Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers
Status:
Terminated
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
Heavy drinking (HD) is a risk factor for HIV transmission and is more common in HIV+
individuals than in the general population. HD adversely affects health directly and reduces
adherence to antiretroviral therapies (ARTs), in part due to alcohol-induced cognitive
impairment. Reduced drinking improves cognitive performance and adherence to ARTs.
Medications approved in the United States to treat alcohol dependence have a small effect
size. However, topiramate, FDA-approved as an anticonvulsant and a prophylaxis for migraine,
has a greater effect size in reducing drinking and promoting abstinence in alcohol dependent
individuals. To date, there are no studies of the effects of topiramate in HIV+ heavy
drinkers. The investigators propose to conduct a randomized, parallel-groups,
placebo-controlled, 11-week trial of topiramate in 40 HIV+ heavy drinkers who want to reduce
or stop their drinking. There are three primary hypotheses for this feasibility and
proof-of-concept study. First, the investigators hypothesize that topiramate-treated patients
will decrease the frequency of their HD more than placebo-treated patients. Second, based on
scores from computerized neurocognitive assessments, the investigators hypothesize that
topiramate and placebo groups will show similar performance on a battery of cognitive tests.
Third, based on self-reported medication adherence, the investigators hypothesize that
adherence to ARTs will be greater in the topiramate group than in the placebo group. These
findings will provide preliminary data to support a more definitive trial of topiramate for
the treatment of HD in HIV+ heavy drinkers.