TY - JOUR
T1 - Open-label, multicentre, single-arm trial of monthly injections of depot buprenorphine in people with opioid dependence
T2 - Protocol for the CoLAB study
AU - Larance, Briony
AU - Byrne, Marianne
AU - Lintzeris, Nicholas
AU - Nielsen, Suzanne
AU - Grebely, Jason
AU - Degenhardt, Louisa
AU - Shahbazi, Jeyran
AU - Shanahan, Marian
AU - Lancaster, Kari
AU - Dore, Gregory
AU - Ali, Robert
AU - Farrell, Michael
N1 - Funding Information:
Funding This study is sponsored by the National Drug and Alcohol Research Centre, University of New South Wales, Sydney Australia. The Study is supported by an Externally Sponsored Collaborative Research grant from Indivior. Indivior contributed to the study design and analysis plan. Indivior is supplying its BUP-XR product, Sublocade, for all study participants.
Publisher Copyright:
© 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.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/7/31
Y1 - 2020/7/31
N2 - 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
AB - 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
KW - buprenorphine
KW - drug dependence
KW - extended release formulation
KW - opiate medication-assisted treatment
KW - opioid dependence
UR - http://www.scopus.com/inward/record.url?scp=85089126645&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2019-034389
DO - 10.1136/bmjopen-2019-034389
M3 - Article
C2 - 32737087
AN - SCOPUS:85089126645
SN - 2044-6055
VL - 10
JO - BMJ Open
JF - BMJ Open
IS - 7
M1 - e034389
ER -