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.

Background Chronic hepatitis C infection (HCV) is common in injecting drug users and is a major cause of liver disease. Antiviral treatment can 'cure' HCV, but is frequently associated with side effects and requires regular monitoring. Non-attendance at hospital appointments is frequent. To try and improve attendance and increase the number of current and previous injecting drug users treated we developed three outreach clinics. Objective To review the outcome of patients referred to the outreach clinics. Methods Retrospective service review of three clinics at drug treatment centres in Newcastle and Northumberland. Data was collected on attendance rates, patient demographics, treatment rates and outcomes. Results 141 referrals were received across the three sites with an overall attendance rate of 75% (106 patients, 79% men and median age 36), which compared favourably with that at our hospital (50%). All patients were on methadone/subutex. 45% were infected with Genotype 1 HCV. 10% were cirrhotic. To date, 30% have started treatment and 21% are waiting to start or are still in workup. 13% elected to delay treatment due to early stage disease and 11% were not ready for treatment on psychological or social grounds. Only 12% failed to attend follow up after initial assessment. To date, 24 patients have completed full courses of treatment with sustained viral response in 13 patients. Results are awaited for seven patients. Conclusions The development of outreach clinics for HCV in drug treatment centres can substantially improve clinic attendance and increase access to treatment in this marginalised group.

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BACKGROUND: Sublingual buprenorphine (BUP-SL) and liquid methadone (MET) and are the standard-of-care (SOC), daily maintenance medications for the treatment of opioid use disorder (OUD). A sizable proportion of the OUD treatment population does not adhere to treatment and achieve desired clinical benefit. Two promising therapeutic technologies address this deficit: new medication formulations and psychosocial interventions (PSI). This study will determine: (A) the effectiveness and cost-effectiveness – monthly injectable, extended-release (BUP-XR) a novel formulation in a head-to-head comparison with BUP-SL or MET; and (B) the effectiveness of BUP-XR with PSI versus BUP-SL or MET with PSI. Safety, retention, craving, substance use, quality-adjusted life years, social functioning, and subjective recovery will be also evaluated. METHODS: This is a pragmatic, multi-centre, open-label, four-arm, parallel group, superiority RCT, with a qualitative (mixed-methods) evaluation. The study population is adults. The setting is five specialist National Health Service community treatment programmes in England and Scotland. In all sites, participants will be randomly allocated (1:1) to BUP-XR and BUP-SL or MET. At the London study co-ordinating centre, there will also be allocation of participants to BUP-XR with PSI and BUP-SL or MET with PSI. With 24 weeks of study treatment, the primary outcome is days of abstinence from all 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 and BUP-SL or MET comparison. Using the same planning parameters, 300 participants are needed for the comparison of BUP-XR and BUP-SL or MET with PSI. 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 or MET, and with an adjunctive personalised PSI. If there is evidence for the superiority of BUP-XR over SOC, this will have substantial implications for clinical practice and OUD treatment policy in the UK and elsewhere. TRIAL REGISTRATION: EU Clinical Trials register (number: 2018-004460-63).