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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03176953
The ClinicalTrials.gov registry entry for NCT03176953 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT03176953 reports 0 study locations.
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.
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