To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial.
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
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
Parallel
N-acetyl cysteine
Drug2400mg/day
Placebo
DrugMatched placebo
Heavy Drinking Days
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
Changes in Liver Function
Liver Function will be assessed through blood sample at baseline. We will measurement levels of enzyme gamma-glutamyl transferase (GGT), aspartate transaminase (AST), and alanine transaminase (ALT).
Absence of any HDD
Measured by Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels
Cost-Efficacy
Examine the cost-efficacy between NAC and placebo from both health sector and societal perspectives. Measured by Disability-Adjusted Life Years (DALYs)
Changes in Alcohol Craving
As measured by the Alcohol Craving Experience Questionnaire (ACEQ). Higher scores indicate more severe craving.
Mean alcohol consumption per drinking day
Measured by Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels
Change in dependence Severity
Measured by the Alcohol Dependence Scale. The minimum score is 0 and the maximum score is 47. A higher score indicates more severe dependence.
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University of Sydney
Lead sponsor
Monash University
Collaborator
