Status:
UNKNOWN
Community Studies of Long Acting Buprenorphine (CoLAB)
Lead Sponsor:
The University of New South Wales
Conditions:
Opioid Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Despite research demonstrating the efficacy of buprenorphine (BPN), effectiveness in real-world settings has been limited by shorter retention than for methadone, and the need for daily or near-daily ...
Detailed Description
Opioid agonist treatment (OAT) is effective for opioid dependence and newer extended-release buprenorphine (BUP-XR) injections represent a significant development. The Community Long-Acting Buprenorph...
Eligibility Criteria
Inclusion
- The study population is individuals diagnosed with opioid dependence who are currently receiving sublingual buprenorphine treatment at participating drug and alcohol services, express interest in receiving depot buprenorphine injections and are deemed suitable for treatment with RBP-6000 by the Investigator.
- Inclusion criteria
- To be eligible for the study, participants must meet all of the following inclusion criteria:
- Voluntarily signed the informed consent form
- Aged 18 to 65 years
- Opioid-dependent (ICD-10) currently receiving treatment
- Has been receiving 8-32mg sublingual buprenorphine +/- naloxone tablets/film for at least 7 days
- Negative pregnancy test at screening and baseline in females of childbearing potential (please refer to Section 5.7 for long acting reversible contraceptive methods with efficacy considered to reasonably eliminate pregnancy potential)
- Exclusion criteria
- Participants who meet any of the exclusion criteria are not to be enrolled in this study:
- Currently lactating or pregnant, or of childbearing potential and not willing to avoid becoming pregnant during the study
- History or presence of allergic or adverse response (including rash or anaphylaxis) to buprenorphine or the ATRIGEL® Delivery System
- Significant, medical or psychiatric conditions (other than opioid dependence), or other circumstances which, in the opinion of the Investigator, would compromise compliance with the protocol and/or patient safety. Specific conditions of interest include severe hepatic disease (Child-Pugh Class B), severe renal or respiratory disease, or severe cognitive impairment or psychiatric condition that impairs the ability to provide informed consent (e.g. psychosis, delirium, hypomania, severe depression or suicidal ideation)
- Subjects who are currently participating in any other clinical study involving investigational medication(s)
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
Exclusion
Key Trial Info
Start Date :
May 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03809143
Start Date
May 22 2019
End Date
March 30 2021
Last Update
March 5 2020
Active Locations (6)
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1
Drug and Alcohol Services, Hunter New England Local Health District
Newcastle, New South Wales, Australia, 2300
2
Drug and Alcohol Services, North Sydney Local Health District
Saint Leonards, New South Wales, Australia, 2065
3
Drug and Alcohol Services, South Australia (DASSA)
Morphett Vale, South Australia, Australia, 5162
4
Western Health Drug Services, Footscray Hospital
Footscray, Victoria, Australia, 3011