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Federal Regulation of Methadone Treatment
Richard A. Rettig and Adam Yarmolinsky, Editors
Committee on Federal Regulation of Methadone Treatment
Division of Biobehavioral Sciences and Mental Disorders
INSTITUTE OF MEDICINE
NATIONAL ACADEMY PRESS
Washington, D.C.
1995
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NATIONAL ACADEMY PRESS
2101 Constitution Avenue, N.W. Washington, DC 20418
NOTICE: The project that is the subject of this report was approved by the governing board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competencies and with regard to appropriate balance.
This report has been reviewed by a group other than the authors according to procedures approved by a report review committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.
The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this the Institute acts under both the Academy's 1863 congressional charter responsibility to be an advisor to the federal government and its own initiative in identifying issues of medical care, research, and education.
Support for this project was provided by the U.S. Public Health Service pursuant to Contract No. 282-92-0079.
Library of Congress Catalog Card No. 94-74890
International Standard Book No. 0-309-05240-8
Additional copies of the report are available from:
National Academy Press
2101 Constitution Avenue, N.W. P.O. Box 285 Washington, DC 20055 Call 800-624-6242 or 202-334-3313 (in the Washington Metropolitan Area).
B520
Copyright 1995 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held at the Staatlichemuseen in Berlin.
First Printing, January 1995
Second Printing, May 1995
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COMMITTEE ON THE FEDERAL REGULATION OF METHADONE TREATMENT
ADAM YARMOLINSKY (Chairman), Regents Professor of Public Policy in the University of Maryland System,
University of Maryland, Baltimore County, Baltimore, Maryland
M. DOUGLAS ANGLIN, Director,
Drug Abuse Research Center, UCLA Neuropsychiatric Institute, Los Angeles, California
JOHN C. BALL, Senior Scientist,
Center for Studies on Addiction, University of Pennsylvania, School of Medicine, Philadelphia, Pennsylvania
JANICE F. KAUFFMAN, Director,
Substance Abuse Treatment Services, North Charles, Inc., Harvard Medical School, Department of Psychiatry, The Cambridge Hospital, Somerville, Massachusetts
MARY JEANNE KREEK, Professor and Head of Laboratory,
Laboratory on the Biology of Addictive Diseases, The Rockefeller University, New York, New York
A. THOMAS MCLELLAN, Research Professor of Psychiatry,
Center for Studies on Addiction, University of Pennsylvania, School of Medicine, Philadelphia, Pennsylvania
J. THOMAS PAYTE, Founder and Medical Director,
Drug Dependence Associates, San Antonio, Texas
MICHAEL L. PRENDERGAST,
Drug Abuse Research Center, UCLA Neuropsychiatric Institute, Los Angeles, California
PETER REUTER,
School of Public Affairs, University of Maryland, College Park, Maryland
LEE N. ROBINS, Professor of Social Science in Psychiatry,
University Professor of Social Science, Department of Psychiatry, Washington University, School of Medicine, St. Louis, Missouri
RICHARD J. RUSSO, Consultant,
Substance Abuse Policy, West Trenton, New Jersey
MARGUERITE T. SAUNDERS, Commissioner,
Office of Alcoholism and Substance Abuse Services, State of New York, Albany, New York
LEE SECHREST, Professor,
Department of Psychology, University of Arizona, Tucson, Arizona
EDWARD C. SENAY, Professor of Psychiatry,
University of Chicago, Chicago, Illinois
LISA MOJER-TORRES, Attorney,
Jersey City, New Jersey
WILLIAM W. VODRA, Senior partner,
Arnold & Porter, Washington, D.C.
JERRY V. WILSON, Senior Vice President,
Crime Control Research Corporation, Washington, D.C.
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Study Staff
RICHARD A. RETTIG, Study Director
ELAINE LAWSON, Research Assistant
THELMA L. COX, Project Assistant
ROBERT COOK-DEEGAN, Director,
Division of Biobehavioral Sciences and mental Disorders (until October 1994)
CONSTANCE PECHURA, Director,
Division of Biobehavioral Sciences and Mental Disorders (from October 1994)
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Acknowledgments
This report results from the deliberations of the Institute of Medicine Committee on Federal Regulation of Methadone Treatment and its conclusions and recommendations reflect the judgments of the committee. Support for this study was provided by the U.S. Public Health Service (Contract No. 282-92-0079).
