N-Acetylcysteine for Adolescent Alcohol Use Disorder

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

This is a 8-week randomized, placebo-controlled trial testing the effects of N-acetylcysteine (NAC), on a platform of weekly evidence-based brief alcohol intervention for 120 adolescents with alcohol use disorder (AUD). The primary efficacy endpoint is reduction in alcohol use (total standard drinks), compared between NAC and placebo groups.

Study Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Drug: Placebo oral capsule; Drug: N-acetylcysteine

Detailed Description

Adolescence is a critical developmental stage involving marked elevation in alcohol initiation, progression to AUD, and development of significant, lasting adverse outcomes from use. Effective treatments must be developed for AUD in this especially vulnerable age range. 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 highly promising 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. Randomized participants will be provided and instructed to take their assigned medication at 1200 mg twice daily, in approximately twelve-hour intervals.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subject is 13-25
2. Must be able to understand the study and provide written informed consent (for participants under 18 years old, a parent/legal guardian must be able to provide consent and the participant must be able to provide assent).
3. Current moderate to heavy drinker by established adolescent criteria
4. Meet criteria for alcohol use disorder
5. Females must agree to use appropriate birth control methods during study participation: oral contraceptives, contraceptive patch, barrier (diaphragm or condom), levonorgestrel implant, medroxyprogesterone acetate, complete abstinence from sexual intercourse, or hormonal contraceptive vaginal ring

Exclusion Criteria:

1. Score >10 on the Clinical Institute Withdrawal Assessment for Alcohol
2. Allergy or intolerance to N-acetylcysteine
3. Females who are pregnant, contemplating pregnancy or lactating over the next 6 months
4. Current use of N-acetylcysteine or any supplement containing N-acetylcysteine (must agree not to take any such supplement throughout study participation)
5. Current enrollment in treatment for alcohol use disorder or expectation of other treatment during protocol participation
6. Any other medical or psychiatric condition or other significant concern that in the Investigator's opinion would impact participant safety or compliance with study instructions, or potentially cofound the interpretation of findings

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: N-acetylcysteine; N-acetylcysteine 1200 mg twice daily for 8 weeks; administered orally	Drug: N-acetylcysteine; N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally)
Placebo Comparator: Placebo; Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 8 weeks; administered orally	Drug: Placebo oral capsule; Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol Use During the Final 4 Weeks of Treatment (Weeks 5 - 8)	Alcohol use (total standard drinks) during the final four weeks of treatment (Weeks 5-8), compared between NAC and placebo groups.	Final 4 weeks of treatment

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Kevin M Gray, MD, Professor of Psychiatry and Behavioral Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2019
• Primary Completion (Actual): February 26, 2024
• Study Completion (Actual): February 26, 2024

Study Registration Dates

• First Submitted: October 12, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: adolescent; medication; pharmacotherapy; alcohol; youth; N-acetylcysteine
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Alcohol-Related Disorders; Underage Drinking; Alcoholism; Alcohol Drinking; Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiviral Agents; Antioxidants; Protective Agents; Expectorants; Respiratory System Agents; Free Radical Scavengers; Antidotes; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: PRO#00080921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No