphine implant (Probuphine®) because it had not been 

approved at the time of the RAM review. In addition, the product labeling states that the buprenorphine implant 

dose cannot be adjusted, so it may not be the best treatment option for pregnant patients who frequently need 

dose adjustments in later stages of pregnancy (Braeburn Pharmaceuticals, Inc., 2016).

Limitations to the RAM Process and Gaps Identified in the Research 

Few clinical trials have been conducted on pregnant or parenting women with OUD. In many cases, only a 

few papers exist on this specific topic, and some papers had insufficient statistical power to support strong 

recommendations promoting or discouraging a particular intervention. The RAM process revealed that there 

was a limited evidence base for nearly two-thirds of the clinical actions expected in the management of the 

mother–infant dyad in the context of OUD. Accordingly, expert panelists had to rate the clinical decisions 

based on summary statements from other guidelines and the literature, in tandem with their own clinical 

experience and advice from the scientific advisors and FSC members. A thorough review of the gaps identified 

in the research on pregnant women with OUD is available in Klaman et al. (2017). 
7

Section I: Prenatal Care

• Factsheet #1: Prenatal Screenings and Assessments

• Factsheet #2: Initiating Pharmacotherapy for Opioid Use Disorder

• Factsheet #3: Changing Pharmacotherapy During Pregnancy

• Factsheet #4: Managing Pharmacotherapy Over the Course of Pregnancy

• Factsheet #5: Pregnant Women With Opioid Use Disorder And Comorbid Behavioral Health Disorders

• Factsheet #6: Addressing Polysubstance Use During Pregnancy

• Factsheet #7: Planning Prior to Labor and Delivery

• Factsheet #8: Peripartum Pain Relief 

Section II: Infant Care

• Factsheet #9: Screening and Assessment for Neonatal Abstinence Syndrome

• Factsheet #10: Management of Neonatal Abstinence Syndrome

• Factsheet #11: Breastfeeding Considerations for Infants at Risk for Neonatal Abstinence Syndrome

• Factsheet #12: Infant Discharge Planning

• Factsheet #13: Early Interventions Strategies and Developmental Assessments

Section III: Maternal Postnatal Care

• Factsheet #14: Adjusting Pharmacotherapy Dose Postpartum

• Factsheet #15: Maternal Discharge Planning 

• Factsheet #16: Maternal Return to Substance Use

Exhibit A.5: Factsheets in Clinical Guidance for Treating Pregnant and Parenting Women 

With Opioid Use Disorder and Their Infants

A detailed report on the RAM process was made available 

for public comment for 30 days (SAMHSA, 2016b). 

Relevant comments and suggestions from the public were 

incorporated into the Guide during its development.

Healthcare professionals can use the Guide to help 

women and their families consider their options and make 

critical decisions for themselves and their infants. All RAM 

participants were mindful of patient autonomy throughout 

the deliberation process. Given the principle of patient autonomy, pregnant and parenting women are free to 

make decisions based on their understanding of their illness, its process, and its outcomes. However, because 

of the nature of the maternal–fetal dyad and mother–infant dyad, RAM participants were also attentive to 

the complexity of offering the best treatment options for the mother and the infant and balancing the needs 

of both patients (Velez & Jansson, 2008). The release of this Guide is an important step toward ensuring 

that healthcare professionals have access to and are aware of research relevant to the care of pregnant and 

parenting women who have OUD and their infants.

How To Use the Clinical Guide

With even the soundest of evidence, research findings can be difficult to apply clinically. In practice, unique patient 

variables, the mother’s preferences, the experience of the clinician, and available resources must be considered. 

Because of the lack of robust evidence 

to inform guidance on clinical actions for 

pregnant women, expert panelists used 

the RAND/UCLA Appropriateness Method 

to establish the best recommendations 

possible at the time.
8

The Guide consists of Part A: Introduction, Part B: Clinical Guidance (Factsheets 1–16), Part C: Conclusion, and 

Appendices A–D. References are located at the end of Part A and at the end of each section in Part B. Appendix 

C compiles all the references cited and resources mentioned throughout the Guide for easy reference. 

As shown in Exhibit A.5, the factsheets in Part B are grouped into three categories: Section I: Prenatal Care (Factsheets 

#1–8); Section II: Infant Care (Factsheets #9–13); and Section III: Maternal Postnatal Care (Factsheets #14–16). 

Each factsheet contains four elements, as detailed in Exhibit A.6. The concise recommendations in this Guide 

(the Clinical Action Steps) are accompanied by Supporting Evidence and Clinical Considerations that are 

more discursive and can assist the healthcare professional in making evidence-informed decisions that are 

individualized to the needs of each patient and local circumstances. 

Exhibit A.6: Factsheet Elements

I. Clinical Scenario

Presents a brief statement to orient the healthcare professional to the situation under 

consideration.

II. Clinical Action Steps

Present recommendations that are derived directly from the rated clinical decisions in the 

RAM report and describe what can, might, or should not be done when caring for women 

and their infants.

III. Supporting Evidence and Clinical Considerations

Present strengths and weaknesses of the evidence supporting the clinical action steps. 

This section describes how to address or tailor recommended actions to unique patient 

variables and preferences, the necessary clinical experience of the provider, and available 

community resources. Guidance is based on expert panel and FSC discussions and 

additional information on treatment recommendations. For the most part, the topics in 

this section lack sufficient evidence to recommend a clear course 

of action. Instead, they detail elements that must be taken into 

consideration when making a decision with the pregnant woman 

or new mother about the best course of action.

IV. Web Resources

Provide links to additional online information.

There are three appendices: Appendix A is a compilation of suitable 

development assessments for opioid-exposed infants and children; Appendix B 

is a glossary and list of acronyms; and Appendix C is a master list of references. 

Users may download the Guide as a single PDF document and print out 

sections and factsheets of particular interest. Text in boldface indicates that 

more information about the item or the item itself is hyperlinked and can 

be downloaded directly from this document. The term FS # is used in the 

factsheets to number exhibits (e.g., FS #1.1 indicates the first exhibit in Factsheet 

#1). Healthcare professionals are encouraged to sign up at www.samhsa.gov to 

receive updates on information in the factsheets.
9

2015 National Drug Threat Assessment Summary

This Drug Enforcement Administration report provides recent data on drug availability and usage, 

including heroin and controlled substances. 

Advancing the Care of Women With Opioid Use Disorder While Pregnant or Parenting: Clinical 

Indications for Developing a National Guide

This SAMHSA report describes the process by which clinical indications were prepared and the review of 

current treatment for pregnant and parenting women with OUD.

ASAM National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving 

Opioid Use 

This ASAM publication provides information on evidence-based treatment of OUD.

Children's Bureau Information Memorandum (IM)

The purpose of this information memorandum from the Administration for Children & Families is to inform 

states of the enactment of the 2016 Comprehensive Addiction and Recovery Act (Public Law 114-198) 

and provide basic information on the resulting changes in the Child Abuse Prevention and Treatment Act 

for child abuse or neglect prevention and treatment programs. This memorandum outlines related best 

practices.

Fact Sheet—FDA Opioids Action Plan

This 2016 Food and Drug Administration publication details the plans the agency has developed to combat 

opioid abuse, dependence, and overdose in the United States. 

Protecting Our Infants Act Report to Congress 

This SAMHSA report provides information on the Act mandating that HHS conduct a review of planning 

and coordination activities related to prenatal opioid exposure and NAS; develop recommendations for the 

identification, prevention, and treatment of prenatal opioid exposure and NAS; and develop a strategy to 

address gaps, overlap, and duplication among federal programs and coordination efforts to address NAS.

Substance Use Disorder

This SAMHSA website provides the facts on common SUDs such as those related to alcohol, tobacco, 

cannabis, stimulants, hallucinogens, and opioids.

TIP addressing Medications for Opioid Use Disorder. In press.

SAMHSA will release a new TIP on addressing medications for opioid use disorder in early 2018. Please 

check the SAMHSA Store for the new TIP.

U.S. Department of Health and Human Services Final Rule

This SAMHSA report describes the final rule that expands access to pharmacotherapy by allowing 

eligible healthcare professionals to request approval to treat up to 275 patients under section 303(g)

(2) of the Controlled Substance Act. The final rule also includes requirements to ensure that patients 

receive the full array of evidence-based MAT services and to minimize the risk that the treatment 

medications are misused or diverted.

Final Report: Opioid Use, Misuse, and Overdose in Women

This HHS Office on Women’s Health publication provides an overview of the prevention, treatment, and 

recovery issues for women who misuse opioids, have OUD, and/or overdose on opioids.

WEB RESOURCES
10

References

Ailes, E. C., Dawson, A. L., Lind, J. N., Gilboa, S. M., Frey, M. T., Broussard, C. S., & Honein, M. A. (2015, January 

23). Opioid prescription claims among women of reproductive age—United States, 2008–2012. Morbidity and 

Mortality Weekly Report, 64(2), 37–41.

American Academy of Addiction Psychiatry. (2015). Use of illegal and harmful substances by pregnant women. 

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13

Part B: Factsheets

Part B consists of 16 factsheets organized into three sections:

Section I: Prenatal Care

Factsheet #1: Prenatal Screenings and Assessments

Factsheet #2: Initiating Pharmacotherapy for Opioid Use Disorder

Factsheet #3: Changing Pharmacotherapy During Pregnancy

Factsheet #4: Managing Pharmacotherapy Over the Course of Pregnancy

Factsheet #5: Pregnant Women With Opioid Use Disorder And Comorbid Behavioral Health Disorders

Factsheet #6: Addressing Polysubstance Use During Pregnancy

Factsheet #7: Planning Prior to Labor and Delivery

Factsheet #8: Peripartum Pain Relief

Section II: Infant Care

Factsheet #9: Screening and Assessment for Neonatal Abstinence Syndrome

Factsheet #10: Management of Neonatal Abstinence Syndrome

Factsheet #11: Breastfeeding Considerations for Infants at Risk for Neonatal Abstinence Syndrome

Factsheet #12: Infant Discharge Planning

Factsheet #13: Early Interventions Strategies and Developmental Assessments

Section III: Maternal Postnatal Care

Factsheet #14: Adjusting Pharmacotherapy Dose Postpartum

Factsheet #15: Maternal Discharge Planning

Factsheet #16: Maternal Return to Substance Use
14

Section I: Prenatal Care

Section I consists of eight factsheets:

Factsheet #1: Prenatal Screenings and Assessments

Factsheet #2: Initiating Pharmacotherapy for Opioid Use Disorder

Factsheet #3: Changing Pharmacotherapy During Pregnancy

Factsheet #4: Managing Pharmacotherapy Over the Course of Pregnancy

Factsheet #5: Pregnant Women With Opioid Use Disorder and Comorbid Behavioral Health Disorders

Factsheet #6: Addressing Polysubstance Use During Pregnancy

Factsheet #7: Planning Prior to Labor and Delivery

Factsheet #8: Peripartum Pain Relief

Each factsheet contains four components.

I. Clinical Scenario

Presents a brief statement to orient the reader to the situation under consideration.

II. Clinical Action Steps

Present recommendations that are derived directly from the rated clinical decisions in the 

RAND/UCLA Appropriateness Method report and describe what can, might, or should not be 

done when caring for women and their infants.

III. Supporting Evidence and Clinical Considerations

Present strengths and weaknesses of the evidence supporting the clinical action steps. This 

section describes how to address or tailor recommended actions to unique patient variables 

and preferences, the clinical experience of the provider, and available community resources. 

Guidance is based on expert panel and Federal Steering Committee discussions and additional 

information from published articles. For the most part, the topics in this section lack 

sufficient evidence to recommend a clear course of action. Instead, they detail elements 

that must be taken into consideration when making a decision with the pregnant woman or 

new mother about the best course of action.

IV. Web Resources

Provide links to additional online information.

FACTSHEET #1: Prenatal Screenings and Assessments

CLINICAL SCENARIO: A pregnant woman with opioid use disorder (OUD) presents for care.

• Screenings

• Prescription drug monitoring program

• Social, medical, and legal consequences

• Prenatal care access and OUD

• Pharmacotherapy, pregnancy, and care 

coordination

• Opportunities for positive change

• Adjusting to pharmacotherapy, other medications, 

and pregnancy

• OUD and HIV/AIDS, viral hepatitis infection, and 

sexually transmitted infections
15

FACTSHEET #2: Initiating Pharmacotherapy for Opioid Use Disorder

CLINICAL SCENARIO: A pregnant woman with OUD requests treatment.

• Medication-assisted treatment (MAT)

• Patient education

• Addressing infant safety and pharmacotherapy

• Pharmacotherapy and withdrawals and cravings

• Substance Abuse and Mental Health Services 

Administration treatment directories

• Informed consent for pregnant patients

• Individualized treatment plans

• Discussing treatment-specific potential legal, 

social, and medical consequences, including 

neonatal abstinence syndrome (NAS)

FACTSHEET #3: Changing Pharmacotherapy During Pregnancy

CLINICAL SCENARIO: A pregnant woman wishes to discuss changing her existing pharmacotherapy 

for OUD or wants to undergo medically supervised withdrawal from opioids.

• Prioritizing patient stability

• Medically supervised withdrawal concerns and 

considerations

• Discussing changes to opioid agonist treatment

• NAS severity and maternal pharmacotherapy dose 

not correlated

• Expanding actions for improving maternal and 

infant health

• Evolving positions on transitioning between 

combination buprenorphine/naloxone and 

buprenorphine-only products

• Changes in pharmacotherapy and potential return 

to substance use

• Daily interactions and observed dosing

• Discouraging perinatal pharmacotherapy 

withdrawal

FACTSHEET #4: Managing Pharmacotherapy Over the Course of Pregnancy

CLINICAL SCENARIO: A pregnant woman treated with pharmacotherapy for OUD is experiencing 

withdrawal or cravings.

• Common pharmacotherapy adjustments

• Pregnancy and medication metabolism increases

• Pharmacotherapy dose not associated with NAS

• Benefits of counseling

• Role for peer support specialists

• Support with mutual-aid groups accepting of 

pharmacotherapy

FACTSHEET #5: Pregnant Women with Opioid Use Disorder and Comorbid 

Behavioral Health Disorders

CLINICAL SCENARIO: A pregnant woman with opioid use disorder (OUD) and comorbid behavioral 

health disorders needs help managing these conditions.

• Balancing maternal mental health needs and fetal 

polypharmacy considerations

• Comorbid mental health conditions common with 

OUD

• Considering possible drug interactions

• Complexity of treating comorbid substance use 

and mental health disorders

• Antidepressants, anticonvulsants, anxiolytics, and 

NAS

• Risks of combining benzodiazepines with opioid 

agonist treatment

• Widespread discrimination, prejudice, and bias 

against people with substance use and/or mental 

disorders
16

FACTSHEET #6: Addressing Polysubstance Use During Pregnancy

CLINICAL SCENARIO: A pregnant women with OUD requires help on (1) a return to opioid use; 

(2) her use of alcohol, cocaine, cannabis, or tobacco; (3) her comorbid misuse of prescribed 

medications, including benzodiazepines, amphetamines, or other pharmacotherapies, whether 

licitly or illicitly obtained; and (4) the impact of these medications and other substances on her 

health and that of the fetus.

• Return to opioid use

• Return to other substance use

• Return to substance use is common and often a 

dynamic process

• Polysubstance use concerns for women and infants

• A variety of prescription and illicit substances can 

affect NAS

• Pregnancy, medication metabolism, and dose 

adjustment

• Smoking and association with poorer pregnancy, 

fetal development, and postnatal infant outcomes

• Cannabis and low birth weight infants

• Coordination with hospital resources and 

comprehensive healthcare plans

FACTSHEET #7: Planning Prior to Labor and Delivery

CLINICAL SCENARIO: A pregnant woman with OUD has questions about NAS, support services, and 

postpartum planning.

FACTSHEET #8: Peripartum Pain Relief 

CLINICAL SCENARIO: A pregnant woman with OUD, in treatment or not, needs pain relief during 

her labor, delivery, and postpartum period.

• Patient education on NAS

• Healthy home environment

• Contraception, unintended pregnancies, and 

planning future pregnancies

• Explaining opioid withdrawal and tolerance

• Discussing various steps to maximize maternal and 

fetal health

• Including breastfeeding benefits in delivery planning

• Community-based supports for mothers in recovery

• Consumer-, patient-, and peer-based community 

supports

• Pain management options

• Differentiating OUD pharmacotherapy and pain 

management

• Documenting pain discussion in medical records

• Analgesia adequacy and ensuring pain relief

• Contraindicated medications
17

CLINICAL SCENARIO

A pregnant woman with opioid use disorder (OUD) presents for care.

CLINICAL ACTION STEPS

Screenings

When a pregnant woman presents requesting prenatal care and help with her substance use disorder, 

conduct a careful, empathetic, and nonjudgmental interview with her that lets her know that all new patients 

are asked the same questions about substance use. Because polysubstance use is common, a validated 

screening instrument for other substance use may also be given to the patient for self-completion and 

reviewed by a healthcare professional. This screening should be conducted in a clinically appropriate and 

therapeutic manner. To ensure that information is gathered and addressed effectively, screening may be part 

of a formal screening, brief intervention, and referral to treatment (SBIRT) protocol such as that created by 

the Substance Abuse and Mental Health Services Administration (SAMHSA). 

Prescription Drug Monitoring Program (PDMP)

A review of data in the state’s PDMP to identify all reported medications that have been prescribed to the 

woman needs to be included as part of the initial visit and rechecked over the course of the care. 

Medical, Social, and Legal Consequences 

Pregnant women with OUD should receive counseling 

and education on the medical and social consequences 

of pharmacotherapy for OUD, continued use of legal and 

illicit substances while pregnant, and withdrawal from 

opioids while pregnant with inherent risks to mother and 

fetus of relapse.

Owing to differing state, county and local laws and 

regulations, there is no universal approach to assessing 

the social and legal consequences of legitimate 

pharmacotherapy for OUD or other substance use 

during pregnancy.

FACTSHEET #

PRENATAL SCREENINGS 

AND ASSESSMENTS 

1

SECTION 1

Section 1: Factsheet 1
18

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

Screenings

• Types of screenings vary. The World Health Organization’s (WHO’s) Guidelines for the Identification and 

Management of Substance Use and Substance Use Disorders in Pregnancy recommends that healthcare 

professionals ask all pregnant women about their use of alcohol and other substances (i.e., past, present, 

prescribed, licit, and illicit use) as early as possible in the pregnancy and at every follow-up visit (WHO, 

2014). Healthcare professionals need to determine whether any of their pregnant patients are currently 

taking (or have recently taken) methadone, 

buprenorphine or other long-acting opioids (Breen 

et al., 2003; Chasnoff, 2003; Kraus et al., 2011).

	  Interviews and Instruments

A complete substance use history is essential to 

establishing a safe and appropriate treatment 

plan that the woman and the healthcare 

professionals can agree on (Federation of 

State Medical Boards [FSMB], 2013). This 

history combines interviews and results from 

standardized assessment instruments. Ideally, the history would include (SAMHSA, 2015): 

	  The nature of the patient’s SUDs.

	  Underlying or co-occurring diseases or conditions.

	  The effect of opioid use on the patient’s physical and psychological functioning. 

	  Outcomes of past treatment episodes 

Exhibit FS #1.1 provides a list of common paper-and-pencil screening tools for substance use.

	  Toxicology Screens

The pregnant woman should be asked to provide informed consent for urine, 

blood, or saliva screenings for substance use. Although oral informed consent 

is used in many labor-and-delivery clinics, a signed paper or electronic form is 

preferred. The healthcare professional should review with the pregnant woman 

the risks and limitations of each type of test and the need for confirmatory 

testing for any positive results (e.g., using gas chromatography/mass 

spectrometry confirmation) and ensure that she understands the process and 

meaning of test results before specimen collection (e.g., known false-positive 

test results may be due to cross-reactions of other substances such as cold 

medicines, which can produce a positive amphetamine result). It is helpful to 

ask the pregnant woman what, if anything, she expects might be detected and 

to give her an opportunity to describe her substance use patterns and behavior. 

The toxicology screen should be obtained even when substance use is selfreported so that a baseline can be confirmed. In addition to the routine HIV, 

sexually transmitted infections, and hepatitis screens ordered for all pregnant 

women, other laboratory tests should be ordered when an SUD is possible. The 

standard testing for sexually transmitted infections (e.g., syphilis) done at the 

initial prenatal assessment may be repeated in the third trimester or at delivery.

The mother’s history should include illicit and 

licit substance use before and during pregnancy 

with special attention to high-risk behaviors 

such as injecting drug use, current exposure to 

interpersonal violence, and behavioral health 

history such as anxiety, depression, or trauma.

Section 1: Factsheet 1
19

Measure Substance/ Health 

Problem Screened

# of 

Items

Method of 

Administration

Training in 

Administration 

Necessary?

Validation 

Sample(s)

Sensitivity Specificity

4P’s Plus©a and Integrated 

5P’s

Integrated 5P’s: 

Violence, mental 

health, tobacco, 

alcohol, and illicit 

substances 

4 Paper-andpencilNo Inpatient 

and 

outpatient

87% 76%

Substance Use Risk 

Profile–Pregnancy 

(SURP-Pb,c,d)

Alcohol and 

substances

3 Paper-andpencilNo Prenatal 

clinic

Low risk: 

80–100%

High risk: 

48–100%

Low risk: 

61–64%

High risk: 

84–86%

Tolerance, Annoyed, Cutdown, Eye-opener (T-ACE)Alcohol 4 Paper-andpencilNo Prenatal 

clinic

60–91%d 37–79%d

Tolerance, Worried, 

Eye-opener, Amnesia, 

K[C]ut-down (TWEAK)

Alcohol 5 Paper-andpencilNo Prenatal 

clinic

59–92%d 64–92%d

Exhibit FS #1.1: Examples of Instruments To Detect Substance Use in Pregnant Women

a

Only the 4P’s Plus screening tool includes psychometrics; the 5P’s tool is in the public domain. 

bThe SURP-P does not have an online version. See Yonkers et al. (2010) to review the instrument.

c

Alcohol, marijuana, cocaine, sedatives, and opioids.. 

dSensitivities and specificities vary depending on the cut point used to determine risk. 

Sources: 4P’s Plus: Ewing 1990; Chasnoff et al., 2005; Integrated 5P’s: Finkelstein, Hutchins & 

Mahoney, 2004; SURP-P: Yonkers et al., 2010; T-ACE: Sokol, Martier & Ager, 1989; TWEAK: Russell 

& Skinner, 1988.

Section 1: Factsheet 1
20

PDMPs 

• State-based PDMPs collect data from pharmacies 

on prescriptions of controlled substances. Using 

PDMP data, it is possible to determine whether 

patients are going to multiple doctors to get 

prescriptions for controlled substances (Patrick, 

Fry, Jones, & Buntin, 2016). Healthcare professionals 

should consult their state’s PDMP for the patient’s 

prescription drug use history. Periodically, checking 

the PDMP database can confirm the controlled 

prescription medications the patient reports taking 

and detect unreported use of other controlled 

prescription medications that may be hazardous in 

pregnancy (FSMB, 2013). State boards of medicine 

and pharmacy can provide information about how 

to access the PDMP.

 If drug use is possible or confirmed, WHO 

recommends conducting a brief intervention (WHO, 2014). SAMHSA’s evidence-based SBIRT protocol identifies, 

reduces, and prevents alcohol and illicit drug use. SBIRT builds on a behavioral intervention foundation known 

as motivational interviewing. More about motivational interviewing is available in SAMHSA’s Quick Guide for 

Clinicians Based on TIP 34: Brief Interventions and Brief Therapies for Substance Abuse (SAMHSA, 2001). 

Social, Medical, and Legal Consequences

• Too often, pregnant woman with OUD receive no, or very little, prenatal care. With no healthcare 

professional to monitor their pregnancy, women with OUD may present in a hospital emergency department 

late in pregnancy or in labor. This happens because women may not recognize they were pregnant, fear 

being incarcerated for illicit drug use or for exposing their fetus to illicit drugs, lack funds to pay for services, 

transportation or daycare, and/or fear losing custody of their other children (Howard, 2016). 

 Attending to the woman’s immediate needs is important. For any pregnancy, the healthcare professional’s 

priority is to ensure the well-being of the woman and fetus. In the context of a possible SUD, learning as 

much as possible about her opioid use (i.e., 

type, amount, route, duration, and time of 

last use) provides the foundation for possible 

treatment. It is critical to know whether she 

is on pharmacotherapy for OUD and, if so, 

which medication she receives so that it can be 

continued as appropriate. If she is receiving or 

desires SUD treatment, obtain her consent to 

communicate with her treatment provider or have 

a care manager facilitate an effective referral. 

• For women who are already on pharmacotherapy for OUD and then become pregnant, it is important 

to coordinate care with all healthcare professionals. It could be useful to complete a paper or electronic 

consent form such as those provided at https://pcssmat.org/opioid-resources/clinical-tools/ to secure 

the sort of information releases that will be necessary to coordinate care among healthcare professionals 

who write pharmacotherapy prescriptions, those who may manage other behavioral health issue, and 

those providing prenatal care. Electronic systems for managing patient consent to share protected health 

information are also an option. One example is SAMHSA’s Consent2Share.

Common laboratory tests for pregnant women 

with possible SUD include:*

• Urine toxicology screen for opioids and illicit 

drugs used in the community that includes 

confirmatory testing.

• Urine screen for alcohol that includes 

confirmatory testing.

• Screen for HIV, hepatitis B and C, and sexually 

transmitted infections

• Liver enzymes and serum bilirubin test to 

detect liver disease.

• Serum creatinine levels test to detect silent 

renal disease.

*Sources: Gourlay, Heit, & Caplan, 2010; Saitz, 2009; SAMHSA, 2015

• Public Policy Statement on Women, Alcohol 

and Other Drugs, and Pregnancy (American 

Society of Addiction Medicine [ASAM], 2011)

• Treatment Improvement Protocol (TIP) 

35: Enhancing Motivation for Change in 

Substance Abuse Treatment (SAMHSA, 1999)

RESOURCES TO REVIEW

Section 1: Factsheet 1
21

Other Evidence/Considerations

• Pregnancy is a time of great potential for positive change. 

A woman with OUD may be motivated to enter treatment not only out of concern for the health of the fetus 

but also because during pregnancy she can envision a different future for herself and her child. In the past, it 

was generally believed that people with OUD could not successfully stop smoking or using other substances 

while they discontinued opioid use. However, when people are motivated to change, either to achieve a 

positive outcome or to avoid a negative one, they may be more successful at discontinuing substance use 

if all the addictive substances that they are using 

are addressed at once, whether alcohol, tobacco, 

or illicit drugs, including opioids. SUD is recognized 

to be a chronic disease with expected lapses. The 

pregnant and postpartum woman with OUD should 

be encouraged to keep trying, through a combination 

of pharmacotherapy and behavioral interventions, not 

abstinence, to reach the goal of ending substance use. 

 However, it is important to recognize that immediate and simultaneous discontinuation of all substances (e.g., 

alcohol, benzodiazepines, opioids) may not be feasible or even safe, particularly during pregnancy because 

of the additional risk to the developing fetus, which may also be going through withdrawal unmonitored. 

Withdrawal from one or multiple substances may require inpatient care (ASAM, 2015; Commonwealth of 

Pennsylvania, 2016; Jones et al., 2008, 2016; McCarthy, 

Leamon, Willits, & Salo, 2015; Meyer & Phillips, 2015). 

• Women who are new to pharmacotherapy for OUD 

may struggle to adjust to the changes related to 

pregnancy as well as those related to taking a new 

medication. For women new to treatment, receiving 

support and information about what to expect 

from treatment can ensure that their transition from 

the emergency department, or other settings where she may initially present, to the outpatient treatment 

environment is successful and care is coordinated with all treating healthcare professionals over time. 

Always give patients information on the recovery support and resources available in the community for 

pregnant and parenting women. This information may be available through your State Opioid Treatment 

Authority or a local recovery community organization. 

• Women with OUD are at higher risk for HIV/AIDS and viral hepatitis infection than women who do not 

use substances. Screening for HIV/AIDS and hepatitis B and C should be standard at any initial assessment, 

regardless of the stage of pregnancy, and may be done by the SUD treatment provider or prenatal healthcare 

professional. A significant body of literature informs treatment for HIV/AIDS in pregnant women; in many 

cases, the principles of such medical care also apply to pregnant women with OUD. Appropriate consent 

should be obtained to share the test results, 

coordinate care, and avoid burdening the patient 

with unnecessary repeat testing.

 In the context of OUD, it is important to know 

that methadone has significant pharmacokinetic 

interactions with many drugs, including 

HIV antiretroviral agents (McCance-Katz, 

Sullivan, & Nallani, 2010). If a patient is new to 

pharmacotherapy for OUD or wishes to resume 

SAMHSA offers clinical materials to assess 

clients’ or patients’ readiness to change and 

to end their substance use. Use motivational 

interviewing to identify and support positive 

changes to all health behaviors, starting with 

the riskiest ones.

SUD is recognized to be a chronic disease with 

expected lapses. The pregnant and postpartum 

woman with OUD should be encouraged to 

keep trying, through pharmacotherapy and 

behavioral interventions, not abstinence, to 

reach the goal of ending substance use. 

Section 1: Factsheet 1

Review FS#3 for a discussion of the risks 

associated with medically-supervised withdrawal.

This link provides examples of the sort of 

information releases that will be necessary to 

coordinate care: https://pcssmat.org/opioidresources/clinical-tools/.

CONTENT TO REVIEW
WEB RESOURCES ON THIS TOPIC

22

pharmacotherapy for OUD and is HIV-positive, 

consider using buprenorphine as the firstline treatment. Buprenorphine appears to 

have fewer clinically significant interactions 

with antiretroviral medications (Lee, Kresina, 

Campopiano, Lubran, & Clark, 2015). However, 

if a patient with co-occurring HIV/AIDS and 

OUD is already on a stable, therapeutic dose 

of methadone, she should not be switched 

to buprenorphine treatment, because of the 

potential for destabilization while making this 

transition (Bruce, Moody, Altice, Gourevitch, & 

Friedland, 2013; McCance-Katz et al., 2010).

Some HIV medications interact with OUD 

pharmacotherapy. All healthcare professionals 

must learn which HIV medications will interact 

with which opioid agonist medications and 

be prepared to work with other treating 

healthcare professionals to responsively make 

appropriate dose adjustments as needed. More 

information is available in Exhibit 3. Potential 

Interactions Between Buprenorphine and 

HIV Medications in Advisory: Sublingual and 

Transmucosal Buprenorphine for Opioid Use 

Disorder: Review and Update (SAMHSA, 2016) 

and McCance-Katz (2011).

RESOURCE TO REVIEW

A Collaborative Approach to the Treatment of Pregnant Women With Opioid Use Disorders: Practice and 

Policy Considerations for Child Welfare, Collaborating Medical, and Service Providers

This SAMHSA document provides information on the treatment of pregnant women with OUD, summarizes 

guidelines adopted by a variety of professional organizations, and presents a framework for organizing 

community efforts. It provides a coordinated, multisystem approach grounded in early identification and 

intervention to assist child welfare, medical, SUD treatment, and other systems in supporting families.

Advisory: Sublingual and Transmucosal Buprenorphine for Opioid Use Disorder: Review and Update 

This 2016 SAMHSA publication gives an overview of the use of sublingual and transmucosal buprenorphine 

treatment for OUD. 

Clinician Consultation Center Substance Use Warmline

The University of California, San Francisco’s, Clinician Consultation Center provides 

Substance Use Warmline consultation to health center providers. This is a free, real-time 

clinician-to-clinician telephone consultation, addressing the care and treatment of substance 

abuse, chronic pain, and behavioral health. Access the Warmline toll-free at: 1-855-300-3595 

(Monday-Friday, 10 a.m.-6 p.m. EDT). 

Clinical Drug Testing in Primary Care (Technical Assistance Publication [TAP] 32)

This 2012 SAMHSA TAP provides information that healthcare professionals need when 

deciding whether to introduce drug testing in their practices and gives guidance on 

implementing drug testing.

