Experience gained conducting numerous clinical trials with alcoholics has provided the infrastructure and knowledge for us to address novel treatments in a scientifically vigorous manner. In particular, we have found naltrexone to be efficacious when combined with cognitive behavioral therapy (CBT) and are currently investigating its efficacy when combined with either CBT or motivational enhancement therapy. In both studies, comprising over 250 individuals, most relapse occurs during early treatment (during the first six weeks) during which individuals complain of sleep difficulty, irritability and nervousness. These symptoms are indicative of brain dysregulation and may be related to """"""""protracted alcohol withdrawal"""""""". Gabapentin, a safe and effective FDA approved antiseizure compound used in millions of individuals worldwide, can reduce glutamate and increase GABA neurotransmission in the brain. This unique pharmacology is well suited to the treatment of alcohol withdrawal and could normalize the brain dysregulation seen during the early abstinence period. A number of pre-clinical and clinical studies at our Center have indicated that it can reduce alcohol withdrawal symptoms, reduce drinking in dependent animals, and is safe to use in the clinic. We purpose a randomized double blind clinical trial, to evaluate the adjunctive use of gabapentin with naltrexone for the treatment of alcohol dependent individuals using a three group (placebo alone, placebo plus naltrexone, gabapentin plus naltrexone) design. Gabapentin or placebo will be added to naltrexone for the first six weeks of treatment (the time of greatest relapse and of potential 'protracted withdrawal"""""""" symptoms). Naltrexone and/or placebo treatment will last 16 weeks and all subjects will receive Combined Behavioral Intervention as developed for the COMBINE study (in which we are participating). It is predicted that alcoholics receiving naltrexone and adjunctive gabapentin will have less relapse than those treated with naltrexone alone. Measures of mood, sleep, irritability, and anxiety will be compared between treatment groups. Evaluations occur during treatment and 12 weeks and 24 weeks post-treatment. This evaluation of a novel treatment will allow us to better understand combined pharmacotherapy and develop a new paradigm for medications development for alcoholism.
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