N-Acetylcysteine for Adolescent Alcohol Use Disorder

NCT ID: NCT03707951

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-27
• Study Completion Date: 2024-02-26

Brief Summary

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.

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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

N-acetylcysteine

N-acetylcysteine 1200 mg twice daily for 8 weeks; administered orally

Group Type: EXPERIMENTAL

N-acetylcysteine

Intervention Type: DRUG

N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally)

Placebo

Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 8 weeks; administered orally

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)

Interventions

N-acetylcysteine

N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally)

Intervention Type: DRUG

Placebo oral capsule

Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Kevin Gray

Professor of Psychiatry and Behvavioral Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin M Gray, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Psychiatry and Behavioral Sciences

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

Squeglia LM, Tomko RL, Baker NL, Kirkland AE, McClure EA, Gray KM. A Randomized Controlled Trial of N-acetylcysteine for Adolescent and Young Adult Alcohol Use Disorder. J Am Acad Child Adolesc Psychiatry. 2025 Sep 26:S0890-8567(25)02088-X. doi: 10.1016/j.jaac.2025.09.025. Online ahead of print.

Reference Type: DERIVED

PMID: 41016625 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PRO#00080921

Identifier Type: -

Identifier Source: org_study_id