RecruitingPhase 4NCT05408247

A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder

Sponsor

University of Sydney

Enrollment

280 participants

Start Date

Feb 16, 2023

Study Type

INTERVENTIONAL

Conditions

Alcohol Use Disorder (AUD)

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

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 Criteria6

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