The FASTER-BUP Study, Extended-Release Injectable Buprenorphine for the Treatment of Opioid Use Disorder Among Individuals at High Risk of Overdose: Protocol for an Observational Prospective Study.

Substance use & addiction journal Pub Date : 2024-04-01 Epub Date: 2024-01-22 DOI:10.1177/29767342231222103
Jenna Langlois, Seonaid Nolan, Piper Dickhout, Zishan Cui, Josh Paterson, Nadia Fairbairn, M Eugenia Socías
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Abstract

North America is facing an unprecedented public health emergency of opioid-related morbidity and mortality. The mortality benefits of oral medication treatment for opioid use disorder (MOUD), such as methadone or buprenorphine, are well documented. However, barriers to access and long-term engagement have prevented maximizing their benefits. Long-acting injectable buprenorphine formulations were developed to address some of the challenges associated with oral MOUD. The "Pilot study to assess the feasibility, efficacy, and safety of extended-release injectable buprenorphine for the treatment of opioid use disorder among individuals at high risk of overdose" (FASTER-BUP) was developed to explore this treatment option in populations at high risk of overdose in a real-world Canadian setting. FASTER-BUP is a 24-week observational prospective study evaluating the feasibility and clinical utility of extended-release injectable buprenorphine (XR-BUP) for the treatment of opioid use disorder (OUD) among 40 adults at high risk of overdose (ie, lifetime history of overdose or a positive urine drug test (UDT) for fentanyl within 30 days prior to screening) in Vancouver, BC. The primary outcome is retention in treatment and secondary outcomes include: use of unregulated opioids, safety, overdose events, treatment satisfaction, changes in drug-related problems, changes in quality of life, opioid cravings, health service utilization, and criminal activity. FASTER-BUP is the first study to explore XR-BUP among individuals at high risk of overdose in a real-world Canadian setting. This commentary provides a brief narrative about the study thus far and presents insights on key adaptations to the study protocol, including those adopted to mitigate recruitment challenges.

FASTER-BUP 研究,用于治疗过量高危人群阿片类药物使用障碍的缓释注射用丁丙诺啡:观察性前瞻性研究方案》。
北美正面临着前所未有的阿片类药物相关发病率和死亡率的公共卫生紧急状况。美沙酮或丁丙诺啡等口服药物治疗阿片类药物使用障碍(MOUD)对死亡率的益处有据可查。然而,获得治疗和长期参与治疗方面的障碍阻碍了其效益的最大化。开发长效注射用丁丙诺啡制剂就是为了解决与口服 MOUD 相关的一些难题。评估缓释注射用丁丙诺啡治疗用药过量高危人群阿片类药物使用障碍的可行性、疗效和安全性的试点研究"(FASTER-BUP)就是为了在加拿大的实际环境中探索用药过量高危人群的治疗方案而开发的。FASTER-BUP 是一项为期 24 周的前瞻性观察研究,目的是评估缓释注射用丁丙诺啡 (XR-BUP) 在不列颠哥伦比亚省温哥华市 40 名用药过量高危成人(即终生有用药过量史或筛查前 30 天内芬太尼尿液药物检测 (UDT) 呈阳性)中治疗阿片类药物使用障碍 (OUD) 的可行性和临床实用性。主要结果是继续接受治疗,次要结果包括:使用不受管制的阿片类药物、安全性、用药过量事件、治疗满意度、药物相关问题的变化、生活质量的变化、对阿片类药物的渴望、医疗服务利用率和犯罪活动。FASTER-BUP 是第一项在加拿大实际环境中针对用药过量高危人群开展的 XR-BUP 研究。本评论简要叙述了迄今为止的研究情况,并介绍了对研究方案的主要调整,包括为减轻招募挑战而采取的调整。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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