Gabapentin is a novel anticonvulsant drug that appears to act on both GABA and glutamate systems to reduce CNS excitability characteristic of early abstinence from alcohol. Clinical reports and controlled trials support the efficacy and safety of gabapentin treatment of depression, anxiety, insomnia and alcohol withdrawal. Acamprosate, another glutamate modulating drug, has been found to increase abstinence in controlled trials of alcohol dependence. Thus, a medication that is functionally similar to acamprosate, with efficacy for alcohol withdrawal and the negative affect and disturbances in sleep that are often associated with relapse, is of interest as a potential relapse-prevention medication in alcohol dependence. The primary aim of this study is to evaluate the safety and efficacy of gabapentin for prolonging abstinence and reducing drinking in recently abstinent outpatients with alcohol dependence. A 12-week, double-blind, placebo-controlled, dose-ranging study will be conducted with random assignment to gabapentin 900 mg/d, 1800 mg/d or placebo. Subjects will be 150 outpatients with alcohol dependence. The 3 pharmacological treatment conditions will be administered in conjunction with manual-guided behavioral counseling that incorporates strategies to increase motivation, abstinence, and medication compliance. Counseling and research assessments will occur weekly throughout the 12-week treatment phase. Post-treatment assessments will occur at Weeks 13, 24 and 36. It is hypothesized that administration of gabapentin will result in significantly: 1.) Greater rate of cumulative abstinence duration, 2.) Longer latency to first drink, and 3.) Less alcohol consumption on study than placebo, and will show a linear dose effect. Baseline measures of mood and sleep will be examined as potential predictors of treatment outcome. Results will provide key information about the efficacy and safety of gabapentin for relapse prevention during early abstinence in outpatients with alcohol dependence.
