Topiramate for Alcohol Use Disorder and PTSD

This study is testing if topiramate, an FDA-approved medication, can help people who have both alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD). We want to see if topiramate can reduce drinking and PTSD symptoms. You might be able to join if you are 18-70 years old, have a moderate to severe AUD diagnosis, want to cut down on drinking, and have had at least 4-5 heavy drinking days in the last month. We will compare topiramate to a placebo (a pill with no medicine). We will measure success by looking at how much you drink and your PTSD symptom scores after 9 to 12 weeks. The study is currently recruiting 150 participants, but its overall status is unclear.

Study design
This is a double-blind, randomized controlled trial comparing topiramate to a placebo. It plans to enroll 150 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 9 to 12 weeks to measure changes in drinking and PTSD symptoms.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03667846

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

Recruiting
PHASE2Ages 18–70InterventionalTreatment
NYU Langone Health
~150 participants
Updated 2025-04-01 on ClinicalTrials.gov
What's tested:TopiramatePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Measure of Time-line Follow-back (TLFB)
Measured over Day 1
+2 more outcomes measured
Post Traumatic Stress Disorder
Alcohol Use Disorder
1 sites across 1 states
New York1
  • Charles Marmar, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

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  • Measure of Time-line Follow-back (TLFB)Day 1

    Retrospective estimate of daily alcohol consumption over a time period ranging from 7 days to 24 months prior to initial interview

  • Percent Day Abstinent from AlcoholWeek 9 to Week 12

    Percentage of day abstinent from alcohol between week 9 and week 12

  • PCL-5 scoreWeek 9 to Week 12

    20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items. Each question is measured on a 5-point Likert (0 = "Not at all" to 4 = "Extremely"). A total symptom severity score (range - 0-80; 80 being more severe) can be obtained by summing the scores for each of the 20 items.