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

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.

Conditions

• Post Traumatic Stress Disorder (PTSD)
• Addiction
• Alcohol 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).

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• Medical University of South Carolina

  lead OTHER

Principal Investigators

• Sudie Back, PhD · Medical University of South Carolina

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-10-01

Primary Completion

2021-09-16

Completion

2022-09-19

FDA Drug

Yes

Countries

• United States

Study Locations