# Topiramate as a treatment for Co-occurring AUD and PTSD

> **NIH NIH P01** · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · 2021 · $501,417

## Abstract

Summary
 Alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) are highly comorbid, and
present a clinical challenge for which existing treatments have limited efficacy. Existing clinical evidence
suggests treatments that simultaneously address symptoms of both PTSD and AUD should be more
efficacious than treating either disorder in isolation. The overlap in the neurobiological basis of PTSD and AUD
(involving alterations in incentive salience, stress/negative affect, and executive control network functioning)
suggests that there could be treatments that would effectively treat both disorders. However, there is no
pharmacotherapy or psychotherapy treatment that is clearly effective for both disorders.
 Topiramate, an FDA-approved anticonvulsant with effects on GABAergic and glutamatergic signaling,
has demonstrated efficacy in the treatment of AUD in several randomized clinical trials (RCTs), and has also
been tested in several open-label and small RCTs for treatment of PTSD with some evidence of effectiveness.
Positive results in one open-label trial and one small RCT in patients with co-occurring PTSD and AUD
suggest that topiramate may have beneficial effects on symptoms of both PTSD and AUD in this population.
Preclinical work also supports the efficacy of topiramate in ameliorating anxiety-like behavior and altered stress
response in animal models of stress and chronic alcohol exposure. A recent clinical study demonstrated that
the effects of topiramate on alcohol use were moderated by a polymorphism of the GRIK1 gene (coding for the
kainate receptor GluK1 subunit), such that significant benefit was found only among rs2832407 C-allele
homozygotes.
 The proposed study, Project 2 of the proposed center, is a double-blind, 2-group randomized controlled
trial evaluating the effects of topiramate, in contrast to those of placebo, in patients with comorbid PTSD and
moderate-to-severe AUD. The proposed 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. In support of the overall aims
of the center, the trial will serve as a platform for studies of topiramate’s effects on brain chemistry and function
as measured by MR spectroscopy, fMRI, and EEG (Project 3). Data from Project 2 will also contribute to
Overall Center Aims investigating the relationship of plasma biomarkers in Project 2 to plasma biomarkers in
Project 1, and the relationship of plasma biomarkers in Project 2 to neuroimaging markers i...

## Key facts

- **NIH application ID:** 10237285
- **Project number:** 5P01AA027057-04
- **Recipient organization:** NEW YORK UNIVERSITY SCHOOL OF MEDICINE
- **Principal Investigator:** Michael Parks Bogenschutz
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $501,417
- **Award type:** 5
- **Project period:** 2018-09-20 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10237285

## Citation

> US National Institutes of Health, RePORTER application 10237285, Topiramate as a treatment for Co-occurring AUD and PTSD (5P01AA027057-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10237285. Licensed CC0.

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