A Novel Opioid Treatment Program In Individuals With An Opioid Use Disorder
The Effect Of Methadone-Naloxone Maintenance Therapy On Opioid Use Behaviours In Individuals With An Opioid Use Disorder
Western Sydney Local Health District Drug Health
45 participants
Jul 28, 2025
Interventional
Conditions
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
Eligibility
Inclusion Criteria8
- Patients meeting all of the following criteria will be eligible to participate in the clinical trial:
- Able to provide written informed consent to participate in the trial and able to understand the procedures and trial requirements
- Willingness and ability to comply with the protocol
- Adult male or female patient > 18 years old
- 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
- Female patients of childbearing potential must be willing to use a highly effective method of contraception during the entire trial
- At least 4 weeks on methadone before enrolling in the study
- At least 21 days of last 28 days attendance of Methadone maintaining program.
Exclusion Criteria9
- Patients meeting any of the following criteria will not be eligible to participate in the clinical trial:
- Known mental incapacity or language barriers precluding adequate understanding of the informed consent information and the trial activities
- Patient is pregnant, lactating, or planning to be pregnant during the trial
- 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
- 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
- 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
- Severe respiratory insufficiency
- Severe hepatic insufficiency
- 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
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Interventions
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.
Locations(1)
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ACTRN12621000899842