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

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dc.contributor.authorLarance, B.
dc.contributor.authorByrne, M.
dc.contributor.authorLintzeris, N.
dc.contributor.authorNielsen, S.
dc.contributor.authorGrebely, J.
dc.contributor.authorDegenhardt, L.
dc.contributor.authorShahbazi, J.
dc.contributor.authorShanahan, M.
dc.contributor.authorLancaster, K.
dc.contributor.authorDore, G.
dc.contributor.authorAli, R.
dc.contributor.authorFarrell, M.
dc.contributor.authorCoLAB study team,
dc.date.issued2020
dc.description.abstractIntroduction: 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.
dc.description.statementofresponsibilityBriony Larance, Marianne Byrne, Nicholas Lintzeris, Suzanne Nielsen, Jason Grebely, Louisa Degenhardt, Jeyran Shahbazi, Marian Shanahan, Kari Lancaster, Gregory Dore, Robert Ali, Michael Farrell, On behalf of the CoLAB study team
dc.identifier.citationBMJ Open, 2020; 10(7):e034389-1-e034389-10
dc.identifier.doi10.1136/bmjopen-2019-034389
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.orcidAli, R. [0000-0003-2905-8153]
dc.identifier.urihttps://hdl.handle.net/2440/145318
dc.language.isoen
dc.publisherBMJ Publishing Group
dc.rights© 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. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http:// creativecommons. org/ licenses/ by- nc/ 4. 0/
dc.source.urihttps://doi.org/10.1136/bmjopen-2019-034389
dc.subjectbuprenorphine; drug dependence; extended release formulation; opiate medication-assisted treatment; opioid dependence
dc.subject.meshHumans
dc.subject.meshOpioid-Related Disorders
dc.subject.meshBuprenorphine
dc.subject.meshNarcotic Antagonists
dc.subject.meshProspective Studies
dc.subject.meshNew South Wales
dc.subject.meshSouth Australia
dc.subject.meshVictoria
dc.subject.meshMulticenter Studies as Topic
dc.titleOpen-label, multicentre, single-arm trial of monthly injections of depot buprenorphine in people with opioid dependence: protocol for the CoLAB study.
dc.typeJournal article
pubs.publication-statusPublished online

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