Advances in the neurobiology of alcoholism have led to the investigation of medications or its treatment. Simultaneously, investigation of psychosocial interventions utilizing sound scientific clinical trial methodologies have occurred. The intersection of these events has led to the examination of alcoholism treatments which combine psychosocial treatment with phamacotherapy. Currently our group is evaluating the efficacy of the opiate antagonist medication naltrexone combined with 12 weekly sessions of Cognitive Behavioral Therapy (CBT) for outpatient alcoholics. This treatment shows evidence of high rates of completion and compliance. This continuation proposal will compare CET (12 sessions) with a more time limited (4 sessions) Motivational Enhancement Therapy to which naltrexone 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 or placebo over a 12 week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four group along with measures of alcohol craving, biological measures of alcohol consumption (CDT and GGT), drinking consequences, changes in self-efficacy for avoiding alcohol, and medication compliance (urinary riboflavin maker). All study participants will be assessed at 3 and 6 months after completing the treatment protocol utilizing the same outcome variables. Therapy will be provided by trained therapists according to manuals produced during Project MATCH, the large multi-site psychotherapy study in which our center participated. Quality control of therapy will be achieved by direct supervision and rating of random therapy tapes. State-of-the-art alcohol and craving assessment instruments, biologic markers, and compliance measures will be utilized to assess outcome to treatment. Results of this trial should allow evaluation of whether less intense, and potentially less costly, therapies with good patient acceptance could, when combined with efficacious medication, have equivalent results with a proven more intensive and skill requiring approach. As such, these results will provide data regarding the types of treatment likely to benefit outpatient alcoholics when applied in other health care settings where issues of clinical acceptability and cost might be consideration.
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