Extended-release pharmacotherapy for opioid use disorder (EXPO): protocol for an open-label randomised controlled trial of the effectiveness and cost-effectiveness of injectable buprenorphine versus sublingual tablet buprenorphine and oral liquid methadone

Medientyp: E-Artikel
Titel: Extended-release pharmacotherapy for opioid use disorder (EXPO): protocol for an open-label randomised controlled trial of the effectiveness and cost-effectiveness of injectable buprenorphine versus sublingual tablet buprenorphine and oral liquid methadone
Beteiligte: Marsden, John; Kelleher, Mike; Hoare, Zoë; Hughes, Dyfrig; Bisla, Jatinder; Cape, Angela; Cowden, Fiona; Day, Edward; Dewhurst, Jonathan; Evans, Rachel; Hearn, Andrea; Kelly, Joanna; Lowry, Natalie; McCusker, Martin; Murphy, Caroline; Murray, Robert; Myton, Tracey; Quarshie, Sophie; Scott, Gemma; Turner, Sophie; Vanderwaal, Rob; Wareham, April; Gilvarry, Eilish; Mitcheson, Luke
Erschienen: Springer Science and Business Media LLC, 2022
Erschienen in: Trials
Sprache: Englisch
DOI: 10.1186/s13063-022-06595-0
ISSN: 1745-6215
Entstehung:
Anmerkungen:
Beschreibung: <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration</jats:title> <jats:p>EU Clinical Trials register 2018-004460-63.</jats:p> </jats:sec>
Zugangsstatus: Freier Zugang

Nur in Feld suchen:

Zuletzt gesuchte Begriffe: