Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 Oct;120(10):2055-2066.
doi: 10.1111/add.70106. Epub 2025 Jun 20.

Extended-release buprenorphine treatment for opioid use disorder: A mixed-methods study of response and experience

Natalie Lowry  1   2 , Andrew McKechnie  3 , Edward Day  4   5 , Eilish Gilvarry  6 , Fiona Cowden  3 , Rachel Evans  7 , Rosie Locke  6 , Robbie Murray  6 , Rob Vanderwaal  2 , Stacey Johnstone  3 , Zoe Hoare  7 , Michael Kelleher  1   2 , Luke Mitcheson  1   2 , John Marsden  1   2
Affiliations
Clinical Trial

Extended-release buprenorphine treatment for opioid use disorder: A mixed-methods study of response and experience

Natalie Lowry et al. Addiction. 2025 Oct.

Abstract

Background and aims: An investigation of 24 weeks of extended-release buprenorphine (BUP-XR; Sublocade®) treatment for adults with opioid use disorder (OUD). Study aims were to characterise variations in clinical response, investigate personal factors influencing BUP-XR experience and identify opportunities to tailor treatment interventions.

Design: A convergent parallel mixed-methods evaluation embedded in a five-centre, phase 3, randomised controlled trial of BUP-XR versus daily oral methadone or sublingual buprenorphine.

Setting: Four of five National Health Service addictions treatment clinics in England and Scotland from the trial.

Participants: Participants were recruited after they completed the 24-week endpoint. Forty-nine participants (31%) from the trial completed the qualitative interview.

Measurements: Three outcome measures from the trial's dataset were used descriptively: (1) fortnightly clinic visit administered TimeLine Follow-Back interview and urine drug screen data on use of non-medical opioids, cocaine and benzodiazepines; (2) the frequency version of the 11-item Craving Experience Questionnaire administered at baseline and endpoint; and (3) the Structured Clinical Interview for DSM-5 disorders for diagnosis of early OUD and cocaine use disorder (CUD) remission. Data visualisation (by heatmap) identified drug use response sub-groups. A topic-guided, semi-structured qualitative interview was analysed by Interactive Categorisation.

Findings: Three response sub-groups were identified: Group 1 [14 (28.5%) of 49 participants] had the highest level of response, characterised by continuous abstinence from opioids, cocaine and benzodiazepines, improvements in craving control and mental and physical health in the majority, and a high level of remission and satisfaction with care; Group 2 [14 (28.5%) of 49 participants] had the next level of response, characterised by continuous abstinence from opioids, but some with opioid craving and some with compensatory use of cocaine and benzodiazepine to cope with anxiety and stress; Group 3 [21 (43.0%) of 49 participants] were not continuously abstinent from opioids during follow-up, the majority had dual OUD and CUD at trial enrolment, some reported breakthrough opioid withdrawal symptoms during follow-up, the majority reported improvements in mental health, but many reported opioid and cocaine cravings and compensatory use of cocaine and benzodiazepines.

Conclusions: There appears to be variation in response and experience of extended-release buprenorphine during the first six months of treatment, depending on substance use and physical health. This highlights the need for tailored treatment plans based on differing individual needs.

Keywords: extended‐release buprenorphine; long‐acting injectable buprenorphine; mixed‐methods; opioid use disorder; patient experience; qualitative evaluation.

PubMed Disclaimer

Conflict of interest statement

F.C. and E.G. declare collaborative research grant funding for the EXPO study from Indivior [study sponsor: King's College London (KCL) and South London and Maudsley NHS Trust (SLaM)]. In the past 3years, E.D. has declared research grant funding from the National Institute for Health Research [NIHR; trial of behavioural reinforcement of acamprosate for alcohol use disorder (AUD); study sponsor: KCL and SLaM]; and Indivior for the EXPO study. E.D. is the United Kingdom (UK) Government National Recovery Champion, seconded part‐time to the Home Office. In the past 3 years, M.K. declares research grant funding from Indivior for the EXPO study, and from Beckley PsyTech for a phase 2 trial of 5‐MeO‐DMT for AUD (sponsor: Beckley PsyTech). M.K is the national clinical advisor for the Office for Health Improvement and Disparities, English Department of Health and Social Care. In the past 3 years, L.M. declares research grant funding from the NIHR for a realist evaluation of services for people with co‐occurring mental health and substance use and a study of ketamine for AUD; from Indivior for the EXPO study; and from Beckley PsyTech for a phase 2a trial of 5‐MeO‐DMT for AUD. L.M. has a clinical psychology secondment at the Office for Health Improvement and Disparities, English Department of Health and Social Care. In the past 3 years, J.M. declares research grant funding from the NIHR for a trial of behavioural reinforcement for AUD medication; from Indivior for the EXPO study; from Indivior for the EXPO study; and from Beckley PsyTech (phase 2a trial of 5‐MeO‐DMT for AUD). He is the senior scientific advisor for the Office for Health Improvement and Disparities, English Department of Health and Social Care and a clinical academic consultant for the US National Institute on Drug Abuse, Clinic for Clinical Trials Network. J.M. declares honoraria and travel support from PCM Scientific, OPEN Health and Indivior to contribute to scientific and educational meetings. R.V. declares an honorarium and travel support from Camurus to contribute to an educational meeting. All other authors have no interests to declare.

Figures

FIGURE 1
FIGURE 1
Heatmap data visualisation of abstinence, and use of opioids, cocaine and benzodiazepines during 24 weeks of study treatment with extended‐release buprenorphine (BUP‐XR). Group 1, continuous abstinence from opioids, cocaine and benzodiazepines; group 2, continuous abstinence from opioids; used cocaine or benzodiazepines or both drug on ≥1 days; group 3, used opioids on ≥1 days, and either abstained from cocaine and benzodiazepines or used one or both drugs on ≥1 days.
See this image and copyright information in PMC

References

    1. Public Heath England . Part 1: Introducing opioid substitution treatment (OST). 2021.
    1. Office for Health Improvement & Disparities . Adult substance misuse treatment statistics 2022 to 2023: Report 2023.
    1. Matheson C, Vucic C, Dumbrell J, Robertson R, Ritchie T, Duncan C, et al. Clinical outcomes of benzodiazepine prescribing for people receiving opioid agonist treatment: a systematic review of the evidence. Pharmacy. 2024;12(5):152. 10.3390/pharmacy12050152 - DOI - PMC - PubMed
    1. Marsden J, Eastwood B, Jones H, Bradbury C, Hickman M, Knight J, et al. Risk adjustment of heroin treatment outcomes for comparative performance assessment in England. Addiction. 2012;107(12):2161–2172. 10.1111/j.1360-0443.2012.03971.x - DOI - PubMed
    1. Felberbaum M. FDA approves first once‐monthly buprenorphine injection, a medication‐assisted treatment option for opioid use disorder: U.s. food and drug administration. 2017. https://www.fda.gov/news-events/press-announcements/fda-approves-first-o...

Publication types

Grants and funding