Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
100 participants
INTERVENTIONAL
2019-05-22
2021-03-30
Brief Summary
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Current formulations include six-monthly implants, and once-weekly or once-monthly injections, removing the need for frequent clinic or pharmacy attendance. Improved medication adherence may result in improved patient outcomes and fewer unintended consequences such as diversion, but more data are needed in real-world settings. These innovations have the potential to dramatically change the treatment settings and options for people who are opioid dependent.
The study aims to evaluate the patient outcomes following the implementation of a monthly BPN depot injection for the treatment of opioid dependence in community-based treatment settings with a focus on opioid and other illicit drug use, adherence and retention, and participants' experiences of the implementation.
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Detailed Description
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The CoLAB study is a prospective single-arm, multicentre, open-label trial of monthly BUP-XR injections in people with opioid dependence. Participants are being recruited from a network of general practitioner and specialist drug treatment services located in the states of New South Wales, Victoria and South Australia in Australia. Following a minimum 7 days on 8-32mg of sublingual buprenorphine (+/- naloxone), participants will receive monthly subcutaneous BUP-XR injections administered by a healthcare practitioner at intervals of 28 days (-2/+14 days). The primary endpoint is participant retention in treatment at 48 weeks after treatment initiation. Secondary endpoints will evaluate dosing schedule variations, craving, withdrawal, substance use, health and well-being, and client-reported treatment experience. Qualitative and costing sub-studies will examine implementation barriers and facilitators at the client and provider level.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Depot buprenorphine arm
All participants will receive monthly injections of depot buprenorphine (RBP-6000, Sublocade)
RBP-6000
All study participants are scheduled to receive monthly subcutaneous injections of depot BPN, RBP-6000. RBP-6000 (BPN in the ATRIGEL® Delivery System) contains buprenorphine (200mg/mL) in the ATRIGEL® Delivery System, which provides sustained plasma level of BPN over a minimum of 28 days.
Interventions
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RBP-6000
All study participants are scheduled to receive monthly subcutaneous injections of depot BPN, RBP-6000. RBP-6000 (BPN in the ATRIGEL® Delivery System) contains buprenorphine (200mg/mL) in the ATRIGEL® Delivery System, which provides sustained plasma level of BPN over a minimum of 28 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged 18 to 65 years
3. Opioid-dependent (ICD-10) currently receiving treatment
4. Has been receiving 8-32mg sublingual buprenorphine +/- naloxone tablets/film for at least 7 days
5. 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
2. History or presence of allergic or adverse response (including rash or anaphylaxis) to buprenorphine or the ATRIGEL® Delivery System
3. 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)
4. Subjects who are currently participating in any other clinical study involving investigational medication(s)
5. Inability or unwillingness to provide informed consent or abide by the requirements of the study
18 Years
65 Years
ALL
No
Sponsors
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The University of New South Wales
OTHER
Responsible Party
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Marianne Byrne
Clinical Trials Manager, National Drug and Alcohol Research Centre
Principal Investigators
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Michael Farrell
Role: PRINCIPAL_INVESTIGATOR
National Drug and Alcohol Centre, University of New South Wales
Locations
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Drug and Alcohol Services, Hunter New England Local Health District
Newcastle, New South Wales, Australia
Drug and Alcohol Services, North Sydney Local Health District
Saint Leonards, New South Wales, Australia
Drug and Alcohol Services, South Australia (DASSA)
Morphett Vale, South Australia, Australia
Western Health Drug Services, Footscray Hospital
Footscray, Victoria, Australia
Frankston Healthcare
Frankston, Victoria, Australia
Rankin Court Treatment Centre, St Vincent's Hospital Sydney
Darlinghurst, , Australia
Countries
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References
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Farrell M, Shahbazi J, Byrne M, Grebely J, Lintzeris N, Chambers M, Larance B, Ali R, Nielsen S, Dunlop A, Dore GJ, McDonough M, Montebello M, Nicholas T, Weiss R, Rodgers C, Cook J, Degenhardt L; CoLAB study team. Outcomes of a single-arm implementation trial of extended-release subcutaneous buprenorphine depot injections in people with opioid dependence. Int J Drug Policy. 2022 Feb;100:103492. doi: 10.1016/j.drugpo.2021.103492. Epub 2021 Nov 1.
Larance B, Byrne M, Lintzeris N, Nielsen S, Grebely J, Degenhardt L, Shahbazi J, Shanahan M, Lancaster K, Dore G, Ali R, Farrell M; CoLAB study team. Open-label, multicentre, single-arm trial of monthly injections of depot buprenorphine in people with opioid dependence: protocol for the CoLAB study. BMJ Open. 2020 Jul 31;10(7):e034389. doi: 10.1136/bmjopen-2019-034389.
Other Identifiers
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CoLAB1801
Identifier Type: -
Identifier Source: org_study_id
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