Consent2Share

This web-based application will be available in 2017 for patients to give their healthcare 

professionals consent to share their personal health information across the health system.

Section 1: Factsheet 1
23

Medication Assisted Treatment (MAT)

This SAMHSA website provides up-to-date information on MAT, including opioid treatment programs and 

additional information on behavioral therapy and medications to treat SUDs.

Obstetric Care for Women with Opioid Use Disorder

The Council on Patient Safety in Women’s Health Care is a consortium that promotes safe health care for every 

woman. This Safety Bundle is designed to facilitate standardization of clinical, scientific, and patient safety 

advances. The processes presented are subject to change as new information emerges. 

Public Policy Statement on Women, Alcohol and Other Drugs, and Pregnancy 

This 2011 ASAM publication provides the organization’s policy on care for women with SUDs.

Quick Guide for Clinicians Based on TIP 34: Brief Interventions and Brief Therapies in Substance Abuse 

This quick guide was developed to accompany SAMHSA’s TIP 34: Brief Interventions and Brief Therapies in 

Substance Abuse. It is based entirely on the TIP and is designed to meet the needs of the busy clinician for 

concise, easily accessed how-to information.

TIP 35: Enhancing Motivation for Change in Substance Abuse Treatment 

This SAMHSA TIP is intended to help clinicians influence the change process in their patients by incorporating 

motivational interventions into SUD treatment programs. The document describes different motivational 

interventions that can be used at all stages of change.

Vermont Guidelines for Medication Assisted Treatment for Pregnant Women 

This document provides healthcare professionals with basic information on 

managing OUD in pregnant women.

Viral Hepatitis and Young Persons Who Inject Prescription Opioids and Heroin

This Centers for Disease Control and Prevention website details the threat of 

hepatitis B and C in people who misuse opioids, especially those who inject these 

drugs.

PDMP Resources 

PDMP Training and Technical Assistance Center (TTAC) 

This website provides a variety of services and resources to fight the misuse, abuse, 

and diversion of prescription drugs. It also has information on the Prescription 

Behavior Surveillance System, an early warning tool to measure trends in controlled 

substance prescribing and dispensing and to provide information about medical use 

and possible nonmedical prescription drug abuse and diversion.

PDMP TTAC State Profiles 

This webpage provides links to PDMP profiles for each state and links to each state’s 

PDMP database. Although access to PDMP information varies by state, generally 

the information is available only to prescribing clinicians, law enforcement, and, 

sometimes, patients.

Screening Tool Resources

SBIRT

This SAMHSA webpage provides information and links to resources about SBIRT that 

clinicians can use to identify, reduce, and prevent alcohol and illicit drug problems.

Section 1: Factsheet 1
4P’s Plus/Integrated 5P’s

The 4P’s Plus screen is not available in the public domain. Instead, healthcare professionals can use the 

Institute for Health and Recovery’s Integrated 5P’s tool, which was adapted specifically for pregnant women. 

The questions in the 5P’s tool ask the pregnant woman about her parents’ and her partner’s past and present 

alcohol and drug use in a nonthreatening manner. 

SURP-P

The Substance Use Risk Profile-Pregnancy Scale screens for hazardous substance use in pregnant women. The 

scale has three questions; healthcare professionals assess women with a positive screen to determine which 

women need intervention and treatment. 

T-ACE

The Tolerance, Annoyed, Cut-down, Eye-opener screen detects alcohol use in pregnant women. It takes 

approximately 1 minute to administer and is frequently part of a routine patient questionnaire completed while 

waiting for a prenatal appointment. 

TWEAK

The Tolerance, Worried, Eye-opener, Amnesia, K[C]ut-down screen is a five-item scale to assess alcohol 

consumption during pregnancy. It takes less than 1 minute to administer and can be incorporated into waiting 

room procedures. 
25

A pregnant woman with opioid use disorder (OUD) requests treatment.

Medication-Assisted Treatment (MAT)

A pregnant woman with OUD should be offered MAT consisting of pharmacotherapy with methadone or 

buprenorphine and evidence-based behavioral interventions.

There is insufficient information about the safety of extended-release injectable naltrexone during pregnancy and 

the effects of intrauterine exposure to this medication. The expert panel did not agree on whether women on 

naltrexone should continue to use it during pregnancy. Women stable on naltrexone can be offered treatment with 

buprenorphine or methadone to prevent return to substance use if they choose to discontinue naltrexone injections. 

However, this transition must be carefully managed because patients on long-acting naltrexone are no longer opioid 

tolerant and the falling naltrexone level will result in increasing agonist activity over time during cross-titration. 

Patient Education

As soon as a pregnant woman is diagnosed with OUD, healthcare professionals should review and discuss the risks 

and benefits of each antagonist and agonist treatment option with her. Healthcare professional should inform her 

that pharmacotherapy is strongly recommended and that treatment without any pharmacotherapy is complicated 

by poor fetal health, high rates of return to substance use, and the consequences such as risk of overdose. 

Healthcare professionals should inform the pregnant woman of the possibility of neonatal abstinence syndrome 

(NAS) and counsel her on its diagnosis, management, and consequences. The woman should also receive 

education on ways to optimize the well-being of the fetus such as tobacco cessation and early pediatric care after 

delivery and hospital discharge. Healthcare professionals should ensure that she is aware of nonpharmacological 

interventions that should be provided to her infant to reduce NAS symptoms, including rooming-in.

The pregnant woman should be informed of the potential medical and social consequences of each form of 

therapy, specifically of the consequences that relate to NAS and unmonitored prenatal withdrawal.

No Known Risk of Increased Birth Defects With Pharmacotherapy for OUD

The woman should be informed that experts do not agree on whether intrauterine exposure to buprenorphine, 

buprenorphine/naloxone, or methadone results in lasting developmental or other problems for the 

infant. A woman receiving either buprenorphine or methadone should be informed that the benefits of 

pharmacotherapy for OUD during pregnancy outweigh the risks of untreated OUD. Healthcare professionals 

may want to reassure women that, to date, research has not shown that buprenorphine and methadone can 

cause an increase in birth defects and has minimal long-term neurodevelopmental impact. 

She should be informed that tobacco and alcohol exposure are known to be harmful to her and the fetus and 

should be provided with support to limit or preferably discontinue exposure to these substances. 

FACTSHEET #

INITIATING 

PHARMACOTHERAPY FOR 2

OPIOID USE DISORDER

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION 1

Section 1: Factsheet 2
26

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

MAT

• Pharmacotherapy, combined with behavioral interventions, helps people who misuse opioids avoid 

experiencing withdrawal symptoms or overwhelming cravings when the opioid misuse is stopped.

By blocking cyclic withdrawal symptoms associated with the misuse of short-acting opioids, methadone or 

buprenorphine can provide a more stabilized intrauterine environment. In addition, starting on pharmacotherapy 

can help the pregnant woman stop injecting drugs, a primary route of infection for people who use drugs. By 

controlling the symptoms of OUD (e.g., withdrawal, cravings), the pregnant woman can regain control, reengage 

in important obligations and activities in her life, and rebuild a stable social environment for herself and her 

family. Behavioral interventions are also recommended to provide maximum support for long-term recovery. 

Additional information on these therapies can be found at www.SAMHSA.gov/treatment.

• SAMHSA maintains nationwide directories 

of healthcare professionals who help people 

overcome substance use disorders (SUDs).

Pregnant women and new mothers can seek 

treatment for OUD at behavioral health treatment 

centers or opioid treatment programs. SAMHSA’s 

web-based Behavioral Health Treatment Services 

Locator and Opioid Treatment Program Directory

provide information about locations of treatment 

facilities for SUDs in the United States and U.S. 

territories.

Patient Education

• Conversations about informed consent with 

pregnant women who have OUD or who are on 

pharmacotherapy for opioid use can be complex.

Informed consent helps patients understand 

the likelihood that a specific pharmacotherapy 

will help them. Research indicates that often 

patients do not completely comprehend the 

risk statements that they are given (Krumholz, 

2010). All patients receiving prenatal or medical 

treatment must give their informed consent to 

be treated and indicate that they understand the 

treatment that is being provided, the risks and 

benefits of the treatment, the risk of not treating the OUD, and what to do in an emergency. 

 Experts do agree that any change in type of pharmacotherapy or a decision to continue or stop a particular 

medication during pregnancy should be made only when informed by the patient’s specific needs and 

concerns. In either case, the woman’s fully informed consent should be obtained after review of the risks 

and benefits of the course of treatment selected. 

 Consent requires patient education including answering questions and verifying understanding in order 

to support informed, and patient-centered, shared decision-making. Healthcare professionals should 

inform the pregnant women with OUD about the effects of pharmacotherapy for opioid use on the fetus, 

options for pharmacotherapy (i.e., different medications and scenarios), the risks of not treating OUD, the 

• Medication-Assisted Treatment Website

• Substance Use Disorders

• Treatments for Substance Use Disorders

RESOURCES TO REVIEW

• Factsheet #6: Addressing Polysubstance 

Use During Pregnancy, Exhibit FS #6.1, 

for additional discussion on tobacco use 

cessation and treatment options to address 

other substance use

• Factsheet #9: Screening and Assessment 

for Neonatal Abstinence Syndrome for 

information on the time course of NAS 

expression

• Factsheet #10: Management of Neonatal 

Abstinence Syndrome for strategies to reduce 

NAS symptoms

FACTSHEETS TO REVIEW

Section 1: Factsheet 2
27

likelihood the baby will develop NAS, and the 

possibility that NAS can worsen with the pregnant 

woman’s use of other substances, especially 

tobacco (Jones et al., 2013a; Patrick et al., 2015). 

Through discussion, the healthcare professional 

and the woman can make a shared decision about 

her course of treatment. 

• Treatment plans need to be individualized. 

Each pregnant woman with OUD who is in 

treatment needs her own individualized plan that 

is developed in collaboration with her healthcare 

team. The plan needs to include elements 

such as which medications are being used and 

why; referrals and coordination of care such as 

scheduling help and follow-up appointments with 

other healthcare professionals; family involvement 

and whether family therapy is indicated; and a 

plan to treat co-occurring medical or behavioral 

health disorders that addresses her goals and 

motivations to engage in treatment (Jones et 

al., 2016; SAMHSA, 2014, 2015; World Health 

Organization [WHO], 2014). The plan should 

be based on shared decision-making, in which 

pregnant women seeking treatment and recovery 

can weigh that information against their personal 

preferences and values (SAMHSA, 2016b). The 

plan should also seek to optimize treatment 

issues that are relevant to the developing fetus 

and infant, particularly protocols for addressing 

an infant’s possible NAS and healthy early 

development. 

• Healthcare professionals should educate women 

and their family members about potential legal, 

social, and medical consequences of each 

treatment option, specifically the risks of NAS. 

NAS is a medical condition that can be diagnosed and effectively treated with available interventions. 

Avoidance of NAS should not be the deciding factor in the initiation or dose of pharmacotherapy for 

OUD during pregnancy. The dose of medication does not appear to impact the risk or severity of NAS 

(Jones, Jansson, O’Grady, & Kaltenbach, 2013b; Jones et al., 2014; Lund et al., 2013; Patrick et al., 2015). 

Consequently the dose of medication should be titrated to control withdrawal, limit cravings and prevent 

return to opioid use.

 Women who are pregnant and have OUD or another SUD may be fearful of the legal consequences they 

may face if they seek SUD treatment. Policies on whether and when to assume custody of a newborn or 

older child whose mother has untreated OUD vary by state, county, and even hospital (American Academy 

of Addiction Psychiatry, 2015; Guttmacher Institute, 2017; House, Coker, & Stowe, 2016). Healthcare 

professionals and office staff need to be aware of the regulations in their region (SAMHSA, 2016a).

This link provides sample treatment agreements 

and consent forms: https://pcssmat.org/opioidresources/clinical-tools/.

CONTENT TO REVIEW

While distinct from informed consent, 

treatment agreements can be a useful tool to 

ensure clear communication and expectations 

about the chosen treatment. A treatment 

agreement document typically includes:

• Risks and benefits of treatment and no 

treatment.

• Schedules for follow-up office visits and 

laboratory tests to monitor the patient’s 

progress and health status. 

• Goals for behavioral treatment, social and 

family engagement, or mutual-aid group 

meeting attendance. 

• Opportunities for involvement of family 

members or significant others in treatment.

• Symptoms that should be reported to the 

prescribing physician. 

• A plan for treating co-occurring medical or 

psychiatric conditions, as well as other SUDs 

including tobacco. 

• Expectations for maintenance of 

pharmacotherapy and engagement in other 

therapies and, if needed, more intensive levels 

of care.

Section 1: Factsheet 2
28

• Initiating pharmacotherapy needs to be 

individualized to each patient’s medical 

condition. Protocols can provide a useful 

starting point, but healthcare professionals 

should evaluate the patient and review results 

of the initial screening with her to determine 

whether she has other medical conditions or 

polysubstance use and individualize the initiation 

of pharmacotherapy. Withdrawal from one or 

multiple substances may require inpatient care 

(ASAM, 2015; Commonwealth of Pennsylvania, 

2016; Jones et al., 2008, 2016; McCarthy, Leamon, 

Willits, & Salo, 2015; Meyer & Phillips, 2015). 

 Individuals who select buprenorphine for 

pharmacotherapy need to be aware of the 

potential for spontaneous or precipitated 

withdrawal during pharmacotherapy induction 

(ASAM, 2015) and must be exhibiting clinical 

withdrawal symptoms before administration of 

the first dose. Many clinics now offer induction 

to buprenorphine as an outpatient service and 

sometimes as partial home induction. Partial 

home induction for pregnant women lacks 

sufficient evidence at this time.

 Women who select methadone for 

pharmacotherapy need to be aware that achieving 

a stable therapeutic dose can take days to weeks. 

Some programs will choose to admit a pregnant 

woman to the hospital with a diagnosis of high-risk 

pregnancy to titrate her dose of methadone more 

quickly under continuous medical supervision and 

minimize the chance that she may attempt to cope 

with unrelieved withdrawal by using illicit opioids. 

No Known Risk of Increased Birth 

Defects With Pharmacotherapy 

Medications

• Currently, research indicates no known risk of increased birth defects associated with the use of 

buprenorphine or methadone. A woman receiving either buprenorphine or methadone should be 

informed that the benefits of pharmacotherapy for OUD during pregnancy outweigh the risks of 

untreated OUD. 

Healthcare professionals may want to reassure women that, to date, research has not shown that 

buprenorphine and methadone can cause an increase in birth defects (Committee on Healthcare for 

Underserved Women, ASAM, & American College of Obstetricians and Gynecologists, 2017; Holbrook 

& Rayburn, 2014) and has minimal long-term neurodevelopmental impact (ASAM, 2015).

American Society of Addiction Medicine 

(ASAM) National Practice Guideline for the Use 

of Medications in the Treatment of Addiction 

Involving Opioid Use to obtain more information 

on evidence-based treatment of OUD

RESOURCE TO REVIEW

Tobacco use cessation is critical to the 

health of the dyad and must be addressed 

with specific interventions. Buprenorphine 

or methadone pharmacotherapy does not 

reduce cigarette smoking rates in pregnant 

women (Chisolm et al., 2012). See Factsheet 

#6: Addressing Polysubstance Use During 

Pregnancy for more information on tobacco 

cessation programs in pregnant women. 

FACTSHEET TO REVIEW

Treatment for pregnant women with OUD 

should promote and facilitate family, community, 

and social support as well as social inclusion by 

cultivating strong links with available childcare, 

economic supports, education, housing, 

and other relevant services as reviewed in A 

Collaborative Approach to the Treatment of 

Pregnant Women With Opioid Use Disorders: 

Practice and Policy Considerations for Child 

Welfare, Collaborating Medical, and Service 

Providers (SAMHSA, 2016a).

RESOURCE TO REVIEW

Section 1: Factsheet 2
29

Considerations Buprenorphine Methadone

Patient Selection May be preferable for patients who are new to treatment 

because it is easier to transfer from buprenorphine to 

methadone (it can be very difficult to transfer from 

methadone to buprenorphine), who do not like or want 

methadone, or who have requested this medication. 

May be preferable for patients who do not like or want 

buprenorphine treatment or who have requested this 

medication.

Care Includes a prenatal healthcare professional, parenting 

classes, and SUD treatment. 

Includes a prenatal healthcare professional, parenting 

classes, and SUD treatment.

Dispensing May be prescribed in an office setting with weekly or 

biweekly prescribing/dispensing or provided in an opioid 

treatment program.

Requires daily visits to a federally certified opioid treatment 

program; take-home medication is provided for patients 

meeting specific requirements.

Treatment Retention Some studies show treatment dropout is higher than that for 

methadone. 

Some studies show treatment retention is higher than that 

for buprenorphine.

Risk of Medication 

Interaction

Few known interactions with other medications; risk of 

interaction is greatest with central nervous system (CNS) 

depressants and CYP3A4 inhibitors (e.g., clarithromycin, 

itraconazole, ketoconazole, atazanavir). If these medications 

must be used, the clinic should monitor the patient daily for 

increased effect of buprenorphine; healthcare professionals 

should be aware that the development of sign and symptom 

varies and depends on a variety of factors.

Other agonist/antagonist medications (e.g., butorphanol, 

dezocine, nalbuphine, pentazocine) and full antagonists will 

result in precipitated withdrawal.

Medications that use CYP450 enzymes are commonly 

involved in a methadone-medication interaction. Methadone 

is metabolized primarily by CYP3A4 and CYP2B6. There is 

evidence that other CYP450 enzymes are also involved 

including CYP2D6. Known interactions with other medications 

in pregnant women are detailed in McCance-Katz (2011). If 

these medications must be used, the clinic should monitor 

the patient daily for increased or decreased effect of 

methadone; healthcare professionals should be aware that 

the development of sign and symptom varies and depends 

on a variety of factors.

Other agonist/antagonist medications (e.g., butorphanol, 

dezocine, nalbuphine, pentazocine) and full antagonists will 

result in precipitated withdrawal.

Starting Dose 2–4 mg 20–30 mg

Target Dose Daily, 16 mg or product equivalent to 16 mg, is the most 

common dosage. The optimal dose will be determined by 

regular assessment of the individual and her response to 

treatment.

Daily, 80–120 mg. The optimal dose will be determined by 

regular assessment of the individual and her response to 

treatment.

Interval at Which 

Dose May Be 

Increased

Daily, but dose changes should not be made without patient 

assessment.

3 days is a common interval in a clinical practice, but dose 

changes should not be made without patient assessment.

Exhibit FS #2.1: : Decision Considerations When Selecting an Opioid Agonist Medication for a Pregnant Woman

Section 1: Factsheet 2
30

Considerations Buprenorphine Methadone

Risk of Overdose 

and Death

Generally lower risk compared with full opioid agonists; 

overdose is possible when combined with other CNS 

depressants. 

Continued buprenorphine treatment reduces mortality after 

release from incarceration (Degenhardt et al., 2014).

Buprenorphine treatment reduces the risk of death in people 

dependent on opioids (Gibson et al., 2008) and drug-related 

mortality in the first 4 weeks of treatment, a high-risk period 

(Kimber, Larney, Hickman, Randall & Degenhardt, 2015). 

Generally greater risk of overdose compared with mixed 

agonist/antagonist opioids; overdose is possible when 

combined with other CNS depressants.

Continued methadone treatment reduces mortality after 

release from incarceration (Degenhardt et al., 2014).

Methadone significantly reduces the risk of drug-related 

mortality compared with no treatment (Evans et al., 2015).

Methadone treatment reduces the risk of death in people 

dependent on opioids (Gibson et al., 2008) and drug-related 

mortality in the first 4 weeks of treatment, a high-risk period 

(Kimber et al., 2015).

Risk of Sedation Sedation is possible but typically milder than that with full 

mu opioid agonists.

Sedation is possible and may be greater than that with partial 

agonist opioids (Walsh, Preston, Bigelow, & Stitzer, 1995). 

Ability To Fill a 

Prescription at a 

Local Pharmacy

Is possible depending on pharmacy availability. Can be filled in a certified pharmacy to treat pain, but 

methadone for the treatment of OUD cannot generally be 

obtained from a pharmacy in the United States. It must be 

administered or dispensed for treatment of OUD at a certified 

opioid treatment program. 

Treatment in 

a Healthcare 

Professional’s Office

Healthcare professionals who request a waiver to prescribe 

buprenorphine from SAMHSA and receive a unique Drug 

Enforcement Administration registration number for this 

purpose may prescribe buprenorphine for the treatment of 

opioid use disorder in an office-based setting.

May be possible under federal regulation if specific program 

criteria are fulfilled and relevant state and federal permission 

is sought.

Risk of NAS Approximately 50% of exposed neonates are treated for 

NAS; NAS may be milder with buprenorphine compared with 

full mu opioid agonists such as most opioid analgesics and 

methadone.

Approximately 50% of exposed neonates are treated for NAS.

Time to NAS Onset American Academy of Pediatrics (AAP) recommends 

monitoring prenatally opioid-exposed neonates for a 

minimum of 4–7 days after delivery (Hudak, Tan, & AAP, 2012).

AAP recommends monitoring prenatally opioid-exposed 

neonates for a minimum of 4–7 days after delivery (Hudak, 

Tan, & AAP, 2012).

Duration of NAS Most studies show shorter NAS duration compared with 

methadone.

Most studies show longer NAS duration compared with 

buprenorphine.

Breastfeeding 

Considerations

Generally safe if the mother is stable and the ABM Clinical 

Protocol #21 breastfeeding with SUD guidelines are met.

Generally safe if the mother is stable and the ABM Clinical 

Protocol #21 breastfeeding with SUD guidelines are met.

Neurodevelopmental 

Outcomes of 

Exposed Children

Available research suggests there is not a linear cause 

and effect relationship between prenatal buprenorphine 

exposure and developmental problems when compared with 

other opioids; the research base is limited.

Available research suggests there is not a linear cause and 

effect relationship between prenatal methadone exposure 

and developmental problems when compared with other 

opioids; the research base is limited.

Section 1: Factsheet 2
31

A Collaborative Approach to the Treatment of Pregnant Women With Opioid Use Disorders: Practice and 

Policy Considerations for Child Welfare, Collaborating Medical, and Service Providers

This SAMHSA document provides information on the treatment of pregnant women with OUD, summarizes 

guidelines adopted by a variety of professional organizations, and presents a framework for organizing 

community efforts. It provides a coordinated, multisystem approach grounded in early identification and 

intervention to assist child welfare, medical, SUD treatment, and other systems in supporting families.

Addiction Technology Transfer Center (ATTC) Network 

The ATTC is a nationwide, multidisciplinary resource for professionals in the addictions treatment and 

recovery services field. Established in 1993 by SAMHSA, the ATTC Network comprises 10 Regional Centers, 

4 National Focus Area Centers, and a Network Coordinating Office. The ATTC is a resource for webinars, 

websites, and printed materials related to treating OUD. 

Advisory: Sublingual and Transmucosal Buprenorphine for Opioid Use Disorder: Review and Update 

This 2016 SAMHSA publication gives an overview of the use of sublingual and transmucosal buprenorphine 

treatment for OUD.

ATTC: Tools for Treatment, Family-Centered Behavioral Health Support for Pregnant & Postpartum Women

This Pregnant and Postpartum Women Project ECHO is the first of its kind to address the behavioral health 

needs of pregnant and postpartum women, taking a family-centered approach to the recovery process that 

includes family members ranging from the infant to older children, fathers, and extended family. 

Baby Friendly Hospital Initiative-USA

This global initiative was launched by WHO and the United Nations Children’s Fund in 1991 to encourage and 

recognize hospitals and birthing centers that offer an optimal level of care for infant feeding and mother–

infant bonding. 

Behavioral Health Treatment Services Locator 

This searchable database for treatment services is updated every year based on responses to SAMHSA’s 

National Survey of Substance Abuse Treatment Services and National Mental Health Services Survey. 

Clinician Consultation Center Substance Use Warmline

The University of California, San Francisco’s, Clinician Consultation Center provides Substance Use Warmline 

consultation to health center providers. This is a free, real-time clinician-to-clinician telephone consultation, 

addressing the care and treatment of substance abuse, chronic pain, and behavioral health. Access the 

Warmline toll-free at: 1-855-300-3595 (Monday-Friday, 10 a.m.-6 p.m. EDT). 

Clinical Opiate Withdrawal Scale (COWS) 

This assessment tool measures the adequacy of the initial pharmacotherapy induction dose. It can be readministered throughout the induction process to monitor the pregnant woman’s progress.

Follow Directions: How to Use Methadone Safely

This SAMHSA publication describes the use of methadone in MAT for OUD. It includes information on how to 

use methadone safely, the dangers of methadone overdose, and life-threatening methadone side effects.

WEB RESOURCES ON THIS TOPIC

Section 1: Factsheet 2
32

Legal Action Center

The mission of this nonprofit law and policy organization includes 

fighting discrimination against people with histories of SUD. The center’s 

website links to numerous resources for healthcare professionals, 

patients, employers, and criminal justice personnel. Among these 

resources are a sample treatment letter that healthcare professionals 

can use to support patients ordered off pharmacotherapy by criminal justice and 

child welfare agencies and a document explaining how state driving under the 

influence (DUI) laws treat drivers taking methadone or buprenorphine and what 

legal strategies are available to drivers charged with a DUI offense for driving while on 

these medications. 

Medication-Assisted Treatment 

This SAMHSA website provides up-to-date information on MAT, including opioid 

treatment programs and additional information on behavioral therapy and medications to 

treat SUDs. 

Medication-Assisted Treatment Models of Care for Opioid Use Disorder

This Agency for Healthcare Research and Quality research protocol describes the 

available literature on MAT models of care, methods for effective MAT implementation, 

and key issues and gaps in the evidence base. 

Medication Assisted Treatment of Opioid Use Disorder Pocket Guide 

This SAMHSA product includes guidelines for physicians using MAT for patients with OUD. 

It discusses approved medications, screening and assessment tools, and best practices for 

patient care.

Methadone Treatment for Pregnant Women 

This SAMHSA brochure provides basic information on methadone treatment, the possibility 

and treatment of infant withdrawal, breastfeeding on methadone, the consequences of 

continued drug use, and birth control.

National Center on Substance Abuse and Child Welfare (NCSACW) 

SAMHSA and the Administration for Children & Families jointly fund NCSACW, which is a national resource 

center providing information, expert consultation, training, and technical assistance to child welfare, 

dependency court, and substance abuse treatment professionals to improve the safety, permanency, wellbeing, and recovery outcomes for children, parents, and families.

National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use 

This ASAM publication provides information on evidence-based treatment of OUD.

Non-punitive Treatment for Pregnant and Breast-feeding Women with Substance Use Disorder

This position statement from the American Nurses Association (ANA) Center for Ethics and Human Rights 

recognizes substance addiction is a treatable illness and ANA’s commitment to prevention and treatment as 

primary solutions to perinatal substance abuse and addiction. 

Opioid Overdose Prevention Toolkit: Information for Prescribers 

This SAMHSA toolkit is for healthcare professionals, treatment providers, local communities and 

governments, and first responders. It contains materials to develop practices and policies to prevent opioidrelated overdoses and deaths. 

Section 1: Factsheet 2
33

Opioid Treatment Program Directory 

The dropdown menu on this SAMHSA website links users to information on the availability of opioid 

treatment programs in the United States and its territories.

Providers’ Clinical Support System for Medication Assisted Treatment (PCSS-MAT)

This website describes the overarching goal of PCSS-MAT, which is to make the most effective 

treatments available to patients in a variety of settings, including primary care, psychiatric care, SUD 

treatment, and pain management settings. This network provides mentors and training webinars.

Providers’ Clinical Support System for Opioid Therapies (PCSS-O)

PCSS-O is a consortium of major stakeholders and constituency groups with interests in safe and 

effective use of opioid medications. PCSS-O makes available, at no cost, continuing medical education 

programs on the safe and effective use of opioids for treatment of chronic pain and safe and effective 

treatment of OUD.

Treatment Improvement Protocol (TIP) 35: Enhancing Motivation for Change in Substance Abuse 

Treatment 

This SAMHSA TIP is intended to help clinicians influence the change process in their patients by 

incorporating motivational interventions into SUD treatment programs. The document describes 

different motivational interventions that can be used at all stages of change.

TIP addressing Medications for Opioid Use Disorder. In Press.

SAMHSA will release a new TIP on addressing medications for opioid use disorder in early 2018. Please 

check the SAMHSA Store for the new TIP.

TIP 43: Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs 

This 2012 SAMHSA TIP gives a detailed description of medication-supervised treatment for addiction 

to opioids, including comprehensive maintenance treatment and medically supervised withdrawal. 

Screening, assessment, and administrative and ethical issues are also covered. This publication is due 

to be revised in 2017.

Treatments for Substance Use Disorders 

This SAMHSA webpage provides a list of treatments and services for SUDs.

Turn the Tide: Prescribing Opioids for Chronic Pain

This Surgeon General’s pocket guide provides tools and resources to help clinicians decide whether 

to prescribe opioids and alternative treatments. It explains how to calculate dosage and 

medication changes.

Vermont Child Health Improvement Program: Improving Care of Opioid-Exposed 

Newborns (ICON)

This website provides easy access to Vermont state-based resources for health professionals 

caring for women with OUD. The Care Notebook & Construction Guide, a resource guide for 

mothers with OUD, can be customized to adjust to the procedures of individual clinics. 

Section 1: Factsheet 2
34

A pregnant woman wishes to discuss changing her existing pharmacotherapy for 

OUD or wants to undergo medically supervised withdrawal from opioids.

Maintaining Patient Stability Is Paramount

Pregnancy alone is not an indication to change a woman who is stable on an opioid agonist to another 

opioid agonist. 

A pregnant woman who is experiencing cravings or withdrawal should have the effectiveness of her 

pharmacotherapy dose evaluated, and the dose possibly adjusted. Changing from one opioid agonist to 

another is rarely, if ever, warranted on the basis of cravings or unrelieved withdrawal alone. Cravings can 

occur even when OUD is well managed. Women who experience cravings despite optimal pharmacotherapy 

should receive additional behavioral interventions to address new or aggravated stressors. 

Experts do not agree on whether a woman on buprenorphine/naloxone for OUD who states the intention 

to become pregnant or is in the early stages of pregnancy should be switched from the combination 

buprenorphine/naloxone product to the buprenorphine-only product. Experts do agree that any 

change from buprenorphine/naloxone to the buprenorphine-only product or a decision to continue on a 

buprenorphine/naloxone product during pregnancy should be made only when informed by the patient’s 

specific needs and concerns. In either case, the woman’s fully informed consent should be obtained after 

review of the risks and benefits of the course of treatment selected. 

There is insufficient information about the safety of extended-release injectable naltrexone during 

pregnancy and the effects of intrauterine exposure to this medication. The expert panel did not agree on 

whether women on naltrexone should continue to use it during pregnancy. Women stable on naltrexone 

can be offered treatment with buprenorphine or methadone to prevent return to substance use if they 

choose to discontinue naltrexone injections. However, this transition must be carefully managed because 

patients on long-acting naltrexone are no longer opioid tolerant and the falling naltrexone level will result in 

increasing agonist activity over time during cross-titration.

Medically Supervised Withdrawal Is NOT Recommended

Pregnant women with OUD, with or without a history of pharmacotherapy for OUD, should be advised that 

medically supervised withdrawal from opioids is associated with high rates of return to substance use and is 

not the recommended course of treatment. 

If a pregnant woman on pharmacotherapy for OUD decides to move forward with medically supervised 

withdrawal, it can be conducted in a controlled setting in any trimester in the pregnancy if the benefits 

outweigh the risks. However, the woman should be informed that discontinuing pharmacotherapy is associated 

with high rates of return to substance use poorer fetal health and is not the recommended course of treatment. 

FACTSHEET #

CHANGING 

PHARMACOTHERAPY 3

DURING PREGNANCY

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION 1

Section 1: Factsheet 3
35

Maintaining Patient Stability Is Paramount

• Requests to change opioid agonist should prompt careful consideration. Significant problems such as 

adverse drug reaction, intolerance of the current pharmacotherapy, or drug–drug interaction may require 

consideration of changing opioid agonist. The anticipated benefit of any medication change must be 

balanced against the risk of destabilization. Destabilization may result in return to substance use. 

