Clinical Trial

Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD

Recruiting Phase 2
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Record status
This record was last updated April 1, 2025 (before its estimated August 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2018-09-10; most recent amendment 2025-03-31.
Status change: Not Yet Recruiting → Recruiting 2019-11-15
Trial Details
NCT Number NCT03667846
Lead Sponsor NYU Langone Health
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions Post Traumatic Stress Disorder, Alcohol Use Disorder
Enrollment 150 participants
Start Date 2019-10-10
Primary Completion 2025-08-31 (estimated)
Study Completion 2025-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-04-01