Addictions Department, Institute of Psychiatry, Psychology & Neuroscience, Division of Academic Psychiatry, King's College London, Addiction Sciences Building, 4 Windsor Walk, Denmark Hill, London, SE5 8AF, UK.
South London & Maudsley NHS Foundation Trust, London, UK.
Trials. 2022 Aug 19;23(1):697. doi: 10.1186/s13063-022-06595-0.
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.
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.
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.
EU Clinical Trials register 2018-004460-63.
舌下片剂丁丙诺啡（BUP-SL）和口服液美沙酮（MET）是阿片类药物使用障碍（OUD）的每日标准治疗药物（SOC）。相当一部分 OUD 治疗人群未接受足够的治疗以达到预期的临床获益。两种有前途的治疗技术可以解决这一不足：长效注射丁丙诺啡和个性化心理社会干预（PSI）。本研究将确定（A）每月注射，延长释放丁丙诺啡（BUP-XR）与 BUP-SL 和 MET 的头对头比较的有效性和成本效益，以及（B）BUP-XR 与附加 PSI 相比 BUP-SL 和 MET 与 PSI 的有效性。安全性、保留率、渴望、物质使用、质量调整生命年、社会功能以及从 OUD 中主观恢复情况也将进行评估。
这是一项实用、多中心、开放标签、平行组、优效性 RCT，同时进行定性（混合方法）评估。研究人群为成年人。研究地点为英格兰和苏格兰的五个国家卫生服务社区治疗中心。在每个中心，参与者将被随机分配（1:1）到 BUP-XR 或 SOC。在伦敦研究协调中心，还将对参与者进行 BUP-XR 与 PSI 或 SOC 与 PSI 的分配。在 24 周的研究治疗中，主要结局是在研究周 2-24 期间非医疗阿片类药物的禁欲天数，结合最多 12 次尿液药物筛选测试。为了达到 90%的功效（α，5%；因流失而增加 15%），需要 304 名参与者参加 BUP-XR 与 SOC 的比较。使用相同的规划参数，需要 300 名参与者参加 BUP-XR 和 PSI 与 SOC 和 PSI 的比较。在数据锁定前，将在开放科学框架上发布统计和健康经济分析计划。将按照《临床试验报告标准》和《综合健康经济评估报告标准》报告研究结果。
这项实用的随机对照试验是首次评估注射用 BUP-XR 与 SOC 药物 BUP-SL 和 MET 联合个性化 PSI。如果有证据表明 BUP-XR 优于 SOC 药物，那么研究结果将对英国和其他地方的 OUD 临床实践和治疗政策产生重大影响。
欧盟临床试验注册处 2018-004460-63。