 It is important to understand the pregnant woman’s motivations for requesting a change in her 

medication. They may include pressure from family and friends, the cost of the medication, time 

needed for other responsibilities vs. time needed to participate in treatment, fear of prejudice and 

discrimination, or concerns for the developing fetus and later child development. She may feel that 

her current medication is not working because she is experiencing previously unreported withdrawal 

symptoms, cravings, or return to substance use. If this is the case, adjusting the dose of the current 

medication is likely the most appropriate action along with increasing social and behavioral supports.

 If there is no indication of return to substance use, withdrawal symptoms, or cravings, identify the 

underlying fears and pressures and help her strategize about how to manage them. Talk about the risk 

of not receiving pharmacotherapy. If withdrawal is agreed on, create a safety plan to help prevent a 

return to substance use and resume pharmacotherapy if return to substance use occurs or is likely.

• Neonatal abstinence syndrome (NAS) expression and severity are not correlated with maternal 

pharmacotherapy dose. In some cases, a woman may want to change or reduce her medication in 

hopes of reducing the risk or severity of NAS in her infant. In a meta-analysis, Cleary et al. (2010) found 

that the severity of NAS was unrelated to methadone dose and suggest that the practice of reducing 

maternal methadone medication to protect the fetus is unwarranted. A similar finding was reported in 

women taking buprenorphine during their pregnancy (Patrick et al., 2015). 

 Healthcare professionals can assure the pregnant woman that, to date, no evidence links the dose of either 

methadone or buprenorphine with a number of measures of severity of NAS, such as peak NAS score; total 

amount of infant treatment medication (morphine); 

length of neonatal hospital stay; duration of 

pharmacotherapy for NAS; estimated gestational 

age at delivery; Apgar score at 5 minutes; and 

neonatal physical parameters of head circumference, 

length, and birth weight (Jones, Jansson, O’Grady, & 

Kaltenbach, 2013; Jones et al., 2014; Lund et al., 2013).

• Healthcare professionals should discuss in detail 

the risk of return to substance use if the pregnant 

woman chooses to change her pharmacotherapy 

during her pregnancy. If changing agonist 

therapy is imperative (e.g., the pharmacotherapy 

is no longer accessible), the woman should be 

informed that any change in medication represents 

a period of vulnerability to return to substance 

use. Behavioral and recovery supports should 

be maximized. Changing from buprenorphine to 

methadone can be accomplished using a standard 

approach to methadone induction. Changing from 

• Factsheet #2: Initiating Pharmacotherapy 

for Opioid Use Disorder for information on 

treatment options

• Factsheet #6: Addressing Polysubstance Use 

During Pregnancy for discussion on tobacco 

use cessation

• Factsheet #9: Screening and Assessment 

for Neonatal Abstinence Syndrome for 

information on the potential for NAS with 

pharmacotherapy for OUD

• Factsheet #10: Management of 

Neonatal Abstinence Syndrome, Exhibit 

Factsheet#10.2, for factors that influence NAS 

expression, severity, and pharmacological and 

nonpharmacological treatment options

FACTSHEET TO REVIEW

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

Section 1: Factsheet 3
36

methadone to buprenorphine requires that the methadone be tapered, and several days of 

abstinence may be required before therapy with buprenorphine is initiated (Jones, Suess, 

Jasinski, & Johnson, 2006). If, as the methadone dose is lowered, the patient begins to 

experience withdrawal that interferes with her functioning or leads to return to substance 

use, it is advisable to discontinue the taper and restabilize her on methadone. The added 

risk of return to substance use during pregnancy cannot be overstated.

 Whatever the reasons for changing pharmacotherapy, discuss them and help the woman 

understand why a medication change may—or may not—be possible.

• Positions are evolving on using the combination product (buprenorphine/naloxone) 

throughout the pregnancy, rather than transitioning the pregnant woman to the 

buprenorphine-only product for the duration of her pregnancy. Historically, pregnant 

women who had been on the combination product (buprenorphine/naloxone) were 

transitioned to the buprenorphine-only product for the remainder of their pregnancy. 

One reason for the change in pharmacotherapy was to protect the fetus from exposure 

to naloxone. Another reason was that a woman who is not stable and who injects the 

combination product at any time (prenatal or postnatal) can have induced precipitated 

withdrawal, owing to the intravenous bioavailability of naloxone (Park, Meltzer-Brody, & 

Suzuki, 2012).

 Evidence is now building that newborn outcomes are not negatively affected by using the combination 

product during gestation and that pregnant women may not need to transition to the buprenorphine-only 

product during pregnancy to protect the fetus (Debelak, Morrone, O’Grady, & Jones, 2013; Dooley et al., 

2016; Gawronski et al., 2014; Jumah et al., 2016; Lund et al., 2013; Wiegand et al., 2015). Pregnant women and 

their healthcare professionals should make a decision with regard to the use of the buprenorphine/naloxone 

combination product in the context of pregnancy based on the benefit vs. the risk to the dyad.

Medically Supervised Withdrawal Is NOT Recommended

• Pregnant women with OUD should not be encouraged to withdraw from pharmacotherapy for OUD 

during their pregnancy or shortly after delivery. Pharmacotherapy is the recommended standard of care, 

and it is the best option for a pregnant woman with OUD. Remaining on pharmacotherapy will help her 

avoid a return to substance use, which has the potential for overdose or death. A decision to withdraw from 

pharmacotherapy should be made with great care on a case-by-case basis, and additional supports such as 

close observation should be put in place.

 Withdrawal of pharmacotherapy for OUD and tapering during pregnancy have a high failure rate (American 

Society of Addiction Medicine, 2015; Jones, O’Grady, Malfi, & Tuten, 2008; Substance Abuse and Mental 

Health Services Administration [SAMHSA], 2014; World Health Organization, 2014), and expectant women 

with OUD often return to opioid misuse and its attendant risks (e.g., Kaltenbach, Berghella, & Finnegan, 

1998; Mattick, Breen, Kimber, & Davoli, 2009). A 

Norwegian study (Ravndal & Amundsen, 2010) 

of the mortality risk after inpatient medically 

supervised withdrawal in a nonpregnant population 

found that the elevated risk of dying from an 

overdose within the first 4 weeks of discharge was 

so dramatic that prevention measures should be 

instituted. 

 Return to substance use exposes the fetus to the 

stress of ongoing drug use and other maternal 

factors related to active SUD. However, some studies support the idea that at least a minority of women are 

Medically supervised withdrawal is associated 

with a high rate of return to substance use, 

putting both the pregnant woman and the 

fetus at risk. Medically supervised withdrawal 

should be avoided whenever possible. Factsheet 

#6: Addressing Polysubstance Use During 

Pregnancy provides more information on return 

to substance use.

Section 1: Factsheet 3
37

successful at completing medically supervised 

withdrawal and remaining in drug-free treatment 

until delivery (e.g., Lund et al., 2012).

Despite the concern about return to opioid use, 

some women will want to try medically supervised 

withdrawal, or their community resources will 

only support medically supervised withdrawal. 

If medically supervised withdrawal is attempted, 

healthcare professionals should anticipate 

providing the pregnant woman with intensive 

behavioral and social supports such as those 

available in residential treatment centers, which 

provide close monitoring and support to avoid 

return to substance use.

Other Evidence/Considerations

• The healthcare professional should discuss 

other actions the pregnant woman can take 

to improve the health of the fetus and herself. 

Several actions are available to the pregnant 

woman on pharmacotherapy for OUD to help 

the developing fetus and her own health. 

The pregnant woman should give up or limit 

cigarettes, alcohol, and drugs. She should be 

provided with tobacco use cessation treatment 

services (Minnes, Lang, & Singer, 2011; SAMHSA, 

2011) and other substance use disorder (SUD) 

treatment services to accomplish this. 

When discussing options to maximize the health 

of the pregnant woman and infant, remind the 

pregnant woman that she CAN take several steps 

to protect her health and the fetus:

• She can enroll in a tobacco cessation program, 

and participate in treatment programs for 

comorbid alcohol, other substance use disorders 

as needed.

• She can maintain a healthy weight and take 

prenatal vitamins as prescribed.

• She can learn how NAS is diagnosed and treated.

• She can learn which nonpharmacological 

interventions can reduce the incidence and 

severity of NAS.

• She can inform and prepare herself for 

breastfeeding.

• She can enroll in parenting classes 

recommended by her prenatal healthcare 

professional.

Advisory: Tobacco Use Cessation During Substance Abuse Treatment Counseling

This 2011 SAMHSA document offers SUD counselors an introduction to tobacco use 

cessation during SUD treatment. It discusses screening and effective treatment approaches 

to quitting, including cessation medications and practical and supportive counseling.

Drug Interaction Checkers:

• Buprenorphine Interaction Checker (Medscape)

• HIV/AIDS Medication Interactions (U.S. Department of Health and Human Services)

• Methadone Interaction Checker. Medscape

• Naltrexone Interaction Checker. Medscape

Individuals can type in the name of any drug and determine whether there is an interaction 

with methadone, buprenorphine, or naltrexone or with HIV/AIDS medications. 

Daily interactions and observed dosing should 

be considered possible behavioral interventions 

regardless of whether the woman is receiving 

buprenorphine or methadone. The level of care 

should be tailored to the woman’s response to 

therapy and not necessarily tied to a specific 

medication.

WEB RESOURCES ON THIS TOPIC

Section 1: Factsheet 3
38

Smokefree.gov

This tobacco cessation program is supported by the National Cancer Institute and can be accessed on mobile 

and online platforms. It provides a variety of ways to personalize support through smartphone apps, text 

messaging, websites, social media accounts, and access to trained counselors. 

Smoking and Mental Illness Among Adults in the United States

This is an updated Center for Behavioral Health Statistics and Quality report detailing the rate of cigarette 

smoking in adults with mental illness vs. adults without mental illness and the differences in tobacco cessation 

rates between the two groups. It is based on data from SAMHSA’s 2014 National Survey on Drug Use and 

Health (NSDUH) report. The SAMHSA NSDUH report is an annual survey of 68,000 people ages 12 and older 

on a wide range of behavioral health issues.

Treatment Improvement Protocol (TIP) addressing Medications for Opioid Use Disorder. In Press.

SAMHSA will release a new TIP on addressing medications for opioid use disorder in early 2018. 

Please check the SAMHSA Store for the new TIP.

TIP 43: Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs 

This 2012 SAMHSA TIP gives a detailed description of medication-supervised treatment for addiction to 

opioids, including comprehensive maintenance treatment and medically supervised withdrawal. Screening, 

assessment, and administrative and ethical issues are also covered. This publication is due to be revised in 2017. 

Section 1: Factsheet 3
39

A pregnant woman treated with pharmacotherapy for opioid use disorder (OUD) 

is experiencing withdrawal or cravings.

Need for Periodic Adjustments of Pharmacotherapy for OUD

A pregnant woman will likely need periodic adjustments to the dose of her pharmacotherapy in response to 

the physiological changes of pregnancy to prevent reemergence of withdrawal symptoms. The behavioral 

interventions provided may also need to be increased or adjusted to prevent return to substance use 

and promote effective strategies for coping with cravings and triggers. By offering the pregnant woman 

information and the opportunity to discuss her concerns, healthcare professionals can support her in arriving 

at a treatment plan that is effective both in preventing withdrawal or return to substance use and in bringing 

about abstinence from other substances, especially tobacco.

Dose of Pharmacotherapy Does NOT Affect Degree of Neonatal Abstinence Syndrome (NAS)

The pregnant woman will need reassurance that the amount or dose of the medication used to treat her OUD is not 

associated with the degree of NAS the baby may experience. However, she must also be informed that tobacco use 

is associated with the degree of NAS the baby may experience.

FACTSHEET # MANAGING 

PHARMACOTHERAPY 

OVER THE COURSE OF 4

PREGNANCY

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION 1

Need for Periodic Adjustments of Pharmacotherapy for OUD

• Medication metabolism rate increases as the pregnancy progresses. As the pregnancy 

progresses, doses of methadone typically need adjusting upward, particularly in the third 

trimester (Albright et al., 2011; Jones et al., 2008). These dose increases are needed because 

the rate of methadone clearance is increased when progesterone levels are elevated during 

pregnancy. The increased clearance rates result in decreased blood levels of methadone 

(Park, Meltzer-Brody, & Suzuki, 2012). Dividing the dose of methadone in half (split dosing) 

can help manage the impact of metabolic changes on the methadone level for women in the 

third trimester of pregnancy (Bogen et al., 2013; Jansson et al., 2008).

 Pregnant women using buprenorphine typically have a similar need for increased dose in the 

third trimester (Jones et al., 2005). No standardized approach to dose increases with either 

methadone or buprenorphine can be recommended, because these adjustments need to be 

individualized based on patient assessment.

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

Section 1: Factsheet 4
40

Dose of Pharmacotherapy Does NOT Affect Degree of NAS

• NAS expression and severity are not correlated with maternal pharmacotherapy dose. A woman may 

want to change or reduce her medication in hopes of reducing the chance or severity of NAS in her infant. 

Randomized trials of the medications have found no relationship between methadone or buprenorphine 

dose and outcomes such as NAS peak score; total morphine needed to treat NAS; neonatal hospital stay 

duration; number of days that pharmacotherapy was given for NAS; estimated gestational age at delivery; 

Apgar score at 5 minutes; and neonatal head circumference, length, and weight at birth (Jones, Jansson, 

O’Grady, & Kaltenbach, 2013; Jones et al., 2014; Lund et al., 2013). 

Other Evidence and Considerations

• Counseling can encourage and motivate women to continue with treatment, while enhancing coping 

skills and reducing the risk of a return to substance use. Counseling helps people learn how to make 

healthful decisions; handle setbacks, triggers, and stress; and move forward with their lives. A pregnant woman 

using pharmacotherapy for OUD should also have access to and be encouraged to talk with a behavioral 

health professional, either one-on-one or in a group with others in treatment. Behavioral health treatments may 

include cognitive behavioral therapy (CBT), family therapy, and contingency management (CM) to name just 

a few. Additional information on these therapies can be found at SAMHSA’s Behavioral Health Treatments 

and Services website. Optimally, the woman’s care would be provided by a coordinated team of healthcare 

professionals including OB/GYNs, substance use disorder (SUD) treatment specialists, nurses, case managers, 

and peer recovery coaches.

• SAMHSA recommends that people seeking 

recovery from substance use have access to 

peer support specialists. Pharmacotherapy 

can significantly stabilize patients, but patients 

may still have unmet needs for long-term 

recovery (Chang, Carroll, Behr, & Kosten, 1992). 

An example of how to meet these needs is to 

connect patients with peer support specialists 

(PSS) in the community. PSS are individuals who 

are in recovery and have undergone training and 

certification to ensure that they operate within the 

bounds of sound practice, especially in terms of 

privacy and confidentiality (Chinman et al., 2014). 

PSS can help others in recovery from a serious 

mental illness, an SUD, or co-occurring behavioral 

health and substance use disorders, across the 

treatment continuum (SAMHSA, 2009). The PSS 

approach is relatively new, and evidence about 

its effectiveness is still limited (Barlow et al., 2015; 

Sanders, Trinh, Sherman, & Banks 1998).

 In some states, Medicaid or other payers reimburse 

for PSS services; in some instances, PSS staff may 

be volunteers. In other circumstances they are 

hired by healthcare organizations, such as hospitals 

and rehabilitation centers, inpatient and outpatient 

facilities, day treatment programs, and community 

programs (Salzer, Schwenk, & Brusilovskiy, 2010). 

A Collaborative Approach to the Treatment of 

Pregnant Women With Opioid Use Disorders: 

Practice and Policy Considerations for Child 

Welfare, Collaborating Medical, and Service 

Providers (SAMHSA, 2016). This document 

provides information on treating pregnant women 

with OUD, summarizes guidelines adopted by a 

variety of professional organizations, and presents 

a framework for organizing community efforts. 

It provides a coordinated, multisystem approach 

grounded in early identification and intervention to 

assist child welfare, medical, SUD treatment, and 

other systems in supporting families.

RESOURCE TO REVIEW

Recovery requires more than pharmacotherapy.

SAMHSA has established a working definition of 

recovery that defines recovery as a process of 

change through which individuals improve their 

health and wellness, live self-directed lives, and 

strive to reach their full potential. Recovery is built 

on access to evidence-based clinical treatment 

and recovery support services for all populations. 

To optimize chances of achieving full recovery, 

SAMHSA recommends having the individual 

engage in a variety of behavioral therapies (e.g., 

CBT, CM, family therapy) to determine the best fit. 

Section 1: Factsheet 4
41

• Many people seek support from 

organizations known as mutual-aid, 

mutual-support, or 12-step programs. 

These organizations, which are generally 

set up and run by volunteers, can 

provide a supportive environment that 

helps some people maintain recovery. 

Women on pharmacotherapy for OUD 

are encouraged to seek out programs 

where pharmacotherapy is accepted as 

complementary to traditional 12-step 

treatment programs and are supportive 

of using pharmacotherapy.

• Factsheet #3: Changing Pharmacotherapy During 

Pregnancy for more information on changes the pregnant 

woman can make to ensure a healthy pregnancy

• Factsheet #6: Addressing Polysubstance Use During 

Pregnancy for additional discussion on tobacco use 

cessation

• Factsheet #10: Management of Neonatal Abstinence 

Syndrome, Exhibit Factsheet#10.2, for factors that 

influence NAS expression, severity, and pharmacological 

and nonpharmacological treatment options

FACTSHEETS TO REVIEW

A Collaborative Approach to the Treatment of Pregnant Women With Opioid Use Disorders: Practice and 

Policy Considerations for Child Welfare, Collaborating Medical, and Service Providers 

This document provides information on treating pregnant women with OUD, summarizes guidelines adopted 

by a variety of professional organizations, and presents a framework for organizing community efforts. It 

provides a coordinated, multisystem approach grounded in early identification and intervention to assist child 

welfare, medical, SUD treatment, and other systems in supporting families.

Core Competencies for Peer Workers in Behavioral Health Services 

On this website, SAMHSA defines peer workers and recovery and lists several categories of core competencies 

for peer workers.

Methadone Treatment for Pregnant Women 

This SAMHSA brochure provides basic information on methadone treatment, the possibility and treatment of 

infant withdrawal, breastfeeding on methadone, the consequences of continued drug use, and birth control.

National Alliance for Medication Assisted Recovery

This organization is led by people in recovery and supports all pathways to recovery, including medication. 

Recovery Community Centers offer peer support and opportunities to socialize with others in recovery. 

Treatment Improvement Protocol (TIP) 35: Enhancing Motivation for Change in Substance Abuse Treatment

This SAMHSA TIP is intended to help clinicians influence the change process in their patients by incorporating 

motivational interventions into SUD treatment programs. The document describes different motivational 

interventions that can be used at all stages of change.

TIP 40: Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction

This 2007 SAMHSA TIP offers practice guidelines to help physicians make decisions about using buprenorphine 

to treat opioid addiction. It includes information on patient assessment; protocols for opioid withdrawal; and the 

treatment of pregnant women, teens, and polysubstance users. This publication is due to be revised in 2017.

TIP 43: Medication-Assisted Treatment for Opioid Addiction in Opioid Treatment Programs 

This 2012 SAMHSA TIP gives a detailed description of medication-supervised treatment for addiction to 

opioids, including comprehensive maintenance treatment and medically supervised withdrawal. Screening, 

assessment, and administrative and ethical issues are also covered. This publication is due to be revised in 2017.

WEB RESOURCES ON THIS TOPIC

Section 1: Factsheet 4
42

A pregnant woman with opioid use disorder (OUD) and comorbid behavioral 

health disorders needs help managing these conditions.

Comorbid behavioral health disorders are common and may also require pharmacotherapy

A woman with comorbid behavioral health disorders that would typically require her to take benzodiazepines, selective 

serotonin reuptake inhibitors (SSRIs), amphetamines, and/or other pharmacotherapies may need to continue these 

medications during her pregnancy. Decisions regarding use of such pharmacotherapy must balance the pregnant 

woman’s mental health needs with the impact of psychotropic medications on the developing fetus. Healthcare 

professionals should help her understand the risks and benefits of continuing vs. discontinuing such pharmacotherapy 

to her baby, her physical health, and her health and recovery, with input from specialists as appropriate.

Healthcare professionals should also discuss whether any of the other needed medications carry with them a risk 

of producing a specific withdrawal syndrome, impact the expression or severity of neonatal abstinence syndrome 

(NAS) due to opioid exposure, may affect the infant’s development, or have consequences for breastfeeding.

FACTSHEET # PREGNANT WOMEN WITH 

OPIOID USE DISORDER AND 

COMORBID BEHAVIORAL 5

HEALTH DISORDERS

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION 1

Comorbid behavioral health disorders are common and may also require 

pharmacotherapy

• Depression and other psychiatric disorders are common among women with OUD. Research has found 

that the majority of women entering treatment for OUD have a history of sexual assault, trauma, or domestic 

violence and/or come from homes where their caregivers used drugs (Committee on Healthcare for Underserved 

Women, American Society of Addiction Medicine [ASAM], & American College of Obstetricians and Gynecologists 

[ACOG], 2012, 2017; Covington, 2008). Therefore, when obtaining a psychosocial history to evaluate pregnant 

women for OUD, follow the Substance Abuse and Mental Health Services Administration’s (SAMHSA’s) screening, 

brief intervention, and referral to treatment (SBIRT) practice and screen them for trauma, depression, anxiety, and 

tobacco and alcohol use. Maintaining a caring and nonjudgmental approach to such screening may produce the 

most inclusive and accurate disclosure (ASAM, 2015; Banderali et al., 2015; McLafferty et al., 2016). 

• Prescribers need to keep in mind possible drug interactions with pharmacotherapies for OUD. Research 

on adult males and nonpregnant women finds that when pharmacotherapies for OUD are concurrently used 

with psychotropic medications, problematic pharmacokinetic drug interactions may occur. Examples include 

the potential for respiratory depression when benzodiazepines are combined with either methadone or 

buprenorphine, prolonged QTc when SSRIs or tricyclic antidepressants are concurrently used with methadone, 

and serotonin syndrome when monoamine oxidase inhibitors are used with either buprenorphine or methadone 

(reviewed in Saber-Tehrani, Bruce, & Altice, 2011). 

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

Section 1: Factsheet 5
43

 In pregnant women, these interactions may be further compounded by a cascade of physiological changes such as 

increased hepatic and renal blood flow and increased plasma volume. These changes may alter medication needs 

and exacerbate drug interactions; however, few studies address these issues (McCance-Katz, 2011).

• Selecting the best management for pregnant women who have OUD and concurrent depression and/or anxiety 

is a complex decision. Healthcare professionals are aware of the consequences of unaddressed depression 

for mother–infant interactions, the pregnant woman’s own health and well-being, and the baby’s development 

(Committee on Healthcare for Underserved Women, ASAM, & ACOG, 2012; Yonkers et al., 2009). However, the 

impact on the fetus and newborn of chronic exposure to multiple psychotropic drugs is not fully understood at this 

time. This lack of understanding extends to whether the infant’s development will be impacted. 

 Although healthcare professionals and patient decision-making about the use of antidepressants and 

anxiolytics during pregnancy is complex given the real and possible risks of in utero exposure including 

increased severity of NAS, these risks must be 

weighed against the risks of untreated depression 

or anxiety, their contribution to risk of return to 

substance use and the risks of abrupt cessation of 

either type of medication.

• Some antidepressants, anticonvulsants, and 

anxiolytics may impact the expression and severity 

of NAS. Many psychiatric medications are associated 

with specific withdrawal syndromes in the newborn. 

For example, infants whose mothers received SSRIs 

during pregnancy are at risk for manifesting clinical 

signs of drug toxicity including NAS during their first 

week of life (Chisolm & Payne, 2016; Committed on 

Healthcare for Underserved Women, ASAM, & ACOG, 

2012; Hudak, Tan, American Academy of Pediatrics 

[AAP] Committee on Drugs, & AAP Committee on 

Fetus and Newborn, 2012; Patrick et al., 2015). 

 NAS due to in utero exposure may also be 

exacerbated when a pregnant woman takes 

antidepressants or anxiolytics (Chisolm & Payne, 

2016; Kaltenbach et al., 2012). There has also been a report that gabapentin, an anticonvulsant, can 

exacerbate NAS (Fujii et al., 2013). Both depression and continuous use of SSRIs during pregnancy are 

associated with premature birth (Weisner et al., 2009). 

 Expectant mothers receiving treatment with buprenorphine or methadone who use benzodiazepines should 

work with a psychiatrist to stabilize their anxiety and reduce their use of benzodiazepines if possible (Lee, 

Kresina, Campopiano, Lubran, & Clark, 2015; World Health Organization, 2014), with a gradual taper of a 

long-acting benzodiazepine (e.g., diazepam) toward the goal of being benzodiazepine free at delivery. 

The mother’s stability and well-being should not be adversely impacted in service of achieving this goal 

however as unrelieved anxiety is associated with return to substance use and may directly have adverse 

effects on the fetus. Infants persistently exposed to benzodiazepines in utero should be expected to 

manifest a benzodiazepine withdrawal syndrome and managed accordingly.

• The dose of individual psychiatric medications should be evaluated for possible adjustment in the third 

trimester. Just as with opioid agonists, the pharmacokinetic changes and increased volume of distribution 

associated with the third trimester of pregnancy can lead to decreased serum levels, so it may be necessary 

to increase some antidepressant medications in the third trimester to keep depression from worsening or 

recurring (Sit, Perel, Helsel, & Wisner, 2008; Sit, Perel, Luther, & Wisner, 2010).

A significant body of literature exists 

on treating and managing co-occurring 

depression and anxiety in pregnant and 

postpartum women. However, little has 

been published on treating and managing 

co-occurring behavioral health problems in 

pregnant women who have OUD. What is 

known about the impact of these conditions 

and their management during pregnancy should 

inform decision making for pregnant women 

with OUD as well. Figures 4 and 5 in Chisolm 

and Payne (2016) provide a recent review of the 

use of psychotropic drugs during pregnancy. 

See Factsheet #15: Maternal Discharge 

Planning for more information on postnatal 

comorbid mental disorders. 

RESOURCE TO REVIEW

Section 1: Factsheet 5
44

Other Evidence and Considerations

• Discrimination and bias against people who live with serious 

mental illness or OUD are widespread—not only among 

the general public, but among healthcare professionals, 

community leaders, and the media. Discrimination is the 

unfair treatment of people for any number of reasons, whereas 

bias involves stigmatizing attitudes (Botticelli & Koh, 2016; 

Clement et al., 2013). Bias and discrimination stem from similar 

roots: misperceptions, misunderstandings, and misinformation. 

Individuals who have a substance use disorder (SUD) or severe 

mental illness may have their own negative perceptions of their 

illness, which could be based on personal experiences with others—including friends and family—or inaccurate 

public information. The potent combination of discrimination and bias may compound the reluctance and 

fear that pregnant women with OUD or severe mental illness often experience when deciding whether to seek 

help for these disorders. Medical care should never be denied to pregnant women with OUD or behavioral 

health disorders. Healthcare professionals should take great care that program policies and procedures do 

not inadvertently reinforce these fears and reluctance (SAMHSA, 2016). Healthcare professionals are advised 

to review training materials produced by the U.S. Department of Health and Human Services and SAMHSA

to address these issues, as well as Changing the Language of Addiction for specific recommendations on 

terminology to use when referring to individuals with SUD.

Combining benzodiazepines with either 

methadone or buprenorphine is not 

recommended because of the risk of 

enhanced respiratory depression (ASAM 

2015; Lee et al., 2015). See Factsheet #6: 

Addressing Polysubstance Use During 

Pregnancy for additional information 

on how to address benzodiazepine 

misuse during pregnancy.

Current Understanding of the Interaction of Benzodiazepines and Buprenorphine 

This Providers’ Clinical Support System continuing medical education course reviews the dangers of combining 

benzodiazepines and buprenorphine. 

General Principles for the Use of Pharmacological Agents to Treat Individuals with Co-Occurring Mental 

and Substance Use Disorders 

This SAMHSA document provides information to assist in planning, delivering, and evaluating pharmacological 

approaches to supporting the recovery of individuals with co-occurring mental and substance use disorders.

Moms’ Mental Health Matters 

The National Institute of Child Health and Human Development website provides information and materials for 

new mothers and clinicians, including action plans to treat postpartum depression.

SBIRT: Screening, Brief Intervention, and Referral to Treatment 

This SAMHSA webpage provides information and links to resources about SBIRT that clinicians can use to 

identify, reduce, and prevent alcohol and illicit drug problems. 

Treating for Two

The Centers for Disease Control and Prevention’s Treating for Two initiative aims to improve the health of 

women and babies by identifying the safest treatment options for managing common conditions before and 

during pregnancy. The program focuses on all drugs, not just illicit drugs, and pharmacotherapy for recovery.

Use of Psychiatric Medications During Pregnancy and Lactation 

This ACOG document provides general recommendations and conclusions on the use of psychiatric 

medications by pregnant and breastfeeding women with mental disorders.

WEB RESOURCES ON THIS TOPIC

Section 1: Factsheet 5
45

A pregnant woman with opioid use disorder (OUD) requests help on (1) a return to opioid use; (2) her use 

of alcohol, cocaine, cannabis, or tobacco; (3) her comorbid misuse of prescribed medications, including 

benzodiazepines, amphetamines, or other pharmacotherapies, whether licitly or illicitly obtained; and (4) the 

impact of these medications and other substances on her health and that of the fetus.

Return to Opioid Use During Pregnancy

A pregnant woman on pharmacotherapy for OUD who returns to opioid use should have the effectiveness of the 

dose of her medication, and possibly the choice of medication, evaluated. She may also benefit from receiving a 

higher level of care, such as residential treatment, as long as her pharmacotherapy is not disrupted. A pregnant 

woman who is experiencing cravings or withdrawal should be evaluated for a possible medication dose or 

schedule change to prevent a possible return to substance use. Changing from one opioid agonist to another is 

rarely, if ever, warranted on the basis of cravings or unrelieved withdrawal alone.

Changing the type of pharmacotherapy (buprenorphine to methadone or vice versa) cannot be specifically 

recommended or advised against based on current evidence but may be considered if the interventions 

recommended above are fully implemented but unsuccessful, particularly if the woman reports continued cravings in 

the absence of unrelieved withdrawal and is receiving maximum behavioral and social supports. Most importantly, the 

woman should be reassured and encouraged to remain in treatment and work to stop the opioid use.

Return to Other Substance Use During Pregnancy

A pregnant woman on pharmacotherapy for OUD who has concurrent other substance use or who returns 

to use of one or more other substances should receive (1) behavioral interventions targeting the use of the 

substance(s) and (2) pharmacotherapy, if available and safe in pregnancy for the substance(s) she is using.

The woman experiencing a return to other substance use may also benefit from a higher level of care (e.g., 

residential treatment) provided her pharmacotherapy is not disrupted.

Polysubstance Use Concerns for Pregnant Women and Infants

Women who misuse benzodiazepines, amphetamines, or other pharmacotherapies—whether licitly or illicitly 

obtained—or who have a substance use disorder (SUD) involving alcohol, cocaine, cannabis, or tobacco should 

receive education on, and have the opportunity to discuss, the known or suspected impact of prenatal exposure 

to these substances on the fetus and their own health.

A woman with an SUD should be offered appropriate evidence-based behavioral, pharmacological, and social 

services to support the discontinuation of these substances, especially nicotine and alcohol. The healthcare 

professional can take this opportunity to discuss the known associated risk of neonatal abstinence syndrome 

(NAS), developmental problems, and impact on breastfeeding when using these substances.

