# Topiramate Treatment of Alcohol Use Disorder in African Americans

> **NIH VA I01** · PHILADELPHIA VA MEDICAL CENTER · 2020 · —

## Abstract

1. Objective(s): Despite having lower rates of drinking and heavy drinking than
European Americans (EAs), African Americans (AA) have significantly higher
rates of mortality from a variety of alcohol-related conditions, including liver
cirrhosis, accidents, and violence. The current proposal aims to improve alcohol
treatment in AA Veterans, who comprise 12% of the Veteran population.
2. Research Design: The proposed study is a two-arm, randomized 12-week,
parallel-groups comparison of topiramate versus placebo to reduce the frequency
of heavy drinking days and increase the number of abstinent days in 160 AA
patients with AUD.
3. Methodology: The following specific aim is used to direct the methods:
Specific Aim 1. To test the efficacy of topiramate (TOP) 200 mg/day in reducing
the frequency of heavy drinking and increasing abstinent days in African-
American (AA) patients with alcohol use disorder (AUD). We hypothesize that,
as in European-Americans (EAs), AA subjects receiving TOP will report fewer
heavy drinking days (HDDs) and more abstinent days than those receiving
placebo (PLA).
The analyses make use of all data provided by all patients to estimate models to
test the TOP effect on days of heavy drinking and abstinent days. Power for the
contrasts will be determined by the patterns of outcomes in the final six weeks,
so power estimates are based on weeks 7 through 12 as a 6-week trial, with
adjustments for loss to attrition between baseline and week 6. Based on our
prior study (Kranzler 2014), we anticipate 92% retention through the first six
weeks for each group, yielding 74 available per group at the end of week 6, an
additional 4% loss due to dropout across the final six weeks, and a within-subject
correlation of about 0.6. The methods of Hedeker et al (1999) show that we will
have 80% power for a TOP main effect size of d=0.40, 0.43, and 0.46, for within-
subject correlations of 0.5, 0.6, and 0.7, respectively, at a corrected alpha level of
0.025.
4. Impact/Significance: The proposal is innovative in that it will focus on AAs
with AUD, an understudied and underserved population for whom no such data
currently exist. Given the far-reaching effects of AUD and its high prevalence
among veterans, added evidence based treatments may realize reduced health
care costs from unnecessary ED visits and reduced complications of illnesses
such as hepatitis C and congestive heart failure.

## Key facts

- **NIH application ID:** 9974484
- **Project number:** 5I01CX001507-04
- **Recipient organization:** PHILADELPHIA VA MEDICAL CENTER
- **Principal Investigator:** DAVID W. OSLIN
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2020
- **Award amount:** —
- **Award type:** 5
- **Project period:** 2017-07-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9974484

## Citation

> US National Institutes of Health, RePORTER application 9974484, Topiramate Treatment of Alcohol Use Disorder in African Americans (5I01CX001507-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9974484. Licensed CC0.

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