Outcomes of a single-arm implementation trial of extended-release subcutaneous buprenorphine depot injections in people with opioid dependence.
Buprenorphine
Opioid agonist treatment
Opioid dependence
Journal
The International journal on drug policy
ISSN: 1873-4758
Titre abrégé: Int J Drug Policy
Pays: Netherlands
ID NLM: 9014759
Informations de publication
Date de publication:
02 2022
02 2022
Historique:
received:
02
08
2021
revised:
29
09
2021
accepted:
02
10
2021
pubmed:
5
11
2021
medline:
9
4
2022
entrez:
4
11
2021
Statut:
ppublish
Résumé
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. 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. 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. 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. Indivior. ClinicalTrials.gov Identifier: NCT03809143.
Sections du résumé
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.
Identifiants
pubmed: 34736130
pii: S0955-3959(21)00405-9
doi: 10.1016/j.drugpo.2021.103492
pii:
doi:
Substances chimiques
Analgesics, Opioid
0
Buprenorphine, Naloxone Drug Combination
0
Delayed-Action Preparations
0
Narcotic Antagonists
0
Buprenorphine
40D3SCR4GZ
Heroin
70D95007SX
Banques de données
ClinicalTrials.gov
['NCT03809143']
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
103492Informations de copyright
Copyright © 2021 The Author(s). Published by Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
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.