Open-label, multicentre, single-arm trial of monthly injections of depot buprenorphine in people with opioid dependence: Preliminary analysis on the CoLAB study
Presenter: Michael Farrell
Briony Larance1,2,3, Marianne Byrne1,4, Nicholas Lintzeris5,6, Suzanne Nielsen1,7, Jason Grebely4, Louisa Degenhardt1,8, Jeyran Shahbazi1, Marian Shanahan1, Kari Lancaster9, Gregory J. Dore4, Robert Ali1,10 and Michael Farrell1 on behalf of the CoLAB study team
National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, NSW, Australia
School of Psychology, University of Wollongong, Wollongong, NSW, Australia
Illawarra Health and Medical Research Institute, University of Wollongong, Wollongong, NSW, Australia
The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia
Discipline of Addiction Medicine, University of Sydney, Surry Hills, NSW, Australia
The Langton Centre, South East Sydney Local Health District, Surry Hills, NSW, Australia
Monash Addiction Research Centre and Eastern Health Clinical School, Monash University Peninsula Campus, Frankston, Victoria, Australia
School of Population and Global Health, University of Melbourne, Melbourne, Victoria Australia
Centre for Social Research in Health, UNSW Sydney, Sydney, NSW, Australia
Faculty of Health and Medical Sciences, University of Adelaide, Adelaide, South Australia, Australia
Opioid agonist treatment is effective for opioid dependence and newer extended-release buprenorphine (BUP-XR) injections represent a significant development. They are administered subcutaneously by a healthcare provider, releasing buprenorphine at a controlled rate over the dosing interval and are expected to be associated with several potential benefits such as eliminating the need to attend frequent dosing, reduce the cost to clients and providers, enhance treatment efficacy and reduce diversion.
Aims: 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: One-hundred participants were 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 received monthly subcutaneous BUP-XR injections administered by a healthcare practitioner at intervals of 28 days (−2/+14 days) as well as completing monthly research interviews. 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.
Initial interim data analysis revealed a treatment retention rate of 82% at the 6-month time point, comparably higher than the six month retention on two BUP-XR formations being 63% and 69% in phase three clinical trials and also substantially higher than the observed retention rate in routine treatment with sublingual buprenorphine.
Treatment satisfaction questionnaire for medication (TSQM) analysis at month 6 reported majority of the participants were either extremely or very satisfied with the treatment taken all things into account (78%), 19% satisfied or somewhat satisfied, while only 3% reported dissatisfaction. Overall, majority of the patients were satisfied with the convenience, time, planning requirements and current form of medication, with over 60% being extremely or very satisfied. Further analysis also revealed median value of TSQM questionnaires improving over time, highlighting significant patient satisfaction improvement as patients gain familiarity with their treatment and medication (p value < 0.001), while the experiences of side effects reduced over time.
CoLAB study will provide important data on the uptake and experience of the clients and treatment service providers with fundamental implications for further development of this new treatment formulation, with potential relevance for policy makers, health service planners, administrators, and practitioners. The future implications of the scale up of new treatments will be discuss briefly