Status:
RECRUITING
A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
Lead Sponsor:
University of Sydney
Collaborating Sponsors:
Monash University
Conditions:
Alcohol Use Disorder (AUD)
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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 g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT05408247
Start Date
February 16 2023
End Date
November 1 2026
Last Update
March 16 2023
Active Locations (3)
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1
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
2
Cornwall Street Medical Centre (UQ Health Care)
Annerley, Queensland, Australia, 4103
3
Turning Point
Richmond, Victoria, Australia, 3121