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

NCT ID: NCT05408247

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-16
• Study Completion Date: 2026-11-30

Brief Summary

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

Detailed 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.

Conditions

Alcohol Use Disorder (AUD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

N-acetyl Cysteine

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.

Group Type: EXPERIMENTAL

N-acetyl cysteine

Intervention Type: DRUG

2400mg/day

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matched placebo

Interventions

N-acetyl cysteine

2400mg/day

Intervention Type: DRUG

Placebo

Matched placebo

Intervention Type: DRUG

Other Intervention Names

NAC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Monash University

OTHER

Sponsor Role: collaborator

University of Sydney

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Drug Health Services, Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Site Status: RECRUITING

Cornwall Street Medical Centre (UQ Health Care)

Annerley, Queensland, Australia

Site Status: NOT_YET_RECRUITING

Turning Point

Richmond, Victoria, Australia

Site Status: ACTIVE_NOT_RECRUITING

Countries

Australia

Central Contacts

Kirsten Morley, PhD

Role: CONTACT

Kirsten.morley@sydney.edu.au

61295153636

Paul Haber, MBBS

Role: CONTACT

paul.haber@sydney.edu.au

Facility Contacts

Kirsten Morley

Role: primary

Kirsten.morley@sydney.edu.au

Paul Clark, MBBS

Role: primary

paul.j.clark@uq.edu.au

References

Morley K, Arunogiri S, Connor JP, Clark PJ, Chatterton ML, Baillie A, Slade T, Berk M, Lubman D, Haber PS. N-acetyl cysteine for the treatment of alcohol use disorder: study protocol for a multi-site, double-blind randomised controlled trial (NAC-AUD study). BMJ Open. 2025 Sep 8;15(9):e091631. doi: 10.1136/bmjopen-2024-091631.

Reference Type: DERIVED

PMID: 40921646 (View on PubMed)

Other Identifiers

X21-0342

Identifier Type: -

Identifier Source: org_study_id