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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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.