Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000899842p
Ethics application status
Not yet submitted
Date submitted
30/03/2021
Date registered
12/07/2021
Date last updated
24/08/2023
Date data sharing statement initially provided
12/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title

A Novel Opioid Treatment Program In Individuals With An Opioid Use Disorder
Scientific title
The Effect Of Methadone-Naloxone Maintenance Therapy On Opioid Use Behaviours In Individuals With An Opioid Use Disorder
Secondary ID [1] 300283 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid Dependence 321355 0
Addiction 321357 0
Condition category
Condition code
Mental Health 319136 319136 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a) the dose administered will be 5 mg/ml methadone + 0.1 mg/ml naloxone. Total daily dose will be decided by Study Doctor based on patient's medical assessment.
b) the duration of administration will be 12 weeks.
c) the mode of administration will be oral syrup form.
d) first dose will be given to the participant at the clinic and the participant will be observed for 1 hour to manage any immediate adverse event.
Intervention code [1] 320136 0
Treatment: Drugs
Comparator / control treatment
a) the dose administered will be 5 mg/ml methadone.Total daily dose will be decided by Study Doctor based on patient's medical assessment.
b) the duration of administration will be 12 weeks.
c) the mode of administration will be oral liquid form.
d) first dose will be given to the participant at the clinic and the participant will be observed for 1 hour to manage any immediate adverse event.
Control group
Active

Outcomes
Primary outcome [1] 327020 0

Change in drug injection behaviour assessed by a composite of Injection site assessment, modified Opioid-Related Behaviours In Treatment (ORBIT) and modified Opiate treatment index injection (OTI-I).
Timepoint [1] 327020 0
Baseline, and 4, 8, and 12 (primary time point) weeks post-intervention commencement.
Secondary outcome [1] 393475 0
change in quality of life in patients with opioid dependence.as assessed with ISLA
Timepoint [1] 393475 0
Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.
Secondary outcome [2] 398059 0

- change in Opioid-Related Behaviours in Treatment as assessed with ORBIT
Timepoint [2] 398059 0
Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.
Secondary outcome [3] 398060 0
- change in Opiate injection behaviour as assessed with OTI-I
Timepoint [3] 398060 0
Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.
Secondary outcome [4] 398061 0
- change in patient satisfaction with treatment as assessed with VAS
Timepoint [4] 398061 0
Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.
Secondary outcome [5] 398062 0
- change in illicit drug use other than opioids as assessed with TLFB-7
Timepoint [5] 398062 0
Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.
Secondary outcome [6] 398063 0
- change in patient functioning as assessed with EQ-5D
Timepoint [6] 398063 0
Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.
Secondary outcome [7] 398065 0

- change in social functioning, health and as assessed with SF-12
Timepoint [7] 398065 0
Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.
Secondary outcome [8] 398066 0

- change in criminal activity as assessed with OTI-C
Timepoint [8] 398066 0
Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.
Secondary outcome [9] 398067 0

- change in opioid withdrawal symptoms as assessed with COWS
Timepoint [9] 398067 0
Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.
Secondary outcome [10] 398068 0

-change in opioid cravings as assessed with VAS
Timepoint [10] 398068 0
Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.

Eligibility
Key inclusion criteria
Inclusion Criteria
Patients meeting all of the following criteria will be eligible to participate in the clinical trial:
1. Able to provide written informed consent to participate in the trial and able to understand the procedures and trial requirements
2. Willingness and ability to comply with the protocol
3. Adult male or female patient > 18 years old
4. Meet the criteria for opioid dependence as defined by either the criteria for moderate to severe opioid use disorder in the Diagnostic and Statistical Manual of Mental Disorders – 5th Edition (DSM-5) OR opioid dependence in the International Statistical Classification of Diseases and Related Health Problems – 10th Edition (ICD-11) according to local practice
5. Female patients of childbearing potential must be willing to use a highly effective method of contraception during the entire trial
6. At least 4 weeks on methadone before enrolling in the study
7. At least 21 days of last 28 days attendance of Methadone maintaining program.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients meeting any of the following criteria will not be eligible to participate in the clinical trial:
1.Known mental incapacity or language barriers precluding adequate understanding of the informed consent information and the trial activities
2. Patient is pregnant, lactating, or planning to be pregnant during the trial
3. Unwilling or unable to comply with the requirements of the protocol (e.g. current or pending incarceration) or are in a situation or condition that, in the opinion of the Investigator, may interfere with participation in the trial
4. Participating in any other clinical trial in which medication(s) are being delivered or have used an investigational drug or device within the last 30 days before screening
5. Any known allergy, hypersensitivity or intolerance to Naloxone or any related drug, or history of any drug hypersensitivity or intolerance which in the opinion of the Investigator, would compromise the safety of the patient or the trial
6. Severe respiratory insufficiency
7. Severe hepatic insufficiency
8. Any other contra-indicated serious medical condition, including unstable mental condition and severe pain, which in the opinion of the investigator may prevent the patient from safely participating in the trial

