RecruitingPhase 2NCT03667846

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

Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With Post Traumatic Stress Disorder


Sponsor

NYU Langone Health

Enrollment

150 participants

Start Date

Oct 10, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying personalized treatment for people who have both alcohol use disorder and PTSD (post-traumatic stress disorder) at the same time, using brain scans and biological markers to match each person to the treatment most likely to help them. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with moderate or severe alcohol use disorder - You want to cut down or stop drinking - You have had at least 4 heavy drinking days in the past 30 days (4+ drinks/day for women, 5+ drinks/day for men) - You have been diagnosed with current PTSD or significant PTSD symptoms **You may NOT be eligible if...** - You are currently using illicit drugs or have another serious substance use disorder - You have a serious psychiatric condition (such as bipolar disorder or psychosis) - You have a serious medical condition that would make the study risky - You are currently on medications that interact with the study drugs - You are pregnant or breastfeeding - You have active suicidal intent requiring immediate care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTopiramate

Generic topiramate, FDA-approve for clinical use, will be purchased in 25mg, 50mg, and 100mg strengths, and encapsulated.

OTHERPlacebo

Placebo tablets will be encapsulated in identical capsules.


Locations(1)

New York University School of Medicine

New York, New York, United States

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NCT03667846


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