ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Opioid Dependence

Addiction

Condition category

Condition code

Mental Health

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]

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]

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]

Baseline, and 4, 8, and 12 (primary time point) weeks post-intervention commencement.

Secondary outcome [1]

change in quality of life in patients with opioid dependence.as assessed with ISLA

Timepoint [1]

Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.

Secondary outcome [2]

- change in Opioid-Related Behaviours in Treatment as assessed with ORBIT

Timepoint [2]

Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.

Secondary outcome [3]

- change in Opiate injection behaviour as assessed with OTI-I

Timepoint [3]

Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.

Secondary outcome [4]

- change in patient satisfaction with treatment as assessed with VAS

Timepoint [4]

Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.

Secondary outcome [5]

- change in illicit drug use other than opioids as assessed with TLFB-7

Timepoint [5]

Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.

Secondary outcome [6]

- change in patient functioning as assessed with EQ-5D

Timepoint [6]

Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.

Secondary outcome [7]

- change in social functioning, health and as assessed with SF-12

Timepoint [7]

Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.

Secondary outcome [8]

- change in criminal activity as assessed with OTI-C

Timepoint [8]

Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.

Secondary outcome [9]

- change in opioid withdrawal symptoms as assessed with COWS

Timepoint [9]

Secondary Objectives will be assessed every 4 weeks as a baseline, week 4, week 8, and week 12.

Secondary outcome [10]

-change in opioid cravings as assessed with VAS

Timepoint [10]

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]

Government body

Name [1]

Western Sydney Local Health District Drug Health

Address [1]

Western Sydney Local Health District Drug Health
Building 83, Cumberland Hospital 5 Fleet Street, North Parramatta NSW 2151 Australia

Country [1]

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]

Commercial sector/Industry

Name [1]

BioMed

Address [1]

PO Box 44069
Auckland 1246
New Zealand

Country [1]

Australia

Secondary sponsor category [2]

Government body

Name [2]

Western Sydney Local Health District Drug Health

Address [2]

Western Sydney Local Health District Drug Health
Building 83, Cumberland Hospital 5 Fleet Street, North Parramatta NSW 2151 Australia

Country [2]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Western Sydney Local Health District Research Office

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

10/02/2025

Approval date [1]

Ethics approval number [1]

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

Dr Robert Graham

Address

Western Sydney Local Health District Drug Health Building 83, Cumberland Hospital 5 Fleet Street, North Parramatta NSW 2151 Australia

Country

Australia

Phone

+61 418474533

Fax

Email

Robert.Graham@health.nsw.gov.au

Contact person for public queries

Name

Meryem Jefferies

Address

Western Sydney Local Health District Drug Health Building 83, Cumberland Hospital 5 Fleet Street, North Parramatta NSW 2151 Australia

Country

Australia

Phone

+61 478 168 518

Fax

Email

Meryem.Jefferies@health.nsw.gov.au

Contact person for scientific queries

Name

Meryem Jefferies

Address

Western Sydney Local Health District Drug Health Building 83, Cumberland Hospital 5 Fleet Street, North Parramatta NSW 2151 Australia

Country

Australia

Phone

+61 478168518

Fax

Email

Meryem.Jefferies@health.nsw.gov.au

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.	Type	Citation	Link	Email	Other Details	Attachment
11216	Study protocol					379073-(Uploaded-30-03-2021-11-45-14)-Study-related document.docx

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.