Outcomes of a single-arm implementation trial of extended-release subcutaneous buprenorphine depot injections in people with opioid dependence

Abstract

Background: Opioid agonist treatment (OAT) is an effective intervention for opioid dependence. Extended-release buprenorphine injections (BUP-XR) may have additional potential benefits over sublingual buprenorphine. This single-arm trial evaluated outcomes among people receiving 48 weeks of BUP-XR in diverse community healthcare settings in Australia, permitting examination of outcomes when BUP-XR is delivered in standard practice.

Methods: Participants were recruited from a network of specialist public drug treatment services, primary care and some private practices in three states. 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 and completed monthly research interviews. The primary endpoint was retention in treatment at 48 weeks.

Findings: Participants (n = 100) were 28% women, mean age 44 years with a long history of OAT (median 5.8 years); heroin was the most common opioid of concern (58%). Treatment retention at 24 and 48 weeks was 86% and 75%, respectively. Participants with past-month injecting drug use (OR 0.23; 95%CI: 0.09-0.61) or heroin use (OR 0.23; 95%CI: 0.08-0.65) at baseline had lower odds of being retained in treatment to 48 weeks. Reductions in multiple forms of extra-medical drug use were observed. Improvements in quality of life, participation in employment, and treatment satisfaction measures were also observed.

Interpretation: This real-world implementation study of BUP-XR demonstrated high retention and treatment satisfaction. This study provides important additional data on the uptake and experience of clients, with relevance for policy makers, health service planners, administrators, and practitioners.

Funding: Indivior.

Trial registration: ClinicalTrials.gov Identifier: NCT03809143.

Keywords: Buprenorphine; Opioid agonist treatment; Opioid dependence.

Conflict of interest statement

Declarations of Interest This study was supported by an Externally Sponsored Collaborative Research grant from Indivior PLC (MF, BL, LD, NL, AD, RA, SN, GD, JG). In the past three years, MF and LD have received funding from Indivior, Seqirus for studies of new opioid medications in Australia. JG reports grants and personal fees from Abbvie, Camurus, Cepheid, Hologic, Indivior, Gilead Sciences, and Merck. NL has received reimbursement for participation in Advisory Boards for Mundipharma, Indivior and Chiesi Pharmaceuticals; he received funding from Camurus for a company-sponsored trial of BUP-XR. RA has received untied educational grants from Reckitt Benckiser and an untied educational grant from Mundipharma. AJD reports grants from Braeburn/Camurus AB, to conduct clinical studies with buprenorphine products and travel support to Hunter New England Local Health District, which employs AJD. He has served as an honorary on advisory boards for Mundipharma and Seqiris. GJD has received research grant funding from Gilead and Abbvie. MM has served as an honorary on advisory boards for Pfizer and AbbVieMC. JS and MB have no conflicts to declare. SN has received untied research funding from Seqirus to conduct research on prescription opioid related harms.

Copyright © 2021 The Author(s). Published by Elsevier B.V. All rights reserved.