The COMBINE Study (often times referred to as COMBINE) is the largest pharmacotherapy trial conducted for alcoholism in the United States, recruiting 1383 alcohol dependent patients, 31% women and 23% ethnic minorities, from 11 sites. This double-blind, randomized placebo-controlled trial evaluated the efficacy of naltrexone and acamprosate, both alone and in combination, in the context of medical management with and without Combined Behavioral Intervention (CBI). CBI is a therapy that integrates aspects of cognitive behavioral therapy, motivational interviewing and 12-step facilitation. The duration of treatment was four months with follow-ups for one year post treatment. There were nine groups including a CBI only group with no pills and no medical management. The main findings were published in JAMA 295:2003-2017, 2006. Other articles either published, or in press, can be found at the COMBINE Study website as indicated below. Individuals requesting the data set for specific analyses are urged to view the website to better understand what has been previously published.
The data set was prepared by staff of the trial’s CoordinatingCenter at the University of North Carolina and reviewed by CSR Incorporated. The project’s website, www.cscc.unc.edu/combine, will carry the most recent information regarding the data set, a list of publications, and other information concerning the trial. > > > > Read More