N-acetyl cysteine for the treatment of alcohol use disorder: study protocol for a multi-site, double-blind randomised controlled trial (NAC-AUD study).
Kirsten Morley, Shalini Arunogiri, Jason P Connor...
https://pubmed.ncbi.nlm.nih.gov/40921646Actively Recruiting
Phase 4
Age: 18Years - 70Years
All Genders
ID05408247
A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
Led by University of Sydney · Updated on 2023-03-16
280
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Sydney
Lead Sponsor
M
Monash University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of N-acetylcysteine (NAC) in improving treatment outcomes for people with alcohol use disorder. This phase 4, double-blind, randomized, placebo-controlled trial aims to address the limited efficacy of current medications for alcohol dependence and explore personalized medicine strategies based on individual differences. The study is sponsored by the University of Sydney and involves 280 participants who have heavy drinking habits and a desire to reduce or stop drinking. Participants will be randomly assigned to receive either NAC at a dose of 2400 mg per day (administered as 600 mg capsules taken twice twice daily for a total of 12 weeks) along with standard medical management, or a matched placebo with the same schedule and standard care. The trial uses quadruple masking to keep participants, care providers, investigators, and outcome assessors unaware of group assignments. Treatment lasts for 12 weeks, followed by monitoring. During the study, participants will be assessed over 24 weeks for outcomes including the number of heavy drinking days, changes in liver function, and absence of heavy drinking days. Researchers will conduct interviews and monitor adherence, cognition, and safety. Participants must have stable housing and be able to consent and complete research interviews in English. Safety monitoring includes exclusion of unstable medical or psychiatric conditions and pregnancy screening. The total study duration includes the 12 weeks of treatment and follow-up assessments to measure drinking behavior and liver function.
CONDITIONS
Brief Title
A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Alcohol Use Disorder according to the DSM-V criteria
- Desire to reduce or stop drinking
- Consumed at least 21 standard drinks per week or 2 heavy drinking days per week 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 will not qualify if you...
- Pregnancy or lactation; women must use reliable contraception during the trial
- Concurrent use of any psychotropic medication other than stable-dose antidepressants
- Any substance dependence other than nicotine
- Clinically unstable systemic medical or psychiatric disorder that precludes participation
- Concurrent use of selenium, vitamin D, or other antioxidants
- Use of any alcohol pharmacotherapy within the past month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive either N-acetylcysteine or a matched placebo daily along with standard medical management.
Weekly visits for up to 12 weeks
Follow-up
Duration - 12 weeks
Participants are monitored for outcomes including heavy drinking days and liver function after treatment ends.
Monthly visits for 3 months post-treatment
Trial Site Locations
Total: 3 locations
1
Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Actively Recruiting
2
Cornwall Street Medical Centre (UQ Health Care)
Annerley, Queensland, Australia, 4103
Not Yet Recruiting
3
Turning Point
Richmond, Victoria, Australia, 3121
Active, Not Recruiting
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Research Team
K
Kirsten Morley, PhD
P
Paul Haber, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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