At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 90 enrolled

Drug / intervention

N-acetylcysteine +2 moredrug

Likely dose

N-acetylcysteine 1200mgfrom 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/NCT02911285

NCT02911285Phase 2Completed

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Glial Regulators for Treating Comorbid Posttraumatic Stress Disorder and Substance Use Disorders

Medical University of South Carolina·interventional·Posted Sep 22, 2016·Updated May 19, 2021

In Brief

A Phase 2 clinical trial evaluating N-acetylcysteine, Placebo, and 1 other intervention for Posttraumatic Stress Disorder (PTSD) and 2 related conditions. Completed, enrolled 90 participants across 2 sites.

Detailed Summary

As a result of sustained operations in Afghanistan and Iraq, there are an increasing number of U.S. military Veterans with substance use disorders and comorbid posttraumatic stress disorder (PTSD). If left untreated, individuals with substance use disorders and PTSD are at increased risk for developing other mental health problems (e.g., depression, anxiety), suicidal ideation and attempts, medical problems, reduced resiliency and military readiness, vocational problems, and family/social impairment. This study will determine the benefits of N-acetylcysteine (NAC) in treating alcohol use disorder and comorbid post-traumatic stress disorder (PTSD) among military Veterans.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPosttraumatic Stress Disorder (PTSD), Alcohol Use Disorder (AUD), Substance Use Disorder (SUD)

CountriesUnited States

CollaboratorsUnited States Department of Defense, Institute for Translational Neuroscience

Timeline

Phase 2CompletedFinished

2017201820192020202120222023202420252026

First PostedSep 2016

Enrollment StartOct 2016

Primary CompletionAug 2019

Study CompletionNov 2019

TodayJul 2026

First PostedSep 22, 2016

Enrollment StartOct 1, 2016

Primary CompletionAug 5, 2019

Study CompletionNov 4, 2019

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 9.8 years ago

Interventions

N-acetylcysteinedrug

1200mg bid (2400mg/day)

Placebodrug

Placebo pills bid

Cognitive behavioral therapybehavioral

CBT for AUD/SUD, one hour/once a week