Medication-Assisted Treatment For Opioid Addiction in Opioid Treatment Programs A Treatment Improvement Protocol TIP 43 U.S. DEPARTMENT OFHEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment MEDICATION- www.samhsa.gov ASSISTED TREATMENT Medication-Assisted Treatment For Opioid Addiction in Opioid Treatment Programs Steven L. Batki, M.D. Consensus Panel Chair Janice F. Kauffman, R.N., M.P.H., LADC, CAS Consensus Panel Co-Chair Ira Marion, M.A. Consensus Panel Co-Chair Mark W. Parrino, M.P.A. Consensus Panel Co-Chair George E. Woody, M.D. Consensus Panel Co-Chair A Treatment Improvement Protocol TIP 43 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Center for Substance Abuse Treatment 1 Choke Cherry Road Rockville, MD 20857 Acknowledgments The guidelines in this document should not be considered substitutes for individualized client Numerous people contributed to the care and treatment decisions. development of this Treatment Improvement Protocol (see pp. xi and xiii as well as Appendixes E and F). This publication was Public Domain Notice produced by Johnson, Bassin & Shaw, Inc. All materials appearing in this volume except (JBS), under the Knowledge Application those taken directly from copyrighted sources Program (KAP) contract numbers 270-99- are in the public domain and may be reproduced 7072 and 270-04-7049 with the Substance or copied without permission from SAMHSA/ Abuse and Mental Health Services CSAT or the authors. Do not reproduce or Administration (SAMHSA), U.S. Department distribute this publication for a fee without of Health and Human Services (DHHS). specific, written authorization from SAMHSAís Christina Currier served as the Center for Office of Communications. Substance Abuse Treatment (CSAT) Government Project Officer, and Andrea Kopstein, Ph.D., M.P.H., served as Deputy Electronic Access and Copies Government Project Officer. Robert Lubran, of Publication M.S., M.P.A., and Alan Trachtenberg, M.D., served as CSAT technical experts. Lynne Copies may be obtained free of charge from McArthur, M.A., A.M.L.S., served as SAMHSAís National Clearinghouse for Alcohol the JBS KAP Executive Project Co-Director. and Drug Information (NCADI), (800) 729-6686 Barbara Fink, R.N., M.P.H., served as or (301) 468-2600; TDD (for hearing impaired), the JBS KAP Managing Project Co-Director. (800) 487-4889; or electronically through the Other JBS KAP personnel included Dennis following Internet World Wide Web site: Burke, M.S., M.A., Deputy Director for www.ncadi.samhsa.gov. Product Development; Wendy Caron, Editorial Quality Assurance Manager; Recommended Citation Frances Nebesky, M.A., Quality Assurance Editor; Leah Bogdan, Junior Editor; Emily Center for Substance Abuse Treatment. Tinkler, Junior Writer; and Pamela Frazier, Medication-Assisted Treatment for Opioid Document Production Specialist. Catalina Addiction in Opioid Treatment Programs. Vallejos Bartlett, M.A., Margaret Brooks, Treatment Improvement Protocol (TIP) Series J.D., Jonathan Max Gilbert, M.A., Randi 43. DHHS Publication No. (SMA) 05-4048. Henderson, and Deborah J. Shuman Rockville, MD: Substance Abuse and Mental were writers. Health Services Administration, 2005. Disclaimer Originating Office The opinions expressed herein are the views Practice Improvement Branch, Division of of the consensus panel members and do not Services Improvement, Center for Substance necessarily reflect the official position of CSAT, Abuse Treatment, Substance Abuse and Mental SAMHSA, or DHHS. No official support of or Health Services Administration, 1 Choke endorsement by CSAT, SAMHSA, or DHHS Cherry Road, Rockville, MD 20857. for these opinions or for particular instruments, DHHS Publication No. (SMA) 05-4048 software, or resources described in this document is intended or should be inferred. Printed 2005 Contents What Is a TIP?............................................................................................................ix Consensus Panel ..........................................................................................................xi KAP Expert Panel and Federal Government Participants ..................................................xiii Foreword...................................................................................................................xv Executive Summary ...................................................................................................xvii Chapter 1óIntroduction ...............................................................................................1 Purpose of This TIP.......................................................................................................1 Key Definitions..............................................................................................................2 Audience for This TIP.....................................................................................................2 A Decade of Change........................................................................................................2 Remaining Challenges......................................................................................................6 The Future of MAT.......................................................................................................10 Chapter 2óHistory of Medication-Assisted Treatment for Opioid Addiction...........................11 Emergence of Opioid Addiction as a Significant Problem and the Roots of Controversy.................11 Origins of Opioid Maintenance Therapy.............................................................................17 Regulatory History........................................................................................................21 Chapter 3óPharmacology of Medications Used To Treat Opioid Addiction...........................25 Pharmacology and Pharmacotherapy................................................................................28 Dosage Forms..............................................................................................................31 Efficacy......................................................................................................................32 Side Effects.................................................................................................................33 Interactions With Other Therapeutic Medications.................................................................36 