Therapeutic Monitoring System (TMS)

摘要 超过50万患者在全国各地的阿片类药物治疗项目（OTP）接受治疗，95% 其中接受美沙酮作为阿片类药物使用障碍（OUD）的药物，这是 治疗OUD。目前美沙酮药物治疗OUD的临床实践遵循长期建立的 联邦和州的监管政策具有高度限制性，要求患者亲自向 每天登记的OTP接受他们的处方美沙酮剂量，造成了巨大的障碍， 治疗对农村人口和低收入社区造成不成比例的影响，因为那里缺乏诊所， 有限的交通和/或不灵活的工作可能使日常约会难以维持。本合规 负担导致了项目的辍学率，并增加了公众对OUD的污名。国家、OTP、 和其他利益相关者报告说，在COVID-19大流行期间放松联邦政策， 允许OTP给稳定的患者开更长的带回家的药物剂量，产生了积极的影响， 从而增加了治疗参与度，提高了患者对护理的满意度， 药物滥用因此，美国药物滥用和心理健康服务管理局 （SAMHSA）建议将这些变化永久化。然而，许多护理提供者仍然不愿意 规定允许带回家的剂量的全部数量，部分原因是根深蒂固的耻辱和恐惧， 药物过量和药物转移。 为了帮助克服提供者的不情愿和增加对带回家服药依从性的信心， 该快速通道项目提出开发一种不引人注目的可穿戴生物传感器设备， 检测和远程监控患者服用的美沙酮剂量， 美沙酮治疗选择，可以扩大获得OUD医疗保健。CARI Health远程医疗系统的核心 药物监测（RMM）系统是一种可以检测和定量美沙酮的电化学传感器 及其代谢产物EDDP在人组织间液（ISF）中的应用 微针阵列。到目前为止，CARI已经成功地创建和测试了所提出的传感器的原型， 微针阵列和测定。该项目建议将这些组件集成到原型设备中， 在第一阶段（目标1-3）开发一个伴随的设备数据管道，然后开发一个商业级产品 (Aim 4），大规模生产工艺（目标5），并清除人类可穿戴使用的CARI RMM（目标6） 在II期阶段，准备在临床研究中测试CARI RMM（目标7、8） 预计成功实现上述目标将有助于FDA批准重新分类 II类设备和开始商业化进程的CARI健康监测系统，及时 创新，这将有助于最大限度地发挥SAMHSA的努力，以更新监管政策，以满足 满足患者的需求。

ABSTRACT More than half a million patients receive treatment at opioid treatment programs (OTPs) around the country, 95% of whom receive methadone as a medication for opioid use disorder (OUD), which is the gold standard for treating OUD. Current clinical practice for methadone medication treatment of OUD follows long-established federal and state regulatory policies that are highly restrictive and require patients to present in-person to a registered OTP every day to receive their prescribed methadone dose, creating an enormous obstacle to treatment that disproportionately impacts rural populations and low-income communities where lack of clinics, limited transportation, and/or inflexible jobs can make daily appointments difficult to sustain. This compliance burden contributes to program drop-out rates and adds to the public stigma surrounding OUD. States, OTPs, and other stakeholders have reported that a relaxation of federal policy during the COVID-19 pandemic, which allowed OTPs to prescribe longer take-home doses of medication to stable patients, had positive impact, resulting in increased treatment engagement, improved patient satisfaction with care, and few incidents of medication misuse. As a result, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) has proposed making the changes permanent. However, many care providers remain reluctant to prescribe the full amount of allowable take-home doses due, in part, to ingrained stigmas and fears regarding overdoses and diversion of medication. To help overcome provider reluctance and increase confidence in take-home medication compliance, this Fast-Track project proposes the development of an unobtrusive wearable biosensor device capable of detecting and remotely monitoring a patient’s taken doses of methadone to enable trustworthy take-home methadone treatment options that can expand access to OUD healthcare. The core of CARI Health’s remote medication monitoring (RMM) system is an electrochemical sensor that can detect and quantitate methadone and its metabolite EDDP in human interstitial fluid (ISF) using differential pulse voltammetry and a custom microneedle array. To date, CARI has successfully created and tested prototypes of the proposed sensor, microneedle array, and assay. This project proposes to integrate these components into a prototype device and develop an accompanying device data pipeline in Phase I (Aims 1-3), then develop a commercial grade product (Aim 4), at-scale manufacturing processes (Aim 5), and clear the CARI RMM for human wearable use (Aim 6) during Phase II to prepare for testing the CARI RMM in clinical studies (Aims 7, 8) It is expected that successful achievement of the above aims will facilitate FDA clearance of a de novo class II device and begin the commercialization process of the CARI Health monitoring system, a timely innovation that will help maximize the impact of SAMHSA’s efforts to update regulatory policies to meet the recognized needs of OUD patients.