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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

Journal Article


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Abstract


  • © 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. 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.

Authors


  •   Larance, Briony
  •   Byrne, Marianne (external author)
  •   Lintzeris, Nicholas (external author)
  •   Nielsen, Suzanne (external author)
  •   Grebely, Jason (external author)
  •   Degenhardt, Louisa (external author)
  •   Shahbazi, Jeyran (external author)
  •   Shanahan, Marian (external author)
  •   Lancaster, Kari (external author)
  •   Dore, Gregory J. (external author)
  •   Ali, Robert (external author)
  •   Farrell, Michael (external author)

Publication Date


  • 2020

Citation


  • Larance, B., Byrne, M., Lintzeris, N., Nielsen, S., Grebely, J., Degenhardt, L., Shahbazi, J., Shanahan, M., Lancaster, K., Dore, G., Ali, R. & Farrell, M. (2020). Open-label, multicentre, single-arm trial of monthly injections of depot buprenorphine in people with opioid dependence: protocol for the CoLAB study. BMJ Open, 10 (7), e034389.

Scopus Eid


  • 2-s2.0-85089126645

Ro Full-text Url


  • https://ro.uow.edu.au/cgi/viewcontent.cgi?article=1114&context=asshpapers

Ro Metadata Url


  • http://ro.uow.edu.au/asshpapers/108

Start Page


  • e034389

Volume


  • 10

Issue


  • 7

Place Of Publication


  • United Kingdom

Abstract


  • © 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. 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.

Authors


  •   Larance, Briony
  •   Byrne, Marianne (external author)
  •   Lintzeris, Nicholas (external author)
  •   Nielsen, Suzanne (external author)
  •   Grebely, Jason (external author)
  •   Degenhardt, Louisa (external author)
  •   Shahbazi, Jeyran (external author)
  •   Shanahan, Marian (external author)
  •   Lancaster, Kari (external author)
  •   Dore, Gregory J. (external author)
  •   Ali, Robert (external author)
  •   Farrell, Michael (external author)

Publication Date


  • 2020

Citation


  • Larance, B., Byrne, M., Lintzeris, N., Nielsen, S., Grebely, J., Degenhardt, L., Shahbazi, J., Shanahan, M., Lancaster, K., Dore, G., Ali, R. & Farrell, M. (2020). Open-label, multicentre, single-arm trial of monthly injections of depot buprenorphine in people with opioid dependence: protocol for the CoLAB study. BMJ Open, 10 (7), e034389.

Scopus Eid


  • 2-s2.0-85089126645

Ro Full-text Url


  • https://ro.uow.edu.au/cgi/viewcontent.cgi?article=1114&context=asshpapers

Ro Metadata Url


  • http://ro.uow.edu.au/asshpapers/108

Start Page


  • e034389

Volume


  • 10

Issue


  • 7

Place Of Publication


  • United Kingdom