# A Proof-of-Concept Trial of N-Acetylcysteine for Adolescent Alcohol Use Disorder

> **NIH NIH R01** · MEDICAL UNIVERSITY OF SOUTH CAROLINA · 2020 · $717,092

## Abstract

ABSTRACT
 Adolescence marks a key period in the development of problematic alcohol use, with approximately 15% of
18 year olds meeting criteria for alcohol use disorder (AUD). Efforts to treat adolescent AUD have been only
modestly effective, with up to 86% of youth returning to use within 12 months following treatment. Inadequate
treatment for adolescents is an important public health concern given that alcohol use during this time is highly
predictive of long-term problematic drinking. While several medications are efficacious in treating adult AUD,
minimal pharmacotherapy research has focused on adolescents. Evaluation of alternative and more efficacious
treatments for adolescents with AUD is warranted. The primary objective of the proposed Phase II proof-of-
concept study is to evaluate the effect of N-acetylcysteine ( NAC), compared to placebo, in reducing alcohol
use among treatment-seeking adolescents with AUD (N=120). Given NAC’s effect on addictive behaviors via
glutamate modulation, accessibility as an over-the-counter supplement, safety and tolerability with adolescents,
and low cost, this medication holds great promise as a potential treatment option for adolescents with AUD. In
response to the National Institute on Alcohol Abuse and Alcoholism’s initiative to accelerate research on the
development of effective pharmacologic treatments for AUD, we will (1) conduct an 8-week, intent-to-treat,
double-blind, parallel-group, randomized, placebo-controlled trial of NAC (2400 mg per day); (2) examine
standardized, repeated dependent measures of clinical outcomes at baseline, throughout treatment, and at post-
treatment follow-up; and (3) employ mobile technology to improve data collection, engagement, and medication
adherence. The identification of a well-tolerated, effective pharmacological treatment would represent a
significant advance and could yield tremendous public health impact. The proposed trial will provide critical data
to evaluate NAC as a pharmacotherapy for adolescent AUD, and regardless of NAC versus placebo outcomes
will provide key methodological guidance for future randomized controlled trials of pharmacotherapies for
adolescent AUD.

## Key facts

- **NIH application ID:** 9991609
- **Project number:** 5R01AA027399-03
- **Recipient organization:** MEDICAL UNIVERSITY OF SOUTH CAROLINA
- **Principal Investigator:** Kevin M. Gray
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $717,092
- **Award type:** 5
- **Project period:** 2018-09-22 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9991609

## Citation

> US National Institutes of Health, RePORTER application 9991609, A Proof-of-Concept Trial of N-Acetylcysteine for Adolescent Alcohol Use Disorder (5R01AA027399-03). Retrieved via AI Analytics 2026-06-14 from https://api.ai-analytics.org/grant/nih/9991609. Licensed CC0.

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