CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 182 enrolled
Drug / intervention
N-Acetylcysteine (NAC) Treatment +4 moredrug
Likely dose
N-Acetylcysteine (NAC) Treatment 2400 mgfrom 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/NCT02966873
NCT02966873Phase 2Completed
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A Randomized Controlled Trial of N-Acetylcysteine for Alcohol Use Disorder and Comorbid Post Traumatic Stress Disorder

Medical University of South Carolina·interventional·Posted Nov 17, 2016·Updated Apr 13, 2026

In Brief

A Phase 2 clinical trial evaluating N-Acetylcysteine (NAC) Treatment, Cognitive Behavioral Therapy (CBT), and 3 other interventions for Post Traumatic Stress Disorder (PTSD) and 2 related conditions. Completed, enrolled 182 participants across 2 sites.

Detailed Summary

This is a randomized controlled Phase II clinical trial designed to evaluate the effects of N-acetylcysteine (NAC) in reducing Alcohol Use Disorder (AUD) severity and Post Traumatic Stress Disorder (PTSD) symptomatology among individuals with current AUD and PTSD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Traumatic Stress Disorder (PTSD), Addiction, Alcohol Abuse
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institutes of Health (NIH)

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 17, 2016
Enrollment StartOct 1, 2016
Primary CompletionSep 16, 2021
Study CompletionSep 19, 2022
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 9.6 years ago

Interventions

N-Acetylcysteine (NAC) Treatmentdrug

Participant will receive 12 weeks of Active Treatment NAC (2400 mg) daily. The study medication will be provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.

Cognitive Behavioral Therapy (CBT)behavioral

Participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.

Inactive Placebo Oral Capsuledrug

Participant will receive 12 weeks of inactive placebo. The study medication will be provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.

Functional magnetic resonance imaging (fMRI)other

Participants will be given the option to complete Functional magnetic resonance imaging (fMRI) at two timepoints (pre-treatment and end of treatment).

Proton magnetic resonance spectroscopy (MRS) Imagingother

Participants will be given the option to complete magnetic resonance spectroscopy (MRS) at two timepoints (pre-treatment and end of treatment).