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NCT03667846 · ClinicalTrials.gov registry record · Phase 2
Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD
A Phase 2 study of Post Traumatic Stress Disorder and Alcohol Use Disorder, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT03667846: Recruiting Phase 2 study of Post Traumatic Stress Disorder and Alcohol Use Disorder, sponsored by NYU Langone Health.
NCT03667846 is a Phase 2 study of Post Traumatic Stress Disorder and Alcohol Use Disorder that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 150 participants, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03667846, a Phase 2 study of Post Traumatic Stress Disorder and Alcohol Use Disorder, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a double-blind, 2-group randomized controlled trial evaluating the effects of topiramate versus placebo in patients with comorbid PTSD and moderate-to-severe AUD. This trial will provide one of the first rigorous tests of whether the effects of topiramate in AUD generalize to patients with co-occurring PTSD, and one of the first rigorous tests of whether topiramate has beneficial effects on PTSD symptoms in this population. It will be the first study to test whether the rs2832407 genotype predicts clinical response to topiramate for AUD and PTSD in patients with both disorders. Further, it will contribute to the understanding of topiramate's mechanisms of action in the co-morbid AUD/PTSD population, and to the discovery of predictors of treatment response.
Primary Outcome
Retrospective estimate of daily alcohol consumption over a time period ranging from 7 days to 24 months prior to initial interview
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Topiramate
Study Locations (1)
New York
- New York University School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2019-10-10 |
| Est. Completion | 2025-08-31 |
| Phase | Phase 2 |
What NCT03667846 shows while recruiting
NCT03667846 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 663-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03667846 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03667846 about?
NCT03667846 is a clinical study titled "Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD". This is a double-blind, 2-group randomized controlled trial evaluating the effects of topiramate versus placebo in patients with comorbid PTSD and moderate-to-severe AUD. This trial will provide one of the first rigorous tests of whether the effects of topiramate in AUD generalize to patients with c...
What is the current status of trial NCT03667846?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2019-10-10. Estimated completion is 2025-08-31.
What conditions does trial NCT03667846 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder, Alcohol Use Disorder.
What interventions are being tested in trial NCT03667846?
The interventions under investigation include: Placebo (OTHER), Topiramate (DRUG).
Who is sponsoring clinical trial NCT03667846?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03667846 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post Traumatic Stress Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03667846's enrollment target sits among peer trials
150 77th of 262 higher than 184 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder 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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