Journal of Studies on

Alcohol

SUPPLEMENT NO. 15
July 2005


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Overview (Pettinati, H.M., Zweben, A. and Mattson, M.E.)

5

Section 1: Conceptual and Methodological Foundations
of COMBINE (Mattson, M.E.)

6
MATTSON, M.E. AND LITTEN, R.Z. Combining Treatments for Alcoholism: Why
and How?   Abstract

8
MILLER, W.R., LOCASTRO, J.S., LONGABAUGH, R., O’MALLEY, S. AND ZWEBEN, A. When Worlds Collide: Blending the Divergent Traditions of
Pharmacotherapy and Psychotherapy Outcome Research   Abstract

17
COUPER, D.J., HOSKING, J.D., CISLER, R.A., GASTFRIEND, D.R. AND KIVLAHAN, D.R. Factorial Designs in Clinical Trials: Options for Combination Treatment Studies   Abstract

24
Section 2: Methodological Aspects of the Design of the COMBINE Study (Couper, D.J. and Anton, R.F.)

 33
HOSKING, J.D., CISLER, R.A., COUPER, D.J., GASTFRIEND, D.R., KIVLAHAN, D.R. AND ANTON, R.F. Design and Analysis of Trials of Combination Therapies   Abstract

34
WEISS, R.D., LOCASTRO, J.S., SWIFT, R., ZWEBEN, A., MILLER, W.R., LONGABAUGH, R. AND HOSKING, J.D. The Use of a “Psychotherapy with No Pills”
Treatment Condition as Part of a Combined Pharmacotherapy- Psychotherapy Research Study of Alcohol Dependence   Abstract

43
ZARKIN, G.A., BRAY, J.W., MITRA, D., CISLER, R.A. AND KIVLAHAN, D.R. Cost
Methodology of COMBINE

 50
GOLDMAN, D., OROSZI, G., O’MALLEY, S. AND ANTON, R. COMBINE Genetics
Study: The Pharmacogenetics of Alcoholism Treatment Response: Genes
and Mechanisms

 56
Section 3: Implementing and Monitoring Multisite Randomized Clinical Trials Combining Medications and Psychotherapy (Randall, C.L.)

 65
O’MALLEY, S.S., MARTIN, D.J., HOSKING, J.D. AND MASON, B.J. How Pilot
Studies Improve Large-Scale Clinical Trials: Lessons Learned from the COMBINE Study

 66
ZWEBEN, A., BARRETT, D., BERGER, L. AND MURRAY, K.T. Recruiting and
Retaining Participants in a Combined Behavioral and Pharmacological Clinical Trial

 72
YOUNGBLOOD, M.E., MURRAY, K.T., DEVINE, E., LATHAM, P.K., AND HUBATCH, S. Coordinating and Monitoring Multisite Clinical Trials that Combine
Pharmacological and Behavioral Treatments

 82
Section 4: Assessment in Combined Pharmacotherapy and Behavior Therapy Trials of Alcoholism Treatment: Issues and Domains (Donovan, D.)

 92
GASTFRIEND, D.R., DONOVAN, D., LEFEBVRE, R. AND MURRAY, K.T. Developing a Baseline Assessment Battery: Balancing Patient Time Burden with
Essential Clinical and Research Monitoring

 94
ANTON, R.F. AND RANDALL, C.L. Measurement and Choice of Drinking
Outcome Variables in the COMBINE Study

 104
CISLER, R.A., KIVLAHAN, D.R., DONOVAN, D. AND MATTSON, M.E. Assessing
Nondrinking Outcomes in Combined Pharmacotherapy and Psychotherapy Clinical Trials for the Treatment of Alcohol Dependence

 110
DONOVAN, D., MATTSON, M.E., CISLER, R.A., LONGABAUGH, R. AND ZWEBEN, A. Quality of Life as an Outcome Measure in Alcoholism Treatment
Research

 119
Section 5: Pharmacological Treatment Selection, Preparation and Monitoring Safety and Compliance (Swift, R.)

 140
SWIFT, R. AND PETTINATI, H.M. Choosing Pharmacotherapies for the COMBINE Study—Process and Procedures: An Investigational Approach to Combination Pharmacotherapy for the Treatment of Alcohol Dependence

 141
MASON, B.J. Rationale for Combining Acamprosate and Naltrexone for Treating Alcohol Dependence

 148
JOHNSON, B.A., AIT-DAOUD, N. AND ROACHE, J.D. The COMBINE SAFTEE: A
Structured Instrument for Collecting Adverse Events Adapted for Clinical Studies in the Alcoholism Field

 157
Section 6: Behavioral Interventions (Longabaugh, R.)

 168
PETTINATI, H.M., WEISS, R.D., DUNDON, W., MILLER, W.R., DONOVAN, D., ERNST, D.B. AND ROUNSAVILLE, B.J. A Structured Approach to Medical Management: A Psychosocial Intervention to Support Pharmacotherapy in the Treatment of Alcohol Dependence

 170
LONGABAUGH, R., ZWEBEN, A., LOCASTRO, J.S. AND MILLER, W.R. Origins,
Issues and Options in the Development of the Combined Behavioral Intervention

 179
MILLER, W.R., MOYERS, T.B., ARCINIEGA, L. ERNST, D. AND FORCEHIMES, A.
Training, Supervision and Quality Monitoring of the COMBINE Study Behavioral Interventions

188