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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of SON-1010 as a single-ascending dose (SAD) in healthy adults.
Timepoint [1] 0 0
Study Duration - Week 1 on Day 1, 2, 3 ,4, 5. Follow-Up on Day 8, 10, 12, 15, 22, 29

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)

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

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/study/NCT05408247
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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
[email protected]
Contact person for scientific queries



Summary Results

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