NCT05408247 A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
| NCT ID | NCT05408247 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Sydney |
| Condition | Alcohol Use Disorder (AUD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2023-02-16 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 280 participants in total. It began in 2023-02-16 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05408247 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Alcohol Use Disorder (AUD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05408247 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05408247 currently recruiting?
Yes, NCT05408247 is actively recruiting participants. Contact the research team at Kirsten.morley@sydney.edu.au for enrollment information.
Where is the NCT05408247 trial being conducted?
This trial is being conducted at Sydney, Australia, Annerley, Australia, Richmond, Australia.
Who is sponsoring the NCT05408247 clinical trial?
NCT05408247 is sponsored by University of Sydney. The trial plans to enroll 280 participants.