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NCT01764685 · ClinicalTrials.gov registry record · Phase 2
Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers
A Phase 2 study, sponsored by University of Pennsylvania.
- Terminated
- Registry status
- Phase 2
- Development phase
- 4
- Enrollment target
NCT01764685: Clinical Trial Phase 2 study, sponsored by University of Pennsylvania.
NCT01764685 is a Phase 2 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01764685, a Phase 2 study, was terminated before completion, sponsored by University of Pennsylvania.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
Total number of heavy drinking days (\>4 drinks for men; \>3 drinks for women) for the placebo + medical management group during the study period. No data analysis will be done due to the small sample size and fact that all subjects received placebo study medication.
Interventions
- DRUG Placebo
- BEHAVIORAL Medical Management
- DRUG Topiramate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
Why NCT01764685 stopped before completion
NCT01764685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01764685 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01764685 about?
NCT01764685 is a clinical study titled "Topiramate to Reduce Heavy Drinking in HIV-Positive Heavy Drinkers". 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 improv...
What is the current status of trial NCT01764685?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2013-01. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01764685?
The interventions under investigation include: Placebo (DRUG), Medical Management (BEHAVIORAL), Topiramate (DRUG).
Who is sponsoring clinical trial NCT01764685?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01764685's enrollment target sits among peer trials
4 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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