The actual preparation of the report under the direction of the committee has been accomplished by the collective efforts of committee members, staff, and other contributors. The committee wishes to acknowledge its gratitude for these various contributions.
Thanks for assistance in the preparation of this report, the provision of information, and the checking of facts are due to many people and organizations. The New York State Office of Alcoholism and Substance Abuse Services, headed by Marguerite Saunders, a member of the committee, deserves special thanks. In particular, the following individuals provided much assistance: Addi Corradi, Vincent Fenlon, William Lachanski, John Perez, Anthony Scro, and Frank Tardalo.
The New York State Committee of Methadone Program Administrators prepared an analysis of federal regulations at the request of the Institute of Medicine. Thanks go especially to Martin Livenstein and Frank McGurk, and to their colleagues, for a document that was highly informative and very useful to the committee in the early stages of its work. Visits to methadone clinics were made in a number of cities. Clinic visits in New York City were facilitated by Sy Dempsky and Richard Marx at Mt. Sinai Hospital Narcotic and Rehabilitation Center, Elizabeth Khuri, the Adolescent Development Program, New York Hospital and Cornell Medical College. A tour of the Rockefeller University laboratories of Mary Jeanne Kreek was arranged by Janel Maki. At Beth Israel Hospital, we met with Robert Newman, Nina Peyser, Stuart Nichols, Marie Marciano, and Donald Des Jarlais, and were shown a treatment program by Lolita Silva. Massachusetts methadone program directors who met with the study director included Vincent Tobin, Edward Bloniari, Matthew Davis, Tim Schuettje, Harvey Kauffman, Norma Reppucci, Brian Foss, and Pat Rushton. Karst Besteman, director of the Substance Abuse Center, Institute for Behavior Resources, Inc., Washington, D.C., provided
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valuable historical information as well as a tour of two facilities. Jeffrey A. Hoffman, of Adapt, Inc., and Koba Associates, Inc., Washington, D.C., also arranged a facility tour and shared with the study the benefits of his research. In Baltimore, we visited Man Alive, courtesy of its long-time director, Richard Lane, who is now deceased. At the Sinai Hospital Drug Dependence Program in Baltimore, Franklin T. Evans hosted our visit.
Robert W. Schuster, former Director of the National Institute on Drug Abuse (NIDA), under whom this study originated, provided counsel early in the study. The oversight committee of the Department of Health and Human Services for this study included Lorraine Fishback, Office of the Assistant Secretary of Health, Nicholas Reuter, Food and Drug Administration (FDA); Dorynne Czechowicz, Steve Molinari, and James Cooper of NIDA, and Robert Lubran, Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration (SAMHSA). At NIDA, we also received help from Bennett Fletcher, Charles Grudzinskas, and Frank Vocci. At SAMHSA, Sue Becker, Jerome Jaffe, Herman Diesenhaus, and Mady Chalk were helpful to the study. Additional help was provided by the following individuals at the FDA: Stuart Nightingale, Curtis Wright, Betty Jones, Ellsworth Dory, and Ross Laderman.
A special note of thanks goes to David E. Joranson, associate director for Policy Studies, Pain Research Group, University of Wisconsin-Madison, for providing his own comments and stimulating communications from others to the committee regarding the effects of the methadone regulations on the management of pain.
At the Drug Enforcement Administration, Thomas Gitchel, Ann Carter, Frank Sapienza, and Howard McLain were helpful at various times during the study. At the Office of National Drug Control Policy (ONDCP), John Gregorich and Sam Schildhaus were helpful, as was Lee Brown, director of ONDCP. Peter Edelman, counsel to the Secretary of Health and Human Services, met with the chairman and study director midway in the study and provided useful guidance on the departmental perspective on drug policy.
Regarding the actual writing of the report, the first draft of chapter 1 was prepared by Richard Rettig and then reviewed extensively by the entire committee. Chapter 2 was written by Mary Jeanne Kreek. Sally Satel assisted on an early draft and Constance Pechura also provided helpful assistance. Chapter 3 was written by Lee Robins and Douglas Anglin. Robins conducted special analyses of the Epidemiologic Catchment Area study data for this chapter. Anglin received assistance in analyzing drug use forecasting data from Vincent Fenlon in the New York State Office of Alcoholism and Substance Abuse Services, Susan Nisenbaum in the California Department of Alcohol and Drug Programs, and Talbert Cottey, at the National Institute of Justice, and for data analysis from Jessie Hsieh and Mel Widawski, at the University of
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California, Los Angeles Drug Abuse Research Center.
