NCT05408247

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for phase_4

Timeline
4mo left

Started Feb 2023

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Feb 2023Nov 2026

First Submitted

Initial submission to the registry

June 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

February 16, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

2.7 years

First QC Date

June 2, 2022

Last Update Submit

March 14, 2023

Conditions

Alcohol Use Disorder (AUD)

Keywords

N-acetyl CysteineNACAlcohol DependenceN-acetylcysteine

Outcome Measures

Primary Outcomes (1)

  • 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

    24 weeks

Secondary Outcomes (2)

  • Changes in Liver Function

    24 weeks

  • Absence of any HDD

    24 weeks

Other Outcomes (28)

  • Cost-Efficacy

    12 weeks

  • Changes in Alcohol Craving

    24 weeks

  • Mean alcohol consumption per drinking day

    24 weeks

  • +25 more other outcomes

Study Arms (2)

N-acetyl Cysteine

EXPERIMENTAL

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.

Drug: N-acetyl cysteine

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

N-acetyl cysteineDRUG

2400mg/day

Also known as: NAC
N-acetyl Cysteine
PlaceboDRUG

Matched placebo

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Drug Health Services, Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

RECRUITING

Cornwall Street Medical Centre (UQ Health Care)

Annerley, Queensland, 4103, Australia

NOT YET RECRUITING

Turning Point

Richmond, Victoria, 3121, Australia

ACTIVE NOT RECRUITING

Related Publications (1)

  • 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.

    PMID: 40921646DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Central Study Contacts

Kirsten Morley, PhD

CONTACT

61295153636Kirsten.morley@sydney.edu.au

Paul Haber, MBBS

CONTACT

paul.haber@sydney.edu.au

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind design
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 7, 2022

Study Start

February 16, 2023

Primary Completion

November 1, 2025

Study Completion (Estimated)

November 1, 2026

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(3)