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

Abstract

IntroductionOpioid 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 analysisThe 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 disseminationThe 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 numberNCT03809143Protocol identifierCoLAB1801, V.4.0 dated 01 August 2019

The effect of person, treatment and prescriber characteristics on retention in opioid agonist treatment: a 15‐year retrospective cohort study

“…For example, it is often the case in this programme that people are required to attend a dosing point multiple times per week [59], which can impede efforts to find and maintain employment as well as negatively affect personal relationships. Depot buprenorphine is a novel approach to delivering treatment that could improve retention through requiring less frequent attendance at dosing points [65]; consideration of providing more take‐home doses is also an option that would improve treatment flexibility and potentially retention. The financial burden caused by OAT can also negatively impact upon retention [66].…”

Retention rates with monthly depot buprenorphine in general practice in Melbourne, Australia

“…: NCT03809143) is investigating the real-world implementation of monthly buprenorphine in general practice and specialist drug treatment services in Australia, and includes qualitative research and costing, as well as clinical outcomes. 19 It is important to identify likely reasons for discontinuation of monthly buprenorphine among patients in the general practice setting, and how this might be avoided. While retention in treatment is important, this needs to be considered alongside additional clinical benefits, particularly abstinence and inhibition of cravings, and patients' personal treatment goals.…”

Depot buprenorphine during COVID-19 in Australia: Opportunities and challenges

“…Clinical trials that developed pre-registration expertise Frost et al, 2019;Lintzeris, Dunlop, & Haber, 2020;Lofwall et al, 2018;Walsh et al, 2017;Larance, Byrne, Lintzeris et al, 2020), clinical guidance (Lintzeris et al, 2019), training programs for service providers, and patient literature from consumer groups (NSW Users and AIDS Association, 2019) have been important in providing strategies to enhance the uptake of this treatment approach. Nevertheless, the uptake of depot buprenorphine treatment prior to March 2020 had been largely concentrated in a number of clinical services that had been involved in clinical trials, or a handful of "early adopter" individual private practitioners.…”