A Randomized Pharmacogenetic Study of the Medication Topiramate in European-American Heavy Drinkers

Brief Description Of Study

This is a 12-week, prospective, randomized clinical trial of the moderating effect of the gene rs2832407 on the efficacy of the medication topiramate in reducing drinking in 200 individuals of European descent with DSM-5 AUD. The investigators will compare the efficacy of topiramate to placebo in reducing drinking.

Clinical Study Identifier: TX1089

Additional Information About The Study

The investigators will use daily data collection to examine changes in drinking and its relevant process variables and their interaction with genotype and medication group. At each visit, all subjects will receive Medication Management, which is brief counseling relevant for both reducing heavy drinking and promoting abstinence. Random assignment to treatment group and double-blind conditions will be maintained throughout the study. Following a one-week pre-treatment assessment period, subjects will receive 12 weeks of treatment, after which there will be a 6-day taper period, during which subjects will reduce their dosage of topiramate gradually and then discontinue it completely. There will be a screening visit, 10 regular study visits, and 2 follow-up visits at 3 and 6 months. Daily reports during the treatment period will be obtained using interactive voice response (IVR) to monitor drinking and medication use. Following the 12-week treatment period, subjects will be asked to return to the clinic for 3-month and 6-month post-treatment follow-up visits to evaluate the durability of treatment effects.

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