FACTSHEET #

ADDRESSING 

POLYSUBSTANCE USE 6

DURING PREGNANCY

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION 1

Section 1: Factsheet 6
46

Return to Opioid Use During Pregnancy

• A return to substance use is a common occurrence among people with an SUD. Returning to substance 

use is a common occurrence with OUD especially early in treatment when the medication dose is still being 

stabilized and the woman is acquiring basic skills to cope with triggers and cravings. Given that returning to 

substance use is predictable and common, doing so should not be viewed as a setback or failure, but as an 

indication of the need to reassess the patient and adjust the treatment plan. Such adjustments may include 

engaging community and behavioral supports. Many people find that, for lasting recovery, they need to control 

stress, avoid places and situations where they once used drugs (triggers), and even end relationships with 

people involved with drugs. When making these changes, people in recovery may find that peers—such as other 

mothers in recovery who experienced a pregnancy affected by OUD—can help them in a way that healthcare 

professionals cannot. Limited but promising research supports the role of peers who are in recovery from an SUD 

(Barlow et al., 2015; Sanders, Trinh, Sherman, & Banks, 1998). Personal safety and adequate food and housing are 

also essential to both short and long-term recovery.

• Medication metabolism rate increases as the 

pregnancy progresses. Dividing the dose of 

methadone from once daily to twice daily (split 

dosing) takes advantage of the long-acting 

properties of methadone to help manage the 

impact of metabolic changes on the methadone 

level for women in the third trimester of pregnancy. 

Metabolism is accelerated during pregnancy resulting 

in larger clearances of medications (Albright et al., 

2011; Bogen et al., 2013; Jansson et al., 2008; Jones et 

al., 2008; Park, Meltzer-Brody, & Suzuki, 2012).

 Pregnant women treated with buprenorphine 

typically have a similar need for increased dose 

in the third trimester (Jones et al., 2005). No 

standardized approach to dose increases with 

either methadone or buprenorphine can be 

recommended, because these adjustments need 

to be tailored to each patient.

Return to Other Substance Use 

During Pregnancy

• Many people in treatment or recovery return to 

substance use one or more times before being 

able to remain free of substance use. The risk 

of return to substance use is highest in the first 

6 to 12 months after stabilization is achieved 

and then diminishes gradually over the years. A 

return to use of depressant drugs (e.g., alcohol, 

benzodiazepines) is highly concerning given the 

risk for respiratory depression when combined 

with opioid agonist therapy. Use of stimulants (e.g., 

Patients and healthcare professionals must learn 

to recognize that, although return to substance 

use is discouraging, it is not a failure. People 

who return to substance use often reestablish a 

substance-free lifestyle, continue to participate 

in treatment, and achieve long-term recovery. 

Healthcare professionals and programs should 

not view a woman’s return to substance use as a 

reason to discontinue treatment. In fact, efforts to 

maintain the woman’s engagement in treatment 

should be redoubled in these circumstances.

As the pregnancy progresses, doses of 

methadone typically need adjusting upward, 

particularly in the third trimester. Dividing 

the dose into a twice daily schedule may also 

help keep the methadone blood levels clinically 

therapeutic. Any adjustment of dose or schedule 

needs to be based on evaluation of the patient. 

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

Return to substance use is rarely caused or 

triggered by a single factor. It is more often 

the result of an interaction of physiological and 

environmental factors and is best seen as a 

dynamic process in which the patient’s strengths 

and vulnerabilities are affected by other 

external and internal factors (SAMHSA, 2014). 

Consequently the therapeutic response needs to 

encompass an array of services. 

Section 1: Factsheet 6
47

methamphetamine, cocaine) may destabilize and 

cause erratic behavior that interferes with effective 

engagement in previously effective treatment and 

services. Healthcare professionals may need to 

increase the intensity of other treatments if return 

to use appears imminent (SAMHSA, 2014).

Polysubstance Use Concerns for 

Pregnant Women and Infants

• Decades of evidence of the dangers of smoking 

during pregnancy document its adverse effects 

on pregnancy, fetal development, and postnatal 

infant outcomes. A tobacco use cessation program 

is one of the most important therapies to begin 

when a woman enters OUD treatment. Between 

88 and 95 percent of pregnant women receiving 

pharmacotherapy for OUD continue to smoke 

(Akerman et al., 2015), and smoking cigarettes is 

known to cause more severe NAS and have lasting 

developmental effects. Heavy daily smoking in 

pregnant women is associated with compromised 

birth outcomes such as lower birth weight, small birth 

length, lower Apgar scores, and increased lengths 

of hospital stays and number of days medicated 

for NAS (Jones et al., 2013; Patrick et al., 2015; 

Winklbaur et al., 2009). Individual reports document 

ways to reduce nicotine consumption in pregnant 

women with OUD, but insufficient evidence exists 

for recommending one tobacco cessation treatment 

approach over another (Akerman et al., 2015).

• Women with OUD frequently misuse other 

substances that can exacerbate NAS. Nicotine and 

benzodiazepines may worsen the symptoms of NAS 

(Bagley, Wachman, Holland, & Brogly, 2014; Bakstad, 

Sarfi, Welle-Strand, & Ravndal, 2009; Jones et al., 

2013; Kaltenbach et al., 2012). Healthcare professionals 

should provide behavioral support to reduce, and 

ideally stop, the misuse of other substances. Among 

the interventions that reduce and end other substance use are cognitive behavioral approaches—including 

motivational interviewing and dialectical behavioral therapy—and contingency management. The World Health 

Organization’s (WHO’s) Guidelines for the Identification and Management of Substance Use and Substance 

Use Disorders in Pregnancy extensively discusses additional interventions to reduce substance use (WHO, 2014). 

 A variety of evidence-based treatments can be offered to pregnant women, regardless of the substance 

use disorder (SUD). These include providing treatment in the early stages of pregnancy, and offering 

residential or outpatient treatment for significant lengths of time. Recently, motivational interviewing and 

contingency management, with a focus on the mother-infant dyad and integration with child protective 

services and the courts have been added to the list of possible approaches (Lester & Twomey, 2008). 

Note that it is recommended that these services be offered with simultaneous access to child care and 

parenting classes. Exhibit FS #6.1 summarizes treatment approaches for several SUDs.

Factors to consider when making a treatment plan 

if a pregnant woman returns to substance use:

• What environmental factors may have 

contributed to the return to substance use? 

Did use occur because others around her were 

using? Was she coerced to use? Under these 

circumstances, behavioral interventions may 

be more appropriate than dose increase.

• At what stage of pregnancy is the woman? 

The later the pregnancy stage, the more likely 

the need for an increased pharmacotherapy 

dose or change in dosing schedule.

• Are blood levels of the medication in a 

therapeutic range?

• What other medication is she taking? Are there 

any potential interactions that would change 

the metabolism of the opioid medication that 

are contributing to her return to substance use?

• Are issues of personal safety or inadequate 

food or housing contributing to the return to 

substance use?

Should return to substance use occur, 

healthcare professionals can consider multiple 

options for treating it, including:

• Examining social, medical, or behavioral factors 

that contribute to the woman’s substance use.

• Increasing or changing the intensity of 

psychosocial services.

• Assessing the effectiveness of current 

pharmacotherapy. 

• Engaging a coordinated team of healthcare 

professionals including obstetricians, nurses, 

case managers, and peer recovery coaches. 

Section 1: Factsheet 6
48

Substance Treatment Approaches Comments References

Alcohol • Withdrawal management: 

Benzodiazepine (e.g., diazepam) 

for medication-assisted 

withdrawal 

• Pharmacotherapy:

• The US Food and Drug 

Administration approved 

naltrexone, disulfiram, and 

acamprosate to treat alcohol use 

disorder. 

• Psychosocial treatment during 

and after withdrawal 

• Alcohol is associated with fetal alcohol spectrum disorders 

and is the number one cause of preventable developmental 

delays in children.

• In non-pregnant patients, behavioral interventions for 

risky/harmful alcohol use are an effective component of 

care. The effectiveness of these interventions has not been 

well studied in pregnant or postpartum women. 

Although pregnant women are counseled to cease drinking 

alcohol, little specific evidence-based guidance is available 

on how to manage alcohol withdrawal in pregnancy. 

Management should be based on alcohol withdrawal for 

non-pregnant women.

• Alcohol withdrawal cannot be managed with behavioral 

therapies alone. A long-acting benzodiazepine similar to 

one that would be used with benzodiazepine detoxification 

can be used in addition to behavioral treatments. 

• No published studies have compared the safety or efficacy 

of disulfiram, acamprosate and naltrexone for alcohol use 

disorder in pregnant women.

Bhat & Hadley, 2015

Bhuvaneswar, Chang, 

Epstein, & Stern, 2007 

Christensen, 2008 

Whitlock, Polen, Green, 

& Klein, 2004

DeVido, Bogunovic & 

Weiss, 2015

Amphetamines/ 

Methamphetamines

• Behavioral interventions such 

as cognitive behavioral therapy, 

contingency management, and 

motivational interviewing

• There is no effective pharmacotherapy for withdrawal or 

maintenance of abstinence from stimulants. 

• Peer support is a helpful component of the treatment and 

recovery process

Rawson, Gonzales, & 

Brethen, 2002

Sherman, Sanders & 

Yearde, 1998

Benzodiazepines • Gradual taper with a longacting benzodiazepine (e.g., 

diazepam) with the goal of being 

benzodiazepine free at birth

• Psychosocial treatment during 

dose reduction and after taper is 

complete

• A long-acting benzodiazepine similar to one that would be 

used with alcohol detoxification can be used in addition 

to behavioral treatments. For withdrawal, behavioral 

treatments alone are not sufficient. 

• May require long term treatment for underlying depression/

anxiety.

McElhatton, 1994 

Cannabis • Behavioral interventions such as 

cognitive behavioral therapy and 

contingency management

• There is no known effective pharmacotherapy. Budney, Roffman, 

Stephens, & Walker, 

2007

Conner et al., 2016

Cocaine • Behavioral interventions such 

as cognitive behavioral therapy, 

contingency management, and 

motivational interviewing 

• There is no known effective pharmacotherapy.

• Peer support is a helpful component of the treatment and 

recovery process

Farkas & Parran, 1993 

Sherman, Sanders & 

Yearde, 1998

Exhibit FS #6.1: Management Options for SUDs Other Than OUD During Pregnancy

Section 1: Factsheet 6
49

Substance Treatment Approaches Comments References

Tobacco • Nicotine replacement therapy (NRT)

• Bupropion 

• Varenicline 

• Behavioral interventions such 

as cognitive behavioral therapy, 

contingency management, 

and especially voucher-based 

reinforcement

• 5As (Ask, Advise, Assess, Assist, 

Arrange) as a brief intervention

• Data are very limited for NRT (nicotine gum, transdermal 

nicotine patches, nicotine nasal spray, nicotine lozenge, and 

nicotine inhaler), bupropion (Wellbutrin®

), and varenicline 

(CHANTIX®

) use in pregnancy. These medications should be 

used during pregnancy only if the benefit outweighs the 

risk to the fetus.

Cressman, Pupco, Kim, 

Koren, & Bozzo, 2012;

Forinash, Pitlick, Clark, 

& Alstat, 2010; 

Minnes, Lang, & Singer, 

2011

Osadchy, Kazmin, & 

Koren, 2009

• When caring for pregnant women with OUD, a 

comprehensive plan of care should be developed 

that lists each health and social problem, how 

it will be addressed, and who is responsible 

for addressing it. Evaluation for pharmacological 

treatment for other SUDs should be provided in 

conjunction with medical, social, and environmental 

interventions (Fanucchi & Lofwall, 2016; SAMHSA, 

2016). A comprehensive assessment of the patient 

for medical conditions commonly associated 

with substance use should be conducted. Such 

an assessment includes examining the patient for 

medical conditions linked to injection drug use such as 

infective endocarditis, osteomyelitis, HIV, and hepatitis 

B and C. Each risk or problem identified should have 

a corresponding plan to address it and minimize its 

lasting effect on the pregnant woman and the fetus.

Other Evidence/Considerations

• Maternal cannabis smoking is associated with 

low birth weight infants. American College 

of Obstetricians and Gynecologists (ACOG) 

recommends against maternal cannabis use 

(Committee on Obstetric Practice, ACOG, 2017) 

as does a recent National Academies of Sciences, 

Engineering, and Medicine (2017) report. Evidence 

shows that maternal cannabis smoking induces low 

birth weight in the infants (Fegusson, Horwood, 

& Northstone, 2002; Gray et al., 2010; Gunn et al., 

2016). Low birth weight is also linked to maternal 

use of nicotine, alcohol, cocaine, and opioid misuse 

(Behnke, Smith, Committee on Substance Abuse, 

& Committee on Fetus and Newborn, 2013; Gouin, Murphy, Shah, & Knowledge 

Synthesis Group on Determinants of Low Birth Weight and Preterm Births, 2011).

• Factsheet #5: Comorbid Psychiatric Illness 

During Pregnancy for additional resources 

on behavioral health treatment plans for 

pregnant women with OUD.

• Factsheet #11: Breastfeeding Considerations 

for Infants at Risk for Neonatal Abstinence 

Syndrome, Exhibit FS #11.1 provides 

examples of when a mother with OUD 

might be advised to breastfeed and when 

breastfeeding is not recommended.

FACTSHEETS TO REVIEW

A Collaborative Approach to the Treatment 

of Pregnant Women With Opioid Use 

Disorders: Practice and Policy Considerations 

for Child Welfare, Collaborating Medical, 

and Service Providers (SAMHSA, 2016). This 

document provides information on treating 

pregnant women with OUD, summarizes 

guidelines adopted by a variety of professional 

organizations, and presents a framework for 

organizing community efforts. It provides a 

coordinated, multisystem approach grounded 

in early identification and intervention to assist 

child welfare, medical, SUD treatment, and 

other systems in supporting families.

RESOURCE TO REVIEW

Section 1: Factsheet 6
50

 New research is expected on both maternal cannabis smoking and ingestion of 

tetrahydrocannabinol, the principal psychoactive component of cannabis, due to the 

legalization of cannabis use in several states. Until research on this issue is complete, 

pregnant and new mothers should be counseled to avoid cannabis (as well as alcohol 

and nicotine), for either recreational or medical purposes (Committee on Obstetric 

Practice, ACOG, 2017; Jansson, Bunik, & Bogen, 2015; Reece-Stremtan et al., 2015; 

Volkow, Compton, & Wargo, 2017; WHO, 2014). 

Advisory: Tobacco Use Cessation During Substance Abuse Treatment Counseling 

This 2011 SAMHSA document offers SUD counselors an introduction to tobacco use cessation during 

SUD treatment. It discusses screening and effective treatment approaches to quitting, including cessation 

medications and practical and supportive counseling.

Alcohol Alert: Alcohol and Other Drugs

This National Institute on Alcohol Abuse and Alcoholism publication includes information on the epidemiology 

of alcohol and drug addiction, the genetics and shared factors of alcohol and drug use disorders, challenges to 

diagnosing SUDs, and addiction terminology.

A Collaborative Approach to the Treatment of Pregnant Women With Opioid Use Disorders: Practice and 

Policy Considerations for Child Welfare, Collaborating Medical, and Service Providers

This document provides information on treating pregnant women with OUD, summarizes guidelines adopted 

by a variety of professional organizations, and presents a framework for organizing community efforts. It 

provides a coordinated, multisystem approach grounded in early identification and intervention to assist child 

welfare, medical, SUD treatment, and other systems in supporting families.

Committee Opinion No. 722: Marijuana Use During Pregnancy and Lactation

The ACOG Committee on Obstetric Practice summarizes recent clinical and scientific advances related to 

cannabis use in pregnant women. 

Current Understanding of the Interaction of Benzodiazepines and Buprenorphine 

This Providers’ Clinical Support System continuing medical education course reviews the dangers of combining 

benzodiazepines and buprenorphine.

Health Effects of Cannabis and Cannabinoids: The current state of evidence and recommendations for 

research

The National Academies of Sciences, Engineering, and Medicine published this report in 2017 to summarize the 

recent changes in cannabis legalization, production and use and provides a review of the scientific evidence 

related to health effects. It concludes with a suggested research agenda. 

Treating for Two

The Centers for Disease Control and Prevention’s Treating for Two initiative aims to improve the health of 

women and babies by identifying the safest treatment options for managing common conditions before and 

during pregnancy. The program focuses on all drugs, not just illicit drugs, and pharmacotherapy for recovery.

WEB RESOURCES ON THIS TOPIC

Section 1: Factsheet 6
51

Treatment Improvement Protocol 40 (TIP): Clinical Guidelines for 

the Use of Buprenorphine in the Treatment of Opioid Addiction

This 2007 SAMHSA TIP offers practice guidelines to help physicians 

make decisions about using buprenorphine to treat opioid addiction. 

It includes information on patient assessment; protocols for opioid 

withdrawal; and the treatment of pregnant women, teens, and 

polysubstance users. This publication is due to be revised in 2017.

TIP 43: Medication-Assisted Treatment for Opioid Addiction in 

Opioid Treatment Programs 

This 2012 SAMHSA TIP gives a detailed description of medicationsupervised treatment for addiction to opioids, including 

comprehensive maintenance treatment and medically supervised 

withdrawal. Screening, assessment, and administrative and ethical 

issues are also covered. This publication is due to be revised in 2017.

WHO Guidelines for the Identification and Management of 

Substance Use and Substance Use Disorders in Pregnancy 

This WHO guideline reviews the use of numerous illicit substances 

in pregnant women and details specific guidelines for the care and 

treatment of pregnant women and their infants.

Section 1: Factsheet 6
52

A pregnant woman with opioid use disorder (OUD) has questions about neonatal 

abstinence syndrome (NAS), support services, and postpartum planning.

Patient Education on NAS

A pregnant woman with OUD should receive the same education and information that all pregnant 

patients receive (e.g., tour of labor and delivery suites, newborn nursery).

Healthcare professionals should inform the pregnant woman of the possibility of neonatal abstinence 

syndrome (NAS) and counsel her on its diagnosis, management, and consequences. The woman should 

also receive education on ways to optimize the well-being of the fetus such as tobacco cessation and early 

pediatric care after delivery and hospital discharge. Healthcare professionals should ensure that she is 

aware of nonpharmacological interventions that should be provided to her infant to reduce NAS symptoms, 

including rooming-in.

Caregivers of opioid-exposed infants should be informed that while the infant may carry a genetic 

risk for substance use disorder the fact of experiencing NAS as an infant does not increase the risk of 

developing a substance use disorder in life.

Healthy Home Environment

Caregivers should be informed about and supported in providing a stable, 

healthy home environment to enhance protective factors and reduce 

social risk factors that may impact the future risk for substance use 

disorder in the child.

Contraception

Women with OUD should be counseled about contraception and have 

immediate, easy access to the contraceptive of their choice after delivery.

FACTSHEET #

PLANNING PRIOR TO LABOR 

AND DELIVERY

7

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION 1

Section 1: Factsheet 7
53

Patient Education on NAS

• Some infants exposed to methadone or buprenorphine in utero experience opioid withdrawal after birth.

NAS is a treatable condition, but caregivers and healthcare professionals need to be alert to signs of NAS in 

the infants of women with OUD so that therapy can begin as necessary. Infant withdrawal usually begins a 

few days after the baby is born but may begin as late as 2 to 4 weeks after birth. All caregivers should know 

what symptoms indicate the onset of NAS and when to seek additional medical care for the infant. Clear 

communication about NAS between the new mother and pediatricians, neonatologists, or family practice 

doctors, in addition to support from OB/GYNs, 

midwives, and nurse practitioners, is critical.

 Predicting the risk of NAS for infants of mothers 

with OUD is difficult, because several substances 

in addition to opioid exposure can influence the 

presentation of NAS, such as smoking tobacco 

(Jones et al., 2013a) and using other substances 

(Patrick et al., 2015). Infant-related variables can 

affect the infant’s NAS course, such as genetics, 

gender, and gestational age (Wachman et al., 2013, 

2015). NAS is an expected and treatable outcome of 

opioid agonist or partial agonist pharmacotherapy 

to treat OUD during pregnancy. Recent studies have 

shown NAS associated with pharmacotherapy is not 

worse than that experienced after untreated heroin 

use (Buckley, Razaghi, & Haber, 2013). Being treated 

with an opioid agonist such as buprenorphine or 

methadone, by itself, is not a basis for determining 

parental fitness or child safety.

 A woman may want to change or reduce her 

medication in hopes of reducing the chance or 

severity of NAS in her infant. Randomized trials of 

the medications have found no relationship between 

methadone or buprenorphine dose and outcomes 

such as NAS peak score; total morphine needed to 

treat NAS; neonatal hospital stay duration; number 

of days that pharmacotherapy was given for NAS; 

estimated gestational age at delivery; Apgar score 

at 5 minutes; and neonatal head circumference, 

length, and weight at birth (Jones, Jansson, O’Grady, 

& Kaltenbach, 2013b; Jones et al., 2013b; 2014; Lund 

et al., 2013). In a meta-analysis, Cleary et al. (2010) 

and Patrick et al. (2015) found the severity of NAS 

was unrelated to methadone dose. The practice of 

minimizing or even reducing maternal opioid agonist 

medication to protect the fetus is unnecessary and 

should be avoided.

When discussing options to maximize the health 

of the pregnant woman and infant, remind the 

pregnant woman that she CAN take several 

steps to protect her health and the fetus:

• She can enroll in a tobacco cessation program, 

and participate in treatment programs for 

comorbid alcohol, other substance use 

disorders as needed.

• She can maintain a healthy weight and take 

prenatal vitamins as prescribed.

• She can learn how NAS is diagnosed and treated.

• She can learn which nonpharmacological 

interventions can reduce the incidence and 

severity of NAS.

• She can inform and prepare herself for 

breastfeeding.

• She can enroll in parenting classes recommended 

by her prenatal healthcare professional.

Reducing the dose of pharmacotherapy 

will not reduce NAS expression or severity. 

No relationship was found between either 

methadone or buprenorphine dose and 

significant infant outcomes, including 

NAS expression or severity. The dose of 

pharmacotherapy should be optimized to 

suppress withdrawal, minimize cravings and 

prevent a return to substance use. Factsheet 

#2 Initiating Pharmacotherapy For Opioid 

Use Disorder and Factsheet #10: Management 

of Neonatal Abstinence Syndrome, Exhibit 

FS #10.2, lists factors that influence NAS 

expression, severity, and pharmacological and 

nonpharmacological treatment options.

FACTSHEETS TO REVIEW

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

Section 1: Factsheet 7
54

• When planning for delivery, healthcare professionals should 

take time to talk about the benefits of breastfeeding. 

Breastfeeding has positive physical and behavioral health 

results for mother and baby. When appropriate, any amount 

of breastfeeding, however brief, can decrease NAS severity, 

reduce the infant’s need for pharmacological treatment, 

and decrease the length of pharmacological therapy and 

hospitalization (Abdel-Latif et al., 2006; Bagley, Wachman, 

Holland, & Brogly, 2014; Jansson et al., 2008a, 2008b; ReeceStremtan, Marinelli, & Academy of Breastfeeding Medicine, 

2015; Ruwanpathirana et al., 2015). Introduce the concept 

of breastfeeding in the last trimester and assure the mother 

that a team will be available at the hospital to facilitate her 

breastfeeding, including a lactation consultant. However, not all 

women with SUD are appropriate candidates for breastfeeding. 

Healthy Home Environment

• Women may be eligible for visits from the Federal 

Home Visiting Program, funded by the Administration 

for Children & Families’ (ACF’s) Early Head Start 

(EHS) programs and Health Resources and Services 

Administration’s (HRSA’s) Healthy Start program, a 

network of more than 100 grantees nationwide. Each 

member program focuses on providing services to families 

in the nation’s poorest neighborhoods. These services 

attempt to reduce infant mortality, advocate for an end 

to health disparities, engage fathers, and encourage 

preconception health.

Contraception

• Preventing unintended pregnancies and planning for future pregnancies is critical. Healthcare 

professionals should offer all women, including those with OUD, non-coercive contraceptive counseling and 

discuss different forms of birth control and the effectiveness of each method before they are discharged from 

the hospital. Whether a woman is on pharmacotherapy 

for OUD or continues to misuse opioids, a conversation 

about the importance of contraception is critical. Women of 

reproductive age who have OUD experience a high rate of 

unintended pregnancy (Heil et al., 2011). One study found that 

only about half of the women with current opioid use were 

using contraception; the majority of women were not using 

long-acting reversible contraception (LARC) options, such 

as implants or intrauterine devices (IUDs) (Terplan, Hand, 

Hutchinson, Salisbury-Afshar, & Heil, 2015).

 The American College of Obstetricians and Gynecologists 

(ACOG), 2017) and the American College of Nurse-Midwives 

and other nurse professional societies recommend offering immediate postpartum LARC to reduce unintended 

or short-interval pregnancy (Committee on Healthcare for Underserved Women, American Society of Addiction 

Medicine, & ACOG, 2017). LARC can consist of IUDs or implants. Although there is a higher chance of expulsion 

Planning for labor and delivery should 

include inviting members of the 

collaborative team to meet with the 

pregnant woman before delivery. Many 

clinics have a pediatrician/neonatologist 

on staff to discuss what to expect after 

birth. This consultation builds trust between 

the pregnant woman and her care team. 

This is an opportune time to introduce the 

pregnant woman to a lactation consultant 

if one is available. Teaching the mother 

how to score NAS in her infant and to 

participate in the NAS scoring is also 

beneficial. Factsheet #11: Breastfeeding 

Considerations for Infants at Risk for 

Neonatal Abstinence Syndrome provides 

a discussion on when to breastfeed and 

when not to breastfeed. 

Discharge plans should be compatible 

with and support the plan of safe care 

for mother and infant; this includes 

addressing potential maternal comorbid 

medical or mental disorders. See 

Factsheet #15: Maternal Discharge 

Planning, for a more extensive discussion 

about implementing a plan of safe care. 

Ideally, each new mother should have the 

option to receive a long-acting reversible 

contraceptive prior to leaving the hospital.

At a minimum, women should receive 

non-coercive contraceptive counseling 

and the option to leave the hospital with a 

prescription for contraception, contraceptive 

supplies, or a contraception plan (Substance 

Abuse and Mental Health Services 

Administration [SAMHSA], 2014).

Section 1: Factsheet 7
55

with the immediate placement of an IUD after delivery, a risk–benefit analysis concluded that, because many 

women do not attend their 6-week postpartum visit (at which time a LARC is often provided), insertion while still 

at the hospital after delivery is an excellent time to implant the device. Concerns with Medicaid reimbursement are 

an issue, but many states are now providing policy statements on reimbursement at time of insertion.

 Healthcare professionals can encourage women already in treatment to consider planning their next 

pregnancy with the healthcare team to make sure they are on safe medications, their treatment status is 

stable, and they are ready for the stresses of motherhood on top of treatment or recovery.

Other Evidence/Considerations

• In some communities, programs to support women with OUD offer services for mothers who 

are in recovery. Examples of relevant programs within medication-assisted treatment services 

include peer support, medication education, family support and education for childrearing, escape 

from interpersonal violence, and stable housing. The support and practical help these programs 

provide can make a difference in the day-to-day life of a mother and her infant. Healthcare 

professionals might check with local child protection services or opioid treatment programs 

(OTPs) to determine whether such programs are available in their area. OTPs can be located 

through SAMHSA’s Opioid Treatment Program Directory Opioid Treatment Program Directory.

• People who are in recovery from SUD or who live with behavioral health disorders often 

find support, encouragement, and community in consumer-/patient-led organizations. 

These organizations, which are generally set up and run by volunteers, can provide a supportive 

environment that helps some people maintain recovery. Women on pharmacotherapy for OUD 

are encouraged to seek out programs where pharmacotherapy is accepted as complementary 

to traditional 12-step treatment programs and is supportive of using pharmacotherapy. Peer 

counselors or recovery coaches can help those who are new to recovery avoid triggers that can 

lead to return to substance use. Coaches can provide practical support such as transportation 

to and from meetings and show new parents how to securely store all medications, including 

pharmacotherapeutics for OUD, so that children cannot get into them.

WEB RESOURCES ON THIS TOPIC

Breastfeeding

Academy of Breastfeeding Medicine Protocol #21: Guidelines for Breastfeeding and Substance Use or 

Substance Use Disorder, 2009, Revised 2015

This protocol provides evidence-based guidelines for the evaluation and management of women with 

SUDs who are considering breastfeeding. It includes information on methadone and buprenorphine.

Baby Friendly Hospital Initiative-USA

This global initiative was launched by the World Health Organization and the United Nations Children’s 

Fund in 1991 to encourage and recognize hospitals and birthing centers that offer an optimal level of care 

for infant feeding and mother–infant bonding.

Breastfeeding Initiatives: Family Resources 

This American Academy of Pediatrics (AAP) webpage lists breastfeeding resources for families; some 

resources are in Spanish.

Section 1: Factsheet 7
56

Childbirth, Breastfeeding, and Infant Care: Methadone and Buprenorphine

This brochure urges pregnant women who use heroin or abuse opioid prescriptions to seek medicationassisted treatment with methadone or buprenorphine. It discusses how methadone therapy works and 

women’s issues such as breastfeeding, opioid withdrawal, birth control, and child protection services.

Drug Entry Into Human Milk

This InfantRisk Center webpage describes in detail the mechanisms of drug entry into human milk and 

provides general rules on breastfeeding.

Drugs and Lactation Database (LactMed)

This National Library of Medicine searchable database provides information on medications and other 

chemicals to which breastfeeding mothers may be exposed.

Medications and Breastfeeding: Tips for Giving Accurate Information to Mothers

This two-page AAP document discusses clinical points to consider when prescribing medications to 

breastfeeding mothers.

Policy Statement: Breastfeeding and the Use of Human Milk

This AAP-updated policy statement reviews the benefits of breastfeeding for the mother and child.

When Should a Mother Avoid Breastfeeding?

This Centers for Disease Control and Prevention webpage provides links to information about illnesses and 

conditions that contraindicate breastfeeding.

Home Visiting and Peer Support Services

Alcoholics Anonymous (AA)

AA has traditionally emphasized recovery without medication. A person receiving recovery 

support from AA may need to attend a variety of meetings to find one that recognizes the 

role of pharmacotherapy in recovery.

Core Competencies for Peer Workers in Behavioral Health Services

On this webpage, SAMHSA defines peer workers and recovery and lists several 

categories of core competencies for peer workers.

Early Head Start Programs

Early Head Start EHS programs administered by HHS’s Administration for Children and 

Families serve infants and toddlers younger than under the age of 3, and pregnant 

women. TheseEHS programs provide intensive comprehensive child development and 

family support services to low-income infants and toddlers and their families, and to 

pregnant women and their families.

Federal Home Visiting Program 

This webpage provides background about the HRSA and ACF program, its structure, and 

its mission and services, which involve evidence-based, voluntary home visiting programs, 

where families receive help from health, social service, and child development professionals.

Section 1: Factsheet 7
57 Section 1: Factsheet 7

Healthy Beginnings

This program meets the U.S. Department of Health and Human Services criterion for an effective childhood 

home visiting service delivery model. In this model, nurse home visitors provide education on infant nutrition, 

family nutrition, and physical activity and address family members’ concerns. Nurse visitors typically made 8 

visits from a prenatal visit through age 24 months. 

Healthy Start

This webpage describes the HRSA Healthy Start program and links to a technical assistance center with more 

information on program approaches and grantees. The program provides depression screening, healthcare 

services, care coordination, public health services such as immunization and health education, and training for 

community health workers and care coordinators.

Narcotics Anonymous (NA)

NA has traditionally emphasized recovery without medication. A person receiving recovery support from NA 

may need to attend a variety of meetings to find one that recognizes the role of pharmacotherapy in recovery.

National Alliance for Medication Assisted Recovery

This organization is led by people in recovery and supports all pathways to recovery, 

including medication. Recovery Community Centers offer peer support and opportunities 

to socialize with others in recovery.

General Resources

Opioid Treatment Program Directory 

The dropdown menu on this SAMHSA website links users to information on the 

availability of OTPs in the United States and its territories.

Strong Start for Mothers and Newborns Initiative

This joint effort by the Centers for Medicare & Medicaid Services, HRSA, and 

ACF aims to reduce preterm births and improve outcomes for newborns 

and pregnant women.
58

A pregnant woman with opioid use disorder (OUD), in treatment or not, needs pain relief 

during her labor, delivery, and postpartum period. 

