A Randomized, Double-blind Placebo-Controlled Pharmacogenetic Study of Topiramate in European-American Heavy Drinkers
Status:
Completed
Trial end date:
2020-02-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to advance the effort to develop personalized pharmacotherapy
for alcohol use disorders (AUDs). The investigators propose to conduct a 12-week,
prospective, randomized clinical trial of the moderating effect of rs2832407 on the efficacy
of TOP in reducing heavy drinking (HD) in 200 individuals of European descent with DSM-5 AUD.
The investigators will stratify the randomization on genotype and oversample rs2832407*C
homozygotes, the most TOP-responsive genotype, to ensure comparable numbers of patients in
the four medication x genotype groups. The investigators will use daily data collection to
examine changes in relevant process variables (e.g., alcohol expectancies) and their
interaction with genotype and medication group as predictors of HD. The proposed study is
innovative in that it will be the first prospective test of a pharmacogenetic hypothesis
involving TOP; it will use daily reports to examine expectancies and how they interact with
medication and genotype to predict HD; and it will enroll DSM-5 AUD patients whose goal is
either to reduce or stop drinking, which will increase the study's external validity.
Phase:
Phase 2
Details
Lead Sponsor:
University of Pennsylvania
Collaborators:
Corporal Michael J. Crescenz VA Medical Center Department of Health and Human Services National Institute on Alcohol Abuse and Alcoholism (NIAAA) National Institutes of Health (NIH)