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

Last updated: March 14, 2023
Sponsor: University of Sydney
Overall Status: Active - Recruiting

Phase

4

Condition

Alcohol Dependence

Alcohol Use Disorder

Substance Abuse

Treatment

N/A

Clinical Study ID

NCT05408247
X21-0342
  • Ages 18-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 completeresearch interviews
  • Stable housing
  • Willingness to give written informed consent

Exclusion

Exclusion Criteria:

  • Pregnancy or lactation (women will be advised to use reliable contraception during thetrial and a pregnancy test will be performed were necessary)
  • Concurrent use of any psychotropic medication other than antidepressants (providedthese 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. MELDscore ≥ 10) or psychiatric disorder (e.g. active psychosis, borderline personalitydisorder, active suicide risk: e.g. MADRAS item 10 score of 6) that precludes trialparticipation
  • Concurrent use of selenium, vitamin D or other anti-oxidants
  • Any alcohol pharmacotherapy within the past month

Study Design

Total Participants: 280
Study Start date:
February 16, 2023
Estimated Completion Date:
November 30, 2026

Study 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.

Connect with a study center

  • Drug Health Services, Royal Prince Alfred Hospital

    Sydney, New South Wales 2050
    Australia

    Active - Recruiting

  • Cornwall Street Medical Centre (UQ Health Care)

    Annerley, Queensland 4103
    Australia

    Site Not Available

  • Turning Point

    Richmond, Victoria 3121
    Australia

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.