COMBINE Monograph Series Volume 2   Medical Management Treatment Manual A Clinical Research Guide for Medically Trained Clinicians Providing Pharmacotherapy as Part of the Treatment for Alcohol Dependence Helen M. Pettinati, Ph.D. Roger D. Weiss, M.D. William R. Miller, Ph.D. Dennis Donovan, Ph.D. Denise B. Ernst, M.A. Bruce J. Rounsaville, M.D. COMBINE Monograph Series Editor Margaret E. Mattson, Ph.D. U.S. Department of Health and Human Services National Institutes of Health National Institute on Alcohol Abuse and Alcoholism 5635 Fishers Lane Bethesda, MD 20892–9304   Copyright Status This manual was constructed, with permission, from several pre-existing manuals that included medical management as part of their interventions. These manuals are cited below. The Medical Management Subgroup (authors), with the assistance of Kelly Tobin Murray (University of North Carolina, COMBINE Coordinating Center), rewrote and edited sections to provide a focused, cohesive set of guidelines for medical practitioners to follow in delivering Medical Management (MM) treatment. We also acknowledge the individual contributions of Amy Schuhl and Carla Nappi (University of Pennsylvania), and Judith Arroyo, Ph.D. (University of New Mexico). We especially credit the MM clinicians from the COMBINE study, who generously provided the authors with feedback on all aspects of the MM treatment and use of the manual. We received permission from the authors of the following manuals to use their materials in the construction of the Medical Management treatment manual. Carroll, K.M., and O’Malley, S. Compliance Enhancement: A Manual for the Psychopharmacotherapy of Alcohol Dependence. Unpublished treatment manual, Yale University, 1996. Fleming, M.; Zweben, A.; Barrett, D.; and Manwell, L. Brief Motivational Enhancement Therapy—Conducting BMET in a Combined Psychosocial and Pharmacotherapy Clinical Trial. Unpublished treatment manual, University of Wisconsin, 1997. Mason, B.J., and Goodman, A.M. Brief Intervention and Medication Compliance Procedures—Therapist’s Manual. 1997. http://www.alcohol-free.com. Volpicelli, J.R.; Pettinati, H.M.; McLellan, A.T.; and O’Brien, C.P. Combining Medication and Psychosocial Treatments for Addictions: The BRENDA Approach. New York: Guilford Press, 2001. Noncopyrighted material appearing in this volume is in the public domain and may be reproduced or copied without permission from NIAAA or the authors. Citation of the source is appreciated. Recommended citation format is as follows: Pettinati, H.M.; Weiss, R.D.; Miller, W.R.; Donovan, D.; Ernst, D.B.; and Rounsaville, B.J. COMBINE Monograph Series, Volume 2. Medical Management Treatment Manual: A Clinical Research Guide for Medically Trained Clinicians Providing Pharmacotherapy as Part of the Treatment for Alcohol Dependence. DHHS Publication No. (NIH) 04–5289. Bethesda, MD: NIAAA, 2004. COMBINE (Combining Medications and Behavioral Interventions) was supported by grants under a collaborative agreement funded by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and implemented by 11 clinical research units and a data coordinating center. Cooperative agreement awardee principal investigators, institutions, and grant numbers: Raymond Anton, Medical University of South Carolina, U10–AA–11783 Dominic Ciraulo, Boston University, U10–AA–11715 Dennis Donovan, University of Washington, U10–AA–11799 James Hosking, University of North Carolina, U10–AA–11721 Bankole Johnson, University of Texas Health Science Center at San Antonio, U10–AA–11776 Richard Longabaugh, Brown University, U10–AA–11777 Barbara Mason, University of Miami, U10–AA–11727 William Miller, University of New Mexico, U10–AA–11716 Stephanie O’Malley, Yale University, U10–AA–11787 Helen Pettinati, University of Pennsylvania, U10–AA–11768 Robert Swift, Brown University, U10–AA–11777 Roger Weiss, McLean Hospital, U10–AA–11756 Allen Zweben, University of Wisconsin, U10–AA–11773 Disclaimer: The contents of this manual are solely the responsibility of the authors and do not necessarily represent the official views of NIAAA or any other part of the National Institutes of Health. DHHS Publication No. (NIH) 04–5289 August 2004   Project COMBINE Monograph Series The following publications are available from the National Institute on Alcohol Abuse and Alcoholism, Publications Distribution Center, P.O. Box 10686, Rockville, MD, 20849–0686. Volume 1 Miller, W.R., ed. COMBINE Monograph Series, Volume 1. Combined Behavioral Intervention Manual: A Clinical Research Guide for Therapists Treating People With Alcohol Abuse and Dependence. DHHS Publication No. (NIH) 04–5288. Bethesda, MD: NIAAA, 2004. Volume 2 Pettinati, H.M.; Weiss, R.D.; Miller, W.R.; Donovan, D.; Ernst, D.B.; and Rounsaville, B.J. COMBINE Monograph Series, Volume 2. Medical Management Treatment Manual: A Clinical Research Guide for Medically Trained Clinicians Providing Pharmacotherapy as Part of the Treatment for Alcohol Dependence. DHHS Publication No. (NIH) 04–5289. Bethesda, MD: NIAAA, 2004.

