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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05408247
Registration number
NCT05408247
Ethics application status
Date submitted
2/06/2022
Date registered
7/06/2022
Date last updated
16/03/2023
Titles & IDs
Public title
A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
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Scientific title
A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
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Secondary ID [1]
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X21-0342
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Universal Trial Number (UTN)
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Trial acronym
NAC-AUD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorder (AUD)
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Condition category
Condition code
Mental Health
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Addiction
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - N-acetyl cysteine
Treatment: Drugs - Placebo
Experimental: 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.
Placebo Comparator: 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.
Treatment: Drugs: N-acetyl cysteine
2400mg/day
Treatment: Drugs: Placebo
Matched placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Heavy Drinking Days
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Assessment method [1]
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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
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Timepoint [1]
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24 weeks
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Secondary outcome [1]
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Changes in Liver Function
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Assessment method [1]
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Liver Function will be assessed through blood sample at baseline. We will measurement levels of enzyme gamma-glutamyl transferase (GGT), aspartate transaminase (AST), and alanine transaminase (ALT).
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Timepoint [1]
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24 weeks
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Secondary outcome [2]
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Absence of any HDD
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Assessment method [2]
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Measured by Timeline Follow Back and corroborated with Phosphatidylethanol (PEth) levels
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Timepoint [2]
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24 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
16/02/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2026
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Actual
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Sample size
Target
280
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Drug Health Services, Royal Prince Alfred Hospital - Sydney
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Recruitment hospital [2]
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Cornwall Street Medical Centre (UQ Health Care) - Annerley
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Recruitment hospital [3]
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Turning Point - Richmond
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Recruitment postcode(s) [1]
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2050 - Sydney
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Recruitment postcode(s) [2]
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4103 - Annerley
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Recruitment postcode(s) [3]
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3121 - Richmond
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Monash University
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05408247
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Kirsten Morley, PhD
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Address
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Country
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Phone
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61295153636
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05408247
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