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Experience and response to a randomised controlled trial of extended-release injectable buprenorphine versus sublingual tablet buprenorphine and oral liquid methadone for opioid use disorder: protocol for a mixed-methods evaluation

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Natalie Lowry, Fiona Cowden, Edward Day, Eilish Gilvarry, Stacey Johnstone, Robbie Murray, Mike Kelleher, Luke Mitcheson, John Marsden

Original languageEnglish
Article numbere067194
Pages (from-to)e067194
JournalBMJ Open
Issue number10
Published21 Oct 2022

Bibliographical note

Funding Information: The study was funded by Indivior (grant number KCLEXPOINDV19). Kings College London and South London and Maudsley NHS Trust are the study sponsors and hold the indemnity insurance policy Funding Information: MK, JM and LM declare an unrestricted research grant at Institute of Psychiatry, Psychology & Neuroscience, King’s College London and South London and Maudsley NHS trust from Indivior via Action on Addiction for a randomised controlled trial (RCT) of personalised psychosocial intervention in opioid agonist medication for OUD (published in 2019). In the past 3 years, JM declared research grants from the National Institute for Health Research (NIHR; RCT of depot naltrexone for OUD and an RCT of acamprosate for AUD), and the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Mental Health Foundation Trust (RCT of novel cognitive therapy for cocaine use disorder). JM is a clinical academic consultant for the US National Institute on Drug Abuse, Centre for Clinical Trials Network. He has received honoraria and travel support from Reckitt-Benckiser (2016, treatment of OUD) and PCM Scientific and Martindale for the Improving Outcomes in Treatment of Opioid Dependence conference (2018 and 2021). FC declares coapplicant status for the Scottish Drug Death Task Force Research Programme to the University of Stirling, exploring the utility and safety of benzodiazepine prescribing among people receiving opiate replacement therapy. Coapplicant for Chief Scientist Office Research Grant for using remote digital respiration monitoring for prevention of drug related deaths–evaluating the feasibility of establishing a virtual safe consumption facility. FC was also author for the Medical Research Scotland (VAC-1437-2019), Characteristics of non-fatal overdoses and associated risk factors in patients attending a specialist community-based substance misuse service. Publisher Copyright: ©

King's Authors


INTRODUCTION: Opioid use disorder (OUD) is a debilitating and persistent disorder. The standard-of-care treatment is daily maintenance dosing of sublingual buprenorphine (BUP-SL) or oral methadone (MET). Monthly, extended-release, subcutaneous injectable buprenorphine (BUP-XR) has been developed to enhance treatment effectiveness. This study aims to investigate the experiences of participants who have been offered BUP-XR (evaluation 1), health-related quality-of-life among participants who have opted to receive BUP-XR longer term (evaluation 2) and the experiences of participants allocated to receive BUP-XR or BUP-SL or MET with the offer of adjunctive personalised psychosocial intervention (evaluation 3). METHODS AND ANALYSIS: Three qualitative-quantitative (mixed-methods) evaluations embedded in a five-centre, head-to-head, randomised controlled trial of BUP-XR versus BUP-SL and MET in the UK. Evaluation 1 is a four-centre interview anchored on an OUD-related topic guide and conducted after the 24-week trial endpoint. Evaluation 2 is a two-centre interview anchored on medications for opioid use disorder-specific quality-of-life topic guide conducted among participants after 12-24 months. Evaluation 3: single-centre interview after the 24-week trial endpoint. All evaluations include selected trial clinical measures, with evaluation 2 incorporating additional questionnaires. Target participant recruitment for evaluations 1 and 2 is 15 participants per centre (n=60 and n=30, respectively). Recruitment for evaluation 3 is 15 participants per treatment arm (n=30). Each evaluation will be underpinned by theory, drawing on constructs from the behavioural model for health service use or the health-related quality-of-life model. Qualitative data analysis will be by iterative categorisation. ETHICS AND DISSEMINATION: Study protocol, consent materials and questionnaires were approved by the London-Brighton and Sussex research ethics committee (reference: 19/LO/0483) and the Health Research Authority (IRAS project number 255522). Participants will be provided with information sheets and informed written consent will be obtained for each evaluation. Study findings will be disseminated through peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: 2018-004460-63.

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