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NCT01087736 · ClinicalTrials.gov registry record · Phase 4
Topiramate Treatment of Alcohol Use Disorders in Veterans With Post Traumatic Stress Disorder (PTSD): A Pilot Controlled Trial of Augmentation Therapy
A Phase 4 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT01087736: Completed Phase 4 study, sponsored by University of California, San Francisco.
NCT01087736 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01087736, a Phase 4 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
The proposed project aims to: 1. Obtain a preliminary assessment of the efficacy of topiramate treatment in reducing alcohol use in veterans with Post Traumatic Stress Disorder (PTSD) and alcohol dependence; 2. Obtain preliminary assessments of safety/tolerability of topiramate in these patients; 3. Assess the feasibility of recruitment and retention for topiramate treatment in this comorbid population; and 4) to inform the design of a planned subsequent larger controlled trial of topiramate. PRIMARY HYPOTHESIS: Topiramate treatment combined with Medical Management alcohol counseling will be associated with a significant decrease in percent drinking days from baseline to end of treatment. SECONDARY HYPOTHESIS: There will be significantly less percent drinking days in the topiramate treatment group compared to the placebo group.
Primary Outcome
Alcohol consumption was assessed at baseline and weekly during the treatment phase (12 weeks) using the Time Line Follow Back (TLFB) interview which yields number of days of alcohol use (DD). DD: day on which alcohol was consumed Standard alcoholic drink defined as containing 13.6 g of pure alcohol.
Interventions
- DRUG Topiramate
- OTHER Placebo administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2010-04 |
| Est. Completion | 2013-12 |
| Phase | Phase 4 |
What the finished NCT01087736 record still lists
NCT01087736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Topiramate is the first listed.
NCT01087736 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01087736 about?
NCT01087736 is a clinical study titled "Topiramate Treatment of Alcohol Use Disorders in Veterans With Post Traumatic Stress Disorder (PTSD): A Pilot Controlled Trial of Augmentation Therapy". The proposed project aims to: 1. Obtain a preliminary assessment of the efficacy of topiramate treatment in reducing alcohol use in veterans with Post Traumatic Stress Disorder (PTSD) and alcohol dependence; 2. Obtain preliminary assessments of safety/tolerability of topiramate in these patients; 3...
What is the current status of trial NCT01087736?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2010-04. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01087736?
The interventions under investigation include: Topiramate (DRUG), Placebo administration (OTHER).
Who is sponsoring clinical trial NCT01087736?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01087736's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 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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