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Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD)
Sponsor: Medical University of South Carolina
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
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.
Cognitive Behavioral Therapy (CBT)
Participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
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.
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).
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