N-Acetylcysteine for Adolescent Alcohol Use Disorder

NCT03707951 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: PRO#00080921
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

alcohol; youth; adolescent; pharmacotherapy; medication; N-acetylcysteine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

N-acetylcysteine

EXPERIMENTAL

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

Drug: N-acetylcysteine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

Interventions

N-acetylcysteine DRUG

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

N-acetylcysteine

Placebo oral capsule DRUG

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

Placebo

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subject is 13-25
• 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).
• Current moderate to heavy drinker by established adolescent criteria
• Meet criteria for alcohol use disorder
• 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

You may not qualify if:

• Score \>10 on the Clinical Institute Withdrawal Assessment for Alcohol
• Allergy or intolerance to N-acetylcysteine
• Females who are pregnant, contemplating pregnancy or lactating over the next 6 months
• Current use of N-acetylcysteine or any supplement containing N-acetylcysteine (must agree not to take any such supplement throughout study participation)
• Current enrollment in treatment for alcohol use disorder or expectation of other treatment during protocol participation
• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

Related Publications (1)

• 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.

  PMID: 41016625 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Kevin M. Gray, M.D.
• Organization: Medical University of South Carolina

graykm@musc.edu

843-792-6330

Study Officials

• Kevin M Gray, MD

  Professor of Psychiatry and Behavioral Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind placebo-controlled pharmacotherapy trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behvavioral Sciences

Model Details: 1:1 parallel group allocation randomized placebo controlled trial

Study Record Dates

• First Submitted: October 12, 2018
• First Posted: October 16, 2018
• Study Start: February 27, 2019
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)