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

Farrell, Michael; Shahbazi, Jeyran; Byrne, Marianne; Grebely, Jason; Lintzeris, Nicholas; Chambers, Mark S.; Larance, Briony; Ali, Robert; Nielsen, Suzanne; Dunlop, Adrian; Dore, Gregory J.; McDonough, M.A.; Montebello, Mark; Nicholas, Thomas J.; Weiss, Rob; Rodgers, C H; Cook, Jon; Degenhardt, Louisa; team, CoLAB study

doi:10.1016/j.drugpo.2021.103492

Cited by 27 publications

(21 citation statements)

References 24 publications

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“…Also, the longer the duration of BUP-XR treatment, the better the outcomes 1 year after treatment cessation, with a higher likelihood of sustained opioid abstinence after 12 months of treatment compared to ≤ 2 months of treatment (75.3% vs. 24.1%; p = 0.001) (Ling et al, 2020b). Similarly, improvements in employment, quality of life and treatment satisfaction were observed in a recent 12-month prospective openlabel study of BUP-XR in Australia (Farrell et al, 2022). In that study, the odds of use of all illicit substances except cannabis decreased significantly with time retained in treatment, together with a significant reduction in the odds of moderate-severe depression and a significant decline in pain.…”

Section: Discussionmentioning

confidence: 80%

Buprenorphine exposure levels to optimize treatment outcomes in opioid use disorder

et al. 2022

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The severity of the ongoing opioid crisis, recently exacerbated by the COVID-19 pandemic, emphasizes the importance for individuals suffering from opioid use disorder (OUD) to have access to and receive efficacious, evidence-based treatments. Optimal treatment of OUD should aim at blocking the effects of illicit opioids while controlling opioid craving and withdrawal to facilitate abstinence from opioid use and promote recovery. The present work analyses the relationship between buprenorphine plasma exposure and clinical efficacy in participants with moderate to severe OUD using data from two clinical studies (39 and 504 participants). Leveraging data from placebo-controlled measures assessing opioid blockade, craving, withdrawal and abstinence, we found that buprenorphine plasma concentrations sustained at 2–3 ng/ml (corresponding to ≥70% brain mu-opioid receptor occupancy) optimized treatment outcomes in the majority of participants, while some individuals (e.g., injecting opioid users) needed higher concentrations. Our work also included non-linear mixed effects modeling and survival analysis, which identified a number of demographic, genetic and social factors modulating treatment response and retention. Altogether, these findings provide key information on buprenorphine plasma levels that optimize clinical outcomes and increase the likelihood of individual treatment success. NLM identifiers: NCT02044094, NCT02357901.

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Section: Discussionmentioning

confidence: 80%

Buprenorphine exposure levels to optimize treatment outcomes in opioid use disorder

et al. 2022

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“…The study received ethical approval from St Vincent's Hospital Sydney Human Research Ethics Committee (HREC/18/ SVH/221) and was registered with ClinicalTrials.gov (NCT03809143). In total, 100 people entered the CoLAB study and 75 were retained in BUP-XR treatment until the end of the study period (Farrell et al, 2022).…”

Section: Methodsmentioning

confidence: 99%

“…The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was supported by an Externally Sponsored Collaborative Research grant from Indivior PLC. Indivior contributed to the study design and analysis plan of the clinical parent study (Farrell et al, 2022) but not this qualitative study; Indivior had no role in collection, analysis and interpretation of data, in the writing of the manuscript, or in the decision to submit the manuscript for publication. The Centre for Social Research in Health at the University of New South Wales (UNSW) is supported by a grant from the Australian Government Department of Health.…”

Section: Declaration Of Conflicting Interestsmentioning

confidence: 99%

“…Administered subcutaneously by a healthcare provider either weekly or monthly, BUP-XR provides rapid onset and sustained release of buprenorphine over the dosing interval (Larance, Byrne, et al, 2020). Emerging clinical trial evidence indicates that BUP-XR is associated with high retention in treatment and that it may have additional benefits compared to sublingual buprenorphine (Farrell et al, 2022; Frost et al, 2019; Haight et al, 2019; Ling et al, 2020; Lintzeris et al, 2021; Lofwall et al, 2018). Integrating BUP-XR into diverse treatment settings presents some challenges (Larance, Byrne, et al, 2020).…”

Section: Introductionmentioning

confidence: 99%

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The Social, Material, and Temporal Effects of Monthly Extended-Release Buprenorphine Depot Treatment for Opioid Dependence: An Australian Qualitative Study

Lancaster

Gendera

Treloar

et al. 2022

Contemporary Drug Problems

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Aims: This study examined the social, material and temporal effects of extended-release buprenorphine depot treatment (BUP-XR), among a group of participants commencing BUP-XR in Australia, and considered the situated potentials of these new opioid agonist treatment technologies. Methods: Using a longitudinal qualitative design, 36 participants (25 men, 11 women; mean age 44 years) were interviewed, with 32 followed-up, to generate accounts of BUP-XR experiences. Analysis was informed by sociological approaches which attend to the multiple effects of novel health interventions as they are put to use and made to work, with a focus on tracing change over time. Analysis: The shift from daily to monthly dosing altered how opioid agonist treatment was experienced, reconfigured participants’ relationship to treatment, and affected the temporal patterns of participants’ lives. Extending temporal relations released participants from short-term cycles of living and produced different forms of subjectivity, bringing about both transformation and loss. Monthly dosing, and a sense of normalcy characterized by absenting the routines and felt effects of drugs or treatment medications, potentiated a feeling of stability for many participants. For some, disrupting daily routines precipitated disconnection from treatment and social care relations. The transition from daily to monthly dosing required adaptation and new ways of engaging with treatment and care, with medication acting as a bridge to care without necessarily being the focal point. Conclusions: As BUP-XR treatment gains traction internationally, it will be important to attend to the multiple, and sometimes unexpected, effects this intervention makes in the social and material lives of clients. How choice, social connection, and care can be maintained to help secure BUP-XR’s longer-term impact, and how clients can be supported to adjust to what is felt to be a new normal, will be considerations in future treatment delivery.

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“…These improvements were sustained over the study period, suggesting that BUP-XR facilitates long-term engagement of life activities that reflect recovery ( Ling et al., 2020 ). A recent 12-month prospective open-label trial in Australia also showed that retention following BUP-XR treatment at 24 and 48 weeks was 86% and 75%, respectively ( Farrell et al., 2022 ). The odds of use of all illicit substances except for cannabis use decreased significantly with time retained in treatment.…”

Section: Introductionmentioning

confidence: 99%

The introduction of a novel formulation of buprenorphine into organized health systems

Mullen

Hedberg

Gadbois³

et al. 2022

Drug and Alcohol Dependence Reports

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

Cited by 27 publications

References 24 publications

Buprenorphine exposure levels to optimize treatment outcomes in opioid use disorder

Buprenorphine exposure levels to optimize treatment outcomes in opioid use disorder

The Social, Material, and Temporal Effects of Monthly Extended-Release Buprenorphine Depot Treatment for Opioid Dependence: An Australian Qualitative Study

The introduction of a novel formulation of buprenorphine into organized health systems

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