A Phase 4 interventional study of naltrexone (Revia) and cognitive behavior therapy in Alcoholism and Alcohol Dependence, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-10-04.
Sponsored by Medical University of South Carolina · Phase 4, Interventional, and Treatment
This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four groups along with measures of alcohol craving, biological measures of alcohol consumption, drinking consequences, changes in self-confidence for avoiding alcohol, and medication compliance. All study participants will be assessed for measures of outcome variables at 3 and 6 months after completing the treatment protocol.
1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 160 is above the median of 88 across 1,395 interventional studies indexed under Alcoholism.
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Studies of the drug tested here: Naltrexone
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