National Drug and Alcohol Research Centre, UNSW Sydney, Sydney, New South Wales, Australia.
School of Psychology, University of Wollongong, Sydney, New South Wales, Australia.
BMJ Open. 2020 Jul 31;10(7):e034389. doi: 10.1136/bmjopen-2019-034389.
Opioid agonist treatment is effective for opioid dependence and newer extended-release buprenorphine (BUP-XR) injections represent a significant development. The Community Long-Acting Buprenorphine (CoLAB) study aims to evaluate client outcomes among people with opioid dependence receiving 48 weeks of BUP-XR treatment, and examines the implementation of BUP-XR in diverse community healthcare settings in Australia.
The CoLAB study is a prospective single-arm, multicentre, open-label trial of monthly BUP-XR injections in people with opioid dependence. Participants are being recruited from a network of general practitioner and specialist drug treatment services located in the states of New South Wales, Victoria and South Australia in Australia. Following a minimum 7 days on 8-32 mg of sublingual buprenorphine (±naloxone), participants will receive monthly subcutaneous BUP-XR injections administered by a healthcare practitioner at intervals of 28 days (-2/+14 days). The primary endpoint is participant retention in treatment at 48 weeks after treatment initiation. Secondary endpoints will evaluate dosing schedule variations, craving, withdrawal, substance use, health and well-being, and client-reported treatment experience. Qualitative and costing substudies will examine implementation barriers and facilitators at the client and provider level.
The study has received ethics approval from the St Vincent's Hospital Sydney Human Research Ethics Committee (Ref. HREC/18/SVH/221). The findings will be disseminated via publication in peer-reviewed journals, presentations at national and international scientific conferences, and in relevant community organisation publications and forums.
NCT03809143 PROTOCOL IDENTIFIER: CoLAB1801, V.4.0 dated 01 August 2019.
阿片类激动剂治疗对阿片类药物依赖有效，新型的丁丙诺啡延长释放剂（BUP-XR）注射剂是一个重要的发展。社区长效丁丙诺啡（CoLAB）研究旨在评估接受 48 周 BUP-XR 治疗的阿片类药物依赖患者的治疗结局，并在澳大利亚不同的社区医疗保健环境中研究 BUP-XR 的实施情况。
CoLAB 研究是一项前瞻性、单臂、多中心、开放性试验，研究对象为阿片类药物依赖患者，每月接受 BUP-XR 注射治疗。研究参与者正在从澳大利亚新南威尔士州、维多利亚州和南澳大利亚州的全科医生和专科药物治疗服务网络中招募。在接受 8-32mg 舌下丁丙诺啡（±纳洛酮）至少 7 天治疗后，参与者将接受每月一次的皮下 BUP-XR 注射，由医疗保健从业者在 28 天间隔（-2/+14 天）内给药。主要终点是治疗开始后 48 周时患者的治疗保留率。次要终点将评估剂量方案变化、渴求、戒断、物质使用、健康和福祉以及患者报告的治疗体验。定性和成本子研究将在患者和提供者层面上评估实施障碍和促进因素。
该研究已获得悉尼圣文森特医院人类研究伦理委员会（参考 HREC/18/SVH/221）的伦理批准。研究结果将通过在同行评议期刊上发表、在国家和国际科学会议上发表、在相关社区组织出版物和论坛上发表来传播。
NCT03809143 方案标识符：CoLAB1801，2019 年 8 月 1 日修订版 V.4.0。