Pain Management Options

A pregnant woman will naturally be nervous about how her pain will be controlled during labor and delivery. 

When a woman is already using pharmacotherapy for OUD or has not started therapy and is misusing opioids, 

her options for pain control should include epidural/spinal anesthesia and short-acting opioid analgesics.

Differentiating OUD Pharmacotherapy and Pain Management During Delivery or Postpartum

A woman’s existing opioid agonist dose should not be expected to provide adequate pain relief either 

intrapartum or postpartum. Do not attempt to increase the woman’s prescribed dose of buprenorphine or 

methadone for short-term intrapartum or postpartum pain control.

Contraindicated Medications

Do NOT administer butorphanol, nalbuphine, or pentazocine to a pregnant woman with OUD, whether 

she is on pharmacotherapy for OUD or not. These medications have partial antagonist properties and will 

precipitate acute opioid withdrawal.

FACTSHEET #

8

PERIPARTUM PAIN RELIEF

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION 1

Pain Management Options

• Pregnant women with OUD need to be assured that they will receive adequate pain relief during labor 

and the postpartum period. Healthcare professionals will need to inform the pregnant woman of her labor 

and delivery pain treatment options, talk with her healthcare professional, and consider arranging for her to 

meet with the anesthesiologist before she goes into labor. 

 Patients with long-term opioid use are at risk for hyperalgesia and may derive insufficient pain relief from 

standard therapeutic doses of a nonsteroidal analgesic (NSAID), acetaminophen, or short-acting opioid 

analgesic (Savage, 1996). During labor and delivery, they are likely to require higher doses of opioid agonist 

medication than women who have not experienced long-term opioid use (Alford, Compton, & Samet, 2006; 

Meyer, Paranya, Norris, & Howard, 2010; Meyer, Wagner, Benvenuto, Plante, & Howard, 2007). If a woman 

needs higher doses of NSAIDs, acetaminophen, or short-acting opioid analgesics for adequate intrapartum 

pain relief, this need may continue into the initial postpartum period regardless of the method of delivery.

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

Section 1: Factsheet 8
59

Providing pain relief to women receiving methadone 

or buprenorphine, whether via epidural and/or shortacting opioids, is essential (Jones, Johnson, & Milio, 2006; 

Jones et al., 2008, 2009). Morphine sulfate, fentanyl, 

or hydromorphone (Dilaudid®) are reasonable options 

for acute pain management during labor and delivery 

for patients with OUD. These medications need to be 

responsibly prescribed following Centers for Disease 

Control and Prevention guidelines that, if opioids must 

be prescribed for acute pain, the effective dose should 

be used for 3 or fewer days and rarely more than 7 days 

(Dowell et al., 2016). 

Opioid Agonist Therapy for OUD 

Cannot Provide Pain Management 

During Delivery or Postpartum

• During labor and delivery, the mother should be 

maintained on her current dose of opioid agonist 

therapy for OUD. The daily pharmacotherapy dose should be considered the new mother’s baseline. 

The daily dose of methadone or buprenorphine should not be expected to provide analgesia, and 

neither the dose nor the schedule should be altered to relieve pain (Committee on Healthcare for 

Underserved Women, American Society of Addiction Medicine, & American College of Obstetricians 

and Gynecologists, 2012, 2017; Meyer et al., 2007). 

 Pregnant women on pharmacotherapy do NOT need to be transitioned from their maintenance 

medication before a planned cesarean section (Jones et al., 2006). Labor and operative pain can be 

managed while pharmacotherapy is still being administered (Jones, et al., 2009).

Contraindicated Medications

• Certain analgesics should NEVER be given to women with OUD. Practitioners must not prescribe 

opioid analgesics with antagonist properties (e.g., nalbuphine, butorphanol) to women receiving opioid 

agonists (e.g., methadone, buprenorphine) or with an OUD, because of the likelihood of precipitating 

acute withdrawal (Cassidy & Cyna, 2004; Jones et al., 2014; Savage, 1996). 

Any antepartum discussion or guidance 

regarding pain relief during labor, delivery, 

and postpartum should be documented in 

the antepartum or intrapartum record and 

accessible to all members of the treating 

team. Documenting recommendations for pain 

relief in the patient’s record so that they are 

available to the treatment team during labor 

and delivery, as well as postpartum, is a simple 

way to improve communication among the 

team members. For example, the healthcare 

professional responsible for prescribing opioid 

agonist therapy can provide instruction to 

the team regarding the management of the 

pharmacotherapy for OUD and guidance for 

acute pain management to support the treating 

team in achieving adequate pain control.

FDA Drug Safety Communication: FDA Has Reviewed Possible 

Risks of Pain Medicine Use During Pregnancy

This Food and Drug Administration 2015 communication 

discusses its review of published research studies on the use 

of pain medicines during pregnancy. It does not make any 

recommendations, because of limitations FDA found in the 

studies. The communication urges pregnant women to discuss 

their medications with their healthcare professionals before 

taking them. 

WEB RESOURCES ON THIS TOPIC

Section 1: Factsheet 8
60

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Factsheet #7 

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105(12), 2071–2084. doi:10.1111/j.1360-0443.2010.03120.x

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smoking in opioid-dependent pregnant women: Neonatal and maternal outcomes. Drug and Alcohol 

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Jones, H. E., Jansson, L. M., O’Grady, K. E., & Kaltenbach, K. (2013b). The relationship between maternal 

methadone dose at delivery and neonatal outcome: Methodological and design considerations. 

Neurotoxicology and Teratology, 39, 110–115. doi:10.1016/j.ntt.2013.05.003

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Buprenorphine versus methadone in the treatment of pregnant opioid-dependent patients: Effects on the 

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Patrick, S. W., Dudley, J., Martin, P. R. Harrell, F. E., Warren, M. D., Hartmann, K. E., ... Cooper, W. O. (2015). 

Prescription opioid epidemic and infant outcomes. Pediatrics, 135(5), 842–850.

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e194. doi:10.1111/apa.12910

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of neonatal abstinence syndrome. JAMA, 309(17), 1821–1827. doi:10.1001/jama.2013.3411

Wachman, E. M., Hayes, M. J., Sherva, R., Brown, M. S., Davis, J. M., Farrer, L. A., & Nielsen, D. A. (2015, October 

1). Variations in opioid receptor genes in neonatal abstinence syndrome. Drug and Alcohol Dependence, 155, 

253–259. doi:10.1016/j.drugalcdep.2015.07.001

Factsheet #8 

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methadone or buprenorphine therapy. Annals of Internal Medicine, 149(10), 698–707. doi:10.7326/0003-4819-

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abuse, dependence, and addiction in pregnancy. Obstetrics and Gynecology, 119, 1070–1076. doi:10.1097/

AOG.0b013e318256496e 

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States, 2016. Morbidity and Mortality Weekly Report, 65(1), 1–49. Retrieved from https://www.cdc.gov/mmwr/

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Journal of Obstetrics and Gynecology, 210(4), 302–310. doi:10.1016/j.ajog.2013.10.010

Jones, H. E., Johnson, R. E., & Milio, L. (2006). Post-cesarean pain management of patients maintained on 

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Jones, H. E., Johnson, R. E., O’Grady, K. E., Jasinski, D. R., Tuten, M., & Milio, L. (2008). Dosing adjustments in 

postpartum patients maintained on buprenorphine or methadone. Journal of Addiction Medicine, 2(2), 103–107. 

doi:10.1097/ADM.0b013e31815ca2c6

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postpartum pain in patients maintained on methadone or buprenorphine during pregnancy. American Journal 

of Drug and Alcohol Abuse, 35(5), 151–156. doi:10.1080/00952990902825413

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maintained on buprenorphine during pregnancy. European Journal of Pain, 14, 939–943. 

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for women maintained on methadone during pregnancy. Obstetrics and Gynecology, 110(2 Pt. 1), 261–266. 

doi:10.1097/01.AOG.0000275288.47258.e0

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76

Section II: Infant Care

Section II consists of five factsheets:

Factsheet #9: Screening and Assessment for Neonatal Abstinence Syndrome

Factsheet #10: Management of Neonatal Abstinence Syndrome

Factsheet #11: Breastfeeding Considerations for Infants at Risk for Neonatal Abstinence Syndrome

Factsheet #12: Infant Discharge Planning

Factsheet #13: Early Intervention Strategies and Developmental Assessments

Each factsheet contains four components.

I. Clinical Scenario

Presents a brief statement to orient the reader to the situation under consideration.

II. Clinical Action Steps

Present recommendations that are derived directly from the rated clinical decisions in the 

RAND/UCLA Appropriateness Method report and describe what can, might, or should not be 

done when caring for women and their infants.

III. Supporting Evidence and Clinical Considerations

Present strengths and weaknesses of the evidence supporting the clinical action steps. This 

section describes how to address or tailor recommended actions to unique patient variables 

and preferences, the clinical experience of the provider, and available community resources. 

Guidance is based on expert panel and Federal Steering Committee discussions and additional 

information from published articles. This section includes supporting information for the Clinical 

Action Steps as well as information in where there was insufficient evidence to recommend a 

clear course of action. Instead, information in this section will provide elements that must be 

taken into consideration when making a decision with the pregnant women or new mother 

about the best course of action for herself or her infant.

IV. Web Resources

Provide links to additional online information.

FACTSHEET #9: Screening and Assessment for Neonatal Abstinence 

Syndrome

CLINICAL SCENARIO: An opioid-exposed infant at risk for neonatal abstinence syndrome (NAS) is 

delivered.

• Screening for NAS

• Maternal and infant toxicology

• Informed consent for screening

• NAS onset time varies

• Opportunities for positive change

• Standardized NAS assessment and treatment can 

improve outcomes
77

FACTSHEET #10: Management of Neonatal Abstinence Syndrome

CLINICAL SCENARIO: An infant begins to exhibit signs of neonatal abstinence syndrome (NAS) shortly 

after birth.

• Managing mild NAS

• Managing moderate to severe NAS

• Adjuvant pharmacotherapy for severe NAS

• Additional medical considerations

• Minimizing hospital stays using standardized 

protocols

• Nonpharmacological interventions for all 

substance-exposed mother—infant dyads

• Nonpharmacological interventions to reduce NAS 

severity

• Recommended medications and medications 

under study

• Not recommended medications for NAS

• Infant observation period variation and type of 

opioid

FACTSHEET #11: Breastfeeding Considerations for Infants at Risk for 

Neonatal Abstinence Syndrome

CLINICAL SCENARIO: A mother with an infant at risk for NAS seeks advice on whether to 

breastfeed.

• Stable mother and breastfeeding

• Low levels of opioid use disorder medications 

found in breastmilk

• Pharmacotherapy and breastfeeding 

decision-making

• Discussing benefits of breastfeeding

• Situations where mother should not breastfeed

FACTSHEET #12: Infant Discharge Planning

CLINICAL SCENARIO: An opioid-exposed infant is ready for discharge home.

• In-home and follow-up services

• Caregiver education and home environment

• Need for acute follow-up

• Discharge planning before birth

• Ongoing support for mothers/caregivers and 

infants who cannot be quickly weaned from opioid 

agonists

• Healthy home environments contribute to healthy 

long-term development

• Ongoing research on genetic components of 

substance use disorders

FACTSHEET #13: Early Intervention Strategies and Developmental 

Assessments

CLINICAL SCENARIO: An opioid-exposed infant is ready for discharge home.

• Effects of NAS on development

• Effects of extended-release injectable naltrexone

• Investigating maternal and infant eligibility for 

early intervention services

• Discussing developmental screens and 

assessments
78

An opioid-exposed infant at risk for neonatal abstinence syndrome (NAS) is delivered.

Screening for NAS

An infant born to a mother who used opioids (licit or illicit) or had pharmacotherapy for opioid use disorder (OUD) 

during her pregnancy should be monitored for 4–7 days and managed according to a formal protocol for NAS.

Maternal and Infant Toxicology Screening

The monitoring and management of infants at risk of NAS should be informed by an interview with the 

mother about all substance and pharmacotherapy use during her pregnancy, by the clinical status of the 

infant, and by toxicology screening of the mother and the infant.

Informed Consent

Any toxicology screening of the mother must be done with her informed consent; 

toxicology screening in infants does not require informed consent.

FACTSHEET # SCREENING AND 

ASSESSMENT FOR 

NEONATAL ABSTINENCE 9

SYNDROME

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION 2

Screening for NAS

• The onset of NAS varies among infants and depends on the opioids to which they were exposed. The 

timing of the onset of NAS varies among opioid-exposed infants. Those exposed to heroin or other short-acting 

opioids will typically present symptoms within 2—3 days of delivery (Beauman, 2005; Chan, Klein, & Koren, 2003), 

whereas those exposed to methadone or buprenorphine usually will exhibit NAS symptoms within the first 4 

days of birth (Jansson, Velez, & Harrow, 2009). Median time to treatment initiation has been shown to be one day 

later in buprenorphine-exposed neonates compared 

with methadone-exposed neonates (mean of 3 vs. 

2 days, respectively; Gaalema, Heil, Badger, Metayer, 

& Johnston, 2013). Consequently, an opioid-exposed 

newborn requires a minimum of 4 days (96 hours) 

in the hospital for NAS scoring. If the infant requires 

medication to manage NAS, the exact observation 

time will depend on the infant’s expression of NAS 

and response to treatment (Hudak et al., 2012).

For more information on factors that influence 

NAS expression, severity, and pharmacological 

and nonpharmacological treatment options, 

see Factsheet #10: Management of Neonatal 

Abstinence Syndrome.

FACTSHEET TO REVIEW

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

Section 2: Factsheet 9
79

• Use of standardized NAS assessment and 

treatment protocols improves outcomes. The 

2012 AAP Neonatal Drug Withdrawal report 

(Hudak et al., 2012) recommends that every labor 

and delivery unit have a standardized protocol 

for assessing and treating infants at risk and/or 

showing signs and symptoms of withdrawal from 

opioids, alcohol, and other substances. Nursing 

staff members must be trained to administer a 

standardized NAS assessment tool reliably to 

ensure the consistency of these assessments. 

Standardizing care has been shown to reduce 

the duration of pharmacological treatment and 

the number of infants discharged on medication 

(Patrick et al., 2016). Exhibit FS #9.1 outlines the 

benefits and challenges of the most common NAS 

scoring scales. Little research has been done on 

the comparative cost-effectiveness of these tests 

or their efficiency in identifying opioid-exposed 

infants at birth. 

Each hospital should adopt a protocol 

for infants exposed to opioids and other 

substances in utero. The following materials 

provide examples of established NAS treatment 

protocols for hospitals to institute:

• Cohort Analysis of a Pharmacokinetic-Modeled 

Methadone Weaning Optimization for Neonatal 

Abstinence Syndrome (Hall et al., 2015)

• Maternal Drug Use, Infant Exposure and 

Neonatal Abstinence Syndrome (Patrick, 2016)

• Neonatal Abstinence Syndrome After 

Methadone or Buprenorphine Exposure

(Jones et al., 2010)

• Neonatal Drug Withdrawal (Hudak et al., 2012) 

• The Opioid Exposed Newborn: Assessment 

and Pharmacologic Management (Jansson, 

Valez, & Harrow, 2009)

RESOURCES TO REVIEW

Scale Name Description References

Finnegan Neonatal 

Abstinence Scoring 

System (Finnegan Scale)

• Dates from the 1970s

• Was first scale for NAS

Original: Finnegan, Kron, Connaughton, 

& Emich, 1975

Most recent: Finnegan & Kaltenbach, 1992

MOTHER NAS Scale (a 

modified Finnegan 

Scale)

• Contains 28 items, of which 19 are used for scoring and medication decisions 

• Eliminates many symptoms listed in Finnegan Scale (e.g., myoclonic jerks, 

mottling, nasal flaring, watery stools) 

• Adds 2 items: irritability and failure to thrive

Jones et al., 2010b

Lipsitz Tool (Neonatal 

Drug Withdrawal 

Scoring System)

• Is recommended in the 1998 AAP statement Neonatal Drug Withdrawal and 

again in 2012 updated statement (Hudak et al., 2012)

• Offers relatively simple metrics with good sensitivity for identifying 

clinically important withdrawal

Lipsitz, 1975

Neonatal Narcotic 

Withdrawal Index

• Evaluates NAS on a 7-item scale 

• Assigns weights of 0 to 2 points per item

• Provides some validity data 

Green & Suffet, 1981

Neonatal Withdrawal 

Inventory

• Provides a sequence of care procedures 

• Uses an 8-point scale to make withdrawal evaluation 

Zahorodny et al., 1998

Withdrawal Assessment 

Tool (WAT-1)

• Assesses signs of opioid and benzodiazepine withdrawal Franck, Harris, Soetenga, Amling, & 

Curley, 2008; Kaltenbach & Jones, 2016

Exhibit FS #9.1: NAS Scoring Scales

Section 2: Factsheet 9
80

Maternal and Infant Toxicology Screening

• When creating a long-term plan for the mother’s recovery and infant’s safety, the healthcare professional 

needs to take into account the toxicology results, but should not make decisions solely based on these 

results. Relying exclusively on maternal drug screens at the time of delivery to identify drug exposure is not 

necessarily the best approach for creating a long-term plan for the mother’s recovery because they generally 

reflect only recent substance use (except for tetrahydrocannabinol in chronic cannabis users). Safe care of 

the infant and effective support of the mother and other caregivers are best achieved through a trusting and 

respectful therapeutic relationship between the mother and the care team. Toxicology screening of the mother 

and/or the infant can be a useful component of a NAS risk assessment and the development of a care plan. In 

addition to collecting specimens for toxicology testing, healthcare professionals can use screening instruments 

and interview the mother about recent drug use and pharmacotherapies she required during her pregnancy 

(Hudak, Tan, American Academy of Pediatrics (AAP) Committee on Drugs, & AAP Committee on Fetus and 

Newborn, 2012). Hospitals should use a standardized protocol for screening for substance exposure, as well as 

for monitoring and treating NAS in an opioid-exposed infant.

 All clinicians and staff members must understand their legal responsibility for reporting substance exposure or 

withdrawal of an infant and should be sensitive to the social and legal consequences for the mother and infant 

of reporting such concerns to state and local authorities. Healthcare professionals need confirm any positive 

test results given the life-changing ramifications for the mother and infant if there is a false positive (Wright, 

2015). Reporting requirements vary by state. A Collaborative Approach to the Treatment of Pregnant 

Women With Opioid Use Disorders: Practice and Policy Considerations for Child Welfare, Collaborating 

Medical, and Service Providers provides more 

information on developing and coordinating a longterm plan for caring for mothers and their infants 

(Substance Abuse and Mental Health Services 

Administration [SAMHSA], 2016).

 Additional testing is often done for benzodiazepines, 

barbiturates, methamphetamines, and methadone 

as well as other drugs used in the local community. 

Testing for synthetic opioids (e.g., oxycodone, 

hydrocodone, fentanyl, buprenorphine) must be 

ordered as an extended opioid panel. Extended panels 

are recommended for women with known substance 

use disorders (SUDs), with the understanding that 

urine testing cannot detect ALL drugs of abuse.

 Exhibit FS #9.2 summarizes the most common 

toxicology screens for infants and mothers at delivery. Little research has been done on the costeffectiveness of such testing. To be useful in identifying infants at risk of NAS, test results must be 

available quickly. This means some of the more definitive tests are not useful for the early identification 

of and intervention in NAS risk.

Informed Consent

• All testing on the mother requires informed consent; testing on the neonate does not require consent. 

Healthcare professionals should review with the woman the risks and limitations of each type of test 

(e.g., false-positive results for amphetamines that can be due to cross-reactions of cold medicines) and 

the possible need for confirmatory testing for all positive results (e.g., using gas chromatography/mass 

spectrometry confirmation). They should also ensure that she understands the specimen collection 

process. See Exhibit FS #9.2 for a review of the most common toxicology screens in use.

Factsheet #1: Prenatal Screenings and 

Assessments for more information on 

appropriate maternal screens including 

interview instruments and maternal toxicology.

FACTSHEET TO REVIEW

The easiest testing method is to collect urine 

from the infant. The most commonly ordered 

panel is the National Institute on Drug Abuse—5 

(NIDA-5) to test for cannabis, opioids, cocaine, 

amphetamine, and phencyclidine. Tests results 

need to be available quickly to inform care.

Section 2: Factsheet 9
81

Exhibit FS #9.2: The Most Common Toxicology Screens for Infants and Mothers at Delivery—Neonatal 

Toxicology Tests

Matrix Benefits Drawbacks

Amniotic Fluid 

and Placental 

Tissues

Placental tissue is noninvasively collected.

Collection is exempt from maternal consent procedures.

Placental tissue is not commonly used clinically.

Amniotic fluid collection is difficult and invasive; the sample may not be 

clinically useful.

Cord Blood Cord blood is relatively easy to collect and does not pose 

a hazard to mother or child.

Provides rapid results. 

Collection is exempt from maternal consent procedures.

The window of detection in cord blood is very narrow, limiting the 

findings of the test.

Hair Specimen has a wide window of detection for drug use.

Collection is relatively noninvasive.

Collection is exempt from maternal consent procedures. 

Extraction from specimen is difficult, and testing requires an 

experienced laboratory.

Accuracy of results are limited by the chemical composition of the 

drug, the color of the hair (dark hair has greater concentration of drug 

metabolites than light hair), and timing of maternal consumption 

(Wright, 2015).

Fetal hair reflects only exposure during the third trimester.

Collection of hair from the infant may be unacceptable in some cultures. 

Meconium Sample is easily collected and readily available.

Method has a relatively wide window for collection and 

detection because meconium continues to pass for up to 

48 hours postnatally.

Collection is exempt from maternal consent procedures

Test is complex and must be done by an experienced laboratory.

Sample appears to form at 12 weeks. The volume of meconium 

increases throughout gestation, with most meconium being produced 

in the last 2 months of gestation (Bakdash et al., 2010); thus, drug 

detection is biased to the last 8 weeks in utero.

Sample is commonly contaminated by fetal urine, which increases the 

concentration of substances to which the fetus was exposed near term.

Testing for drugs is limited by the chemical composition of the drug, 

timing of maternal consumption (Wright, 2015), maternal and fetal 

metabolism, and placental transport.

A major drawback for meconium testing is that is does not reflect 

periods of abstinence close to term so may be harmful for women in 

SUD treatment.

Section 2: Factsheet 9
82

Matrix Benefits Drawbacks

Urine Sample collection is relatively noninvasive and easy to 

collect.

Test is inexpensive and readily available.

Results are rapidly available.

Collection is exempt from maternal consent procedures

Results reflect only recent exposure and depend on the half-life of the 

drug.

Use of workplace standards for drug detection rather than lowest 

detectable limits may lead to false-negative results (Farst, Valentine, & 

Hall 2011). False-positive results are also possible.

Many medications can cross-react with the immunoassays used for 

preliminary screening causing false-positive results; thus, all positive 

results must be confirmed (Markway & Baker, 2011).

Testing for benzodiazepines often looks only for oxazepam or 

nordiazepam, not the parent compound; thus differentiating between 

legitimate maternal prescription medication use and illicit street use 

can be a challenge.

Not completing confirmatory urine testing can be disastrous because it 

can result in false-positive results that may mean the loss of custody 

of children and, in some states, legal prosecution (Wright, 2015). 

Umbilical Cord Sample is easily and noninvasively collected.

Sample appears to accurately reflect fetal drug exposure.

Collection is exempt from maternal consent procedures.

Sample does not have ideal reservoirs for the more lipophilic drugs, so 

the results are limited by the chemical composition of the drug.

Matrix Benefits Drawbacks

Cord Blood Provides rapid results. 

Cord blood is relatively easy to collect and does not pose 

a hazard to mother or infant.

The window for detection for maternal cord blood is very narrow and 

severely limits testing for drugs. 

Hair Specimen has a wide window for detection for drug use.

Collection is noninvasive.

Extraction from specimen is difficult, requires a specialized laboratory, 

and can be degraded by environmental exposures such as hair dyes or 

sun exposure. 

Accuracy of results are limited by the chemical composition of the 

drug, the color of the hair (dark hair has greater concentration of 

drug metabolites than light or gray hair), and timing of maternal 

consumption (Wright, 2015).

Exhibit FS #9.2: The Most Common Toxicology Screens for Infants and Mothers at Delivery—Peripartum 

Maternal Toxicology Tests

Section 2: Factsheet 9
83

Matrix Benefits Drawbacks

Urine Collection is relatively noninvasive.

Samples are easy to collect.

Test is inexpensive and readily available.

Results are rapidly available.

Results reflect only recent exposure and depend on the half-life of the 

drug.

Both false-positive and false-negative results are possible. 

Many medications can cross-react with the immunoassays used for 

preliminary screening; thus, all positive results must be confirmed 

(Markway & Baker, 2011).

Testing for benzodiazepines often looks only for oxazepam or nordiazepam, 

not the parent compound; thus, differentiating between legitimate 

prescription medication use and illicit street use can be a challenge.

Method of ingestion and chronicity of use may affect results.

Urine can be adulterated or diluted; thus, collection should be observed, 

which precludes privacy.

Not completing confirmatory urine testing can be disastrous because it 

can result in false-positive results that may mean the loss of custody 

of children and, in some states, legal prosecution (Wright, 2015).

Saliva Collection is noninvasive and easily obtained.

Collection method is more dignified than observed urine 

sample collection.

Sample often has a shorter detection window than that of urine. 

The majority of substances in saliva are the parent drug rather than 

metabolites. 

Salivary pH influences drug concentrations in that acid pH decreases 

concentrations (Drummer, 2005); this makes test adulteration possible. 

Sweat Specialized patch makes collection noninvasive and well 

tolerated.

Collection method offers a cumulative measure of 

exposure of the drug over an extended period.

Less is known about this type of biological matrix for detecting drugs 

than other methods, because it is a relatively new methodology.

Collection is limited by the chemical composition of the drug.

2017 ICD-10-CM Diagnosis Code 96.1

This website provides detailed information on the codes for neonatal withdrawal 

symptoms used for reimbursement purposes. 

A Collaborative Approach to the Treatment of Pregnant Women With Opioid Use 

Disorders: Practice and Policy Considerations for Child Welfare, Collaborating 

Medical, and Service Providers 

This SAMHSA document provides information on treating pregnant women with 

OUD, summarizes guidelines adopted by a variety of professional organizations, and 

presents a framework for organizing community efforts. It provides a coordinated, 

multisystem approach grounded in early identification and intervention to assist 

child welfare, medical, SUD treatment, and other systems in supporting families.

WEB RESOURCES ON THIS TOPIC

Section 2: Factsheet 9
84

Management of NAS

An infant born to a mother who misused opioids (licit or illicit) or required pharmacotherapy to treat opioid use 

disorder (OUD) during her pregnancy should be monitored and managed according to a formal protocol for NAS.

• Managing Mild Signs

 An infant exhibiting mild signs of NAS should be managed with nonpharmacological interventions such as 

rooming-in and monitored for progression to more severe symptoms according to a formal NAS protocol.

 • Managing Moderate to Severe Signs

 Infants with moderate to severe signs of NAS should be managed with 

nonpharmacological interventions as for infants with mild NAS, with the 

addition of pharmacotherapy such as liquid oral morphine or liquid oral 

methadone. Neither tincture of opium nor phenobarbital should 

be used as first-line agents in the treatment of NAS. Not enough 

evidence exists to recommend for or against the use of sublingual 

buprenorphine for the management of moderate to severe NAS.

• Using Adjuvant Pharmacotherapy for Severe NAS

 Clonidine or phenobarbital may be used as adjuvants for infants 

with severe NAS not adequately relieved by morphine or 

methadone.

Medical Considerations

An infant with NAS who cannot maintain adequate hydration or who loses 

weight despite optimal management should be evaluated to rule out other 

medical conditions, and consideration should be given to transferring the 

infant to a neonatal intensive care unit.

An infant begins to exhibit signs of neonatal abstinence syndrome (NAS) shortly after birth.

FACTSHEET #

MANAGEMENT OF 

NEONATAL ABSTINENCE 

SYNDROME

10

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION 2

Section 2: Factsheet 10
85

Management of NAS

• Hospital stays for infants with NAS are shortened 

when standardized protocols are used. Several 

recent publications have emphasized the value 

of using a standard assessment and treatment 

protocol. The act of implementing a standard NAS 

treatment and weaning protocol shortened the 

length of infant stays (Asti, Magers, & Keels, 2015; 

Patrick et al., 2016). Furthermore, a multicenter 

study comparing infants managed with a standard 

NAS treatment and weaning protocol with infants 

managed without such a protocol found that, 

regardless of medication type (methadone or 

morphine), infants managed with the standard 

protocol required a shorter duration of NAS 

medication treatment and a shorter hospital stay 

(Hall, Wexelblatt, & Crowley, 2015; Holmes et al., 

2016).

 Although a traditional medication regimen uses 

a weight-based approach, some institutions and 

research protocols now use a symptom-based 

approach in which the dose is based on the 

severity of the infant’s symptoms (Jansson et al., 

2009; Kraft & van den Anker, 2012). Exhibit FS 

#10.1 provides NAS scores to define the terms 

mild, moderate, and severe used in this Guide. 

Exhibit FS #10.2 lists the factors that influence 

NAS expresssion and severity. 

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

Each hospital should adopt a protocol 

for infants exposed to opioids and other 

substances in utero. The following materials 

provide examples of established NAS treatment 

protocols for hospitals to institute:

• Cohort Analysis of a Pharmacokinetic-Modeled 

Methadone Weaning Optimization for Neonatal 

Abstinence Syndrome (Hall et al., 2015)

• Maternal Drug Use, Infant Exposure and 

Neonatal Abstinence Syndrome (Patrick, 2016)

• Neonatal Abstinence Syndrome After 

Methadone or Buprenorphine Exposure

(Jones et al., 2010)

• Neonatal Drug Withdrawal (Hudak et al., 0212) 

• The Opioid Exposed Newborn: Assessment 

and Pharmacologic Management (Jansson, 

Valez, & Harrow, 2009)

RESOURCES TO REVIEW

Exhibit FS #10.1: NAS Severity Based on Scores Collected 

Using the MOTHER NAS Scale (a Modified Finnegan Scale)*

Term Score

(based on peak NAS score, 24-hour 

observation with scoring every 3–4 hours)

Mild 0–8

Moderate 9–16

Severe 17+

Section 2: Factsheet 10

See Exhibit FS #9.1: NAS Scoring Scales for a list 

of the most commonly used scoring scales. 

*Source: Jones et al., 2010.
86

Factors References

Gestational Age at Delivery Doberczak, Kandall, & Wilets, 1991; Seligman et al., 2008 

Prenatal Exposure to Tobacco Smoking Jones et al., 2013

Prenatal Exposure to Other Substances (e.g., 

Benzodiazepines, Selective Serotonin Reuptake Inhibitors)

Jansson, Dipietro, Elko, & Velez, 2010; Kaltenbach et al., 2012; Pritham, 

Paul, & Hayes, 2012; Seligman et al., 2008; Wachman et al., 2011 

Genetic and Epigenetic Variation Wachman et al., 2013, 2015

Exhibit FS #10.2: Factors that Influence NAS Expression and Severity

• Beginning at birth all infants, whether they manifest signs of NAS or not, should receive 

nonpharmacologic care, and the pregnant woman and family caregivers should be educated on this 

approach before the infant’s birth. Nonpharmacologic care of the substance-exposed mother–infant dyad 

consists of:

◆ A thorough understanding of the newborn’s functioning with the goals of implementing comforting 

techniques and environmental modifications and promoting the infant’s self-regulation and interactive 

capabilities. 

◆ A thorough understanding of the mother’s strengths and challenges to promote her self-regulation, 

confidence as a parent, and ability to respond contingently to and communicate with her infant.

◆ Attention to the dyadic communication patterns and behaviors and the environment that may need 

modifications to support the infant’s physiologic organization and regulation and to encourage the 

mother to respond sensitively to the infant’s needs (Velez & Jansson, 2008).

