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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 280 (estimated) |
| Sponsor | University of Sydney Academic / other |
| Locations | 3 sites (Sydney, New South Wales and 2 other locations) |
| Status | Recruiting |
| Started | February 16, 2023 |
| Main results expected | November 2025 |
| Study ends | November 2026 |
| Registry record updated | March 16, 2023 |
| Trial ID | NCT05408247 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
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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
- Study coordinator: Kirsten Morley, PhD
- Email: Kirsten.morley@sydney.edu.au
- Phone: 61295153636
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Imaging Mitochondrial Complex-I and Brain Metabolism in Alcohol Use Disorder
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Endurance exercise to see if it lowers alcohol use in adults with AUD and ALD
A 12-week home-based cycling program added to standard care is tested to see if it reduces alcohol use and cravings in adults with alcohol use disorder and alcohol-related liver disease.
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Semaglutide for Alcohol Use Disorder and Obesity: Testing 1.0 mg and 2.0 mg vs Placebo
We’re testing two doses of semaglutide to see if they reduce alcohol craving and use in adults with alcohol use disorder and obesity compared with placebo.
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TRIS: a mobile app with breathalyzer to support sobriety in alcohol use disorder
A smartphone app with a connected breathalyzer tests for abstinence and uses small financial incentives to encourage sobriety for adults with AUD in Brazil.
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Body-focused mindfulness added to inpatient alcohol use disorder treatment
This trial tests whether a body-focused mindfulness program can help people with alcohol use disorder feel more connected to their bodies and reduce cravings while in inpatient care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.