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Medications for Opioid Use Disorder Save Lives (2019)

Chapter: Front Matter

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Medications for Opioid Use Disorder Save Lives. Washington, DC: The National Academies Press. doi: 10.17226/25310.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Medications for Opioid Use Disorder Save Lives Committee on Medication-Assisted Treatment for Opioid Use Disorder Alan I. Leshner and Michelle Mancher, Editors Board on Health Sciences Policy Health and Medicine Division A Consensus Study Report of PREPUBLICATION COPY: UNCORRECTED PROOFS

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW, Washington, DC 20001 This activity was supported by a contract between the National Academy of Sciences and the National Institutes of Health (HHSN263201800029I/HHSN26300005) and the Substance Abuse and Mental Health Services Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project. International Standard Book Number-13: 978-0-309-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X Digital Object Identifier: https://doi.org/10.17226/25310 Library of Congress Control Number: Additional copies of this publication are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. Copyright 2019 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2019. Medications for opioid use disorder save lives. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/25310. PREPUBLICATION COPY: UNCORRECTED PROOFS

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president. The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president. The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president. The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine. Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org. PREPUBLICATION COPY: UNCORRECTED PROOFS

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task. Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo. PREPUBLICATION COPY: UNCORRECTED PROOFS

COMMITTEE ON MEDICATION-ASSISTED TREATMENT FOR OPIOID USE DISORDER ALAN I. LESHNER (Chair), Chief Executive Officer Emeritus, American Association for the Advancement of Science HUDA AKIL, Co-Director and Research Professor, Molecular & Behavioral Neuroscience Institute; Distinguished University Professor and Quarton Professor of Neurosciences, Department of Psychiatry, University of Michigan COLLEEN BARRY, Fred & Julie Soper Professor and Chair, Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health KATHLEEN CARROLL, Albert E. Kent Professor of Psychiatry, Yale School of Medicine CHINAZO CUNNINGHAM, Professor, Albert Einstein College of Medicine, Montefiore Medical Center WALTER GINTER, Project Director, Medication Assisted Recovery Support Project TRACI GREEN, Associate Professor, Emergency Medicine; Associate Director and Senior Scientist, Injury Prevention Research Center, Boston University/Boston Medical Center YASMIN HURD, Ward Coleman Chair of Translational Neuroscience; Director, Addiction Institute at Mount Sinai, Icahn School of Medicine at Mount Sinai ALAN JETTE, Professor, MGH Institute of Health Professions LAURA R. LANDER, Associate Professor and Addiction Therapist, Department of Behavioral Medicine and Psychiatry and Department of Neuroscience, West Virginia University DAVID PATTERSON SILVER WOLF, Associate Professor, Washington University SEUN ROSS, Director, Nursing Practice and Work Environment, American Nurses Association SCOTT STEIGER, Associate Clinical Professor of Medicine and Psychiatry, University of California, San Francisco DAVID VLAHOV, Associate Dean for Research and Professor, Yale University School of Nursing Study Staff MICHELLE MANCHER, Study Director CLARE STROUD, Senior Program Officer EMILY BUSTA, Associate Program Officer (until September 2018) BENJAMIN KAHN, Associate Program Officer DANIEL FLYNN, Research Associate (until December 2018) MEREDITH HACKMANN, Research Associate (until December 2018) MICHAEL BERRIOS, Senior Program Assistant MARIAM SHELTON, Board on Health Sciences Policy Program Coordinator DANIEL BEARSS, Research Librarian ANDREW M. POPE, Director, Board on Health Sciences Policy Consultant ANNA NICHOLSON, Science writer PREPUBLICATION COPY: UNCORRECTED PROOFS v

Reviewers This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We thank the following individuals for their review of this report: JAN M. BROWN, SpiritWorks Foundation Center for the Soul H. WESTLEY CLARK, Santa Clara University KELLY J. CLARK, American Society of Addiction Medicine BRANDEE IZQUIERDO, SAFE Project CHRISTOPHER M. JONES, Centers for Disease Control and Prevention PAULA J. LUM, University of California, San Francisco SANDRA A. SPRINGER, Yale School of Medicine JOYCELYN SUE WOODS, National Alliance for Medication Assisted Recovery Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report, nor did they see the final draft before its release. The review of this report was overseen by JOHN H. KRYSTAL, Yale University School of Medicine, and KRISTINE GEBBIE, Flinders University School of Nursing and Midwifery. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies. PREPUBLICATION COPY: UNCORRECTED PROOFS vii

