A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Alcohol Use Disorder (AUD)
In brief
To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial.
Key facts
- Study ID
- NCT05408247
- Run by
- University of Sydney
- People needed
- 280
- Starts
- 2023-02-16
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2023-03-16
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Drug Health Services, Royal Prince Alfred Hospital — Sydney, New South Wales, Australia (enrolling)
- Cornwall Street Medical Centre (UQ Health Care) — Annerley, Queensland, Australia
- Turning Point — Richmond, Victoria, Australia
Full record on ClinicalTrials.gov
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