Topiramate Treatment of Alcohol Use Disorders in African Americans

Recruiting at 1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: VA Office of Research and Development

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial aims to test the effectiveness of topiramate in reducing heavy drinking among African American Veterans with alcohol problems. African American Veterans are targeted because they face higher death rates from alcohol-related issues. Topiramate helps by reducing the desire to drink and making alcohol less enjoyable, potentially leading to fewer heavy drinking days and more days without drinking. Topiramate has been shown to reduce drinking and heavy drinking in individuals with alcohol dependence.

Research Team

David W. Oslin, MD

Principal Investigator

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Eligibility Criteria

Inclusion Criteria

self-identification as African American;

age 18 to 70 years, inclusive;

average weekly ethanol consumption of >24 standard drinks for men or >18 standard drinks for women, with a weekly average of > 2 heavy drinking days (men: > 5 standard drinks; women: > 4 standard drinks) during the month before screening;

Treatment Details

Interventions

• Placebo (Behavioural Intervention)
• Topiramate (Anti-epileptic drug)

Participant Groups

Group I: Topiramate Experimental Treatment 1 Intervention

Topiramate an FDA approved anticonvulsant has been shown effective in the treatment of alcohol use disorder but there is no data supporting use in minority patients. The medication was dosed orally twice per day with a starting dose of 25 mg, increasing the dose as tolerated to 200mg daily in divided doses. Patient were titrated to the highest dose tolerable.

Group II: Placebo Placebo Group 1 Intervention

a placebo control arm

Topiramate is already approved in Canada, Japan for the following indications:

Approved in Canada as Topamax for:

• Epilepsy
• Migraine prophylaxis

Approved in Japan as Topamax for:

• Epilepsy

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+