Safety........................................................................................................................42 Chapter 4óInitial Screening, Admission Procedures, and Assessment Techniques ..................43 Initial Screening...........................................................................................................43 Admission Procedures and Initial Evaluation......................................................................46 Medical Assessment.......................................................................................................49 Induction Assessment ....................................................................................................53 Comprehensive Assessment .............................................................................................53 Appendix 4-A. Example of Standard Consent to Opioid Maintenance Treatment..........................61 iii Chapter 5óClinical Pharmacotherapy............................................................................63 Contraindications to Opioid Pharmacotherapy....................................................................64 Stages of Pharmacotherapy.............................................................................................65 Medically Supervised Withdrawal ....................................................................................78 Take-Home Medications ................................................................................................81 Office-Based Opioid Therapy...........................................................................................85 Chapter 6óPatientñTreatment Matching: Types of Services and Levels of Care..........................................................................87 Steps in PatientñTreatment Matching ................................................................................88 Patients With Special Needs............................................................................................91 Treatment Planning.......................................................................................................95 Chapter 7óPhases of Treatment..................................................................................101 Rationale for a Phased-Treatment Approach and Duration...................................................101 Phases of MAT ...........................................................................................................102 Transition Between Treatment Phases in MAT....................................................................119 Readmission to the OTP ...............................................................................................120 Chapter 8óApproaches to Providing Comprehensive Care and Maximizing Patient Retention .................................................................................121 Core Services.............................................................................................................121 Retaining Patients in MAT.............................................................................................122 Counseling and Case Management, Behavioral Treatments, and Psychotherapy .........................124 Benefits of Family Involvement.......................................................................................133 Integrative Approaches.................................................................................................135 Relapse Prevention......................................................................................................136 Referral to Social Services.............................................................................................138 Involuntary Discharge From MAT...................................................................................138 Patient Advocacy........................................................................................................142 Chapter 9óDrug Testing as a Tool...............................................................................143 Purposes of Drug Testing in OTPs...................................................................................143 Benefits and Limitations of Drug Tests .............................................................................144 Drug-Testing Components and Methods............................................................................148 Development of Written Procedures.................................................................................151 Other Considerations in Drug-Testing Procedures...............................................................154 Interpreting and Using Drug Test Results..........................................................................155 Reliability, Validity, and Accuracy of Drug Test Results........................................................158 iv Contents Chapter 10óAssociated Medical Problems in Patients Who Are Opioid Addicted.................161 Integrated Versus Referral Services.................................................................................162 Routine Testing and Followup for Medical Problems............................................................163 Acute, Life-Threatening Infections ..................................................................................163 Infectious Diseases.......................................................................................................164 Patients With Disabilities..............................................................................................173 Pain Management........................................................................................................174 Hospitalization of Patients in MAT..................................................................................178 General Medical Conditions and MAT..............................................................................178 Chapter 11óTreatment of Multiple Substance Use..........................................................179 Prevalence of Multiple Substance Use in MAT....................................................................180 Common Drug Combinations Used by Patients in MAT ........................................................181 Effects of Other Substance Use.......................................................................................182 