Preface The United States is experiencing a public health crisis of almost unprecedented scale: an epidemic of opioid use disorder and related overdose deaths. It is not wholly new, since opioid addiction and the resulting societal disruption have been major problems in many countries for hundreds of years, but its magnitude has increased exponentially in the past decades. As this Consensus Study Report articulates, modern medicine and the science that underpins it have developed and provided a set of highly effective tools that can help address the opioid epidemic—specifically, three U.S. Food and Drug Administration–approved medications—that have been severely underused, even in the health care sector. Their effectiveness and why they are not more widely used are the subjects of this report. Most of the factors impeding their full use can and must be dealt with if real progress is to be made. These factors include the misunderstandings and stigma surrounding both addiction and the medications used to treat it as well as counterproductive ideologies that consider addiction simply a failure of will or a moral weakness, as opposed to understanding opioid use disorder as a chronic disease of the brain that requires medical treatment. This misunderstanding and stigma must be addressed; they have resulted in hundreds of thousands of patients being denied access to life-saving medications on non-medical, non-scientific grounds, which our committee considers to be unethical. As with all such studies, the committee developed its conclusions based on a review of the scientific literature as it stands at the point in time of the committee’s work. Fortunately, there is a robust research enterprise that is continuing to work on opioid use disorder and its treatment. We are confident that these efforts will yield results that will continue to increase understanding of opioid use disorder and the most effective ways to prevent and treat it. Knowledge needs include refining in detail the most effective protocols for administering medications to specific individuals and subpopulations and the identification of additional molecular targets and approaches to enable the development of new and even more effective medications. Other research needs are discussed throughout the report. The committee would like to express its great appreciation to the study director, Michelle Mancher, and her colleagues on the National Academies staff whose dedication, competence, and hard work have greatly improved the quality of this report. We also greatly appreciate the insight and support of our sponsors, the National Institute on Drug Abuse of the National Institutes of Health and the Substance Abuse and Mental Health Services Administration. Alan I. Leshner, Chair Committee on Medication-Assisted Treatment of Opioid Use Disorder PREPUBLICATION COPY: UNCORRECTED PROOFS ix

Contents ACRONYMS AND ABBREVIATIONS xv SUMMARY S-1 1 INTRODUCTION 1-1 Charge to the Committee and Study Scope, 1-5 Conceptual Framework and Key Terms, 1-6 Study Methodology, 1-10 Organization of the Report, 1-10 Conclusion, 1-11 References, 1-11 2 THE EFFECTIVENESS OF MEDICATION-BASED TREATMENT FOR OPIOID USE DISORDER 2-1 Methadone, 2-2 Buprenorphine, 2-3 Extended-Release Naltrexone, 2-4 Naloxone, 2-5 Evidence on the Effectiveness of FDA-Approved Medications in Treating OUD, 2-5 Knowledge Gaps and Future Directions for Research on Medications for OUD, 2-8 Behavioral Therapy in Conjunction with Medications, 2-12 Knowledge Gaps and Additional Research Needed on the Role of Behavioral Interventions with Medications in Treatment for OUD, 2-14 Conclusions, 2-15 References, 2-16 3 TREATMENT WITH MEDICATIONS FOR OPIOID USE DISORDER IN DIFFERENT POPULATIONS 3-1 Medication-Based Treatment for OUD Across the Life Course, 3-2 Sex-Related Differences in Medication-Based Treatment for OUD, 3-4 Pregnant Women, 3-5 Sexual Minorities, 3-6 Individuals with Other Comorbidities, 3-7 Racial and Ethnic Minority Populations, 3-10 Low Socioeconomic Status Populations, 3-12 Rural and Urban Populations, 3-12 Conclusion, 3-13 References, 3-13 4 MEDICATIONS FOR OPIOID USE DISORDER BY TREATMENT SETTING 4-1 Opioid Treatment Programs, 4-3 Office-Based Opioid Treatment, 4-4 Acute Care Settings, 4-6 Other Care Settings, 4-6 PREPUBLICATION COPY: UNCORRECTED PROOFS xi

