Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers

• Status: Terminated
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Seropositive for HIV

• Age 18-70

• Report average of at least twice weekly heavy drinking

• Willing to reduce drinking to non-hazardous levels

• Verbal Intelligence Quotient (Verbal IQ) of 80 or higher

• Willing to provide signed informed consent

• Willing to nominate an individual to help locate the participant's whereabouts for follow-up

• If female: non-lactating and practicing a reliable method of birth control

Exclusion Criteria:

• Current clinically significant and/or uncontrolled physical disease (e.g., pancreatitis, diabetes)

• History of nephrolithiasis

• Severe psychiatric illness (i.e., psychosis or mania)

• Current diagnosis of drug abuse or dependence (other than nicotine abuse/dependence and cannabis abuse)

• Current diagnosis of alcohol dependence (AD) too severe for participation in a trial in which the goal is reduced drinking

• Gross cognitive impairment

• Glaucoma

• Serious/confounding neurological disease (e.g, stroke, seizure)

• Pregnancy