Naltrexone and acamprosate have shown efficacy as adjuncts to psychosocial/behavioral alcoholism treatments. A number of studies have suggested that time limited outpatient behavioral approaches may have similar efficacy to more intense and skill based therapies. A multisite study is proposed to compare the effectiveness of combining medications with therapies which differ in intensity and content. A primary main study and a pilot study are proposed in this application. In the primary study 240 alcohol dependent individuals, at our site, will be assigned to eight treatment cells formed by the combination of 4 medication (placebo, naltrexone, acamprosate, naltrexone plus acamprosate) and 2 behavioral (cognitive behavioral (CBT) and modified motivational enhancement [MET-light]) therapies. Subjects will receive behavioral therapy for 12 weeks and medication for 26 weeks and follow-up assessments will occur at 3, 6, 9 and 12 months post-therapy. Standard alcohol consumption instruments, biological markers, and collateral will be used. The measurement of medication compliance (riboflavin as a marker) will be emphasized. In the pilot study 40 alcohol dependent individuals will be assigned to four treatment cells formed by the combination of 2 medication (placebo or naltrexone plus acamprosate) and 2 behavioral (CBT or MET-light) treatments. Subjects will be assessed and treated as proposed for the primary study. However, half of the subjects will receive the medication packaged in blister packs and half in MEMS cap bottles to determine (based on riboflavin measurements) which method has better compliance monitoring capabilities. In addition, one of the subjects will receive """"""""booster therapy"""""""" at week 20 with retention and medication compliance evaluated in both groups. Patient satisfaction and adverse medication effects will also be evaluated between the two medication groups. If the primary study occurs at eight sites, a total of 1920 subjects (240/treatment cell) should provide enough power to detect medication versus placebo effects in both therapies.
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