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2026
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 304705 0
Government body
Name [1] 304705 0
Western Sydney Local Health District Drug Health
Country [1] 304705 0
New Zealand
Primary sponsor type
Government body
Name
Western Sydney Local Health District Drug Health
Address
Western Sydney Local Health District Drug Health
Building 83, Cumberland Hospital 5 Fleet Street, North Parramatta NSW 2151 Australia
Country
Australia
Secondary sponsor category [1] 305020 0
Commercial sector/Industry
Name [1] 305020 0
BioMed
Address [1] 305020 0
PO Box 44069
Auckland 1246
New Zealand
Country [1] 305020 0
Australia
Secondary sponsor category [2] 309020 0
Government body
Name [2] 309020 0
Western Sydney Local Health District Drug Health
Address [2] 309020 0
Western Sydney Local Health District Drug Health
Building 83, Cumberland Hospital 5 Fleet Street, North Parramatta NSW 2151 Australia
Country [2] 309020 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305131 0
Western Sydney Local Health District Research Office
Ethics committee address [1] 305131 0
This trial has not been submitted for Ethics approval. Ethics application will be submitted after obtaining Clinical trial number.

Western Sydney Local Health District Human Research Ethics Committee

Westmead Hospital, Cnr Hawkesbury & Darcy Rds, Westmead NSW 2145
Ethics committee country [1] 305131 0
Australia
Date submitted for ethics approval [1] 305131 0
10/02/2025
Approval date [1] 305131 0
Ethics approval number [1] 305131 0

Summary
Brief summary

Currently, opioid dependency has been managed with methadone treatment per NSW Health Clinical guidelines treatment of opioid dependence. Patients are attending the clinic every day to get treatment. Methadone takes away doses creates a risk of injection and harming others.


There is a need for a new medication to maintain opioid dependence and also provide takeaway doses safely. New medication will help to minimize intravenous methadone use and harming others. The Methadone Naloxone (M&Nx) has a potential medication to maintain opioid dependence and will be given as taking away doses in this study.

The (M&Nx) has been tested in a patient group with opioid dependence. In this study, patients with opioid dependence were given M&Nx at different doses according to the patient’s condition and the Specialist Doctor's decision. M&Nx at 50:1 was tested for acceptability, safety, and tolerability at Drug Health Clinic and the medication was well tolerated. The clinical trial phases 1 a and 1 b for M&Nx were performed by applying multiple doses to the patients with opioid dependence.


M&Nx medication needs to be investigated further to identify the utility of treatment in Drug Health clinical settings by Clinical trial phase 2a. This study aims to use M&Nx to increase the quality of patient life with enhanced harm reduction.


Opioid prescribing has increased significantly, and diversion of prescribed opioids has become a major problem of drug misuse. Combining M&Nx treatment may reduce the attractiveness of selling, diverting, or injecting methadone.

This trial intends to study M&Nx in the treatment of adult outpatients with opioid dependence to minimize infection transmission in the drug health clinic setting. The study aimed to promote a better approach for patients by offering potential advantages over methadone maintenance alone such as minimizing the risks of diversion, injection, and selling in the black market.

Primary Objectives
To compare feasibility and harm reduction of M&Nx to methadone alone standard of care in adult outpatients with opioid dependence.

Secondary Objectives

a)To assess patient satisfaction with treatment
b) To assess treatment effects on illicit drug use other than opioids
c) To assess treatment effects on quality of life and patient functioning
Trial website
Trial related presentations / publications
Public notes
This study is also relevant for COVID-19 restriction rule. Currently, opioid dependency has been managed with methadone treatment per NSW Health Clinical guidelines treatment of opioid dependence. Patients are attending the clinic every day to get treatment. During the COVID-19 pandemic, take away dose was required to maintain patients with opioid dependence and also reduce infection transmission. Methadone takeaway doses were provided for the patients as per WSLHD Drug Health policy temporarily. Methadone takes away doses creates a risk of injection and harming others.


There is a need for a new medication to maintain opioid dependence and also provide takeaway doses safely. New medication will help to minimize intravenous methadone use and harming others. The Methadone Naloxone (M&Nx) has a potential medication to maintain opioid dependence and will be given as taking away doses in this study.

Contacts
Principal investigator
Name 99350 0
Dr Robert Graham
Address 99350 0
Western Sydney Local Health District Drug Health Building 83, Cumberland Hospital 5 Fleet Street, North Parramatta NSW 2151 Australia
Country 99350 0
Australia
Phone 99350 0
+61 418474533
Fax 99350 0
Email 99350 0
[email protected]
Contact person for public queries
Name 99351 0
Dr Meryem Jefferies
Address 99351 0
Western Sydney Local Health District Drug Health Building 83, Cumberland Hospital 5 Fleet Street, North Parramatta NSW 2151 Australia
Country 99351 0
Australia
Phone 99351 0
+61 478 168 518
Fax 99351 0
Email 99351 0
[email protected]
Contact person for scientific queries
Name 99352 0
Dr Meryem Jefferies
Address 99352 0
Western Sydney Local Health District Drug Health Building 83, Cumberland Hospital 5 Fleet Street, North Parramatta NSW 2151 Australia
Country 99352 0
Australia
Phone 99352 0
+61 478168518
Fax 99352 0
Email 99352 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11216Study protocol    379073-(Uploaded-30-03-2021-11-45-14)-Study-related document.docx



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.