Actively Recruiting
Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD
Led by NYU Langone Health · Updated on 2025-04-01
150
Participants Needed
1
Research Sites
307 weeks
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Leveraging Biomarkers for Personalized Treatment of Alcohol Use Disorder Comorbid With PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18-70 years old
- Diagnosis of moderate or severe alcohol use disorder based on DSM-5 criteria
- Desire to reduce or stop drinking
- At least 4 heavy drinking days in the 30 days before screening
- Current diagnosis of PTSD or subthreshold PTSD based on Clinician Administered PTSD Scale
- Willingness to use contraception if of childbearing potential
- Ability to provide at least 2 locator contacts
- Ability to give voluntary informed consent
- Reliable housing status
You will not qualify if you...
- Current alcohol withdrawal with CIWA-Ar score greater than 7
- Diagnosis of schizophrenia, schizoaffective disorder, bipolar I disorder, or significant suicidality
- Severe substance use disorder other than alcohol or nicotine
- History of severe traumatic brain injury
- Trauma exposure in the last 30 days
- Significantly impaired liver function or other medical conditions precluding safe participation
- Significant laboratory abnormalities including impaired hepatic function
- Use of medications with potential adverse interactions with study drug
- Pregnancy or lactation
- Current treatment for AUD or opioid abuse
- Recent psychotherapy for PTSD or other psychiatric conditions
- Allergy or hypersensitivity to topiramate
- Active legal issues likely to cause incarceration within 12 weeks
- Significantly impaired kidney function
- High risk for adverse emotional or behavioral reactions or inability to understand study
- Psychiatric inpatient treatment within last 12 months except detox or extended emergency stays
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
New York University School of Medicine
New York, New York, United States, 10016
Actively Recruiting
Research Team
D
Dayeon Cho
CONTACT
M
Michael Bogenschutz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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