NCT05408247

A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: University of Sydney · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial.

Detailed description

Australia urgently requires new treatment strategies for the treatment of alcohol dependence. Although alcohol use disorders are a leading cause of preventable death in Australia, their treatment is generally not evidence based. The medications currently approved for use in Australia for the management of alcohol dependence have limited efficacy, and existing research does not address the heterogeneity of treatment response. Targeted personalised medicine addresses this heterogeneity with better medicine selection for patients based on their genotype and clinical comorbidities. Following on from a recent pilot study conducted by CI Morley (NCT03879759), this project will evaluate the clinical efficacy and tolerability of NAC, relative to a placebo, in heavy drinkers. We hypothesise that NAC-treated participants will be better able to achieve a reduction in heavy drinking. We will utilise a double-blind, randomised, controlled design. A sample of 280 individuals will receive 12 weeks of treatment with NAC (2400 mg/day) or placebo.

Conditions

• Alcohol Use Disorder (AUD)

Interventions

Type	Name	Description
DRUG	N-acetyl cysteine	2400mg/day
DRUG	Placebo	Matched placebo

Timeline

• Start date: 2023-02-16
• Primary completion: 2025-11-01
• Completion: 2026-11-01
• First posted: 2022-06-07
• Last updated: 2023-03-16

Locations

3 sites across 1 country: Australia