CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
topiramate +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03176953
NCT03176953Phase 3Completed

Combining Topiramate and Prolonged Exposure for PTSD and Alcohol Use Disorder

VA Office of Research and Development·interventional·Posted Jun 6, 2017·Updated Nov 18, 2023

In Brief

A Phase 3 clinical trial evaluating topiramate, prolonged exposure, and 1 other intervention for PTSD and Alcohol Use Disorder. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) frequently co-occur, and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. The most effective PTSD treatment, prolonged exposure (PE) is sometimes less effective when individuals also have AUD. Anti-relapse medication appears promising to improve the effectiveness of PE to help individuals reduce alcohol use and PTSD symptoms and improve functioning. This study compares PE with and without topiramate, a medication shown to both reduce drinking and PTSD symptoms, with the hypothesis that combined PE and topiramate will be more effective than PE and placebo. The aim of this grant is to improve treatment outcomes for Veterans with AUD and PTSD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJun 6, 2017
Enrollment StartNov 1, 2017
Primary CompletionOct 31, 2022
Study CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 9.1 years ago

Interventions

topiramatedrug

active medication

prolonged exposurebehavioral

psychotherapy

placebodrug

non-active medication