Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Heavy Drinking, HIV, Alcohol Dependence
In brief
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.
Key facts
- Study ID
- NCT01764685
- Run by
- University of Pennsylvania
- People needed
- 4
- Starts
- 2013-01-01
- Expected to finish
- 2014-01-01
- Last updated by the study team
- 2016-03-15
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Pennsylvania Treatment Research Center — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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