# A Randomized Controlled Trial of N-Acetylcysteine for Alcohol Use Disorder and Comorbid PTSD

> **NIH NIH R01** · MEDICAL UNIVERSITY OF SOUTH CAROLINA · 2020 · $602,982

## Abstract

ABSTRACT
Alcohol use disorder (AUD) and post-traumatic stress disorder (PTSD) are chronic and debilitating psychiatric
conditions which frequently co-occur. If left untreated, individuals with AUD and co-occurring PTSD are at
increased risk for developing other mental health problems (e.g., depression, anxiety), suicidal ideation and
attempts, medical problems, family/relationship impairment, and employment problems. Despite the frequent
co-occurrence and deleterious consequences associated with comorbid AUD/PTSD, there is little scientific
evidence available to guide the provision of care. The proposed study directly addresses this critical
knowledge gap by testing the efficacy of N-acetylcysteine (NAC) as compared to placebo in reducing
AUD and PTSD severity. NAC represents a promising and novel candidate pharmacotherapy for individuals
with AUD and comorbid PTSD. Accumulating preclinical and preliminary clinical research suggests a role for
NAC in the treatment of substance use disorders and PTSD via glutamate modulation. Data from a
randomized, double-blind pilot study recently completed by the investigative team in Veterans with substance
use disorders (primarily alcohol) and PTSD provides encouraging support for the therapeutic potential of NAC
in the treatment of AUD and PTSD. Moreover, NAC is an inexpensive, over-the-counter agent with a favorable
tolerability profile, all of which confer ease of transferability from the research setting to clinical practice. In this
Stage II study, we will (1) employ a two-arm randomized, double-blind, between-groups experimental design
that will consist of 12 weeks of treatment with NAC or placebo medication; (2) use standardized, repeated
dependent measures to rigorously assess AUD severity and PTSD symptomatology at 6 time points (baseline,
week 6, week 12, and 3-, 6-, and 12-month follow-up); (3) measure impairment in associated mental and
behavioral health problems (e.g., depression, sleep, suicidality, risky sexual behaviors, family/social
functioning); and (4) use functional magnetic resonance imaging (fMRI) and proton magnetic resonance
spectroscopy (MRS) to investigate the underlying pathophysiology of comorbid AUD/PTSD and prognostic
indicators of treatment outcome. To achieve these aims, we have assembled a multidisciplinary team of
investigators with nationally-recognized expertise in AUD and comorbid PTSD, clinical trials, human laboratory
paradigms, and neuroimaging who have successfully collaborated in the past and are uniquely qualified to
implement this type of investigation. The proposed project is directly responsive to the mission of the National
Institute on Alcohol Abuse and Alcoholism (NIAAA) and the new AUD/PTSD initiative to accelerate research on
the development of effective pharmacologic treatments for this common and highly disabling comorbidity. The
findings from this study will provide critically needed empirical evidence to help inform clinical practice
guidelines and accel...

## Key facts

- **NIH application ID:** 9982151
- **Project number:** 5R01AA025086-05
- **Recipient organization:** MEDICAL UNIVERSITY OF SOUTH CAROLINA
- **Principal Investigator:** Sudie E. Back
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $602,982
- **Award type:** 5
- **Project period:** 2016-08-10 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9982151

## Citation

> US National Institutes of Health, RePORTER application 9982151, A Randomized Controlled Trial of N-Acetylcysteine for Alcohol Use Disorder and Comorbid PTSD (5R01AA025086-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9982151. Licensed CC0.

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