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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Sydney

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • N-acetyl cysteine
  • Placebo

Treatment groups

280 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Sydney

Lead sponsor

Monash University

Collaborator