Tuesday, April 23, 2024
4/23/2024
Project Summary Despite substantial advances in the development of pharmacological and behavioral interventions, alcohol use disorder continues to be a significant public health problem in the United States, and significant gaps in the treatment armamentarium remain. Conceptually, the ideal pharmacotherapy for alcohol use disorder would be safe when administered to actively drinking patients, provide protection against mild-to- moderate alcohol withdrawal, and promote reductions in alcohol intake. No current pharmacotherapy for alcohol use disorder meets these criteria and thus represents an important unmet public health need. Pregabalin is a gabapentinoid with limited evidence of efficacy in treating the symptoms of alcohol withdrawal, as well as limited evidence of efficacy as a relapse prevention agent. A pilot study (n=15) conducted by our research group found pregabalin in doses up to 600 mg daily to be a safe, feasible, and generally well tolerated treatment for alcohol use disorder. The proposed study aims to build on these results and evaluate gabapentin as a potential antidipsotropic agent for alcohol use disorder. Pregabalin has proven to be a well- tolerated medication with a low abuse liability, thereby making it ideal for use in the outpatient setting. The proposed pilot project is to study the effects of pregabalin on the participants’ harmful drinking behavior in actively drinking outpatients with alcohol use disorder. Participants will be actively drinking alcohol at study entry, and the change in use pattern from baseline is measured throughout the study period. The specific aim is to determine if pregabalin treatment will significantly reduce harmful alcohol consumption as compared to placebo. The primary outcome measure will be the proportion of the heavy drinking days (defined as any day where the number of standard drinks was at least 5 for men and at least 4 for women) per week as measured by the timeline followback method. The proposed project is an 8-week randomized double-blind placebo- controlled pilot trial to evaluate the efficacy of pregabalin in the treatment of alcohol use disorder in 50 outpatients. All participants will receive weekly supportive behavioral treatment that promotes reductions in alcohol use, encourages 12-step meeting attendance, and facilitates compliance with study medication. The proposed research project would be the first study of pregabalin as a treatment for actively drinking outpatients, which would be of great clinical utility if proven to be effective.
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