Zonisamide Outpatient Study

Status Withdrawn

Clinical Trial Summary

The objective of this study is to determine if, compared to placebo, zonisamide (400mg/day) is a safe and efficacious treatment for post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) in Veterans with PTSD and co-occurring AUD.

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled study to examine the ability of 5-weeks treatment with zonisamide to reduce symptoms of PTSD and AUD. The study population will consist of 60 Veterans with combat-related PTSD and co-morbid AUD. Veterans will be randomized 1:1 to receive either zonisamide (up to 400 mg/day) or placebo daily for 35±4days, followed by a 14-day down-titration period with follow-up. Primary efficacy variables are scores on the CAPS-5, fear-potentiated startle (FPS) responses, and percent of heavy drinking days (%HDD). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03376139
Study type	Interventional
Source	Pharmacotherapies for Alcohol and Substance Abuse Consortium
Contact
Status	Withdrawn
Phase	Phase 2
Start date	March 1, 2019
Completion date	August 31, 2019

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