A Randomized, Controlled Trial of Sublingual Buprenorphine through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder

阿片类药物使用障碍（OUD）每年影响160万美国人，并导致显著的 发病率和死亡率，由阿片类药物过量流行病驱动。尽管FDA批准了3种有效的药物， 治疗OUD（MOUD），在所有受OUD影响的人中，只有一小部分人参与有效的MOUD， 而在这些患者中，只有更少的一部分人能够坚持足够长的治疗时间以达到稳定的缓解。而 COVID-19大流行导致OUD现有治疗格局的广泛中断， 强调了技术在处理OUD方面的应用机会，包括广泛的 利用远程保健，并得到多层次监管改革的进一步支持。传统的处方 实体诊所和初创的远程医疗企业迅速适应了新的环境， 远程医疗是提供MOUD的主要手段。2020年3月，美国远程医疗的使用率 在不到一个月的时间里增长了154%。MOUD远程保健的倡导者确定了更好的访问， 可行性和便利性，减少耻辱作为潜在的好处。尽管大规模的拥抱 在过去一年中，MOUD的远程医疗，证据表明COVID-19的负面影响不同 流行病对OUD患者的影响，包括过量死亡率增加。远程保健有其局限性 与亲自护理相比，包括更大的转移或滥用处方药物的风险。最好 实践，如如何完成高保真药物筛选或哪些患者可能更适合在 个人护理，尚未建立，无法跟上提供者采用的步伐 远程保健，特别是作为没有成瘾培训的从业人员提供MOUD。 随着SARS-Co-V2疫苗接种率的提高，以及沿着提供安全、有效疫苗的机会 个人护理，了解远程医疗MOUD与个人护理的好处和局限性至关重要 重要的是，特别是因为它有可能影响远远超出大流行的监管变化。匆忙 公共卫生危机不允许采取以证据为基础的办法，以取得比较效果 使用远程医疗MOUD和面对面MOUD的研究试验。 我们提出了一个早期的II期临床试验，其中50名寻求MOUD的患者将被随机 分配至两组之一：组1将接受舌下给药的亲自诱导和维持给药 组2将完成舌下给药的诱导和维持给药， 通过全面的远程保健课程、远程保健MOUD，利用标准化方案， 针对我们的成瘾专家开发的每个医疗保健提供者会话。这种远程医疗 协议作为MOUD中基于证据的实践整合的模型，可以由非 大规模的成瘾专家我们的主要结果将是保留治疗12周。迄今为止，这 将是第一个前瞻性的，随机的，对照试验比较远程医疗MOUD和MOUD像往常一样。

Opioid Use Disorder (OUD) effects 1.6 million Americans per year, and contributes to significant morbidity and mortality, driven by the opioid overdose epidemic. Despite 3 FDA approved, effective medication treatments for OUD (MOUD), among all people affected by OUD, only a fraction engage in effective MOUD, and of those, an even smaller fraction remain in treatment long enough to achieve stable remission. While the COVID-19 pandemic resulted in widespread disruption in the existing treatment landscape for OUD, it also highlighted opportunities for applications of technology in the treatment of OUD, including widespread utilization of telehealth, that were further supported by multi-level regulatory changes. Prescribers in traditional brick-and-mortar clinics and start-up telehealth businesses quickly adapted to the new environment in utilizing telemedicine as a primary means of providing MOUD. In March 2020, utilization of telehealth in the US increased 154% in less than 1 month. Advocates of telehealth for MOUD identify improved access, increased feasibility, and convenience with diminished stigma as potential benefits. Despite the largescale embrace of telehealth for MOUD during the last year, evidence points to a differentially negative impact of the COVID-19 pandemic on patients with OUD, including increased overdose death rates. There are limitations of telehealth as compared to in-person care, including greater risk of diversion or misuse of prescribed medications. Best practices, such as how to complete high fidelity drug screening or which patients may be better suited to in person care, have not been established and have not been able to keep up with the pace of provider adoption of telehealth, particularly as practitioners without addiction training provide MOUD. As vaccination rates against SARS-Co-V2 increase, along with the opportunity to provide safe, in- person care, understanding the benefits and limitations of telehealth MOUD vs in-person care is critically important, especially as it has the potential to impact regulatory changes far beyond the pandemic. Haste in the public health crisis did not permit an evidence-based approach to allow for comparative effectiveness research trials in the use of telehealth MOUD and in-person MOUD. We propose an early Phase II clinical trial, in which 50 patients seeking MOUD will be randomly assigned to one of two arms: Arm 1 will receive in-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual, and Arm 2 will complete induction and maintenance dosing of sublingual buprenorphine through comprehensive telehealth sessions, telehealth MOUD, utilizing a standardized protocol for each healthcare provider session that has been developed by our addiction specialists. This telehealth protocol serves as a model of the integration of evidence-based practices in MOUD and could be used by non- addiction specialists at scale. Our primary outcome will be retention in treatment for 12-weeks. To date, this would be the first prospective, randomized, controlled trial comparing telehealth MOUD to MOUD as usual.