Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000902796
Ethics application status
Approved
Date submitted
18/06/2022
Date registered
24/06/2022
Date last updated
24/06/2022
Date data sharing statement initially provided
24/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of N-Acetylcysteine for loss of control eating: an open-label study
Scientific title
Feasibility and preliminary efficacy of N-Acetylcysteine for loss of control eating: an open-label study
Secondary ID [1] 306673 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
loss of control eating 325614 0
Condition category
Condition code
Mental Health 322971 322971 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
N-Acetylcysteine (NAC) intervention will be taken orally as capsules at a daily dose of 2400 mg for 12 weeks (2 capsules of 600mg, twice daily). The 10-item Medication Adherence Rating Scale as well as pill count at the end of week 6 and 12 will be used to determine compliance with the study medication.
Intervention code [1] 323115 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330740 0
Participant recruitment rate. Data is collected from study record.
Timepoint [1] 330740 0
12 weeks after intervention commencement
Primary outcome [2] 331768 0
Retention rate. Data is collected from study record.
Timepoint [2] 331768 0
12 weeks after intervention commencement
Primary outcome [3] 331769 0
Adherence to the intervention assessed using capsule count and The Medication Adherence Rating Scale
Timepoint [3] 331769 0
6 and 12 weeks after intervention commencement
Secondary outcome [1] 407390 0
Change in the degree of loss of control of eating [Eating Loss of Control Scale] from baseline to week 12.
Timepoint [1] 407390 0
Baseline and 12 weeks after intervention commencement

Eligibility
Key inclusion criteria
- Adult (age >18 years) with loss of control eating, defined as at least one episode of loss of control eating in the past month as assessed using the Eating Loss of Control Scale
- Negative pregnancy test at baseline for participants of childbearing potential
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Participant with cognitive impairment which will hinder their ability to provide informed consent or to complete the surveys
- Participants who are pregnant or lactating or planning to become pregnant during the study
- Use of any medication containing N-Acetylcysteine or other contraindicated medications within 4 weeks prior to enrolment,
- Known previous hypersensitivity to N-Acetylcysteine
- Any serious medical illness that N-Acetylcysteine may adversely affect.
- Surgery within the past 28 days
- Currently using or planning to use a formal weight loss program during the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2024
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 311004 0
University
Name [1] 311004 0
The University of Melbourne
Country [1] 311004 0
Australia
Primary sponsor type
University
Name
Florey Institute of Neuroscience and Mental Health
Address
30 Royal Parade, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 313080 0
None
Name [1] 313080 0
Address [1] 313080 0
Country [1] 313080 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310555 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 310555 0
Human Research Ethics
Office of Research Ethics and Integrity
Level 5, Alan Gilbert Building, 161 Barry St, Carlton
The University of Melbourne, Victoria, 3010, Australia
Ethics committee country [1] 310555 0
Australia
Date submitted for ethics approval [1] 310555 0
21/02/2022
Approval date [1] 310555 0
06/06/2022
Ethics approval number [1] 310555 0

Summary
Brief summary
A single site, open-label pilot study to examine the feasibility of a randomised controlled trial of N-Acetylcysteine (NAC) on loss of control eating. All eligible participants will receive NAC orally at a daily dose of 2400 mg for 12 weeks. Outcome assessment will be made at baseline and at 12 week using questionnaires and ecological momentary assessment (EMA)
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118066 0
Dr Andrea Gogos
Address 118066 0
The Florey Institute of Neuroscience and Mental health
30 Royal Parade, Parkville VIC 3052
Country 118066 0
Australia
Phone 118066 0
+61401621380
Fax 118066 0
Email 118066 0
[email protected]
Contact person for public queries
Name 118067 0
Muthmainah
Address 118067 0
The Florey Institute of Neuroscience and Mental health
30 Royal Parade, Parkville VIC 3052
Country 118067 0
Australia
Phone 118067 0
+613 9035 3000
Fax 118067 0
Email 118067 0
[email protected]
Contact person for scientific queries
Name 118068 0
Muthmainah
Address 118068 0
The Florey Institute of Neuroscience and Mental health
30 Royal Parade, Parkville VIC 3052
Country 118068 0
Australia
Phone 118068 0
+613 9035 3000
Fax 118068 0
Email 118068 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not applicable for feasibility study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.