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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
Scientific title
A Randomised Controlled Trial of N-acetylcysteine for the Management of Alcohol Use Disorder
Secondary ID [1] 0 0
X21-0342
Universal Trial Number (UTN)
Trial acronym
NAC-AUD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol Use Disorder (AUD) 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Addiction
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Heavy Drinking Days
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Changes in Liver Function
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Absence of any HDD
Timepoint [2] 0 0
24 weeks

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
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/02/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Drug Health Services, Royal Prince Alfred Hospital - Sydney
Recruitment hospital [2] 0 0
Cornwall Street Medical Centre (UQ Health Care) - Annerley
Recruitment hospital [3] 0 0
Turning Point - Richmond
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
4103 - Annerley
Recruitment postcode(s) [3] 0 0
3121 - Richmond

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05408247
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Kirsten Morley, PhD
Address 0 0
Country 0 0
Phone 0 0
61295153636
Fax 0 0
Email 0 0
Kirsten.morley@sydney.edu.au
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05408247