The Effect Of Methadone-Naloxone Maintenance Therapy On Opioid Use Behaviours In Individuals With An Opioid Use Disorder

Western Sydney Local Health District Drug Health0 sites45 target enrollmentJuly 12, 2021

Overview

No summary available.

Registry

who.int

Start Date

July 12, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Western Sydney Local Health District Drug Health

•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.

•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