NCT03707951

N-Acetylcysteine for Adolescent Alcohol Use Disorder

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 13 Years – 25 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	N-acetylcysteine	N-acetylcysteine 1200 mg 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)

Timeline

• Start date: 2019-02-27
• Primary completion: 2024-02-26
• Completion: 2024-02-26
• First posted: 2018-10-16
• Last updated: 2025-01-08
• Results posted: 2025-01-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study