Criminal Justice Settings, 4-7 Innovative Settings for OUD Treatment, 4-9 Conclusion, 4-10 References, 4-10 5 BARRIERS TO BROADER USE OF MEDICATIONS TO TREAT OPIOID USE DISORDER 5-1 Stigma, 5-2 Inadequate Professional Education and Training, 5-5 System Fragmentation, 5-6 Legal and Regulatory Barriers, 5-7 Public and Private Insurance Barriers, 5-11 Conclusion, 5-14 References, 5-14 APPENDIXES A Study Approach and Methods A-1 B Public Workshop Agenda B-1 C Biographical Sketches of Committee Members C-1 PREPUBLICATION COPY: UNCORRECTED PROOFS xii

Boxes and Figures BOXES S-1 Medication-Based Treatment for Opioid Use Disorder, S-2 S-2 Summary of Conclusions, S-2 S-3 Statement of Task, S-8 1-1 Medication-Based Treatment for Opioid Use Disorder, 1-3 1-2 U.S. Food and Drug Administration–Approved Medications for the Treatment of Opioid Use Disorder, 1-3 1-3 Statement of Task, 1-5 1-4 Diagnostic Criteria for Opioid Use Disorder, 1-7 1-5 Key Terms, 1-8 2-1 FDA-Approved Medications for the Treatment of Opioid Use Disorder, 2-2 2-2 Types of Behavioral Interventions, 2-12 3-1 National Estimates of People with Opioid Use Disorder (OUD) Receiving Medication- Based Treatment, 3-1 4-1 Office-Based Methadone Treatment, 4-4 FIGURES 4-1 All substance use disorder facilities, by county (2018), 4-2 4-2 Substance use disorder facilities offering medications for OUD, by county (2018), 4-2 4-3 Substance use disorder treatment facilities offering all three medications for OUD, by county (2018), 4-3 PREPUBLICATION COPY: UNCORRECTED PROOFS xiii

Acronyms and Abbreviations AAP American Academy of Pediatrics ACA Patient Protection and Affordable Care Act CARA Comprehensive Addiction and Recovery Act CFR Code of Federal Regulations CHC community health center DATA Drug Addiction Treatment Act DEA Drug Enforcement Administration EHR electronic health record FDA U.S. Food and Drug Administration HCV hepatitis C virus HIV human immunodeficiency virus MAT medication-assisted treatment MHPA Mental Health Parity Act NP nurse practitioner NSDUH National Survey on Drug Use and Health OTP opioid treatment program OUD opioid use disorder PA physician assistant QTc corrected QT interval SAMHSA Substance Abuse and Mental Health Services Administration siOAT supervised injectable opioid agonist treatment SROM slow-release oral morphine SUD substance use disorder THC tetrahydrocannabinol PREPUBLICATION COPY: UNCORRECTED PROOFS xv

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The opioid crisis in the United States has come about because of excessive use of these drugs for both legal and illicit purposes and unprecedented levels of consequent opioid use disorder (OUD). More than 2 million people in the United States are estimated to have OUD, which is caused by prolonged use of prescription opioids, heroin, or other illicit opioids. OUD is a life-threatening condition associated with a 20-fold greater risk of early death due to overdose, infectious diseases, trauma, and suicide. Mortality related to OUD continues to escalate as this public health crisis gathers momentum across the country, with opioid overdoses killing more than 47,000 people in 2017 in the United States. Efforts to date have made no real headway in stemming this crisis, in large part because tools that already exist—like evidence-based medications—are not being deployed to maximum impact.

To support the dissemination of accurate patient-focused information about treatments for addiction, and to help provide scientific solutions to the current opioid crisis, this report studies the evidence base on medication assisted treatment (MAT) for OUD. It examines available evidence on the range of parameters and circumstances in which MAT can be effectively delivered and identifies additional research needed.

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