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Recruiting NCT05408247

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

Phase IV Interventional Alcohol Use Disorder (AUD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: N-acetyl cysteine, Placebo.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder (AUD). Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Detailed description

Australia urgently requires new treatment strategies for the treatment of alcohol dependence. Although alcohol use disorders are a leading cause of preventable death in Australia, their treatment is generally not evidence based. The medications currently approved for use in Australia for the management of alcohol dependence have limited efficacy, and existing research does not address the heterogeneity of treatment response. Targeted personalised medicine addresses this heterogeneity with better medicine selection for patients based on their genotype and clinical comorbidities.

Following on from a recent pilot study conducted by CI Morley (NCT03879759), this project will evaluate the clinical efficacy and tolerability of NAC, relative to a placebo, in heavy drinkers. We hypothesise that NAC-treated participants will be better able to achieve a reduction in heavy drinking. We will utilise a double-blind, randomised, controlled design. A sample of 280 individuals will receive 12 weeks of treatment with NAC (2400 mg/day) or placebo.

Interventions

  • Drug N-acetyl cysteine
    2400mg/day
  • Drug Placebo
    Matched placebo

Primary outcome measures

  • Heavy Drinking Days [Time frame: 24 weeks]
Secondary outcome measures (2)
  • Changes in Liver Function [Time frame: 24 weeks]
  • Absence of any HDD [Time frame: 24 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Australia · 3 centers
  • Drug Health Services, Royal Prince Alfred Hospital — Sydney
  • Cornwall Street Medical Centre (UQ Health Care) — Annerley
  • Turning Point — Richmond

Publications

  • Morley K, Arunogiri S, Connor JP, Clark PJ, Chatterton ML, Baillie A, Slade T, Berk M, Lubman D, Haber PS. N-acetyl cysteine for the treatment of alcohol use disorder: study protocol for a multi-site, double-blind randomised controlled trial (NAC-AUD study). BMJ Open. 2025 Sep 8;15(9):e091631. doi: 10.1136/bmjopen-2024-091631. PMID 40921646

Identifiers

NCT: NCT05408247 · X21-0342

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