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

PHASE2CompletedINTERVENTIONAL
Enrollment

182

Participants

Timeline

Start Date

October 1, 2016

Primary Completion Date

September 16, 2021

Study Completion Date

September 19, 2022

Conditions
Post Traumatic Stress Disorder (PTSD)AddictionAlcohol Abuse
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).

Trial Locations (2)

29401

Medical University of South Carolina, Charleston

29425

The Charleston Center, Charleston

All Listed Sponsors
collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

Medical University of South Carolina

OTHER

NCT02966873 - Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD) | Biotech Hunter | Biotech Hunter