Background Sublingual tablet buprenorphine (BUP-SL) and oral liquid methadone (MET) are the daily, standard-of-care (SOC) opioid agonist treatment medications for opioid use disorder (OUD). A sizable proportion of the OUD treatment population is not exposed to sufficient treatment to attain the desired clinical benefit. Two promising therapeutic technologies address this deficit: long-acting injectable buprenorphine and personalised psychosocial interventions (PSI). This study will determine (A) the effectiveness and cost-effectiveness — monthly injectable, extended-release (BUP-XR) in a head-to-head comparison with BUP-SL and MET, and (B) the effectiveness of BUP-XR with adjunctive PSI versus BUP-SL and MET with PSI. Safety, retention, craving, substance use, quality-adjusted life years, social functioning, and subjective recovery from OUD will be also evaluated. Methods This is a pragmatic, multi-centre, open-label, parallel-group, superiority RCT, with a qualitative (mixed-methods) evaluation. The study population is adults. The setting is five National Health Service community treatment centres in England and Scotland. At each centre, participants will be randomly allocated (1:1) to BUP-XR or SOC. At the London study co-ordinating centre, there will also be allocation of participants to BUP-XR with PSI or SOC with PSI. With 24 weeks of study treatment, the primary outcome is days of abstinence from non-medical opioids during study weeks 2–24 combined with up to 12 urine drug screen tests for opioids. For 90% power (alpha, 5%; 15% inflation for attrition), 304 participants are needed for the BUP-XR versus SOC comparison. With the same planning parameters, 300 participants are needed for the BUP-XR and PSI versus SOC and PSI comparison. Statistical and health economic analysis plans will be published before data-lock on the Open Science Framework. Findings will be reported in accordance with the Consolidated Standards of Reporting Trials and Consolidated Health Economic Evaluation Reporting Standards. Discussion This pragmatic randomised controlled trial is the first evaluation of injectable BUP-XR versus the SOC medications BUP-SL and MET, with personalised PSI. If there is evidence for the superiority of BUP-XR over SOC medication, study findings will have substantial implications for OUD clinical practice and treatment policy in the UK and elsewhere. Trial registration EU Clinical Trials register 2018-004460-63.

ObjectivesDuring the COVID-19 pandemic, addiction treatment services received official guidance asking them to limit face-to-face contact with patients and to prescribe opioid agonist treatment (OAT) medication flexibly. With the aim for most patients to receive take-home supplies for self-administration rather than attendance for observed daily dosing.DesignThis was a theory-driven, clinically applied qualitative study, with data for thematic analysis collected by semi-structured, audio-recorded, telephone interviews.ParticipantsTwenty-seven adults (aged ≥18 years) enrolled in sublingual (tablet) buprenorphine and oral (liquid) methadone OAT.SettingCommunity addictions centre in the London Borough of Lambeth operated by South London and Maudsley NHS Trust.ResultsThree major themes were identified: (1) dissatisfaction and perceived stigma with OAT medication dispensing arrangements before the pandemic; (2) positive adaptations in response to COVID-19 by services; (3) participants recommended that, according to preference and evidence of adherence, OAT should be personalised to offer increasing medication supplies for self-administration from as early as 7 days after commencement of maintenance prescribing.ConclusionsIn an applied qualitative study of patients enrolled in OAT during the COVID-19 pandemic, participants endorsed their opportunity to take medication themselves at home and with virtual addiction support. Most patients described a preference for self-administration with increased dispensing supplies, from as early as 7 days into maintenance treatment, if they could demonstrate adherence to their prescription.

IntroductionOpioid 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 analysisThree 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 disseminationStudy 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 number2018-004460-63.

Background and Aims Interprofessional simulation has the potential to enhance the perceived realism of clinical simulation in the education of different healthcare professionals. This study considers how the inclusion of more than one profession in clinical simulation contributes to this psychological fidelity, defined as the subjective perception of the realism of a simulation, and the cues identified by medical and nursing students. Methods Eight focus groups were carried out with 27 medical and 18 nursing students in Newcastle and Oxford, UK. These were carried out immediately after students' participation in simulation sessions consisting of three acute scenarios. Focus group discussions encompassed perceptions of the realism of the simulation and of participants' own and other professional groups. Thematic analysis was carried out on transcripts. Results The analysis identified features of psychological fidelity that were influenced by the interprofessional element of the simulation. These included overall impressions of realism, and the perceived roles and expectations of doctors and nurses within the simulation. In particular, the presence of the other professional group afforded a more authentic response. Other features varied with the viewpoint of the student groups, in particular the realism of the patient manikin, which held lower psychological fidelity for the nursing students, because it did not allow them to fulfill their perceived role of delivering holistic, relational care. Conclusion Recognizing “psychological fidelity” as a subjective response to simulation allows greater consideration of the limitations of fidelity as a designed or engineered property of a simulation. While interprofessional involvement directly enhances psychological fidelity in some ways, potential differences in the views of students from different professional groups should be considered when implementing interprofessional simulation.