Management of Multiple Substance Use in MAT..................................................................186 Inpatient Detoxification and Short-Term Stabilization..........................................................188 Chapter 12óTreatment of Co-Occurring Disorders ........................................................189 Prevalence of Co-Occurring Disorders..............................................................................190 Motivation for Treatment and Co-Occurring Disorders.........................................................191 Etiology of Co-Occurring Disorders.................................................................................191 Screening for Co-Occurring Disorders..............................................................................192 Making and Confirming a Psychiatric Diagnosis .................................................................194 Prognosis for Patients With Co-Occurring Disorders ...........................................................197 Treatment Issues.........................................................................................................199 Appendix 12-A. Internet Resources for Accessing Psychiatric Instruments................................209 Chapter 13óMedication-Assisted Treatment for Opioid Addiction During Pregnancy............211 Acceptance of Methadone Maintenance as the Standard of Care.............................................211 Diagnosing Opioid Addiction in Pregnant Patients ..............................................................212 Medical and Obstetrical Concerns and Complications ..........................................................212 Methadone Dosage and Management................................................................................215 Postpartum Treatment of Mothers in MAT........................................................................218 Breast-Feeding ...........................................................................................................218 Effects on Neonatal Outcome .........................................................................................218 Use of Buprenorphine During Pregnancy..........................................................................220 Importance of Integrated, Comprehensive Services .............................................................222 Nutrition Assessment, Counseling, and Assistance...............................................................223 Contents v Chapter 14óAdministrative Considerations...................................................................225 Staffing.....................................................................................................................225 Medication Diversion Control Plans.................................................................................230 The Community Effort .................................................................................................231 OTPs and National Community Education Initiatives ..........................................................236 Evaluating Program and Staff Performance.......................................................................238 Appendix AóBibliography..........................................................................................241 Appendix BóAbbreviations and Acronyms....................................................................279 Appendix CóGlossary................................................................................................283 Appendix DóEthical Considerations in MAT..................................................................297 Fundamental Ethical Principles......................................................................................297 Ethics in Practice........................................................................................................298 Ethics: Conclusion.......................................................................................................303 Appendix EóResource Panel......................................................................................305 Appendix FóField Reviewers......................................................................................307 Index......................................................................................................................317 CSAT TIPs and Publications Based on TIPs...................................................................331 vi Contents Exhibits 1-1 NIDA Comprehensive Care-Related Principles of Effective Drug Addiction Treatment.............8 3-1 Pharmacotherapeutic Medications for Opioid Addiction Treatment ...................................26 3-2 Requirements for Physiciansí Waivers To Dispense or Prescribe Buprenorphine and Buprenorphine-Naloxone to Patients Who Are Opioid Addicted.....................................27 3-3 Intrinsic Activity of Full Agonist (Methadone), Partial Agonist (Buprenorphine), and Antagonist (Naloxone) Therapy..............................................................................31 3-4 Possible Side Effects of Opioid Agonist and Partial Agonist Therapy..................................34 3-5 Reported Drug Interactions With Methadone ...............................................................37 3-6 Other Inducers and Inhibitors of CYP450 and CYP3A4..................................................40 4-1 Suicide Risk Factors...............................................................................................45 4-2 Recommended Responses to Indicators of Suicidality.....................................................45 4-3 Recommended Procedures for Identifying and Addressing Domestic Violence.......................57 5-1 Using Signs and Symptoms To Determine Optimal Methadone Levels .................................68 5-2 Induction SimulationóModerate to High Tolerance.......................................................69 5-3 Heroin Use in Preceding 30 Days (407 Methadone-Maintained Patients by Current Methadone Dose).................................73 5-4 Methadone Dose/Mean Plasma Levels.........................................................................74 5-5 Blood Plasma Levels Over 4 and 24 Hours With an Adequate and Inadequate Methadone Dose..................................................................................75 5-6 SMLs After Single and Split