Development of the OpiAID strength band platform

OpiAID 力量带平台的开发

• 批准号: 10684399
• 负责人: David Alderson MacQueen
• 金额: $ 31.96万
• 依托单位: OPIAID, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10684399
• 关键词: Accelerometer; Acute; Address; Adopted; Adoption; Agonist; Algorithms; Anxiety; Behavioral; Biometry; Buprenorphine; COVID-19 pandemic; Cessation of life; Charge; Client satisfaction; Clinical; Clinical Trials; Counseling; Criminal Justice; Data; Dependence; Development; Devices; Dose; Epidemic; Event; Health Care Costs; Healthcare; Imprisonment; Intervention; Machine Learning; Maintenance; Methadone; Methods; Opiate Addiction; Opioid; Opioid agonist; Overdose; Pain; Participant; Patient Care; Patient Monitoring; Patient Self-Report; Patients; Performance; Persons; Pharmaceutical Preparations; Pharmacotherapy; Phase; Photoplethysmography; Physicians; Pilot Projects; Price; Productivity; Protocols documentation; Provider; Randomized; Randomized, Controlled Trials; Relapse; Research; Risk Reduction; Services; Site; Sleeplessness; Social Functioning; Survival Analysis; Symptoms; Technology; Telephone; Temperature; Time; Toxicology; Urine; Withdrawal; Withdrawal Symptom; Work; arm; cost; craving; detection platform; digital platform; drug seeking behavior; evidence base; experience; fitbit; flu; improved; innovation; medication for opioid use disorder; monitoring device; opioid agonist therapy; opioid misuse; opioid mortality; opioid overdose; opioid use; opioid withdrawal; overdose death; overdose risk; patient retention; recruit; relapse prevention; relapse risk; satisfaction; sensor; standard of care; success; supervised learning; wearable device

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.

项目摘要 阿片类小姐在美国已经达到流行病，声称在 截至2022年2月，十二个月。阿片类药物是高度添加剂的，是通过严重的 戒断症状，​​例如焦虑，普遍疼痛，失眠和类似流感的症状，有助于 复发。阿片类药物过量，小姐和依赖性导致估计$ 35B的医疗保健费用，14B美元 刑事司法费用，每年在美国治疗阿片类药物使用障碍的药物中每年的生产力损失损失 （moud），将行为咨询与激动剂药物疗法（例如丁丙诺啡或 Metagadone管理戒断是一种基于证据的，全患者的方法来治疗阿片类药物依赖性。 已显示它可以减少阿片类药物的使用和过量的死亡，并增加社交功能和 保留治疗。但是，建立阿片类药物激动剂的正确初始剂量以在 MOUD诱导阶段很困难；低剂量可能无法减轻戒断症状，​​并增加 复发，而高剂量可能无法降低过量的风险。这些因素呈现出患者的障碍 通过MOUD感应阶段的保留率，目前提供者缺乏患者监测的方法 可以告知改进的剂量方案。 Opiaid，Inc正在通过强度带来满足这种未满足的需求 平台，一种创新的基于AI的数字平台，可在整个MOUD归纳中进行患者监控 时期。患者生物识别技术是通过带有多传感器阵列的可穿戴设备捕获的，并由我们的 专有算法可检测植物期间的救济和退出。这是一种首先的技术 旨在使医生能够实施即时干预措施，以增强患者的保留率，防止继电器， 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 收集并综合复合数量和及时确定急性所需的生物特征数据 Oopioid使用和戒断。但是，我们的工作是使用研究级设备Empatica E4完成的，他的工作 价格点和有限的采用可能会阻碍可销售性。在这项工作的基础上，我们打算扩大我们的 可容纳市售和广泛采用的设备（例如Whoop Strap 4.0和 Fitbit Charge 5。此外，我们计划进行大型临床试验以评估强度带的性能 现实世界中的平台。该项目的成功完成将确认OpiaId的实力的实用性 用于检测救济和退出的乐队平台，并增强临床医生提供质量的能力， 阿片类药物依赖患者的可持续护理。