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

• Status: Not yet recruiting
• Trial end date: 2026-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: South West Sydney Local Health District
• Collaborators: National Health and Medical Research Council, Australia; Sydney Local Health District
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Alcohol Use Disorder according to the DSM-V criteria

• A desire to reduce or stop drinking

• Consumed at least 21 standard drinks per week or 2 heavy drinking days per week (HDD:

≥ 5 standard drinks/day for men; ≥4 for women) in the month prior to screening

• Adequate cognition and English language skills to give valid consent and complete research interviews

• Stable housing

• Willingness to give written informed consent

Exclusion Criteria:

• Pregnancy or lactation (women will be advised to use reliable contraception during the trial and a pregnancy test will be performed were necessary)

• Concurrent use of any psychotropic medication other than antidepressants (provided these are taken at stable doses for at least two months)

• Any substance dependence other than nicotine

• Clinically unstable systemic medical (e.g. cancer, end stage liver disease: e.g. MELD score ≥ 10) or psychiatric disorder (e.g. active psychosis, borderline personality disorder, active suicide risk: e.g. MADRAS item 10 score of 6) that precludes trial participation

• Concurrent use of selenium, vitamin D or other anti-oxidants

• Any alcohol pharmacotherapy within the past month