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COMPLETED
NCT02966873
PHASE2

Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD)

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

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.

Official title: A Randomized Controlled Trial of N-Acetylcysteine for Alcohol Use Disorder and Comorbid Post Traumatic Stress Disorder

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

182

Start Date

2016-10-01

Completion Date

2022-09-19

Last Updated

2026-04-13

Healthy Volunteers

Yes

Interventions

DRUG

N-Acetylcysteine (NAC) Treatment

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.

BEHAVIORAL

Cognitive Behavioral Therapy (CBT)

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

DRUG

Inactive Placebo Oral Capsule

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.

OTHER

Functional magnetic resonance imaging (fMRI)

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

OTHER

Proton magnetic resonance spectroscopy (MRS) Imaging

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

Locations (2)

Medical University of South Carolina

Charleston, South Carolina, United States

The Charleston Center

Charleston, South Carolina, United States