Current treatments for alcoholism both pharmacological and psychological, help some but not all patients. As a result, the potential efficacy of combined behavioral and pharmacological treatments should be evaluated. In response to RFA AA-97-004, this Clinical Research Unit application proposes to assess the efficacy of two promising pharmacotherapies, acamprosate and naltrexone, combined with a low intensity portable behavioral treatment designed to enhance medication compliance (Compliance Enhancement, CE) and a more intensive treatment designed to optimize outcome in which Compliance Enhancement and Cognitive Behavioral Coping Skills Therapy are combined (CE + CBT. In this eight cell design, 150 alcohol dependent subjects at 6-8 sites will be randomized to receive one of the two behavioral interventions and either placebo, acamprosate alone, naltrexone alone or combine treatment with acamprosate and naltrexone. Active treatment is provided for six months, partial responders are augmented with 50 mg of naltrexone after 10 weeks, and all subjects are followed for one year after treatment termination. In addition, a pilot study is proposed to address key aspects of the main study, including the safety and preliminary efficacy of combined acamprosate-naltrexone treatment compared to naltrexone alone. Seventy alcohol dependent subjects will be randomized to one of two groups in which they receive either acamprosate or placebo for 8 weeks. Subjects are given a """"""""quit date"""""""" seven days after initiation of acamprosate treatment, seven days later naltrexone treatment is begun and continued for the remainder of the study. Based on the hypothesis that acamprosate attenuates alcohol withdrawal and that naltrexone's side effects may be related to precipitated withdrawal, the secondary aims of the pilot are to examine the effect of pretreatment with acamprosate on alcohol withdrawal symptomatology following abstinence initiation and following an initial dose of naltrexone, and to evaluate whether beneficial effects of acamprosate co-treatment may be mediated by improved naltrexone compliance.
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