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NCT00626925 · ClinicalTrials.gov registry record · Phase 4
Topiramate Treatment of Problem Drinkers
A Phase 4 study, sponsored by UConn Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
NCT00626925: Completed Phase 4 study, sponsored by UConn Health.
NCT00626925 is a Phase 4 study that has completed, run by UConn Health. The registered enrollment target is 200 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00626925, a Phase 4 study, has completed, sponsored by UConn Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of topiramate in reducing drinking and heavy drinking frequency in problem drinkers. We hypothesize that at a dosage of up to 200mg/day, topiramate will be well tolerated in this patient population and that, compared to placebo treatment, topiramate will result in a greater reduction in the frequency of both drinking days and heavy drinking days.
Primary Outcome
Change in the number of heavy drinking days during treatment phase of study. Drinking data were aggregated to the weekly level. The number of days per week of heavy drinking (i.e., four or more drinks in a day for women and five or more drinks in a day for men) and of abstinence were the primary outcomes.
Interventions
- DRUG placebo
- DRUG topiramate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2008-02 |
| Est. Completion | 2013-11 |
| Phase | Phase 4 |
What the finished NCT00626925 record still lists
NCT00626925 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00626925 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00626925 about?
NCT00626925 is a clinical study titled "Topiramate Treatment of Problem Drinkers". The purpose of this study is to evaluate the safety and efficacy of topiramate in reducing drinking and heavy drinking frequency in problem drinkers. We hypothesize that at a dosage of up to 200mg/day, topiramate will be well tolerated in this patient population and that, compared to placebo treatme...
What is the current status of trial NCT00626925?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2008-02. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00626925?
The interventions under investigation include: placebo (DRUG), topiramate (DRUG).
Who is sponsoring clinical trial NCT00626925?
This trial is sponsored by UConn Health, which has 178 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00626925's enrollment target sits among peer trials
200 407th of 2000 higher than 1,556 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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