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NCT03176953 · ClinicalTrials.gov registry record · Phase 2
Topiramate and Prolonged Exposure
A Phase 2 study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT03176953: Completed Phase 2 study, sponsored by VA Office of Research and Development.
NCT03176953 is a Phase 2 study that has completed, run by VA Office of Research and Development. The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03176953, a Phase 2 study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) frequently co-occur, and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. The most effective PTSD treatment, prolonged exposure (PE) is sometimes less effective when individuals also have AUD. Anti-relapse medication appears promising to improve the effectiveness of PE to help individuals reduce alcohol use and PTSD symptoms and improve functioning. This study compares PE with and without topiramate, a medication shown to both reduce drinking and PTSD symptoms, with the hypothesis that combined PE and topiramate will be more effective than PE and placebo. The aim of this grant is to improve treatment outcomes for Veterans with AUD and PTSD.
Primary Outcome
PTSD symptom diagnostic interview CAPS-5 score range = 0 - 80 Higher scores = more severe PTSD symptoms
Interventions
- DRUG placebo
- DRUG topiramate
- BEHAVIORAL prolonged exposure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2017-11-01 |
| Est. Completion | 2023-09-30 |
| Phase | Phase 2 |
What the finished NCT03176953 record still lists
NCT03176953 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT03176953 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03176953 about?
NCT03176953 is a clinical study titled "Topiramate and Prolonged Exposure". Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) frequently co-occur, and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. The most effective PTSD treatment, prolonged exposure (PE) is sometimes less effect...
What is the current status of trial NCT03176953?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2017-11-01. Estimated completion is 2023-09-30.
What interventions are being tested in trial NCT03176953?
The interventions under investigation include: placebo (DRUG), topiramate (DRUG), prolonged exposure (BEHAVIORAL).
Who is sponsoring clinical trial NCT03176953?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03176953's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 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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