 Infants with NAS can be described as having 

“dysfunctional regulation” (Velez & Jansson, 2008). The 

nervous system of each infant will mature at a different 

rate, and infants exposed to opioids in utero may have 

specific problems related to neuromaturation. As the 

timing of the developmental milestones related to selforganization and self-regulation may vary, it is particularly 

important to create individualized NAS management 

plans for caregivers that take into consideration each 

infant’s developmental milestones. This plan and training 

should be sensitive to the individual strengths and 

vulnerabilities of the infant and the mother. 

• Research supports using nonpharmacological 

interventions to reduce the severity of NAS before 

or in conjunction with medical treatment. Predicting 

the risk of NAS for infants of mothers with opioid use 

disorder (OUD) is difficult, because the mother may be using several different substances that can influence 

the presentation of NAS (Jones et al., 2013a; Patrick et al., 2015). Infant-related variables can affect the infant’s 

NAS course, such as genetics, gender, and gestational age (Wachman, et al., 2013; Wachman, et al., 2015).

 NAS is an expected and treatable outcome of opioid agonist or partial agonist pharmacotherapy to treat 

OUD during pregnancy. Recent studies have shown NAS associated with pharmacotherapy is not worse 

than that experienced after untreated heroin use (Buckley, Razaghi, & Haber, 2013).

Interventions that target both the mother’s 

understanding of and responses to the 

infant and the infant’s regulatory capacity 

and ability to relay interpretable cues to 

the mother will facilitate mother–infant 

interactions. The goal of the individualized 

infant NAS management plan is to help:

• The infant self-regulate by increasing the 

length of sleep, increasing time spent 

in the quiet alert state, and promoting 

motor and autonomic control.

• The mother to understand and respond 

to her infant’s communication sensitively 

and contingently.

Section 2: Factsheet 10
 Any amount of breastfeeding when appropriate and however brief, can decrease the infant’s need 

for pharmacological treatment, lead to a decrease in NAS scores, and decrease the duration of 

pharmacological therapy and hospitalization (Abdel-Latif et al., 2006; Bagley, Wachman, Holland, & 

Brogly, 2014; Jansson et al., 2008a, 2008b). 

 Promising nonpharmacological treatments include rooming in, extended skin-to-skin contact with the 

mother, gentle handling, swaddling, pacifiers, quiet environments, supine positioning and waterbeds 

(American Academy of Pediatrics [AAP], 2012; Bagley et al., 2014; d’Apolito, 1999; MacMullen, Dulski, 

& Blobaum, 2014; Oro & Dixon, 1988; d’Apolito, 1999; Velez and& Jansson, 2008; American Academy 

of Pediatrics [AAP], 2012; Bagley et al., 2014; MacMullen, Dulski, & Blobaum, 2014; World Health 

Organization, 2014). 

 Rooming-in has been consistently associated with a reduced need for medication to treat NAS and a 

shortened neonatal hospital stay (Abrahams et al., 2007; Hünseler, Brückle, Roth, & Kribs, 2013; McKnight 

et al., 2016; Saiki, Lee, Hannam, & Greenough, 2010). Breastfeeding and rooming-in may go hand in hand, 

although it is not clear to what extent extensive breastfeeding while rooming-in drives the reductions 

in NAS severity (Bagley et al., 2014). Rooming-in is now the standard of care and as such should be 

offered to all mother-infant dyads. Healthcare 

professionals need to work to minimize barriers to 

breastfeeding and seek opportunities to support 

mother–infant bonding and secure attachment 

during the immediate postpartum period; these 

efforts will maximize the well-being of the mother 

and the infant. Exhibit FS #10.3 lists resources on 

nonpharmacological approaches currently available.

For more information on when it is appropriate 

to recommend breastfeeding and for 

additional web resources, see Factsheet #11: 

Breastfeeding Considerations for Infants at 

Risk for Neonatal Abstinence Syndrome. 

FACTSHEET TO REVIEW

Factors References

Breastfeeding and skinto-skin contactAbdel-Latif et al., 2006; Ballard, 2002; McQueen, Murphy-Oikonen, Gerlach, & Montelpare, 2011; O’Connor, Collett, Alto, & 

O’Brien, 2013; Welle-Strand et al., 2013

Rooming-in Abrahams et al., 2007; Bagley et al., 2014; Holmes et al., 2016; Hünseler et al., 2013; McKnight et al., 2016; Saiki et al., 2010, 

Acupuncture/Acupressure Filippelli et al., 2012; Schwartz, Xiao, Brown, & Sommers, 2011

Waterbeds d’Apolito, 1999; Oro & Dixon, 1988

Exhibit FS #10.3: Nonpharmacological Approaches Currently in Use

 The caregiver will most likely need education in how to respond to the infant’s behaviors, intensive social 

supports during the postpartum period, and continued therapy for any maternal psychiatric problems.

• Several medications are available to treat NAS. AAP recommends either oral morphine solution or 

methadone to treat withdrawal that infants experience following cessation of prenatal opioid exposure 

(Hudak, Tan, AAP Committee on Drugs, & AAP Committee on Fetus and Newborn, 2012). Because of 

the short half-life of morphine, dosing is needed at least every 4 hours. Healthcare professionals should 

be aware that these medications are usually dissolved in alcohol for compounding. Where possible, 

compounding with alcohol should be avoided and preservative-free preparations should be used.

 Other medications for the treatment of NAS, such as buprenorphine, are under study (Kraft et al., 2008, 

2011). Although there is preliminary evidence that sublingual buprenorphine may be more effective than 

87 Section 2: Factsheet 10
2017 ICD-10-CM Diagnosis Code 96.1

This website provides detailed information on the codes for neonatal withdrawal symptoms used for 

reimbursement purposes.

Advisory: Tobacco Use Cessation During Substance Abuse Treatment Counseling

This 2011 Substance Abuse and Mental Health Services Administration document offers substance use 

disorder (SUD) counselors an introduction to tobacco use cessation during SUD treatment. It discusses 

screening and effective treatment approaches to quitting, including cessation medications and 

practical and supportive counseling.

Childbirth, Breastfeeding, and Infant Care: Methadone and Buprenorphine

This brochure urges pregnant women who use heroin or abuse opioid prescriptions to seek medicationassisted treatment with methadone or buprenorphine. It discusses how methadone therapy works and 

women’s issues such as breastfeeding, opioid withdrawal, birth control, and child protection services.

Neonatal Abstinence Syndrome: A Guide for Families

This 2014 guide was produced by the Ohio Prenatal Quality Collaborative in conjunction with 

Dartmouth-Hitchcock Medical Center. It was written to help family members care for infants with NAS, 

both while in the hospital and after discharge. 

SIDS and Other Sleep-Related Infant Deaths

This 2016 AAP policy statement on sudden infant death syndrome (SIDS) and other sleep-related infant 

deaths provides recommendations for a safe infant sleeping environment.

WEB RESOURCES ON THIS TOPIC

morphine for treatment of moderate to severe NAS (Kraft, Stover, & Davis, 2016, Kraft Adeniyi-Jones, 

Chernvoneva, Greenspan, Abatemarco, Kaltenbach & Ehrlich, 2017), further study is needed. Phenobarbital 

and clonidine are effective adjuvant therapies to morphine and methadone when maximum dose of the 

first-line medication has been reached or when weaning is unsuccessful (Agthe et al., 2009; Kocherlakota, 

2014; Kraft, Stover, & Davis, 2016). 

• For several reasons, including avoiding medication errors, diluted tincture of opium is no longer widely 

used for treating NAS. Diluted tincture of opium is easily confused with deodorized tincture of opium 

(both commonly abbreviated DTO) and has a high alcohol content (Langenfeld et al., 2005). Oral morphine 

sulfate is now preferred over diluted tincture of opium and is as effective as diluted tincture of opium.

• Women with OUD who are not receiving treatment with an opioid agonist are likely to misuse a 

combination of short- and long-acting opioids, which complicates the infant observation period. 

Opioids with a short half-life include codeine, fentanyl, heroin, hydrocodone, hydromorphone, meperidine, 

morphine, and oxycodone. Examples of opioids with a long half-life are buprenorphine, levorphanol, and 

methadone. If the infant was exposed only to short half-life opioids in utero, observe the infant closely 

for 96 hours and then discharge if NAS medication is no longer needed for the infant. If the infant was 

exposed to any long half-life opioids in utero, it may be necessary to extend the observation period to 4–7 

days from birth before discharge (Hudak, et al., 2012).

88 Section 2: Factsheet 10
Stable Mother and Breastfeeding

Upon delivery, women who are stable on buprenorphine, buprenorphine/naloxone 

combination, or methadone should be advised to breastfeed, if appropriate.

Although naltrexone in breastmilk has not been studied extensively in the United States, 

the benefits of breastfeeding are generally thought to outweigh any risk from naltrexone 

exposure. The decision to breastfeed while on naltrexone should be made collaboratively with 

the new mother after a full discussion of the lack of research and individual considerations.

Medical Considerations

An infant with NAS who cannot maintain adequate hydration or who loses weight despite 

optimal management should be evaluated to rule out other medical conditions, and 

consideration should be given to transferring the infant to a neonatal intensive care unit.

A mother with an infant at risk for neonatal abstinence syndrome (NAS) seeks advice on whether to breastfeed.

FACTSHEET # BREASTFEEDING 

CONSIDERATIONS FOR INFANTS 

AT RISK FOR NEONATAL 

ABSTINENCE SYNDROME

11

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION 2

Stable Mother and Breastfeeding

• Levels of buprenorphine and methadone are very low in breast milk. Few studies have focused on 

breastfeeding as an outcome of opioid agonist pharmacotherapy for pregnant women with opioid use 

disorder (OUD) (Abrahams et al., 2007; Debelak, Morrone, O’Grady, & Jones, 2013; Johnson et al., 2001). 

Buprenorphine and methadone levels in breast milk are very low when the mother is on pharmacotherapy 

and pose little risk to infants (Ilett et al., 2012; Jansson et al., 2008a, 2008b, 2016).

• The decision to use the combination buprenorphine/naloxone product while breastfeeding is a shared 

decision, but one that ultimately must be made by the patient once she understands the risks and benefits 

to herself and her newborn. Available data suggest that naloxone does not affect lactation hormone levels 

in breastfeeding mothers. The mother’s use of buprenorphine with naloxone is not a reason for discontinuing 

breastfeeding (Cholst, Wardlaw, Newman, & Frantz, 1984; Johnson, Andrews, Seckl, & Lightman, 1990). 

Naloxone’s poor bioavailability when taken either sublingually or transmucosally in the buprenorphine/naloxone 

combination product (Ilett et al., 2012) makes it even less likely to transfer to the neonate via breast milk.

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

89 Section 2: Factsheet 11
 Recent studies suggest that maternal and infant outcomes on 

the combination buprenorphine/naloxone product do not differ 

from those of buprenorphine only (Debelak et al., 2013; Dooley 

et al., 2016; Gawronski et al., 2014; Jumah et al., 2016; Lund et 

al., 2013; Wiegand et al., 2015). Small nonclinically meaningful 

amounts of naloxone are present in cord blood (Wiegand et al., 

2016). No increased birth defect risks have been reported after naloxone was used in pregnant women as 

an antidote to opioid overdose (Bailey, 2003). However, no long-term follow-up studies that investigate 

neurodevelopment in infants exposed to buprenorphine/naloxone in utero have been published.

• The effects, if any, of naltrexone on child development are not known. There are at least 25 published 

prenatal naltrexone implant exposure cases, and all show normal birth outcomes (Hulse, Arnold-Reed, 

O’Neil, & Hansson, 2003; Hulse, O’Neil, & Arnold-Reed, 2004; Jones, Chisolm, Jansson, & Terplan, 2012). A 

mother’s preference for beginning antagonist therapy may be considered if she resumes pharmacotherapy 

in the postpartum period. However, only one case study has reported examining how much naltrexone 

is secreted into breast milk (Chan, Page-Sharp, Kristensen, O’Neil, & Ilett, 2004). In this case, only very 

low levels of the naltrexone metabolite were detected in the infant plasma (1.1 micro g/L), and the infant 

appeared to be healthy, was meeting developmental milestones on time, and showed no adverse effects. 

• Healthcare professionals should take time to talk about the benefits of breastfeeding. Any breastfeeding, 

however brief, can decrease the infant’s need for pharmacological treatment for NAS and the length of 

pharmacological therapy and hospitalization (Abdel-Latif et al., 2006; Bagley, Wachman, Holland, & Brogly, 

2014; Jansson et al., 2008a, 2008b; Reece-Stremtan, et al., 2015; Ruwanpathirana et al., 2015). The benefit 

that the infants with NAS derive from breastfeeding is attributed to the act of breastfeeding (e.g., making 

skin-to-skin contact, holding infant closely) rather than to the amount of maternal opioid agonist secreted 

into the breast milk (Kaltenbach & Jones, 2016).

• Mothers need to know when they should or should not breastfeed. Although a stable mother being 

treated for OUD with pharmacotherapy is encouraged to breastfeed her infant, there are some situations 

where breastfeeding is not recommended (e.g., the mother is HIV-positive, has tuberculosis, has cracked or 

bleeding nipples, is hepatitis C-positive, has returned to illicit drug use including cannabis). Mothers who are 

hepatitis B surface antigen-positive or who are infected with the hepatitis C virus may breastfeed (American 

Academy of Pediatrics [AAP], Section on Breastfeeding, 2012; Centers for Disease Control and Prevention 

[CDC], 2015). CDC (2016) describes other situations in which a mother should avoid breastfeeding.

Breastfeeding has many positive 

physical and behavioral health 

effects for mother and infant.

90 Section 2: Factsheet 11

Careful consideration regarding breastfeeding is needed for women who 

present to prenatal care and/or SUD treatment during or after the second 

trimester, women who return to illicit substance use/licit substance misuse, 

and women who attained abstinence only in an inpatient setting. In these 

cases, a recommendation for lactation should be determined with the 

collaborative care team and the new mother. Factsheet #16: Maternal 

Return to Substance Use provides more guidance on breastfeeding should 

the mother return to substance use. 
Factors Breastfeeding May Not Be Recommended*

The mother is enrolled in a medication-assisted treatment program (with 

either buprenorphine or methadone) with significant social support and 

plans to continue treatment. She has demonstrated that she is stable in 

treatment. 

The mother has a medical condition or takes medications that are 

contraindicated for lactation. 

The mother has given written informed consent for healthcare 

professionals to discuss her SUD treatment.

The mother did not receive prenatal care

The mother’s pain management medications after delivery are not 

contraindicated for newborns.

Close to delivery, the mother has a pattern of regular illicit drug use or 

licit substance use meeting criteria for an active SUD.

The mother’s urine toxicology results were negative except for prescribed 

medications at delivery.

The mother is not willing to engage in SUD treatment or is engaged in 

treatment but is not willing to provide consent for contact with anyone in 

the program.

The mother has received consistent prenatal care. The mother’s urine toxicology results were positive for substances or 

their metabolites indicating recent use of alcohol or other substances 

that are not prescribed to her for the treatment of a medical condition.

The mother plans to consider SUD treatment in the postpartum period. The mother does not have confirmed plans for postpartum SUD 

treatment and pediatric care.

The mother has been advised of the risk and benefits of taking 

antidepressants, anxiolytics, and mood stabilizers during the 

breastfeeding period.

The mother demonstrates behaviors or other indicators of an active SUD

If the infant has significant NAS, lactation support is available.

Exhibit FS #11.1: Breastfeeding Recommendations

* If the mother meets one or more of these criteria, further evaluation should be conducted to determine whether she can support safe 

infant breastfeeding. Evidence is accumulating to recommend eliminating cannabis use during pregnancy, while breastfeeding, or through 

secondhand smoke exposure (Jansson, Bunik, & Bogen, 2015).

Sources: AAP, Section on Breastfeeding, 2012; CDC, 2016; Committee on Obstetric Practice, ACOG, 2017; Hudak et al., 2012; Jansson et al., 2008a, 

2008b, 2016; Jansson & Velez, 2015; Reece-Stremtan et al., 2015; WHO, 2014.

91 Section 2: Factsheet 11

 The American College of Obstetricians and Gynecologists (ACOG) 

recommends against maternal cannabis use (Committee on Obstetric 

Practice, ACOG, 2017) as does a recent National Academies of Science 

report (National Academies of Sciences, Engineering, & Medicine, 2017). 

New research is expected on both maternal cannabis smoking and ingestion 

of tetrahydrocannabinol, the principal psychoactive component of cannabis, 

due to the legalization of cannabis use in several states. Until research 

on this issue is provided, pregnant women and new mothers should be 

counseled to avoid cannabis, as well as alcohol and nicotine, for either 

recreational or medicinal purposes (Committee on Obstetric 

Practice, ACOG, 2017; Jansson, Bunik, & Bogen, 2015; ReeceStremtan et al., 2015; Volkow, Compton & Wargo, 2017; World Health 

Organization [WHO], 2014). Exhibit FS #11.1 provides examples of 

when a mother with OUD might be advised to breastfeed and when 

breastfeeding is not recommended. 
ABM Protocol #21: Guidelines for Breastfeeding and Substance Use or Substance Use Disorder, Revised 2015 

This ABM protocol provides evidence-based guidelines for the evaluation and management of women with 

SUDs who are considering breastfeeding. It includes information on methadone and buprenorphine.

Baby Friendly Hospital Initiative-USA

This global initiative was launched by WHO and the United Nations Children’s Fund in 1991 to encourage 

and recognize hospitals and birthing centers that offer an optimal level of care for infant feeding and 

mother–infant bonding. 

Breastfeeding Initiatives: Family Resources 

This AAP webpage lists breastfeeding resources for families; some resources are in Spanish.

Childbirth, Breastfeeding, and Infant Care: Methadone and Buprenorphine

This brochure urges pregnant women who use heroin or abuse opioid prescriptions to seek medicationassisted treatment with methadone or buprenorphine. It discusses how methadone therapy works and 

women’s issues such as breastfeeding, opioid withdrawal, birth control, and child protection services.

Clinician Consultation Center Substance Use Warmline

The University of California, San Francisco’s, Clinician Consultation Center provides Substance Use 

Warmline consultation to health center providers. This is a free, real-time clinician-to-clinician telephone 

consultation, addressing the care and treatment of substance abuse, chronic pain, and behavioral health. 

Access the Warmline toll-free at: 1-855-300-3595 (Monday-Friday, 10 a.m.-6 p.m. EDT). 

Drug Entry Into Human Milk 

This InfantRisk Center webpage describes in detail the mechanisms of drug entry into human milk and 

provides some general rules on breastfeeding.

Drugs and Lactation Database (LactMed) 

This National Library of Medicine searchable database provides information on medications and other 

chemicals to which breastfeeding mothers may be exposed.

LactMed 

This website provides the most current and comprehensive information on transference of substances to 

breast milk. 

Medications and Breastfeeding: Tips for Giving Accurate Information to Mothers

This two-page AAP document discusses clinical points to consider when prescribing medications to 

breastfeeding mothers.

Policy Statement: Breastfeeding and the Use of Human Milk

This AAP-updated policy statement discusses the benefits of breastfeeding for mother and child.

SIDS and Other Sleep-Related Infant Deaths

This 2016 AAP policy statement on sudden infant death syndrome (SIDS) and other sleep-related infant 

deaths provides recommendations for a safe infant sleeping environment.

When Should a Mother Avoid Breastfeeding?

This CDC webpage provides links to information about illnesses and conditions that contraindicate breastfeeding.

WEB RESOURCES ON THIS TOPIC

92 Section 2: Factsheet 11
93

In-home and Follow-up Services

The discharge plan for infants treated for neonatal abstinence syndrome (NAS) should include home 

visitation and early intervention services, such as including attachment-based parenting support, a home 

nursing consult, a social work consult, and referrals to healthcare professionals who are knowledgeable 

about NAS and are accessible to the family immediately after discharge.

Caregiver Education and Home Environment

Caregivers should receive home visitations and early intervention services that help them to recognize NAS 

signs in the infant.

Healthcare professionals can present the benefits of a stable and enriched home environment for the family 

and provide support to achieve such a positive environment. 

A mother who is worried that her substance use disorder (SUD) history increases the likelihood that her child 

will have an SUD in the future should be counseled that genetic and social factors increase the risk of SUD in 

children of parents with SUDs but that a stable, healthy home environment can reduce that risk.

Need for Acute Follow-up

An infant treated for NAS who has trouble eating or sleeping, is crying more than expected, or has loose 

stools after discharge should be promptly evaluated by a healthcare professional.

An opioid-exposed infant is ready for discharge home.

FACTSHEET #

INFANT DISCHARGE 

PLANNING 

12

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION 2

In-home and Follow-up Services

• When completing the discharge checklist, the assumption is that the infant has remained in the hospital 

for a minimum of 4 days or until NAS medical treatment, if warranted, has been completed. It is assumed 

that the mother is ready for discharge at the same time as the infant and the proper protocols for maternal 

discharge have been followed. In addition to following standard infant discharge procedures (Benitz & 

American Academy of Pediatrics [AAP] Committee on Fetus and New Born, 2015), it is recommended that 

the checklists in Exhibit FS # 12.1 be completed at discharge and at follow-up visits.

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

Section 2: Factsheet 12
94

Infant Discharge Checklist

Healthcare Professionals Considerations When Determining Infant Discharge Eligibility Is Infant Ready for Discharge?†

Infant weaned off medication (if applied) and observed for at least 24 hours after weaning, following a hospital 

protocol.



Infant is successfully feeding. 

Caregivers received education about recognition of infant signs of NAS and have the contact information of 

responsive medical personnel to call with concerns.



Caregivers have received education about techniques to soothe the infant (e.g., dim lights, softly playing white 

noise, skin-to-skin contact, pacifier, swaddling) and ways to recognize and respond to infant dysregulation.



Caregivers are responding to the infant’s needs in a safe and responsive way. 

Caregivers have been educated on the Safe to Sleep campaign and the infant has its own place to sleep to 

reduce the risk of sudden infant death syndrome (SIDS), especially as infants with NAS are at an increased risk 

for sleep-related deaths.



Caregivers have received education about follow-up plans that include home visits and early pediatric followup appointments (within 5 days of discharge).



Exhibit FS #12.1: Sample Protocol for Discharge and Follow-up Visits*

†If all boxes are checked, the infant is ready to be considered for discharge.

Best Practices for Infant Follow-up

Actions for the Social Worker or Case Manager at or Shortly After Discharge

• Schedule a pediatric medical follow-up appointment within 2–5 days of discharge.

• Help the family get to the appointment (e.g., arrange transportation).

• Call or text family members to remind them of the appointment.

Medical Follow-up 

• Contact the family if the infant misses an appointment and attempt to reschedule it. 

• Ensure adequate follow-up if the infant has been exposed to hepatitis B and C.

• Notify other healthcare professionals involved in the postnatal mother-infant dyad 

care if the family cannot be reached. 

• Ensure the infant visit schedule follows the AAP Bright Futures Periodicity Schedule or 

schedule more frequent visits if there are concerns about the dyad.

Infants should only be swaddled 

at home if the caregivers have 

been given training in swaddling.

The following recommendations on 

swaddling were released in the 2016 

AAP policy statement on safe sleep 

practices (AAP Task Force on Sudden 

Infant Death Syndrome, 2016):

• When an infant is 

swaddled, he or she 

should always be 

placed on the 

back.

• Because there 

is a high risk 

of death if a 

swaddled infant 

rolls into the facedown position, 

when an infant 

attempts to roll over, 

swaddling should be 

discontinued.

Section 2: Factsheet 12
95

• Although the majority of infants can be weaned from methadone or morphine relatively quickly, some 

cannot. These infants will require ongoing help and support, as will their mothers or caregivers. Eighty 

percent of infants can be successfully weaned from methadone completely within 5 to 10 days (Hudak, 

Tan, AAP Committee on Drugs, & AAP Committee on Fetus and Newborn, 2012). When infants remain in 

the hospital for pharmacotherapy, the mothers should be invited to stay with the infant so as to promote 

rooming-in and other nonpharmacological practices until the infant is weaned from medication.

Caregiver Education and Home Environment

• Infant discharge planning should begin before birth, with discussions on ways to reduce NAS expression 

and severity and promote healthy attachment. Maternal support in the hospital that promotes rooming-in, 

breastfeeding when appropriate, and skin-to-skin contact increases the opportunities for mothers to nurture 

their infant and develop parenting skills. With education, 

support, and mentoring resources, mothers may develop 

healthy attachment, bonding, and other caregiving behaviors 

(Abrahams et al., 2007). A small study following prenatally 

opioid-exposed children for 5 years concluded that a parent–

healthcare professional relationship established in pregnancy 

and continued during the postpartum period facilitated a longlasting relationship with childhood professionals and reduced 

court-ordered placements and reports of developmental 

disorders (Roy et al., 2011).

• Healthcare professionals should remind parents that 

a healthy home environment is critical to healthy 

development—from infancy to adolescence—and work to ensure the necessary in-home services and 

resources are available to make this possible regardless of the family’s circumstances. The home must 

be secured from safety hazards, and prescription drugs must be out of reach, preferably stored under lock 

and key. Routine pediatric health maintenance is critical, especially in the first 2 years (Smith & Wilson, 

2016). This includes pediatric well-child visits for growth and development assessment, preventive care, and 

immunizations. Healthcare professionals have a unique opportunity to recognize and assess a child’s risk, to 

intervene to protect the child, and to help parents improve both parenting skills and the home environment.

 The most promising prevention interventions provide reduction of risks and boosts 

of protective factors across multiple domains (individual and peer, family, school 

and community; Jackson, Geddes, Haw & Frank, 2012).

• Research to understand the genetics of SUDs is still emerging. Researchers 

believe that some of the same genes that increase a person’s risk for problems with 

alcohol might also put him or her at greater risk for other SUDs. Moreover, those 

same genes might increase the risk for other psychiatric problems, such as conduct 

disorder and adult antisocial behavior (i.e., externalizing behaviors) (Dick & Agrawal, 

2008). Recent studies suggest that the genetic variability of μ-, δ-, and κ-opioid 

receptor genes OPRM1, OPRD1, and OPRK1 can modulate the efficacy of opioid 

treatments (Bauer, Soares, & Nielsen, 2015; Wachman et al., 2013, 2015). Currently, it 

is difficult to translate these findings into meaningful guidance 

for families. Healthcare professionals should emphasize 

modifiable risk factors such as maintaining parental recovery 

and supporting a stable home environment.

The infant discharge plan should 

be compatible with and support 

the plan of safe care for mother 

and infant; this includes addressing 

potential maternal comorbid medical 

or mental disorders. See Factsheet 

#15: Maternal Discharge Planning, 

for a more extensive discussion about 

implementing a plan of safe care for 

both the mother and infant. 

The mother’s ongoing engagement 

in treatment and recovery support 

for OUD is an essential element of a 

healthy home environment. 

Section 2: Factsheet 12
96

Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition

This multimodal library of materials for stakeholders involved in improving health care for infants, children, 

and adolescents was first published in 2000 by AAP. It includes evidence-based toolkits that cover all 

aspects of pediatric health care. 

Bright Futures/AAP Periodicity Schedule 

This chart presents the screenings, assessments, physical examinations, procedures, and timing of 

anticipatory guidance recommended for each age-related well-child visit in Bright Futures: Guidelines for 

Health Supervision of Infants, Children, and Adolescents (Hagan, Shaw, & Duncan, 2017).

Federal Home Visiting Program 

This webpage provides background about the Health Resources and Services Administration (HRSA) and 

Administration for Children & Families program, its structure, and its mission and services, which involve 

evidence-based, voluntary home visiting programs, where families receive help from health, social service, 

and child development professionals.

Healthy Start 

This webpage describes the HRSA Healthy Start program and links to a technical assistance center with 

more information on program approaches and grantees. The program provides depression screening, 

healthcare services, care coordination, public health services such as immunization and health education, 

and training for community health workers and care coordinators.

Maternal & Child Health Topics: Perinatal and Infant Health

This webpage describes HRSA goals related to perinatal and infant health and lists programs and 

initiatives that help HRSA achieve its goals. 

Neonatal Abstinence Syndrome: A Guide for Families

This 2014 guide was produced by the Ohio Prenatal 

Quality Collaborative in conjunction with DartmouthHitchcock Medical Center. It was written to help 

family members care for infants with NAS, both 

while in the hospital and after discharge.

WEB RESOURCES ON THIS TOPIC

Section 2: Factsheet 12
97

Effects of NAS on Development

Caregivers of prenatally opioid-exposed infants should be told that although genetic and social risk and protective 

factors contribute to the child’s eventual risk for developing substance use disorders (SUDs), future SUDs or 

developmental problems are not known to be long-term consequences of NAS. However, caregivers who 

express concerns about the development of a child who was exposed to opioids in utero or who 

experienced NAS should be carefully interviewed about their concerns by a knowledgeable pediatric 

professional. The child should have developmental screenings and ongoing assessments and should 

receive early intervention services if requested by the caregiver.

Effects of Extended-Release Injectable Naltrexone on Development

There is no information on the safety of extended-release injectable naltrexone during 

pregnancy or the long-term effects on the infant of in utero exposure to this medication.

At a routine pediatric visit, a mother is concerned that her child has developmental delays 

from opioid exposure or from experiencing neonatal abstinence syndrome (NAS).

FACTSHEET # EARLY INTERVENTION 

STRATEGIES AND 

DEVELOPMENTAL 

ASSESSMENTS

13

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION 2

Effects of NAS on Development

• When a mother expresses concern about her child’s development, a healthcare professional should 

discuss assessments and screenings to address these concerns. As with all infants, experts recommend 

that opioid-exposed infants be screened while in the hospital and on subsequent pediatric visits for 

developmental milestones and whenever concerns arise about neurodevelopment. There are many 

unknowns; the recommendation is to follow the infant closely and order specialized assessments if the 

healthcare professional or caregiver have concerns.

 Healthcare professionals should review normal developmental milestones with caregivers of opioid-exposed 

infants (e.g., infant smiles, sits alone, makes eyes contact), so they can better understand the importance of 

achieving these milestones within a certain timeframe.

 Infants born to mothers who received methadone or buprenorphine during pregnancy were found as 

toddlers to have no more problems with certain developmental tasks than those from a normative sample of 

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

Section 2: Factsheet 13
98

children of mothers without SUD, after controlling for 

confounding factors, such as maternal psychological 

distress and instability in the home environment. 

(Sarfi, Sundet, & Waal, 2013). The American College 

of Obstetricians and Gynecologists (ACOG) reports 

that current data on in utero opioid-exposed 

infants are limited (Committee on Healthcare 

for Underserved Women, American Society of 

Addiction Medicine, & ACOG, 2012, 2017); however, 

earlier studies did not find significant differences in 

cognitive development between children up to age 

5 who had been exposed to methadone in utero and 

those who had not. 

Effects of Extended-Release Injectable 

Naltrexone

• The effects, if any, of naltrexone on child 

development are not known. There are at least 25 

published prenatal naltrexone implant exposure 

cases, and all show normal birth outcomes (Hulse, 

Arnold-Reed, O’Neil, & Hansson, 2003; Hulse, 

O’Neil, & Arnold-Reed, 2004; Jones, Chisolm, 

Jansson, & Terplan, 2012). A mother’s preference for 

beginning antagonist therapy may be considered if 

she resumes pharmacotherapy in the postpartum 

period. However, only one case study has reported 

examining how much naltrexone is secreted into 

breast milk (Chan, Page-Sharp, Kristensen, O’Neil, & 

Ilett, 2004). In this case, only very low levels of the 

naltrexone metabolite were detected in the infant 

plasma (1.1 micro g/L), and the infant appeared to 

be healthy, was meeting developmental milestones 

on time, and showed no adverse effects. 

The process used in developing this Guide 

determined that there was insufficient evidence 

to attribute subsequent neurodevelopmental 

problems to a history of NAS but did 

conclude that developmental assessments 

should be conducted whenever there is 

concern. Appendix A: Suitable Developmental 

Assessments for Opioid-Exposed Infants 

and Children provides information on ageappropriate developmental screens. Chapter 3 in 

the National Institute on Drug Abuse’s (NIDA’s) 

Principles of Substance Abuse Prevention for 

Early Childhood describes evidence-based early 

childhood interventions (NIDA, 2016).

