Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 70

Using N-acetylcysteine to help manage alcohol use disorder

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

Run by University of Sydney · NCT05408247 · Data updated 2026-11-12

This study is testing if a medication called N-acetylcysteine can help people with alcohol use disorder reduce their drinking and improve their treatment results.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment280 (estimated)
SponsorUniversity of Sydney
Academic / other
Locations3 sites (Sydney, New South Wales and 2 other locations)
StatusRecruiting
StartedFebruary 16, 2023
Main results expectedNovember 2025
Study endsNovember 2026
Registry record updatedMarch 16, 2023
Trial IDNCT05408247 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals diagnosed with alcohol use disorder who have a desire to reduce or stop drinking and meet specific drinking criteria.

Probably not a fit

Patients who are pregnant, have concurrent substance dependence, or are experiencing clinically unstable medical or psychiatric conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of N-acetylcysteine (NAC) in improving treatment outcomes for individuals with alcohol use disorder (AUD). Conducted in Australia, the study will involve a double-blind, randomized, placebo-controlled design with 280 participants receiving either NAC or a placebo for 12 weeks. The trial seeks to address the urgent need for new treatment strategies for AUD, which is a leading cause of preventable death in the country. By personalizing treatment based on genotype and clinical comorbidities, the study hopes to enhance the efficacy of interventions for heavy drinkers.

Why it matters

Potential benefit: If successful, this trial could provide a new, effective treatment option for individuals struggling with alcohol use disorder.

How similar studies have gone: Previous studies have shown promise in using N-acetylcysteine for substance use disorders, suggesting potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Drug Health Services, Royal Prince Alfred Hospital
    Sydney, New South Wales, Australia
    Recruiting
  • Cornwall Street Medical Centre (UQ Health Care)
    Annerley, Queensland, Australia
    Not yet recruiting
  • Turning Point
    Richmond, Victoria, Australia
    Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.