Development of the OpiAID strength band platform

项目摘要 阿片类药物滥用在美国已经达到了流行病的水平，造成104，000多人死亡， 到2022年2月为止的12个月。阿片类药物具有高度成瘾性，并伴有严重的 戒断症状，如焦虑、全身疼痛、失眠和流感样症状， 复发阿片类药物过量，滥用和依赖导致估计350亿美元的医疗保健费用，140亿美元的 刑事司法成本，以及美国每年920亿美元的生产力损失。 （MOUD），它结合了行为咨询与激动剂药物治疗，如丁丙诺啡或 美沙酮管理戒断，是一种以证据为基础的，全患者的方法来治疗阿片类药物依赖。 它已被证明可以减少阿片类药物的使用和过量死亡，并增加社会功能， 治疗保留。然而，确定阿片类激动剂的正确初始剂量以在治疗期间施用， MOUD诱导阶段是困难的;低剂量可能无法缓解戒断症状，并增加 高剂量可能无法降低过量服用的风险。这些因素对患者造成了障碍 保留通过MOUD诱导阶段，提供者目前缺乏患者监测的方法， 可以改进给药方案。OpiAID，Inc正在通过Strength Band解决这一未满足的需求 平台，一个创新的基于AI的数字平台，可在整个MOUD诱导过程中进行患者监测 期患者生物特征通过具有多传感器阵列的可穿戴设备捕获，并由我们的 专有算法，以检测复发和戒断在MOUD诱导。这项史无前例的技术 旨在使医生能够及时实施干预措施，以提高患者的保留率，防止复发， 并改善戒断症状的管理。我们的试点研究表明，我们的平台可以 收集和综合生物特征数据，用于综合量化和及时识别急性 阿片类药物的使用和戒断。然而，我们的工作是使用研究级设备Empatica E4完成的， 价格点和有限的采用可能会阻碍市场化。在这项工作的基础上，我们打算扩大 平台，以适应市售和广泛采用的设备，如WHOOP表带4.0和 5.第五章此外，我们计划进行一项大型临床试验，以评估强度带的性能 平台在现实世界中的设置。该项目的成功完成将证实OpiAID的优势的效用 Band平台用于检测复发和戒断，并提高临床医生提供质量的能力， 为阿片类药物依赖患者提供可持续护理。

PROJECT SUMMARY Opioid misuse has reached epidemic levels in the U.S., claiming the lives of more than 104,000 people in the twelve months up to February 2022 alone. Opioids are highly addictive and are accompanied by severe withdrawal symptoms such as anxiety, generalized pain, insomnia, and flu-like symptoms that contribute to relapse. Opioid overdose, misuse, and dependence result in an estimated $35B in health care costs, $14B in criminal justice costs, and $92B in lost productivity each year in the U.S. Medications for opioid use disorder (MOUD), which combines behavioral counseling with agonist drug therapies such as buprenorphine or methadone to manage withdrawal, is an evidence-based, whole-patient approach to treating opioid dependence. It has been shown to decrease opioid use and deaths from overdose and increase social functioning and treatment retention. However, establishing the correct initial dose of an opioid agonist to administer during the MOUD induction phase is difficult; low doses may fail to alleviate withdrawal symptoms and increase the risk of relapse, while high doses may fail to reduce the risk of overdose. Such factors present a barrier to patient retention through the MOUD induction phase, and providers currently lack methods for patient monitoring that could inform improved dosing protocols. OpiAID, Inc is addressing this unmet need with the Strength Band Platform, an innovative AI-based digital platform that enables patient monitoring throughout the MOUD induction period. Patient biometrics are captured via a wearable device with a multi-sensor array and are used by our proprietary algorithm to detect relapse and withdrawal during MOUD induction. This first-of-its-kind technology aims to enable physicians to implement just-in-time interventions to enhance patient retention, prevent relapse, and improve the management of withdrawal symptoms. Our pilot studies have shown that our platform can gather and synthesize the biometric data needed for composite quantification and timely identification of acute opioid use and withdrawal. However, our work was done using a research-grade device, the Empatica E4, whose price point and limited adoption may hinder marketability. Building upon this work, we intend to expand our platform to accommodate commercially available and widely adopted devices like the WHOOP Strap 4.0 and Fitbit Charge 5. Further, we plan to conduct a large clinical trial to evaluate the performance of the Strength Band Platform in real-world settings. Successful completion of this project will confirm the utility of OpiAID’s Strength Band Platform for detecting relapse and withdrawal, and for enhancing clinicians’ ability to deliver quality, sustainable care for patients with opioid dependency.