This document can be downloaded in its original graphic format—[PDF] | Ordering Information. CONTENTS Acknowledgments Foreword Overview of COMBINE 1. Introduction 1.1 Rationale for Medical Management (MM) Treatment 1.2 Treatment Overview 1.3 Pitfalls to Avoid When Using MM Treatment in a Research Context 1.3a Non–MM Treatment Therapeutic Strategies 1.3b Nonabstinent Goals 1.4 Materials 1.4a Appendix A: Clinician Packet 1.4b Appendix B: Medical Management Training and Session Adherence Checklists 1.4c Appendix C: Patient Packet 2. Initial MM Session (40 to 60 minutes) 2.1 Overview of Initial Session 2.2 Guidelines for Reviewing Each Area at the Initial Session 2.2a Reviewing Results From Patient’s Evaluation 2.2b Relaying Feedback From the Clinician Report 2.2c Providing Rationale and Information on Medications 2.2d Providing Rationale and Information on Medication Compliance 2.2e Designing a Patient-Tailored Medication Compliance Plan 2.2f Reviewing Benefits of Participating in Mutual-Support Groups 2.2g Concluding the Initial Session 3. Followup Sessions (15 to 25 minutes) 3.1 Overview 3.2 Medical Status, Medication Safety, and Compliance (5 to 10 minutes) 3.2a Pill-Taking 3.3 Drinking Status (5 to 10 minutes) 3.4 Recommendations/Troubleshooting for the Four Possible Outcomes (5 to 10 minutes) 3.4a Scenario 1: The Patient Is Not Drinking and Is Medication Compliant 3.4b Scenario 2: The Patient Is Drinking but Is Medication Compliant 3.4c Scenario 3: The Patient Is Not Drinking but Is Medication Noncompliant 3.4d Scenario 4: The Patient Is Drinking and Is Medication Noncompliant 3.5 Family Education/Social Service Referrals 3.6 Emergency Crisis Intervention 3.7 Psychosocial Issues 3.8 If Patients Request Additional Treatment 3.9 Preparing for the Final MM Treatment Session 4. Medication Compliance and Treatment Session Attendance 4.1 Strategies for Handling Medication Noncompliance 4.1a Forgets to Take or Loses Medications 4.1b Worries About Side Effects 4.1c Believes He/She Is Taking Placebo 4.1d Has Misinformation About Medications 4.1e Has Never Liked Taking Pills 4.1f Desires to Drink or “Get High” 4.1g Disagrees About Having an Alcohol Disorder or Feels Like He/She No Longer Needs Medications 4.1h Takes Medication at Nonprescribed Times and in “Catchup” Doses 4.2 Attendance 4.2a Missed Appointments 4.2b Inactive Status 4.2c Patients Dissatisfied With Treatment 5. Answers to Frequently Asked Medication Questions 5.1 Naltrexone 5.2 Acamprosate 6. Medical Attention 6.1 What Is Medical Attention (MA)? 6.2 Frequency of MA Visits 6.3 Treatment Overview 6.4 Pitfalls to Avoid When Using MA in a Research Context 6.4a Non–MA Therapeutic Strategies 6.4b Nonabstinent Goals 6.5 Brief Assessment: Functioning and Drinking Status Review (5 minutes) 6.6 Review of Attendance at Mutual-Support Group Meetings 6.7 Recommendations/Troubleshooting (5 to 10 minutes) 6.7a The Patient Is Not Drinking 6.7b The Patient Is Drinking 6.8 Coexisting Medical/Psychiatric Problems Appendix A Clinician Packet Appendix B Medical Management Training and Session Adherence Checklists Appendix C Patient Packet