Chapter 4 was written by Michael Prendergast, who was assisted by Dana Baldwin. Chapter 5 was written by Richard Rettig, who benefited from extensive documentation provided by Steve Molinari and James Cooper of NIDA, and from presentations to the committee by Peter Hutt, Jerome Jaffe, and Stewart Nightingale. Chapter 6 was written by Miriam Davis, consultant to the committee. She wishes to acknowledge the assistance of Daniel Melnick and Robert Lubran, SAMHSA; Elsworth Dory, FDA; Ralph Swindle, Veterans Affairs Medical Center, Palo Alto, Department of Veterans Affairs; Henrick Harwood and Douglas Fountain, Lewin-VHI, Inc.; Thomas D'Aunno, University of Michigan;, Helen Levine Batten, Brandeis University; William Butynski, National Association of State Alcohol and Drug Abuse Directors; Mark Parrino, American Methadone Treatment Association; Addie Corradi, New York State Office of Alcoholism and Substance Abuse Services; Joy Jarfors, California Department of Alcohol and Drug Programs; Phil Emenheiser, Florida Department of health and Rehabilitative Services; Richard Weisskopf, Illinois Department of Alcoholism and Substance Abuse; and Barbara Espey, Massachusetts Department of Public Health. Chapter 7 was written by Janice Kauffman, Thomas Payte, and Thomas McLellan. Chapter 8 was written by Richard Rettig.
Thelma Cox, with patience, good humor, and grace, supported the project throughout its duration and prepared the many drafts and the camera-ready copy of this report with her usual competence. The readability of the report benefited immensely from the exemplary editorial work of Andrea Posner.
Lastly, the chairman wishes to add that this report could not have been produced without the extraordinary efforts of Richard Rettig, who devoted more time, energy, and common sense to the effort than the committee and its chairman had any reason to expect or ask for. Neither could it have been produced without the active participation of committee members in the actual writing of the report—a practice that has characterized the Institute of Medicine from its beginnings—and in their willingness to resolve their differences in an amicable and reasonable fashion, making the task of the chairman that much less difficult.
ADAM YARMOLINSKY, CHAIRMAN
COMMITTEE ON THE FEDERAL REGULATION OF METHADONE TREATMENT
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Contents
Executive Summary
1
1
Introduction
17
The Charge to the Committee
19
Objectives of Opiate Addiction Treatment
20
Effectiveness of Methadone Maintenance Treatment
21
Why Methadone Is Regulated Differently from Other Drugs
27
The Committee's View
30
Report Organization
31
Study Methods
33
A Note on Terminology
34
2
Pharmacology and Medical Aspects of Methadone Treatment
37
The Rationale for Pharmacotherapy
37
Pharmacokinetics of Methadone
42
Methadone Maintenance
43
Interactions of Methadone with Other Drugs
48
Impact of Methadone Maintenance on Infectious Diseases
50
3
Who are the Recipients of Treatment?
61
Heroin Use and Dependence
63
Characteristics of Untreated and Treated Heroin Addicts
71
Methadone Patient Characteristics
73
Summary
88
4
Methadone Diversion Control
92
Early Concern Over Diversion
92
The Narcotic Addict Treatment Act of 1974
96
More Recent Official Views on Diversion
97
The Data on Diversion
100
How Is Methadone Diverted?
110
Who Uses Diverted Methadone and Why?
112
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Consequences of Methadone Diversion
113
Summary
115
Appendix: Harris County, Texas
117
5
Federal Regulation of Methadone Treatment
120
The 1960s
121
The Nixon Administration
123
Defining the Regulatory Regime: 1970–1974
125
The Current Regulatory Regime
136
Levo-Alpha-Acetyl-Methadol
145
Summary
148
6
Methadone Treatment
151
The Provider Community
151
Financing of Methadone Treatment
161
State Substance Abuse Agencies
169
Summary
181
7
Treatment Standards and Optimal Treatment
185
Definition of Terms
186
Patient Evaluation and Admission Criteria
189
Maintenance Pharmacotherapy
192
Medically Supervised Withdrawal
205
Inpatient Treatment
207
Pain Management
210
Concluding Comments
213
8
Implementing Standards—And Beyond
217
Regulations and Their Enforcement
218
Clinical Practice Guidelines
222
Formal Quality Assurance Systems
225
What Can Be Done Now?
226
Federal Government Leadership
229
Summary
236
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Federal Regulation of Methadone Treatment
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