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Supplements > Supplement 15, 2005 -- The COMBINE Study: Conceptual, Methodological and Practical Issues in a Clinical Trial that Combined Medication and Behavioral Treatments

    Overview

    Helen M. Pettinati, Allen Zweben, Margaret E. Mattson (JSA Sup 15: 5)

    Section 1: Conceptual and Methodological Foundations of COMBINE

    Margaret E. Mattson (JSA Sup 15: 6)

    Combining Treatments for Alcoholism: Why and How?

    Margaret E. Mattson, Raye Z. Litten (JSA Sup 15: 8)

    When Worlds Collide: Blending the Divergent Traditions of Pharmacotherapy and Psychotherapy Outcome Research

    William R. Miller, Joseph S. LoCastro, Richard Longabaugh, Stephanie O'Malley, Allen Zweben (JSA Sup 15: 17)

    Factorial Designs in Clinical Trials: Options for Combination Treatment Studies

    David J. Couper, James D. Hosking, Ron A. Cisler, David R. Gastfriend, Daniel R. Kivlahan (JSA Sup 15: 24)

    Section 2: Methodological Aspects of the Design of the COMBINE Study

    David J. Couper, Raymond F. Anton (JSA Sup 15: 33)

    Design and Analysis of Trials of Combination Therapies

    James D. Hosking, Ron A. Cisler, David J. Couper, David R. Gastfriend, Daniel R. Kivlahan, Raymond F. Anton (JSA Sup 15: 34)

    Use of a “Psychotherapy with No Pills” Treatment Condition as Part of a Combined Pharmacotherapy- Psychotherapy Research Study of Alcohol Dependence

    Roger D. Weiss, Joseph S. LoCastro, Robert Swift, Allen Zweben, William R. Miller, Richard Longabaugh, James D. Hosking (JSA Sup 15: 43)

    Cost Methodology of COMBINE

    Gary A. Zarkin, Jeremy W. Bray, Debanjali Mitra, Ron A. Cisler, Daniel R. Kivlahan (JSA Sup 15: 50)

    COMBINE Genetics Study: The Pharmacogenetics of Alcoholism Treatment Response: Genes and Mechanisms

    David Goldman, Gabor Oroszi, Stephanie O'Malley, Raymond Anton (JSA Sup 15: 56)

    Section 3: Implementing and Monitoring Multisite Randomized Clinical Trials Combining Medications and Psychotherapy

    Carrie L. Randall (JSA Sup 15: 65)

    How Pilot Studies Improve Large-Scale Clinical Trials: Lessons Learned from the COMBINE Study

    Stephanie S. O'Malley, Daniel J. Martin, James D. Hosking, Barbara J. Mason (JSA Sup 15: 66)

    Recruiting and Retaining Participants in a Combined Behavioral and Pharmacological Clinical Trial

    Allen Zweben, David Barrett, Lisa Berger, Kelly Tobin Murray (JSA Sup 15: 72)

    Coordinating and Monitoring Multisite Clinical Trials that Combine Pharmacological and Behavioral Treatments

    Marston E. Youngblood, Kelly T. Murray, Eric Devine, Patricia K. Latham, Sandra Hubatch (JSA Sup 15: 82)

    Section 4: Assessment in Combined Pharmacotherapy and Behavior Therapy Trials of Alcoholism Treatment: Issues and Domains

    Dennis Donovan (JSA Sup 15: 92)

    Developing a Baseline Assessment Battery: Balancing Patient Time Burden with Essential Clinical and Research Monitoring

    David R. Gastfriend, Dennis Donovan, Rachel Lefebvre, Kelly T. Murray (JSA Sup 15: 94)

    Measurement and Choice of Drinking Outcome Variables in the COMBINE Study

    Raymond F. Anton, Carrie L. Randall (JSA Sup 15: 104)

    Assessing Nondrinking Outcomes in Combined Pharmacotherapy and Psychotherapy Clinical Trials for the Treatment of Alcohol Dependence

    Ron A. Cisler, Daniel R. Kivlahan, Dennis Donovan, Margaret E. Mattson (JSA Sup 15: 110)

    Quality of Life as an Outcome Measure in Alcoholism Treatment Research

    Dennis Donovan, Margaret E. Mattson, Ron A. Cisler, Richard Longabaugh, Allen Zweben (JSA Sup 15: 119)

    Section 5: Pharmacological Treatment Selection, Preparation and Monitoring Safety and Compliance

    Robert Swift (JSA Sup 15: 140)

    Choosing Pharmacotherapies for the COMBINE Study— Process and Procedures: An Investigational Approach to Combination Pharmacotherapy for the Treatment of Alcohol Dependence

    Robert Swift, Helen M. Pettinati (JSA Sup 15: 141)

    Rationale for Combining Acamprosate and Naltrexone for Treating Alcohol Dependence

    Barbara J. Mason (JSA Sup 15: 148)

    The COMBINE SAFTEE: A Structured Instrument for Collecting Adverse Events Adapted for Clinical Studies in the Alcoholism Field

    Bankole A. Johnson, Nassima Ait-Daoud, John D. Roache (JSA Sup 15: 157)

    Section 6: Behavioral Interventions

    Richard Longabaugh (JSA Sup 15: 168)

    A Structured Approach to Medical Management: A Psychosocial Intervention to Support Pharmacotherapy in the Treatment of Alcohol Dependence

    Helen M. Pettinati, Roger D. Weiss, William Dundon, William R. Miller, Dennis Donovan, Denise B. Ernst, Bruce J. Rounsaville (JSA Sup 15: 170)

    Origins, Issues and Options in the Development of the Combined Behavioral Intervention

    Richard Longabaugh, Allen Zweben, Joseph S. LoCastro, William R. Miller (JSA Sup 15: 179)

    Training, Supervision and Quality Monitoring of the COMBINE Study Behavioral Interventions

    William R. Miller, Theresa B. Moyers, Lisa Arciniega, Denise Ernst, Alyssa Forcehimes (JSA Sup 15: 188)

    INDEX

    (JSA Sup 15: 197)



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