Medicaid may support postpartum care, which 

would include home visits after the birth of 

the child through the Health Resources and 

Services Administration (HRSA) Federal Home 

Visiting Program and the Administration 

for Children & Families’ (ACF’s) Early Head 

Start (EHS) programs. Caregivers who are 

concerned about their child’s development 

after exposure to opioids in utero may request 

a developmental assessment through this 

program. Infants exposed to opioids in utero 

and their mothers may be eligible for early 

intervention services (e.g., screenings, case 

management, family support, counseling, 

parent/caregiver skills training). 

A Collaborative Approach to the Treatment of Pregnant Women With Opioid Use Disorders: Practice 

and Policy Considerations for Child Welfare, Collaborating Medical, and Service Providers 

This Substance Abuse and Mental Health Services Administration document provides information on the 

treatment of pregnant women with OUD, summarizes guidelines adopted by a variety of professional 

organizations, and presents a framework for organizing community efforts. It provides a coordinated, 

multisystem approach grounded in early identification and intervention to assist child welfare, medical, 

SUD treatment, and other systems in supporting families.

WEB RESOURCES ON THIS TOPIC

Section 2: Factsheet 13

Factsheet #15: Maternal Discharge Planning 

for more information on managing postnatal 

mental disorders including depression and 

anxiety.

FACTSHEET TO REVIEW
99

Ages and Stages Questionnaire, 3rd Edition (ASQ-3) 

This screening tool measures developmental progress in children between ages 1 month and 5 years.

Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition

This multimodal library of materials for stakeholders involved in improving health care for infants, children, 

and adolescents was first published in 2000 by the American Academy of Pediatrics. It includes evidencebased toolkits that cover all aspects of pediatric health care.

Early Head Start Programs 

EHS programs administered by ACF serve infants and toddlers younger than age 3 and pregnant women. 

These programs provide intensive comprehensive child development and family support services to lowincome infants and toddlers and their families and to pregnant women and their families.

Federal Home Visiting Program 

This webpage provides background information about the HRSA and ACF program, its structure, and its 

mission and services, which involve evidence-based, voluntary home visiting programs, where families 

receive help from health, social service, and child development professionals.

Healthy Beginnings

This program meets the HHS criterion for an effective childhood home visiting service delivery model. In 

this model, nurse home visitors provide education on infant nutrition, 

family nutrition, and physical activity and address family members’ 

concerns. Nurse visitors typically make 8 visits from a prenatal visit 

through age 24 months. 

Principles of Substance Abuse Prevention for Early Childhood: A 

Research Based Guide 

This 2016 comprehensive NIDA guide provides research on risk 

factors and interventions in the early childhood period. Chapters 

1–4 cover three decades of research-based early intervention and 

prevention for children ages 0–3. Chapter 3 includes a table of risks 

addressed through specific age-appropriate strategies, and Chapter 4 

highlights research-based substance abuse prevention program, with 

contact details.

Section 2: Factsheet 13
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110

Section III: Maternal Postnatal Care

Section III consists of three factsheets:

Factsheet #14: Adjusting Pharmacotherapy Dose Postpartum

Factsheet #15: Maternal Discharge Planning

Factsheet #16: Maternal Return to Substance Use.

I. Clinical Scenario

Presents a brief statement to orient the reader to the situation under consideration.

II. Clinical Action Steps

Present recommendations that are derived directly from the rated clinical decisions in the 

RAND/UCLA Appropriateness Method report and describe what can, might, or should not be 

done when caring for women and their infants.

III. Supporting Evidence and Clinical Considerations

Present strengths and weaknesses of the evidence supporting the clinical action steps. This 

section describes how to address or tailor recommended actions to unique patient variables 

and preferences, the clinical experience of the provider, and available community resources. 

Guidance is based on expert panel and Federal Steering Committee discussions and additional 

information from published articles. This section includes supporting information for the Clinical 

Action Steps as well as information in where there was insufficient evidence to recommend a 

clear course of action. Instead, information in this section will provide elements that must be 

taken into consideration when making a decision with the pregnant women or new mother 

about the best course of action for herself or her infant.

IV. Web Resources

Provide links to additional online information.

FACTSHEET #14: Adjusting Pharmacotherapy Dose Postpartum

CLINICAL SCENARIO: A new mother with opioid use disorder (OUD) is interested in changing her 

pharmacotherapy.

• Dose adjustments due to oversedation

• Dangers of mixing opioid agonists and 

benzodiazepines

• Closely observing postpartum dosing

• Discussing risks and benefits of changing or 

tapering pharmacotherapy

• Cost, availability, preauthorization requirements, 

and complications with transitioning
111

FACTSHEET #15: Maternal Discharge Planning

CLINICAL SCENARIO: A new mother with OUD is ready for discharge after delivery.

• Comorbid mental disorder care planning

• Mental health and/or substance use disorders and 

consumer-/patient-led organizations

• Avoiding abrupt discontinuation of 

pharmacotherapy

• Referring families to federal programs providing 

perinatal and infant health services

FACTSHEET #16: Maternal Return to Substance Use

CLINICAL SCENARIO: A new mother returns to substance use, whether alcohol, benzodiazepines, 

cocaine, marijuana, methamphetamine, opioids, or tobacco.

• Adjusting pharmacotherapy dose

• Changing or resuming pharmacotherapy

• Breastfeeding in the context of return to substance 

use

• Working across disciplines and specialties and 

providing additional services via a collaborative 

care model

• Assessing marijuana, alcohol, and tobacco use in 

the context of many unknowns

• Considerations for discontinuation of 

breastfeeding
112

Dose Adjustment Due to Oversedation

In the immediate postpartum period, complaints of drowsiness and somnolence (a strong desire for sleep, or 

sleeping for unusually long periods) should prompt evaluation of the new mother’s dose of agonist therapy. 

A dose effective in pregnancy may be too high during the postpartum period. The patient may present with 

these complaints while still in the hospital or shortly after discharge.

Pharmacotherapy Changes

Struggling with cravings even without a return to substance use may prompt a new mother to ask about 

changing her medication. Cravings alone do not justify changing to a different pharmacotherapy for OUD. 

The effectiveness of the patient’s pharmacotherapy dose should be evaluated, and the dose possibly 

adjusted. Cravings can occur even when OUD is well managed. Patients who report cravings during the 

postpartum period should receive additional behavioral interventions to address new or aggravated stressors. 

Consideration may be given to a new mother’s request to change the form of pharmacotherapy for OUD 

based on her preference and on health or social considerations after delivery. The reasons for and risks and 

benefits of such a change should be thoroughly discussed with other treating healthcare professionals, with 

the patient’s permission, before the decision is made.

A new mother with opioid use disorder (OUD) is interested in changing her pharmacotherapy.

FACTSHEET #

ADJUSTING 

PHARMACOTHERAPY DOSE 

POSTPARTUM

14

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION III

Dose Adjustment Due to Oversedation

• If a new mother is exhibiting signs of oversedation and is breastfeeding, the healthcare professional 

should assess both the mother and the infant. Because of the variability in dosing amounts 

before delivery, healthcare professionals are advised to use signs of somnolence to guide their 

recommendations on tapering the postpartum dose for new mothers using either methadone 

or buprenorphine (Jones et al., 2008a, 2008b). The mother could be drowsy because she 

has a demanding newborn who does not sleep or eat well. Thus, dose changes need to be 

individualized, and uniform dose changes postpartum cannot be made. Evidence supporting 

the need to lower methadone or buprenorphine doses after delivery is mixed (Bastian et al., 

2016; Bogen et al., 2013; Jones et al., 2008a; Pace, Kaminetzky, Winter, & Walley, 2014).

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

Section 3: Factsheet 14
113

 After delivery, a new mother’s body will go through multiple 

physiological changes; her previously effective dose 

pharmacotherapy for OUD may, therefore, need to be adjusted. 

When oversedation is reported or observed, pharmacotherapy 

dosages can be titrated as indicated (Bogen et al., 2013; 

Committee on Healthcare for Underserved Women, American 

Society of Addiction Medicine, & American College of 

Obstetricians and Gynecologists, 2012, 2017; Jones et al., 2008a; 

Pace et al., 2014). 

 Mothers being treated with opioid agonists need to be especially 

careful to avoid alcohol or any sedating medications, especially 

benzodiazepines. Between 2000 and 2010, the number of 

substance use treatment admissions involving a benzodiazepine 

and narcotic pain reliever combination increased from 5,032 

to 33,701 (Wyatt, 2015). Many more people have begun using 

these medications without prescriptions, and this combination is 

especially dangerous to breastfed infants.

Pharmacotherapy Changes

• A mother who wants to change pharmacotherapy for OUD 

should first consider the risks and benefits with her clinician. 

When a new mother who is currently stable on methadone 

or buprenorphine requests a switch to naltrexone, begin a 

conversation about the risks of changing a medication, including 

the potential for destabilization and return to substance use. 

The risk of return to substance use is high in this case, and the 

woman should be advised that the change should not be made 

without a compelling reason. A new mother who is not stable 

on her current medication may need to have behavioral health 

and support services added to her care plan, and healthcare 

professionals can consider making dose adjustments to her 

postpartum care plan to address cravings or withdrawal signs 

(Bogen et al., 2013; Jones, 2008a; Pace et al., 2014). 

 Naltrexone may be the best pharmacotherapy for some women. 

Because no systematic research exists on the safety of naltrexone 

exposure via breast milk, the healthcare professional and the 

mother should carefully discuss the risks and benefits of continued 

breastfeeding. Every effort should be made to avoid premature 

discontinuation of agonist therapy given the overall benefits of 

breastfeeding to both mother and child in appropriate dyads. 

Nevertheless, the result of the discussion may be a decision to 

begin formula-feeding the infant. In general, unless safety is a 

concern, discontinuing one pharmacotherapy to start another 

should be avoided until breastfeeding is naturally concluded.

• Some mothers will want to taper off their pharmacotherapy 

during the period they are breastfeeding. Some women will 

attempt to taper off pharmacotherapy while breastfeeding and 

Watch for signs of oversedation. The 

mother and family members should 

be informed of what to watch for and 

instructed to contact the healthcare 

professionals if signs or symptoms of 

oversedation appear. The healthcare 

professional should schedule a 

follow-up visit with the mother as 

early as possible after discharge. 

Healthcare professionals must 

be keenly aware of the dangers 

of mixing opioid agonists and 

benzodiazepines for both the 

mother and infant.

Factsheet #3: Changing 

Pharmacotherapy During Pregnancy

includes more information about 

the risks associated with changing 

pharmacotherapy.

FACTSHEET TO REVIEW

Section 3: Factsheet 14

Given the lack of research 

on the safety of naltrexone 

for breastfeeding infants, the 

decision to use naltrexone 

during breastfeeding should be 

undertaken only after an individual 

risk–benefit analysis.
be faced with deciding whether to resume pharmacotherapy because of a return to substance use or a risk 

of returning to use. The mother can be reassured that the amount of prescribed pharmacotherapy to which 

the baby is exposed via breast milk is extremely small, while the risk of harm to the infant from her return to 

substance use is much greater. 

 Healthcare professionals should make every effort to avoid premature discontinuation of pharmacotherapy 

for OUD in light of the overall benefits of breastfeeding to both mother and child. Discontinuation of 

pharmacotherapy should, at the very least, be delayed until after the infant is consistently sleeping through 

the night and has completed breastfeeding. The longer the patient continues on OUD pharmacotherapy, the 

lower her risk of return to substance use when she eventually chooses to taper.

• Transitioning medications can be challenging because of cost, availability, and preauthorization 

requirements. Sometimes the logistics, reimbursement, or regulatory issues accompanying a change in 

pharmacotherapy for OUD can be daunting. The costs of medications may become an issue, regardless of 

the patient’s insurance payer; securing the required insurance prior authorization can be challenging and 

time consuming. If the patient opts to switch medications, all documentation needs to be completed and the 

preauthorization received before the change is made to avoid gaps in treatment (Krans & Patrick, 2016).

National Center on Substance Abuse and Child Welfare (NCSACW) 

Webinar Series on Opioid Use Disorders and Treatment

Several NCSACW-sponsored webinars are specific to treatment of pregnant 

women with OUD or are focused on infants and children prenatally exposed 

to opioids.

WEB RESOURCES ON THIS TOPIC

114 Section 3: Factsheet 14
Comorbid Mental Disorders

Any new mother with OUD should be screened for comorbid mental disorders before discharge from the 

hospital and again at the postpartum outpatient appointment.

Discontinuation of Pharmacotherapy

Discontinuation of pharmacotherapy for OUD should generally be avoided in the immediate postpartum 

period but may be considered later if the mother is stable and the mother and child are well bonded and 

have a safe, stable social environment and home.

Every effort should be made to avoid discontinuing pharmacotherapy for OUD at the request of the 

patient’s family, social service provider, parole or probation officer, or judge. Pharmacotherapy for OUD 

should be discontinued only when in the best interest of the mother and infant.

Contraception

A woman with OUD, whether she is receiving pharmacotherapy or not, should be counseled regarding 

contraception and have immediate, easy access to her contraceptive of choice before her discharge.

A new mother with opioid use disorder (OUD) is ready for discharge after delivery.

FACTSHEET #

MATERNAL DISCHARGE 

PLANNING 

15

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION III

Comorbid Mental Disorders

• The discharge plan should be compatible with and support the plan of safe care for mother and infant; 

this includes addressing potential maternal comorbid medical or mental disorders. The plan of safe 

care should be made for the mother and the infant that includes addressing potential maternal comorbid 

medical or mental disorders. The plan of safe care should address any existing maternal comorbid 

medical or psychiatric condition and recognize that the physiologic change after delivery, stress and sleep 

deprivation the new mother experiences may exacerbate these conditions or trigger a return to some form 

of substance use. The discharge plan should include strategies for the new mother to get immediate and 

nonjudgmental assistance if she feels she is or may become unstable.

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

115 Section 3: Factsheet 15
• People who are in recovery from a substance use disorder (SUD) 

or who live with behavioral health disorders often find support, 

encouragement, and community in consumer-/patient-led 

organizations. Peer counselors or recovery coaches assist people 

seeking recovery from SUDs by supporting them and helping them 

avoid triggers that can lead to return to substance use (Substance 

Abuse and Mental Health Services Administration [SAMHSA], 

2015). Coaches can provide transportation to and from meetings 

and show parents how to securely store all medications, including 

pharmacotherapy for OUD, so that young children cannot get 

into them. SAMHSA has compiled a list of core competencies that 

healthcare professionals should expect from peer support staff 

(SAMHSA, 2015). The effectiveness of peer support has not been 

extensively evaluated, and such evaluations are even rarer for 

programs involving pregnant women with SUDs (Barlow et al., 

2015; Sanders, Trinh, Sherman, & Banks, 1998).

Discontinuation of Pharmacotherapy

• Explain the importance of not abruptly discontinuing 

pharmacotherapy. Sometimes people feel that they no longer 

need pharmacotherapy for OUD and would like to stop taking 

these medications. Plans to stop taking a medication should be 

made by the mother in conjunction with her treatment team. 

Pharmacotherapy with methadone or buprenorphine must 

be tapered gradually to prevent withdrawal. A safety plan for the mother and family needs to be in place 

before the tapering starts in order to know what to do if she relapses to opioid use. Discontinuation of 

pharmacotherapy should, at the very least, be delayed until after the infant is consistently sleeping through 

the night and has completed breastfeeding. The longer the patient continues on OUD pharmacotherapy, the 

lower her risk of return to substance use when she eventually chooses to taper.

 Reducing the pharmacotherapy dosage can be considered if the 

mother chooses when she is living in a safe and stable environment 

(Jones et al., 2014). The best time to begin initiating discontinuation 

of medication-assisted treatment is after the infant is consistently 

sleeping through the night, has completed breastfeeding, and the 

dyad has multiple indicators of life stability (Jones et al., 2014).

Contraception

• Preventing unintended pregnancies and planning for future pregnancies are critical. Healthcare 

professionals should offer all women, including those with OUD, non-coercive contraceptive counseling and 

discuss different forms of birth control and the effectiveness of each method before they are discharged 

from the hospital. Whether a woman is on pharmacotherapy for OUD or continues to misuse opioids, a 

conversation about the importance of contraception is critical. Women of reproductive age who have OUD 

experience a high rate of unintended pregnancy (Heil et al., 2011). One study found that only approximately 

half of women with a history of current opioid use were using contraception; the majority were not using 

long-acting reversible contraception (LARC), such as implants or intrauterine devices (IUDs) (Terplan, Hand, 

Hutchinson, Salisbury-Afshar, & Heil, 2015).

116 Section 3: Factsheet 15

The relapse rate for women 

with SUD increases for women 

after delivery (Helmbrecht & 

Thiagarajah, 2008) and can 

be impacted by issues such as 

postpartum/maternal depression 

and the stress of parenting. 

Healthcare professionals should 

consider providing the mother 

with support services for longer 

than the traditional 6-week 

postpartum period. 

See also Factsheet #14: Adjusting 

Pharmacotherapy Dose Postpartum 

and FS #16 Maternal Return to 

Substance Use for additional 

information on adjusting medications 

and support postpartum.

FACTSHEET TO REVIEW

People can safely continue 

pharmacotherapy for OUD for as 

long as they need it. For some, 

this may be months or a year; for 

others, it may be a lifetime. 
 The American College of Obstetricians and Gynecologists 

(Committee on Healthcare for Underserved Women, American 

Society of Addiction Medicine, & American College of Obstetricians 

and Gynecologists [ACOG], 2012, 2017) and the American College of 

Nurse-Midwives and other nurse professional societies recommend 

offering immediate postpartum LARC to reduce unintended or 

short-interval pregnancy. Although there is a higher chance of 

expulsion with the immediate placement of an IUD after delivery, 

a risk–benefit analysis concluded that, because many women do 

not attend their 6-week postpartum visit (at which time a LARC 

is often provided), insertion while still at the hospital after delivery 

is an excellent time to implant the device. Concerns with Medicaid 

reimbursement are an issue, but many states are now providing 

policy statements on reimbursement at time of insertion.

 Healthcare professionals can encourage women already in treatment to consider planning their next 

pregnancy with the healthcare team to make sure they are on safe medications, their treatment status is 

stable, and they are ready for the stresses of motherhood on top of treatment or recovery.

Other Evidence/Considerations

• Give referrals to services that provide perinatal and infant 

healthcare to increase access to quality care, promote 

healthy development, and reduce the risk of infant or 

maternal morbidity and mortality. Support for the new mother 

is important to facilitate her bonding with the infant. The Health 

Resources and Services Administration (HRSA) Federal Home 

Visiting Program provides an array of services to vulnerable 

families through home visits, which may include assisting 

mothers with guidance on how best to breastfeed and care for 

their babies; helping parents understand child development 

milestones and behaviors; promoting parents’ use of praise and 

other positive parenting techniques; and working with mothers 

to set goals for the future, continue their education, and find 

employment and childcare solutions.

• Factsheet #7: Planning Prior to 

Labor and Delivery for topics to 

discuss with women during their 

pregnancy, including postpartum 

contraception plans

• Factsheet #12: Infant Discharge 

Planning for discussions of home 

visitation services and peer 

support services available to new 

mothers and caregivers

• Factsheet #16: Maternal Return 

to Substance Use for guidance on 

preventing return to substance use 

and supporting recovery

FACTSHEETS TO REVIEW

117 Section 3: Factsheet 15

Ideally, each new mother should 

have the option to receive a longacting reversible contraceptive 

prior to leaving the hospital. 

At a minimum, women should 

receive non-coercive contraceptive 

counseling and the option to leave 

the hospital with a prescription 

for contraception, contraceptive 

supplies, or a contraception plan 

(SAMHSA, 2014).
ACOG Immediate Postpartum Contraception Options

This ACOG website provides numerous policy documents and practice bulletins on the use of LARC 

immediately postpartum as well as material on access to contraception.

Current Understanding of the Interaction of Benzodiazepines and Buprenorphine

This Providers’ Clinical Support System continuing medical education course reviews the dangers of 

combining benzodiazepines and buprenorphine.

Federal Home Visiting Program 

This webpage provides background about the HRSA and Administration for Children & Families program, 

its structure, and its mission and services, which involve evidence-based, voluntary home visiting 

programs, where families receive help from health, social service, and child development professionals.

Healthy Start 

This webpage describes the HRSA Healthy Start program and links to a technical assistance center with 

more information on program approaches and grantees. The program provides depression screening, 

healthcare services, care coordination, public health services such as immunization and health education, 

and training for community health workers and care coordinators.

Resources for Consumers and Families 

This joint SAMHSA–HRSA Center for Integrated Health Solutions webpage provides links to information 

to help families understand medication-assisted treatment and how it helps, as well as a guide for 

patients developed by the American Society of Addiction Medicine and essays collected by Faces and 

Voices of Recovery and the National Association of Medication Assisted Recovery.

WEB RESOURCES ON THIS TOPIC
119

Adjusting Pharmacotherapy Dose

A new mother who returns to substance use should be assessed for possible adjustment of the dose 

or schedule of her pharmacotherapy for opioid use disorder (OUD) and should receive more intensive 

behavioral interventions.

Changing or Resumption of Pharmacotherapy

If changing from one pharmacotherapy to another is necessary, healthcare professionals should carefully 

discuss with the new mother the risks of further destabilization in the context of active substance use. No 

change should be undertaken without her fully informed consent.

Breastfeeding in the Context of Return to Substance Use

A new mother who was previously stable on buprenorphine or methadone but has returned to opioid use 

should be assessed for dose adjustment, should receive additional behavioral interventions, and should be 

counseled on her lactation options.

A new mother returns to substance use, whether alcohol, benzodiazepines, cocaine, marijuana, 

methamphetamine, opioids, or tobacco

FACTSHEET #

MATERNAL RETURN TO 

SUBSTANCE USE

16

CLINICAL SCENARIO

CLINICAL ACTION STEPS

SECTION III

Adjusting Pharmacotherapy Dose

• Return to substance use is a common occurrence among people with a substance use disorder (SUD). 

Some people in recovery may never return to substance use; others may do so many times before 

establishing stable and lasting recovery. Given that returning to substance use is predictable and 

common, doing so should not be viewed as a setback or failure, but as an indication of the need to 

reassess the patient and adjust the treatment plan. Such adjustments may include engaging community 

and behavioral supports. Many people find that, for lasting recovery, they need to control stress, avoid 

places and situations where they once used drugs (triggers), and even end relationships with people 

involved with drugs. When making these changes, people in recovery may find that peers—such as 

other mothers in recovery who experienced a pregnancy affected by OUD—can help them in a way that 

healthcare professionals cannot. Limited but promising research supports the role of peers who are in 

recovery from an SUD (Barlow et al., 2015; Sanders, Trinh, Sherman, & Banks, 1998).

SUPPORTING EVIDENCE AND CLINICAL CONSIDERATIONS

Section 3: Factsheet 16
• A collaborative care model enables healthcare professionals 

to work across disciplines and specialties and to provide 

services as needed to reduce maternal stress and risk of 

return to substance use. Using a collaborative care approach 

(McLafferty et al., 2016; Substance Abuse and Mental Health 

Services Administration [SAMHSA], 2016), prenatal healthcare 

professionals, pediatricians, and behavioral health treatment 

providers work together to provide behavioral health services to 

reduce maternal stress. Behavioral health services often focus on 

preventing a return to substance use, such as through teaching 

new mothers how to manage triggers and connecting these 

clients to peer recovery support groups and programs that help 

new parents. Ideally, these healthcare professionals should be 

co-located in the same building, if not integrated into a single 

program, to facilitate postnatal care. If this is not feasible, then 

providing referrals and regularly communicating with all the 

healthcare professionals involved in the case is recommended. 

Healthcare professionals are advised to review the 2016 SAMHSA report A Collaborative Approach to the 

Treatment of Pregnant Women With Opioid Use Disorders: Practice and Policy Considerations for Child 

Welfare, Collaborating Medical, and Service Providers for a more detailed description of this approach. 

 Privacy requirements are higher with issues of SUD than with other conditions, so it is especially important 

to obtain signed informed consent agreements tailored to SUD issues to facilitate sharing of information 

among healthcare professionals. It could be useful to complete a paper or electronic consent form 

such as those provided at https://pcssmat.org/opioid-resources/clinical-tools/ to secure the sort of 

information releases that will be necessary to coordinate care 

among healthcare professionals who write pharmacotherapy 

prescriptions, those who may manage other behavioral health 

issue, and those providing prenatal care. Electronic systems 

for managing patient consent to share protected health 

information are also an option. One example is SAMHSA’s 

Consent2Share.

Resumption of Pharmacotherapy

• If pharmacotherapy is discontinued postpartum and 

the behavioral supports are insufficient to prevent or 

interrupt return to substance use, the option to resume 

pharmacotherapy should be considered. A new mother 

should restart pharmacotherapy for OUD if behavioral 

supports are insufficient to prevent a return to substance use. 

Pharmacotherapy selection should be informed by what worked 

well in the past and whether the mother is breastfeeding. 

 A mother’s preference for beginning antagonist therapy may be considered if she resumes 

pharmacotherapy in the postpartum period. However, only one case study has reported examining how 

much naltrexone is secreted into breast milk (Chan, Page-Sharp, Kristensen, O’Neil, & Ilett, 2004). In this 

case, only very low levels of the naltrexone metabolite were detected in the infant plasma (1.1 micro g/L), 

and the infant appeared to be healthy, was meeting developmental milestones on time, and showed no 

adverse effects. 

• Factsheet #6: Addressing 

Polysubstance Use During 

Pregnancy for recommendations 

on how to treat a return to 

substance use in the prenatal 

period

• Factsheet #14: Adjusting 

Pharmacotherapy Dose 

Postpartum for information 

on adjusting current 

pharmacotherapy doses 

before considering changing 

pharmacotherapy

FACTSHEETS TO REVIEW

120

This link provides treatment 

agreements and consent forms to 

promote collaborative care plans in 

a SUD treatment setting: https://

pcssmat.org/opioid-resources/

clinical-tools/. The two exceptions 

to the privacy rule affecting 

behavioral health care are:

• If it appears the woman may 

harm herself or others.

• If she has been ordered into 

treatment by the courts.

CONTENT TO REVIEW

Section 3: Factsheet 16
Breastfeeding in the Context of Return to Substance Use

• If the new mother returns to substance use, healthcare team members will have to consider whether to 

discontinue breastfeeding based on their knowledge of the 

patient and her access to behavioral and recovery support 

services. If there is a return to substance use, healthcare 

professionals are advised to review the American Academy of 

Pediatrics (AAP) policy statement on breastfeeding (Hudak, 

Tan, & AAP, 2012) and the Academy of Breastfeeding Medicine 

(ABM) Clinical Protocol #21: Guidelines for Breastfeeding 

and Substance Use or Substance Use Disorder, Revised 2015

(Reece-Stremtan, Marinelli, & ABM, 2009, revised 2015).

 It may not be necessary to stop breastfeeding after an isolated 

incident of substance use that is quickly under control. The World 

Health Organization’s (WHO’s) Guidelines for the Identification 

and Management of Substance Use and Substance Use Disorders in Pregnancy suggest carefully reviewing 

the mother’s situation before recommending discontinuation of breastfeeding (WHO, 2014).

Other Evidence/Considerations

• There are many unknowns when assessing cannabis, alcohol, and tobacco use by pregnant women and 

new mothers. Not enough data exist to determine the long-term consequences of cannabis exposure in 

infancy. The prevalence of past-month cannabis use increased from 2.37 percent in 2002 to 3.85 percent 

in 2015 (Brown et al., 2017). Although fetal exposure to cannabis, the illicit drug most commonly used by 

pregnant women, is not known to cause clinically important neonatal withdrawal signs, such exposure 

may have effects on long-term neurobehavioral outcomes (Campolongo, Trezza, Palmery, Trabace, & 

Cuomo, 2009). Maternal cannabis smoking has been found to be related to lower birth weight in offspring 

(Fegusson, Horwood, & Northstone, 2002; Gray et al., 2010; Gunn et al., 

2016; National Academies of Sciences, Engineering, & Medicine, 2017).

 Return to use of these substances by a mother while caring for her infant 

should prompt review of her treatment plan and consideration of adjusting 

medical, behavioral, and peer services to support discontinuation of these 

substances.

 Until more is known about the long-term effects of exposure to these 

substances through breast milk or secondhand smoke, mothers should 

be counseled to avoid cannabis and tobacco smoke, as well as alcohol 

(Committee on Obstetric Practice, American College of Obstetricians 

and Gynecologists, 2017; National Academies of Science, Engineering, & 

Medicine, 2017; Reece-Stremtan et al., 2015; Volkow, Compton & Wargo, 

2017; WHO, 2014).

121

Factsheet #11: Breastfeeding 

Considerations for Infants at 

Risk for Neonatal Abstinence 

Syndrome for information on the 

benefits of breastfeeding if the 

mother is stable on medicationassisted treatment and when to 

bottle feed

FACTSHEET TO REVIEW

Section 3: Factsheet 16
122

ABM Protocol #21: Guidelines for Breastfeeding and Substance Use or Substance Use Disorder, 

Revised 2015 

This protocol provides evidence-based guidelines for the evaluation and management of women with 

SUDs who are considering breastfeeding. It includes information on methadone and buprenorphine.

Breastfeeding Initiatives: Family Resources 

This AAP webpage lists breastfeeding resources for families; some resources are in Spanish.

A Collaborative Approach to the Treatment of Pregnant Women With Opioid Use Disorders: 

Practice and Policy Considerations for Child Welfare, Collaborating Medical, and Service Providers

This SAMHSA document provides information on the treatment of pregnant women with OUD, 

summarizes guidelines adopted by a variety of professional organizations, and presents a framework 

for organizing community efforts. It provides a coordinated, multisystem approach grounded in early 

identification and intervention to assist child welfare, medical, SUD treatment, and other systems in 

supporting families.

Drug Entry Into Human Milk 

This InfantRisk Center webpage describes in detail the mechanisms of drug entry into human milk 

and provides some general rules on breastfeeding.

Drugs and Lactation Database (LactMed) 

This National Library of Medicine searchable database provides information on medications and other 

chemicals to which breastfeeding mothers may be exposed.

Medications and Breastfeeding: Tips for Giving Accurate Information to Mothers

This two-page AAP document discusses clinical points to consider when prescribing medications to 

breastfeeding mothers.

Policy Statement: Breastfeeding and the Use of Human Milk

This AAP-updated policy statement reviews the benefits of breastfeeding for mother and child.

When Should a Mother Avoid Breastfeeding? 

This Centers for Disease Control and Prevention webpage provides links to information about 

illnesses and conditions that contraindicate breastfeeding.

WEB RESOURCES ON THIS TOPIC

Section 3: Factsheet 16
123

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plasma concentrations of sublingual buprenorphine are lower during than after pregnancy. American Journal of 

Obstetrics and Gynecology. doi:10.1016/j.ajog2016.09.095

Bogen, D. L., Perel, J. M., Helsel, J. C., Hanusa, B. H., Romkes, M., Nukui, T., ... Wisner, K. L. (2013). Pharmacologic 

evidence to support clinical decision making for peripartum methadone treatment. Psychopharmacology 

(Berl), 225(2), 441–451. doi:10.1007/s00213-012-2833-7

Committee on Healthcare for Underserved Women, American Society of Addiction Medicine, & American 

College of Obstetricians and Gynecologists. (2017). Committee Opinion No. 711: Opioid use and opioid use 

disorder in pregnancy. Obstetrics and Gynecology, 130, e81–e94. Retrieved from https://www.acog.org/

Resources-And-Publications/Committee-Opinions/Committee-on-Obstetric-Practice/Opioid-Use-andOpioid-Use-Disorder-in-Pregnancy

Jones, H. E., Johnson, R. E., O’Grady, K. E., Jasinski, D. R., Tuten, M., & Milio, L. (2008a). Dosing adjustments in 

postpartum patients maintained on buprenorphine or methadone. Journal of Addiction Medicine, 2(2), 103–107. 

doi:10.1097/ADM.0b013e31815ca2c6

Jones, H. E., Martin, P. R., Heil, S. H., Stine, S. M., Kaltenbach, K., Selby, P., ... Fischer, G. (2008b, October). 

