Phase 2 N=126 Randomized Quadruple-blind Treatment

N-Acetylcysteine for Adolescent Alcohol Use Disorder

Alcohol Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT03707951 ↗

Enrolled (actual)

126

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: Alcohol Use During the Final 4 Weeks of Treatment (Weeks 5 - 8) — 37.9; 42.6 Standard drinks

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: N-acetylcysteine (Drug); Placebo oral capsule (Drug)
Age: Pediatric, Adult · 13+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Alcohol Use During the Final 4 Weeks of Treatment (Weeks 5 - 8)	37.9; 42.6	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03707951). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.