The COMBINE Study-: An Overview of the Largest Pharmacotherapy Study to Date for Treating Alcohol Dependence.

36 T reatment for alcohol dependence in the 21st century has the option of adding pharmacotherapy to traditional treatment approaches, which have primarily included drug and alcohol counseling, newer specialized behavioral therapies, and support groups. While alcohol treatment outcomes with counseling or behavioral treatments are better than what most people think, relapse rates remain unacceptably high given the devastation caused by the illness. The growing knowledge of alcohol’s neurobiological effects on the brain has led to both the development of promising pharmacotherapies that can be added to counseling in treating alcohol disorders and a series of controlled trials to evaluate the impact of combining medications with counseling or behavioral treatments. Currently, there are four medications that have been approved by the Food and Drug Administration (FDA) for use in treating alcohol dependence: Disulfiram (Antabuse), oral naltrexone (Revia), acamprosate (Campral), and an intramuscular (IM) once-a-month naltrexone injection (Vivitrol). [For a summary of these medications, see the brief report in the May issue of Psychiatry 2006.] In the May 3, 2006, issue of the Journal of the American Medical Association, Anton and colleagues reported results from the largest known controlled pharmacotherapy clinical trial for treating alcohol dependence, i.e., the COMBINE study, which was supported by the National Institute on Alcohol Abuse and Alcoholism. This study evaluated the efficacy of specific pharmacotherapies, behavioral or psychosocial interventions, and their combinations for the treatment of alcohol dependence. The COMBINE study evaluated treatment response to novel medication and psychosocial treatment combinations for 1,383 alcohol-dependent, treatmentseeking patients from 11 US sites. What follows is a brief summary of the design and results of the COMBINE study. Detailed information on the study’s conceptual, methodological, and practical issues are available in a supplement to the Journal of Studies on Alcohol. In the COMBINE study, alcoholdependent patients were randomly assigned for four months to Brief Report