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Krans, E. E., & Patrick, S. W. (2016, July). Opioid use disorder in pregnancy: Health policy and practice in the 

midst of an epidemic. Obstetrics and Gynecology, 128(1), 4–10. doi:10.1097/AOG.0000000000001446

Pace, C. A., Kaminetzky, L. B., Winter, M., & Walley, A. (2014). Postpartum changes in methadone maintenance 

dose. Journal of Substance Abuse Treatment, 47(3), 229–232. doi:10.1016/j.jsat.2014.04.004

Wyatt, S. A. (2015). Current understanding of the interaction of benzodiazepines and buprenorphine (Providers’ 

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Factsheet #15 

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abuse, dependence, and addiction in pregnancy. Obstetrics and Gynecology, 119, 1070–1076. doi:10.1097/

AOG.0b013e318256496e

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College of Obstetricians and Gynecologists. (2017). Committee Opinion No. 711: Opioid use and opioid use 

disorder in pregnancy. Obstetrics and Gynecology, 130, e81–e94. Retrieved from https://www.acog.org/

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124

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Addiction Medicine, 2(1), 1–16.

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doi:10.1097/ADM.0b013e31815ca2c6

Sanders, L. M., Trinh, C., Sherman, B. R., & Banks, S. M. (1998, February). Assessment of client satisfaction in a 

peer counseling substance abuse treatment program for pregnant and postpartum women. Evaluation and 

Program Planning, 21(3), 287–296. doi:10.1016/S0149-7189(98)00018-4

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workers. Retrieved from http://www.samhsa.gov/brss-tacs/core-competencies-peer-workers

Terplan, M., Hand, D. J., Hutchinson, M., Salisbury-Afshar, E., & Heil, S. H. (2015, November). Contraceptive 

use and method choice among women with opioid and other substance use disorders: A systematic review. 

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Medical Association, 317(2), 207–208. 

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cannabinoids causes subtle and enduring neurofunctional alterations. International Review of Neurobiology, 85, 

117–133.

Chan, C. F., Page-Sharp, M., Kristensen, J. H., O’Neil, G., & Ilett, K. F. (2004). Transfer of naltrexone and its 

metabolite 6, beta-naltrexol into human milk. Journal of Human Lactation, 20(3), 322–326. Retrieved from 

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British Journal of Obstetrics and Gynaecology, 109(1), 21–27.

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125

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guidelines/en/
126

Part C: Conclusion
127

This Guide responds to urgent calls from across the United States for clinical guidance to help healthcare 

professionals deliver evidence-based individualized care to pregnant and parenting women with opioid use 

disorder (OUD) and their infants.

The clinical recommendations presented in this Guide are informed by the best available evidence and clinical 

experience. They are notable for their emphasis on the need for individualized, risk–benefit-based clinical decisionmaking and the imperative to ensure the health and well-being of mothers to promote optimal outcomes for their 

infants. Several strategies are critical to success in caring for women with OUD and their infants:

• Identifying and implementing screening for pregnant women for substance use disorders (SUDs), including 

OUD, and mental health comorbidities using appropriate screening, assessment, and diagnostic procedures.

• Identifying and implementing a community-based team of clinicians (prenatal healthcare professionals, 

pediatrics, and SUD treatment provider), counselors, and social workers, with 

an emphasis on rapid referral and engagement into treatment. Methods for 

multidisciplinary communication and compliance should be developed.

• Making available and offering pharmacotherapy for OUD and mental health 

comorbidities at the earliest opportunity.

• Including pregnancy monitoring assessment of fetal growth and risk of preterm 

birth, as well as strategies to reduce tobacco use.

• Focusing on the postpartum period as an especially vulnerable time for return 

to substance use and managing treatment accordingly. Breastfeeding should be 

encouraged when appropriate.

• Offering non-coercive contraceptive counseling and the option to leave the 

hospital with a prescription for contraception, contraceptive supplies, or a 

contraception plan.

• Developing protocol-driven screening, assessment, monitoring, and treatment of 

neonatal abstinence syndrome (NAS) for substance-exposed infants. Postnatal 

care should include careful discharge planning and in-home supports 

Where should you begin to address the needs of your patients and community? Numerous 

online resources and educational materials are provided and hyperlinked in the body of this Guide and its 

appendices. For example, https://pcssmat.org/opioid-resources/clinical-tools/ provides templates of consent 

forms and treatment agreements that can be modified to meet the specific requirements of the healthcare 

program and the unique needs of each patient. How to implement the guidance provided in the factsheets 

depends on what types of care you provide and how care is coordinated in your community. 

Exhibit C.1 presents to-do lists for engaging in the care of pregnant and parenting women with OUD. If you are 

new to the treatment of pregnant women with OUD, you should begin with the items in the column labeled 

“Easy Steps You Can Take.” If you are already treating pregnant women with OUD, you should look closely at 

the column titled “Advanced Steps.”

CONCLUSION
128

1. Have your staff review this Guide.

2. Explore websites of the Substance Abuse and Mental Health 

Services Administration (SAMHSA) and professional organizations 

(e.g., American Society of Addiction Medicine [ASAM]) for training 

opportunities for you and your staff.

3. Attend national meetings of your society to learn about specific 

clinical practices for pregnant and parenting women.

4. Learn about state regulations for mandatory reporting of positive 

drug test results for pregnant and parenting women.

5. Complete buprenorphine waiver training. 

6. Instruct your staff to participate in online or in-person MAT training.

7. Get a mentor at PCSS-MAT.org.

8. Join listservs to receive alerts, guidance, and information from 

experts (e.g., SAMHSA–Health Resources and Services Administration 

Center for Integrated Solutions, Providers’ Clinical System Support).

9. Identify and implement screening tools for SUDs.

10. Ask public and commercial insurance companies or agencies with 

whom you have contracts what billing and reimbursement methods 

are available.

1. Develop multidisciplinary protocols for the identifying, referring, 

and prioritizing pregnant and parenting women for treatment.

2. Develop a mechanism for communication on treatment compliance, 

sharing of urine testing results, and other procedures.

3. Build a team (e.g., comprising a maternity care provider, an advance 

nurse practitioner, physician assistants, and peer counselors) with 

knowledge in treating pregnant and parenting women.

4. Prepare for the transition of care after delivery. Ensure the patient 

has a primary care provider and pediatrician. Develop a long-term 

treatment and recovery program.

5. Implement MAT for the treatment of pregnant and parenting 

women.

6. Educate and encourage staff to commit to a patient-centered, 

flexible, and accepting practice for pregnant women in treatment.

7. Learn about business strategies to sustain your practice within the 

healthcare marketplace through SAMHSA’s Business Plus Project for 

Providers.

Exhibit C.1: Getting Started and Staying Engaged With Treatment for Pregnant and Parenting Women With OUD 

In Your Clinic

Easy Steps You Can Take Advanced Steps
1. Take advantage of existing resources and reach out to partners 

and local experts (e.g., state chapters of ASAM, American Academy 

of Pediatrics, American College of Obstetrician and Gynecologists, 

American Academy of Family Physicians, nurse practitioner/

physician assistance [NP/PA] associations, nurse midwife groups, 

state opioid task force). 

2. Check with your single state agency (SSA), state opioid treatment 

authority (SOTA), and state Medicaid authority about resources and the 

process for accessing treatment and supports in your community.

3. Visit a nearby opioid treatment program (OTP) or office-based opioid 

treatment (OBOT) practices to find out how clients are being served 

and learn best practice for the care of pregnant and parenting women. 

Assess how your program might participant in a network.

4. Develop relationships with an experienced referral center. Check 

with your SSA or SOTA to identify potential referral centers.

5. Initiate or participate in regular calls with other care providers in 

your community to informally discuss cases and share expertise.

6. Initiate or participate in local meetings with your staff and staff 

at nearby labor and delivery units, nurseries, and local treatment 

specialists.

1. If you are a prenatal healthcare professional, partner with treatment 

centers and aid in the early and easy entrance of newly pregnant 

women in recovery to your practice.

2. If you are currently caring for patients with OUD and would like 

to treat pregnant or parenting women, identify OB/GYNs, family 

practice physicians, nurses, psychiatrists, and other healthcare 

professionals who will accept referrals for women with OUD and 

their infants. 

3. Identify pediatricians who can provide best care for newborns at 

risk for the development of NAS.

4. Identify and reach out to community health centers, OTPs, OBOT 

practices, outpatient and residential services, and inpatient detoxification 

settings to identify resources for your clients, coordinate services, 

and aid in the early and smooth care coordination.

In Your Professional Community

Easy Steps You Can Take Advanced Steps

1. Identify patient-appropriate resources and use them to educate 

all of your patients about the needs of women with SUDs and 

substance-exposed infants (e.g., Childbirth, Breastfeeding, and 

Infant Care: Methadone and Buprenorphine; Pregnancy: Methadone or 

Buprenorphine; Methadone Treatment for Pregnant Women).

2. Develop a mentoring group by attending local conferences related to 

the education of professionals treating pregnant women with OUD.

3. Offer to mentor/educate your peers or trainees in your community.

4. Encourage clients who have been successful in treatment to share their 

stories with individuals in their community who may need support.

1. Reach out to child welfare agencies, courts, social workers, and other 

stakeholders working with pregnant and parenting women to provide 

education about the benefits of MAT and start building trust.

2. Work with partners (e.g., law enforcement, hospitals, university 

medical centers, SSA, SOTA) to develop and host forums or town 

halls to educate your community.

3. Engage state and local public health leaders in your community and 

offer to be a resource for pregnant and parenting women with OUD.

In Your Stakeholder Community

Easy Steps You Can Take Advanced Steps

129

Exhibit C.1: Getting Started and Staying Engaged With Treatment for Pregnant and Parenting Women With OUD 

If you have questions or need additional information to get started, contact SAMHSAinfo@SAMHSA.gov. 

Acting now can produce better outcomes for both mothers and opioid-exposed infants.
Measure Description Age Range Format Time

Screening Measures

Ages & Stages 

Questionnaire®, 

Third Edition (ASQ3TM)

• Screens infants and young children for developmental 

delays.

• 30 questions provide scores on 5 skills: fine motor, 

gross motor, problem solving, personal—social, and 

communication.

1—66 months Parent or 

caregiver, 

teacher, or 

clinician

10—20 minutes

Developmental 

Activities Screening 

Inventory, Second 

Edition (DASI-II)

• Provides early detection of children with developmental 

disabilities. 

• 67 questions cover 15 skills including sensory intactness, 

means-end relationships, and causality to memory, seriation, 

and reasoning yielding a developmental quotient.

Birth—60 months Teacher or 

clinician

25—30 minutes

Targeted Assessment Measures

Infant Behavior 

Questionnaire, 

Revised (IBQ-R)

• Measures infant’s temperament. 

• 191 items yield scores in 14 domains: activity level, distress 

to limitations, fear, duration of orienting, smiling/laughter, 

high-intensity pleasure, low-intensity pleasure, ability to 

be soothed, falling reactivity/rate of recovery from distress, 

cuddliness, perceptual sensitivity, sadness, approach, and 

vocal reactivity.

3—12 months Parent or 

caregiver

15—30 minutes

Infant Toddler 

Sensory Profile®

(ITSP)

• Evaluates child’s sensory processing abilities and the effect 

of sensory processing on functional performance in daily life.

• 36 items assess children 0—6 months and 48 items assess 

children 7—36 months yielding scores in 4 areas: low 

registration, sensation seeking, sensory sensitivity, and 

sensation avoiding. 

• Low threshold score is a total of the sensory sensitivity and 

sensation avoiding quadrant scores.

Birth—36 months Parent or 

caregiver

15 minutes

Mullen Scales of 

Early Learning, AG5 

Edition (MSEL-AG5)

• Assesses cognitive functioning in young children.

• 5 skill areas are scored: gross motor, visual reception, fine 

motor, expressive language, and receptive language.

Birth—68 months Trained examiner Age 1: 15 minutes 

Age 3: 25—35 

minutes 

Age 5: 40—60 

minutes

130

Appendix A: Suitable Development 

Assesments for Opioid-Exposed Infants 

and Children
Measure Description Age Range Format Time

Screening Measures

Neonatal Intensive 

Care Unit Network 

Neurobehavioral 

Scale (NNNS)

• Assesses neonatal neurologic and behavioral functioning and 

stress/abstinence signs in infants.

• Neurologic items reflect central nervous system integrity and 

maturity.

• Behavioral assessment items are adapted from the Neonatal 

Behavioral Assessment Scale, and stress/abstinence items 

are adapted from the Finnegan Neonatal Abstinence Scoring 

System.

• Additional items capture stress signs exhibited by infants 

exposed to drugs and other at-risk infants. 

• NNNS yields 13 summary scales: habituation, attention, 

handling, quality of movement, regulation, nonoptimal 

reflexes, asymmetric reflexes, stress/abstinence, arousal, 

hypertonicity, hypotonicity, excitability, and lethargy.

Gestational age > 

30—48 weeks

Trained examiner 30 minutes

Parenting Stress 

IndexTM, Fourth 

Edition (PSITM-4)

• Assesses parental stress from the parent—child relationship. 

• 120 items measure stress in 2 domains: child domain, with 

6 subscales (distractibility/hyperactivity, adaptability, 

reinforces parent, demandingness, mood, and acceptability) 

that measure stress from child behavior as reported by 

the parent; parent domain, with 7 subscales (competence, 

isolation, attachment, health, role restriction, depression, and 

spouse/parenting partner relationship) that measure stress 

from parent functioning.

• Life stress scale measures amount of parent stress caused by 

situational factors other than those from the child or parent.

Birth—144 months Parent or caregiver 15 minutes

Receptive-Expressive 

Emergent Language 

Test, Third Edition 

(REEL-3)

• Identifies infants and toddlers with language impairments or 

developmental issues that affect language development.

• 66 items measure 2 areas: receptive language and expressive 

language.

• Supplementary subtest provides inventory of vocabulary 

words.

Birth—36 months Trained examiner 

with a parent or 

caregiver

10—15 minutes

Temperament and 

Atypical Behavior 

Scale (TABS) 

Assessment Tool

• Identifies potential problems with temperament and/or selfregulation. 

• 55 items cover areas such as temperament, attention, 

attachment, social behavior, play, vocal and oral behavior, 

sense and movement, self-stimulation and self-injury, and 

neurobehavioral state. 

11—71 months Parent or 

caregiver

15 minutes

131
Measure Description Age Range Format Time

Screening Measures

Battelle 

Developmental 

InventoryTM, Second 

Edition Normative 

Update (BDI-2TM NU)

• Depicts child progress in intervention programs, identifies 

children with special needs, and provides a comprehensive 

analysis of functional capabilities. 

• 341 items use 3 sources to gather information: direct observation, 

structured task, and interview with parents and teachers.

• 96 items identify a child who may need further assessment 

and provide scores on motor skills (fine, gross, and perceptual), 

language (expressive and receptive), cognition (conceptual 

development, reasoning, academic skills, attention, and 

memory), personal—social expressions (adult interaction, selfconcept and social growth, and peer interaction), and adaptive 

skills (personal responsibility and self-care).

Birth—95 months Teacher and 

behavioral health 

professional

60—90 minutes

Screening test: 

10—30 minutes

Bayley Scales of 

Infant and Toddler 

Development®

, Third 

Edition (Bayley-III®

)

• Provides comprehensive assessment of infant development. 

• 5 core scales consist of 3 based on interaction with the child 

(cognitive, motor, and language) and 2 based on parent 

questionnaire (social-emotional and adaptive behavior).

1—42 months Trained examiner 30—90 minutes

BRIGANCE® Inventory 

of Early Development, 

Second Edition (IED II)

• Assesses child’s strengths and weaknesses in multiple areas 

of functioning. 

• Number of items depends on section. 

• Developmental section assesses behaviors with regard to 

pre-ambulatory motor skills, gross motor skill, and fine 

motor skills; self-help skills; speech and language skills; and 

social-emotional development. 

• Early academic skills section assesses general knowledge 

and comprehension, readiness, basic reading skills, 

manuscript writing, and math.

Birth—84 months Teachers, no 

training required

Developmental 

section: varies 

by age

Early academic 

skills section: 

varies by age

Devereaux 

Early Childhood 

Assessment Infant 

and Toddler Program 

(DECA-I/T)

• Assesses protective factors that lead to the development of 

child resilience. 

• 4 scoring profiles are used in DECA-I for children 1—18 

months, and 1 scoring profile is used in DECA-T for children 

18—36 months. 

• 37 items provide scores in 3 areas: initiative, attachment, and 

self-control.

• 10 items screens for possible problem behaviors.

1—36 months Parent and 

teacher

20 minutes over 

4 weeks 

Devereaux 

Early Childhood 

Assessment 

Preschool Program, 

Second Edition 

(DECA-P2)

• Extends DECA-I/T up to age 5.

• 38 items measure initiative, attachment/relationships, selfregulation, and behavioral concerns.

36—60 months Parent and 

teacher

20 minutes over 

4 weeks 

132
GLOSSARY

12-step program

A group providing mutual support and fellowship for people recovering from addictive behaviors. The first 

12-step program was Alcoholics Anonymous (AA), founded in 1935; an array of 12-step groups following 

a similar model have since emerged and are the most widely used mutual aid groups and steps for 

maintaining recovery from alcohol and drug use disorders. It is not a form of treatment, and it is not to 

be confused with the treatment modality called Twelve-Step Facilitation.

Abstinence

Refraining from the use of alcohol, illicit drugs, and the misuse of prescription and over-the-counter 

medications. Abstinence includes refraining from the inappropriate use of prescription medications 

including opioid agonists to treat opioid use disorder. See also the entry for medically supervised 

withdrawal.

Addiction

See the entry for substance use disorder.

Analgesic

Compound that alleviates pain without causing loss of consciousness. Opioids have pain relieving 

properties mediated by binding to specific receptors in the central nervous system to block the perception 

of pain or affect the emotional response to pain. Opioids as an analgesic class include opium and its 

derivatives, as well as several synthetic compounds.

Assessment

Process of identifying the precise nature and extent of a patient’s 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 use 

history, physical examination, laboratory evaluation, and determination of disease morbidity. Severity 

of disease often is assessed further in terms of physiological symptoms, organ system damage, and 

psychosocial morbidity. Assessment may also involve determining the patient’s coping skills, motivation, 

and readiness for change.

Behavioral health

The condition of well-being aligned with the prevention and intervention, treatment, and recovery supports 

for people with mental and substance use problems or disorders.

Benzodiazepine

One of a group of medications having a common molecular structure and similar pharmacologic activity, 

including antianxiety, sedative, hypnotic, amnestic, anticonvulsant, and muscle-relaxing effects. Diazepam, 

chlordiazepoxide, clonazepam, alprazolam, and lorazepam are examples of benzodiazepines.

Buprenorphine

Synthetic mu opioid receptor partial agonist approved by the Food and Drug Administration for 

use in maintenance treatment for opioid use disorder. Buprenorphine is commercially available as a 

buprenorphine-only product or a combination buprenorphine/naloxone product. When taken as directed 

it does not produce the euphoria and sedation associated with heroin or other opioids but can reduce or 

eliminate withdrawal symptoms, including cravings, in individuals with opioid use disorder.

133

Appendix B: Glossary and Acronyms
Cannabis 

The dried leaves, flowers, stems, and seeds of the marijuana plant Cannabis sativa, which contains 

psychoactive compounds. Concentrated forms of cannabis include hashish and hash oil.

Cocaine

Powerful central nervous system stimulant made from the leaves of the South American coca plant. Cocaine 

is used nonmedically to produce euphoria or mental alertness. Chronic use may have serious physiological 

and psychological effects, such as seizures, paranoia and substance use disorder.

Cognitive behavioral therapy (CBT)

A type of psychotherapy where the client works with a psychotherapist in a structured format, working on 

specific problem behaviors or negative emotions during a limited number of sessions.

Comorbidity

Coexistence of two or more illnesses.

Contingency management (CM)

A treatment where tangible rewards (e.g., money or reduced appointments) are used to reinforce positive 

behaviors.

Coordinated Care

Care that integrates the efforts of medical, social service, and behavioral health service professionals 

to address an individual’s health and wellness.

Craving

Urgent, seemingly overpowering desire to use a substance; often associated with tension, anxiety, 

or other dysphoric, depressive, or negative affective states.

Detoxification

See the entry for medically supervised withdrawal.

Evidence-based practice (EBP)

Evidence-based practice “requires the integration of the best research evidence with ... clinical expertise and 

... patient’s unique values and circumstances” (Straus, Glasziou, Richardson, & Haynes, 2011, p. 1). An EBP is a 

continually evolving process, with repeated integration of clinical expertise with current research findings.

Fetal alcohol spectrum disorder (FASD)

Pattern of impaired growth, cognitive and behavioral deficits, and characteristic facial abnormalities found in 

some children exposed to alcohol during pregnancy.

Healthcare professional 

Individuals providing medical care in a variety of settings. The term includes nurse practitioners, midwives, 

family medicine doctors, obstetricians, pediatricians, neonatologists, and behavioral health care professionals. 

Level of care

Intensity and type of treatment needed by an individual based on severity of disease. Different levels of care 

may be provided in a single setting or across a range of settings.

Maintenance treatment

Providing medications to achieve and sustain clinical remission of signs and symptoms of opioid use disorder 

and support the individual process of recovery without a specific endpoint.

134
Medically supervised withdrawal

Using a medication in tapering doses to help a patient discontinue illicit or prescription medications. 

(This guide does not use the term detoxification to mean the process of dose tapering from maintenance 

medication, because that usage incorrectly suggests that opioid treatment medications are toxic.)

Medication-assisted treatment (MAT) for opioid use disorder (OUD)

Type of comprehensive substance use disorder (SUD) treatment that provides both maintenance 

pharmacotherapy—using an opioid agonist, a partial agonist, or an antagonist medication, usually 

provided in a certified, licensed opioid treatment program or a healthcare professional’s office-based 

treatment setting—and other treatment services, including medical and psychosocial support services 

such as employment assistance or family services. Some healthcare professionals use the term MAT when 

any medication is used for an SUD regardless of whether specialized behavior therapy or counseling is 

provided. The use of medications to treat OUD is also referred to as pharmacotherapy.

Methadone 

A synthetic, long-acting, full mu opioid receptor agonist that can produce analgesia, sedation, euphoria and 

respiratory depression by binding to mu opioid receptors. At a therapeutic dose and schedule methadone 

can eliminate withdrawal symptoms and reduce cravings in individuals with opioid use disorder.

Mutual-aid, mutual-help, mutual-support program 

Program offering the benefits of peer support to people with substance use disorders, through attendance 

at group meetings and other activities. Twelve-step programs are one type of mutual-help program. See 

also the entry on 12-step program.

Naloxone 

Short-acting opioid antagonist or blocker. Naloxone is used in emergencies to reverse opioid poisoning 

or overdose. The naloxone molecule has a higher affinity for the mu opioid receptor and displaces opioids 

from these receptors. In this way it interrupts their action but can also precipitate acute withdrawal. It does 

not activate the mu receptor, cannot cause euphoria and has no abuse potential. Naloxone is combined 

with buprenorphine in some products as an abuse deterrent. It may also be used to assess the physiologic 

readiness of an individual to begin pharmacotherapy with a long-acting antagonist such as naltrexone.

Naltrexone 

Synthetic opioid antagonist approved by the FDA for the prevention of relapse to opioid use in persons 

who have completed medically supervised withdrawal from opioids.

Neonatal abstinence syndrome (NAS)

Group of physiologic and neurobehavioral signs of withdrawal that may occur in a newborn who was 

exposed to psychotropic substances in utero. The syndrome may be managed with nonpharmacologic 

interventions, but may require pharmacotherapy.

Neonatal opioid withdrawal syndrome (NOWS)

The constellation of physiologic manifestations of withdrawal specifically attributable to opioids seen 

in opioid exposed newborns. NOWS can occur as part of multidrug withdrawal syndromes in mothers 

using multiple substances. The opioid withdrawal symptoms are observed in some newborns of mothers 

who had opioid use disorder or were using pharmacotherapy for opioid use disorder during pregnancy. 

The term NOWS captures more accurately than does the term NAS the numbers of infants experiencing 

withdrawal from opioid exposure in utero. The infant’s withdrawal symptoms can be reduced using 

medications and nonpharmacological treatments. See also the entry for neonatal abstinence syndrome.

135
Office-based opioid treatment (OBOT)

Providing medication for opioid use disorder in settings other than certified opioid treatment programs.

Opiates

Opiates are compounds that are directly derived from opium, including its three natural derivatives: morphine, 

codeine, and thebaine. Note, opioids are compounds that are broadly related to opium, although not all opioids 

will be structurally similar or derived from derivatives of opium. These include medications such as methadone, 

buprenorphine, and oxycodone.

Opioid addiction

See the entry for opioid use disorder.

Opioid agonist

Drug that has an affinity for and stimulates physiological activity at cell receptors in the central nervous system 

that are normally stimulated by opioids.

Opioid antagonist 

Drug that binds to cell receptors in the central nervous system that normally are bound by opioid psychoactive 

substances but that blocks the activity of opioids at these receptors without producing the physiologic effects 

of opioid agonists. Naltrexone is an opioid antagonist.

Opioid receptor partial agonist

Drug that binds to opioid receptors in the central nervous system without fully activating them. Partial/agonists 

produce effects similar to those of a full mu opioid receptor agonist, but may not produce additional effects 

above a certain dose. Buprenorphine is an opioid receptor partial agonist.

Opioid treatment program (OTP)

Refers to specialized programs that are certified by SAMHSA to provide methadone and/or buprenorphine, 

counseling, and urine testing to treat OUD.

Opioid use disorder (OUD)

Is defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (American Psychiatric 

Association [APA], 2013). The diagnosis of OUD can be applied to someone who uses opioid drugs and has 

at least 2 of the 11 symptoms occurring within a 12-month period. Key aspects of OUD include loss of control, 

continued use despite adverse consequences, tolerance, and withdrawal. It is important to note that tolerance 

and withdrawal are not counted toward the diagnosis in individuals experiencing these symptoms when using 

opioids under appropriate medical supervision (APA, 2013). Medications for OUD should not be used in a 

person without physical dependence on opioids except in special circumstances (e.g., a person with a history 

of moderate to severe OUD who is not currently physically dependent, but assessed to be at high risk for 

relapse).

Opioids

Opioids are compounds that are broadly related to opium, although not all opioids will be structurally similar 

or derived from derivatives of opium. These include medications such as methadone, buprenorphine, and 

oxycodone. Note, opiates are compounds that are directly derived from opium, including its three natural 

derivatives: morphine, codeine, and thebaine.

Pain management

The treatment of acute or chronic pain by various methods that may include administration of opioid 

medications.

136
Peer support services, peer support specialist, peer coach, peer worker

Peer support services involve the use of peer support specialists in recovery to provide nonclinical (i.e., not 

requiring training in diagnosis or treatment) recovery support services to individuals in recovery from SUDs and 

to their families. 

A peer support specialist is someone in recovery who has lived experience with mental illness, trauma, and/or 

substance use disorder, plus skills learned in formal training. Peer support specialists may be paid professionals 

or volunteers. They are distinguished from members of mutual-help groups because they maintain contact 

with treatment staff. They offer experiential knowledge that treatment staff often lack (e.g., what to expect at 

different mutual help meetings, how to talk to people they spent time with when using drugs).

People-first language (PFL) 

Language that emphasizes the person rather than the person’s disability or disorder. An example is using “a 

person with a substance use disorder” rather than “an addict.”

Person in recovery

An individual who is consciously seeking to improve his or her health and wellness by changing substance use 

behaviors. 

Pharmacotherapy 

The use of prescribed medication to treat disease.

Recovery

A process of change through which individuals improve their health and wellness, live a self-directed life, and 

strive to reach their full potential (SAMHSA, 2012).

Referral

A means of assuring access to needed treatment, recovery or social services when not all services are offered 

at a single program site. When a person must see a variety of service providers in multiple settings in order to 

obtain needed services, treatment program staff members should arrange the referrals, coordinate care and 

monitor patient progress.

Relapse

See the entry for return to substance use.

Return to substance use

A single instance or pattern of substance use occurring after a period of abstinence. It is preferred to the term 

relapse.

Screening

Process of determining whether a person is at risk of harm from substance use or has a substance use disorder. 

Screening usually involves use of one or more standardized techniques, most of which include a questionnaire 

or a structured interview. Screening may also include observation of known presenting complaints and 

symptoms that are indicators of substance use disorders.

Screening, brief intervention, and referral to treatment (SBIRT)

Comprehensive, integrated public health approach to the delivery of early intervention and treatment services 

for people with substance use disorders, as well as those who are at risk of developing such disorders. SBIRT 

may be conducted at primary care centers, hospital emergency departments, trauma centers, and other 

community settings provide opportunities for early intervention with people who are at risk for substance 

abuse before more severe consequences occur.

137
Stabilization (stability) 

Provision of immediate assistance, such as with an opioid agonist, to eliminate withdrawal symptoms and drug 

craving in order to promote an individual’s safety.

Substance use disorder (SUD)

Condition in which repeated or continuous use of alcohol and/or drugs causes an individual clinically and functionally 

significant impairments, such as health problems, disability, and failure to meet major responsibilities at work, school, 

or home. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5; American Psychiatric 

Association, 2013) determines the level of severity (mild, moderate, or severe) of a substance use disorder by the 

number of diagnostic criteria met by an individual. According to the DSM-5, a diagnosis of substance use disorder is 

based on evidence of impaired control, social impairment, risky use, and pharmacological criteria.

Take-home medication 

Medication for the treatment of opioid use disorder furnished to patients for unsupervised self-administration.

Tolerance

A state of physiologic adaptation in which repeat or sustained exposure to a drug induces changes that result 

in a decrease of one or more of the drug's effects. See also withdrawal.

Treatment guidelines

A listing of best practices for assessing or managing a health condition; the majority of guidelines are produced 

by a group of experts after a review of the evidence.

Treatment plan

Describes the patient’s short and longer term goals and what strategies, including therapeutic modalities, their 

schedule and frequency, recovery supports, care coordination and social supports will be employed to achieve 

them. 

Urine drug screen, urine testing

Analysis of urine samples from patients to determine the presence or absence of specific drugs. Widely used 

in substance use disorder treatment, urine testing is an important tool for assessing individual progress in 

treatment, effectiveness of the individual treatment plan, and safety. In aggregate, the test results can be used 

to make programmatic decisions. Methods of urine testing vary widely.

Withdrawal 

Expected syndrome of signs and symptoms experienced to varying degrees after abrupt discontinuation or 

rapid decrease in use of a substance that has been consumed regularly over a period of time. Withdrawal signs 

and symptoms are usually the opposite of the pharmacological effects of a psychoactive substance.

138
ACRONYMS

Acronym Definition

ACF Administration for Children & Families 

ATTC Addiction Technology Transfer Center 

CDC Centers for Disease Control and Prevention 

FDA Food and Drug Administration 

HHS U.S. Department of Health and Human Services 

HRSA Health Resources and Services Administration 

MAT Medication-assisted treatment 

MOTHER Maternal Opioid Treatment: Human Experimental Research 

NAS Neonatal abstinence syndrome 

NCSACW National Center on Substance Abuse and Child Welfare 

NICHD National Institute of Child Health and Human Development 

NICU Neonatal intensive care unit 

NIDA National Institute on Drug Abuse 

NIH National Institutes of Health 

NOWS Neonatal opioid withdrawal syndrome 

NSDUH National Survey on Drug Use and Health 

N-SSATS National Survey of Substance Abuse Treatment Services 

OUD Opioid use disorder 

OWH Office on Women’s Health 

RAM RAND/UCLA Appropriateness Method 

SAMHSA Substance Abuse and Mental Health Services Administration 

SBIRT Screening, brief intervention, and referral to treatment 

SSRI Selective serotonin reuptake inhibitor 

SUD Substance use disorder 

WHO World Health Organization 

139
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