Efficacy and Safety of Baclofen for Alcohol Dependence

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DESCRIPTION (provided by applicant): The more than $100 billon annual cost of alcohol dependence in lost productivity and alcohol-related criminal activities, injuries, accidents, and diseases underscores the need to provide effective treatments for alcohol disorders. Testing novel pharmacologic agents represents an especially important strategy for alcohol treatment, given the small number and limited effectiveness of existing medications . Recently, the GABAB receptor agonist baclofen has drawn attention because preclinical pharmacologic and behavioral data indicate that it modifies neurobiological factors contributing to alcohol consumption. Moreover, pilot clinical trials have been positive. To determine whether baclofen is, indeed, a promising pharmacotherapeutic agent for alcohol dependence, it is important to expand the clinical trial database using randomized, double-blind, placebo-controlled methods. Assessment of the tolerability of baclofen in alcohol-dependent individuals is also important. The proposed study will gather data toward both of these goals and will represent the first placebo-controlled trial of baclofen for alcohol dependence in the United States. The study will explore the efficacy and tolerability of a 12-week regimen of 30 mg/d baclofen in conjunction with behavioral therapy for reducing heavy drinking in alcohol-dependent individuals. Several studies also have found that baclofen reduces self-reported anxiety and craving; thus, the proposed study will assess baclofen's ability to reduce these symptoms as well.