A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder (NAC-AUD)

University of Sydney

Status and phase: Enrolling; Phase 4

Conditions: Alcohol Use Disorder (AUD)

Treatments: Drug: N-acetyl cysteine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05408247

X21-0342

Details and patient eligibility

About

To explore the effectiveness of n-acetylcysteine in improving treatment outcomes for alcohol use disorder in a double-blind randomised placebo-controlled trial.

Full description

Australia urgently requires new treatment strategies for the treatment of alcohol dependence. Although alcohol use disorders are a leading cause of preventable death in Australia, their treatment is generally not evidence based. The medications currently approved for use in Australia for the management of alcohol dependence have limited efficacy, and existing research does not address the heterogeneity of treatment response. Targeted personalised medicine addresses this heterogeneity with better medicine selection for patients based on their genotype and clinical comorbidities.

Following on from a recent pilot study conducted by CI Morley (NCT03879759), this project will evaluate the clinical efficacy and tolerability of NAC, relative to a placebo, in heavy drinkers. We hypothesise that NAC-treated participants will be better able to achieve a reduction in heavy drinking. We will utilise a double-blind, randomised, controlled design. A sample of 280 individuals will receive 12 weeks of treatment with NAC (2400 mg/day) or placebo.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

280 participants in 2 patient groups, including a placebo group

N-acetyl Cysteine

Experimental group

Description:

Generic name: N-acetyl cysteine. Brand: ACC-600 (Acetylcysteine). Strength: 600mg per capsule. Form: capsule Route: oral Frequency: 2x capsules twice per day = total 4 capsules/day Duration: 12 weeks + Standard of Care: Medical Management.

Treatment:

Drug: N-acetyl cysteine

Placebo

Placebo Comparator group

Description:

Matched placebo Generic name: dicalcium phosphate Strength: 600mg per capsule Form: capsule Route: oral Frequency: 2x capsules twice per day = total 4 capsules/day Duration: 12 weeks. + Standard of Care: Medical Management.

Treatment:

Drug: Placebo