Study of N-acetylcysteine Treatment to Reduce Heavy Drinking in Adults with Alcohol Use Disorder

What this Trial Is About

Researchers are evaluating the effectiveness of N-acetylcysteine NAC in improving treatment outcomes for people with alcohol use disorder. This phase 4, double-blind, randomized, placebo-controlled trial aims to address the limited efficacy of current medications for alcohol dependence and explore personalized medicine strategies based on individual differences. The study is sponsored by the University of Sydney and involves 280 participants who have heavy drinking habits and a desire to reduce or stop drinking. Participants will be randomly assigned to receive either NAC at a dose of 2400 mg per day administered as 600 mg capsules taken twice twice daily for a total of 12 weeks along with standard medical management, or a matched placebo with the same schedule and standard care. The trial uses quadruple masking to keep participants, care providers, investigators, and outcome assessors unaware of group assignments. Treatment lasts for 12 weeks, followed by monitoring. During the study, participants will be assessed over 24 weeks for outcomes including the number of heavy drinking days, changes in liver function, and absence of heavy drinking days. Researchers will conduct interviews and monitor adherence, cognition, and safety. Participants must have stable housing and be able to consent and complete research interviews in English. Safety monitoring includes exclusion of unstable medical or psychiatric conditions and pregnancy screening. The total study duration includes the 12 weeks of treatment and follow-up assessments to measure drinking behavior and liver function.

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