A Randomized, Double-blind Placebo-Controlled Pharmacogenetic Study of Topiramate in European-American Heavy Drinkers

PHASE2CompletedINTERVENTIONAL
Enrollment

320

Participants

Timeline

Start Date

December 18, 2014

Primary Completion Date

February 29, 2020

Study Completion Date

February 29, 2020

Conditions
AlcoholismAlcohol Use Disorder (AUD)
Interventions
DRUG

Topiramate

Max therapeutic dose of 200mg/day

BEHAVIORAL

Medical Management

Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The subject is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the subject's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 3 drinks 4 times per week; women will be advised to consume no more than 2 drinks 4 times per week.

DRUG

Inactive Placebo

In capsules indistinguishable from topiramate capsules and gradually increased to a maximum equivalent of 200 mg of topiramate/day

Trial Locations (2)

19104

Corporal Michael J. Crescenz VA Medical Center, Philadelphia

University of Pennsylvania Treatment Research Center, Philadelphia

All Listed Sponsors
collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

collaborator

National Institutes of Health (NIH)

NIH

collaborator

Department of Health and Human Services

FED

collaborator

Corporal Michael J. Crescenz VA Medical Center

FED

lead

University of Pennsylvania

OTHER

NCT02371889 - A Randomized, Double-blind Placebo-Controlled Pharmacogenetic Study of Topiramate in European-American Heavy Drinkers | Biotech Hunter | Biotech Hunter