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RECRUITINGPhase 4INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

N-acetyl cysteine

2400mg/day

DRUG

Placebo

Matched placebo

Locations (3)

Drug Health Services, Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
Cornwall Street Medical Centre (UQ Health Care)
Annerley, Queensland, Australia
Turning Point
Richmond, Victoria, Australia