Using N-acetylcysteine to help manage alcohol use disorder

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

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: PHASE4
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: University of Sydney (other)
• Locations: 3 sites (Sydney, New South Wales and 2 other locations)
• Trial ID: NCT05408247 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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

Eligibility 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 this trial is running

Sydney, New South Wales and 2 other locations

• 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

Conditions: Alcohol Use Disorder, N-acetyl Cysteine, NAC, Alcohol Dependence, N-acetylcysteine