Methadone Dosing in a Fast Metabolizer.................................76 5-7 Types of Detoxification From Illicit Opioids.................................................................80 6-1 Case Study: PatientñTreatment Planning in MAT..........................................................97 7-1 Acute Phase of MAT.............................................................................................104 7-2 Rehabilitative Phase of MAT...................................................................................109 7-3 Supportive-Care Phase of MAT...............................................................................114 7-4 Medical Maintenance Phase of MAT .........................................................................116 7-5 Tapering Phase of MAT.........................................................................................118 8-1 Resource Materials for Psychoeducational, Skill-Building, and Group Counseling Sessions..................................................................................127 8-2 Strategy for Contingency Management in MAT............................................................129 8-3 Common Strategies for Psychotherapy in MAT............................................................131 8-4 Strategies for Psychoeducation in MAT .....................................................................133 8-5 Patient Goals in Building Relapse Prevention Skills......................................................137 9-1 Typical Testing and Confirmation Cutoff Concentrations and Detection Times for Various Substances of Abuse................................................................................145 9-2 Common Immunoassays.........................................................................................150 9-3 Sample OTP Guidelines for Monitoring Urine Drug Test Specimen Collection.....................151 9-4 Examples of Onsite Analytical Methods for Drug Tests..................................................156 10-1 Classification of TB..............................................................................................165 10-2 Hepatitis C Evaluation Flowchart ............................................................................169 Contents vii 10-3 Nonpharmacologic Approaches to Managing Chronic Nonmalignant Pain..........................177 11-1 Reported Use of Other Substances by Patients Admitted to OTPs....................................180 11-2 Current Substance Use Disorders in Patients Dependent on Another Substance While Addicted to Opioids and Admitted to OTPs, With and Without Co-Occurring Disorders (N=716)...................................................181 11-3 Drug Combinations and Common Reasons for Use.......................................................182 12-1 Common Co-Occurring Disorders in Patients Who Are Opioid Addicted............................191 12-2 DSM-IV-TR Classification of Diagnoses Associated With Different Classes of Substances.............................................................................196 12-3 Mutual-Help Groups for People With Co-Occurring Disorders........................................203 12-4 Topics for Psychoeducational Groups for People With Co-Occurring Disorders...................204 12-5 Interactions of Some Medications for Depression and Bipolar Disorder With Methadone and Recommended Treatment Response in MAT.................................206 13-1 Common Medical Complications Among Pregnant Women Who Are Opioid Addicted............213 13-2 Laboratory Tests for Pregnant Women Who Are Opioid Addicted....................................214 13-3 Common Obstetrical Complications Among Women Addicted to Opioids............................215 D-1 Case Example......................................................................................................299 D-2 AATOD Canon of Ethics........................................................................................303 D-3 Ethical Codes of Selected Treatment-Oriented Organizations and Their Web Sites...............304 viii Contents What Is a TIP? Treatment Improvement Protocols (TIPs), developed by the Center for Substance Abuse Treatment (CSAT), part of the Substance Abuse and Mental Health Services Administration (SAMHSA), within the U.S. Department of Health and Human Services (DHHS), are best-practice guidelines for the treatment of substance use disorders. CSAT draws on the experience and knowledge of clinical, research, and administrative experts to produce the TIPs, which are distributed to facilities and indi- viduals across the country. The audience for the TIPs is expanding beyond public and private treatment facilities to include practitioners in mental health, criminal justice, primary care, and other health care and social service settings. CSATís Knowledge Application Program (KAP) expert panel, a distin- guished group of experts on substance use disorders and professionals in such related fields as primary care, mental health, and social services, works with the State Alcohol and Drug Abuse Directors to generate topics for the TIPs. Topics are based on the fieldís current needs for information and guidance. After selecting a topic, CSAT invites staff from pertinent Federal agencies and national organizations to be members of a resource panel that recommends specific areas of focus as well as resources that should be considered in developing the content for the TIP. These recommenda- tions are communicated to a consensus panel composed of experts on the topic who have been nominated by their peers. This consensus panel participates in a series of discussions. The information and recommen- dations on which they reach consensus form the foundation of the TIP. The members of each consensus panel represent substance abuse treat- ment programs, hospitals, community health centers, counseling pro- grams, criminal justice and child welfare agencies, and private practi- tioners. A panel chair (or co-chairs) ensures that the contents of the TIP mirror the results of the groupís collaboration. A large and diverse group of experts closely reviews the draft document. Once the changes recommended by these field reviewers have been incorporated, the TIP is prepared for publication, in print and on line. TIPs can be accessed via the Internet at www.kap.samhsa.gov. The ix
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