A Novel Opioid Treatment Program In Individuals With An Opioid Use Disorder

Phase 2

• Conditions: Opioid Dependence; Addiction; Mental Health - Addiction

• Registration Number: ACTRN12621000899842
• Lead Sponsor: Western Sydney Local Health District Drug Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-12
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 45

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.

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>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).[Baseline, and 4, 8, and 12 (primary time point) weeks post-intervention commencement.]