Open-label, multicentre, single-arm trial of monthly injections of depot buprenorphine in people with opioid dependence: protocol for the CoLAB study

Briony Larance, Marianne Byrne, Nicholas Lintzeris, Suzanne Nielsen, Jason Grebely, Louisa Degenhardt, Jeyran Shahbazi, Marian Shanahan, Kari Lancaster, Gregory Dore, Robert Ali, Michael Farrell, CoLAB study team, Louisa Degenhardt, Nicholas Lintzeris, Briony Larance, Suzanne Nielsen, Jason Grebely, Gregory Dore, Robert Ali, Kari Lancaster, Marian Shanahan, Carla Treloar, Marianne Byrne, Jeyran Shahbazi, Stella Nalukwago, Craig Rodgers, Adrian Dunlop, Michael McDonough, Jon Cook, Mark Montebello, Michael Aufgang, Robert Weiss, Zoe Griffin, Briony Larance, Marianne Byrne, Nicholas Lintzeris, Suzanne Nielsen, Jason Grebely, Louisa Degenhardt, Jeyran Shahbazi, Marian Shanahan, Kari Lancaster, Gregory Dore, Robert Ali, Michael Farrell, CoLAB study team, Louisa Degenhardt, Nicholas Lintzeris, Briony Larance, Suzanne Nielsen, Jason Grebely, Gregory Dore, Robert Ali, Kari Lancaster, Marian Shanahan, Carla Treloar, Marianne Byrne, Jeyran Shahbazi, Stella Nalukwago, Craig Rodgers, Adrian Dunlop, Michael McDonough, Jon Cook, Mark Montebello, Michael Aufgang, Robert Weiss, Zoe Griffin

Abstract

Introduction: Opioid agonist treatment is effective for opioid dependence and newer extended-release buprenorphine (BUP-XR) injections represent a significant development. The Community Long-Acting Buprenorphine (CoLAB) study aims to evaluate client outcomes among people with opioid dependence receiving 48 weeks of BUP-XR treatment, and examines the implementation of BUP-XR in diverse community healthcare settings in Australia.

Methods and analysis: 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 8-32 mg 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 substudies will examine implementation barriers and facilitators at the client and provider level.

Ethics and dissemination: The study has received ethics approval from the St Vincent's Hospital Sydney Human Research Ethics Committee (Ref. HREC/18/SVH/221). The findings will be disseminated via publication in peer-reviewed journals, presentations at national and international scientific conferences, and in relevant community organisation publications and forums.

Trial registration number: NCT03809143 PROTOCOL IDENTIFIER: CoLAB1801, V.4.0 dated 01 August 2019.

Keywords: buprenorphine; drug dependence; extended release formulation; opiate medication-assisted treatment; opioid dependence.

Conflict of interest statement

Competing interests: Many of the investigators have received investigator-initiated, untied educational grants for opioid-related studies from: Indivior (Briony Larance, Louisa Degenhardt, Nicholas Lintzeris, Michael Farrell, Suzanne Neilsen); Reckitt Benckiser (Briony Larance, Louisa Degenhardt, Nicholas Lintzeris, Michael Farrell, Suzanne Nielsen, Robert Ali, Adrian Dunlop); Mundipharma (Briony Larance, Louisa Degenhardt, Nicholas Lintzeris, Michael Farrell); and Seqirus (Briony Larance, Louisa Degenhardt, Michael Farrell, Suzanne Nielsen).

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
CoLAB study schema. CoLAB, Community studies of Long-Acting Buprenorphine; GP, general practitioner; BUP-XR, extended-release buprenorphine.

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