Clinical Trials in Australia / NCT05408247
Recruiting
Phase 4
A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
NCT05408247 · tracked via the Priya Life Science Australia tracker
Condition(s) studied
Alcohol Use Disorder (AUD)
Investigational drug(s) / intervention(s)
N-acetyl cysteine →Placebo
N-acetyl cysteine: 2400mg/day
Placebo: Matched placebo
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
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
Primary outcome measure(s)
- Heavy Drinking Days — 24 weeks
Reduction in Heavy Drinking Days (HDD; defined as 4 or more drinks in a day for women and five or more drinks in a day for men). This will be measured by the Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Drug Health Services, Royal Prince Alfred Hospital | Sydney | New South Wales | Recruiting |
| Cornwall Street Medical Centre (UQ Health Care) | Annerley | Queensland | Not Yet Recruiting |
| Turning Point | Richmond | Victoria | Active Not Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05408247 on ClinicalTrials.gov ↗ ← All trials in Australia