BioMote for Opioid Use Disorder (OUD) Recovery

BioMote 用于阿片类药物使用障碍 (OUD) 康复

• 批准号: 10012958
• 负责人: Patrik Schmidle
• 金额: $ 178.19万
• 依托单位: CARI HEALTH, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2022-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10012958
• 关键词: Acute; Address; Adherence; Adopted; Adverse event; Alcohol or Other Drugs use; Analgesics; Animals; Biological Assay; Biosensor; Blood; Blood specimen; Buffers; Buprenorphine; Cessation of life; Clinical Research; Communication; Consult; Custom; Data; Detection; Development; Devices; Dimensions; Dose; Drug Screening; Drug usage; Electrodes; Emergency Situation; Ensure; Epidemic; FDA approved; Family suidae; Fentanyl; Grain; Health Personnel; Heroin; Human; Implant; In Vitro; Infrastructure; Injectable; Intercellular Fluid; Laboratories; Measurement; Measures; Methods; Monitor; Morphine; Nature; New Agents; Opioid; Overdose; Oxycodone; Patient Monitoring; Patient Self-Report; Patients; Pattern; Pharmaceutical Preparations; Phase; Procedures; Process; Protocols documentation; Public Health; Reading; Recovery; Relapse; Rice; Risk; Safety; Sensitivity and Specificity; Serum; Severities; Street Drugs; Substance Use Disorder; System; Technology; Testing; Therapeutic; Time; Treatment Effectiveness; United States; Urine; Work; accurate diagnosis; aqueous; base; design; experimental study; glucose monitor; high risk; improved; in vivo; innovation; meetings; minimally invasive; novel; opioid misuse; opioid overdose; opioid use; opioid use disorder; overdose death; overdose risk; prevent; programs; response; screening; sensor; subcutaneous; synthetic opioid; tool; voltage

PROJECT ABSTRACT Substance use disorders (SUDs) are estimated to cause over $400 billion worth of monetary damage to the US economy on an annual basis [1]. Recently, the misuse of heroin and prescription pain medications has become a major public health concern, The number of deaths related to overdose from either heroin or prescription pain medications has more than quadrupled over the last decade from approximately 16,000 in 2006 to more than 70,000 in 2017 [2]. With the rising overdose deaths and more than 3 million US citizens and more than 16 million citizens worldwide suffering from opioid use disorders (OUD), opioid overdose was declared a national emergency in the United States in 2017 [3]. CARI Therapeutics proposes to develop a continuous monitoring system based on an injectable biosensor, approximately the size of a grain of rice, implanted subcutaneously that detects and monitors substance use by products in the interstitial fluid. This continuous monitoring system not only has the potential to improve upon the current screening capabilities by detecting a higher number of at-risk patients, but the data it will provide doctors on substance use patterns over time will also enable them to more accurately diagnose the presence and severity of substance use disorders. Furthermore, it will allow health care providers to treat patients more effectively by giving them access to continuous monitoring data of their patients’ prescription pain medication as well as street drug use. The current methods enable neither reliable substance use measurements over time nor detection of newer agents where screening tests are not available. There is a critical need to not only simplify data needed to detect substance use disorders, but to enable doctors to recommend or prescribe the appropriate treatment, followed by measuring adherence to the treatment, thereby making it more effective. In particular, there is a national opioid misuse epidemic with increasing overdose deaths [2], and the risk of overdose among users has become even greater with the introduction of highly potent synthetic opioids that require better detection methods than current urine drug screens [4]. A novel, minimally invasive, biosensor-based approach constitutes an innovative new way to detect substance use, monitor patients and inform treatment solutions. Currently no other commercially available solutions exist that can detect multiple substances and measure them continuously over time. In Phase I, we successfully built a minimally invasive opioid BioMote based on a non-enzymatic assay that is highly selective, sensitive, accurate, and stable in solution and serum and showed excellent catalytic response to two types of opioids: morphine and fentanyl. In Phase II, we will begin the FDA approval process (Aim 1), expand the lifetime and functionality of the biosensor to include detection of synthetic opioids (Aim 2), develop a reliable and safe deployment and extraction procedure (Aim 3), and validate the accuracy, safety, and reliability of the device in animal and human testing (Aim 4).

项目摘要 据估计，药物使用障碍（SUD）造成价值超过4000亿美元的货币损失 美国经济每年[1]。最近，对海洛因和处方止痛药的失误 成为一个主要的公共卫生问题，与海洛因或过量用药有关的死亡人数或 在过去的十年中，处方止痛药已经从大约16,000英寸 2006年在2017年超过70,000 [2]。随着过量死亡人数增加，美国公民超过300万， 全球有1600万公民患有阿片类药物使用障碍（OUD），阿片类药物过量是 2017年在美国宣布全国紧急情况[3]。 Cari Therapeutics提案，以开发基于可注射生物传感器的连续监测系统， 大约相当于一粒大米的大小，皮下植入，检测和监控物质的使用 间质流体中的产品。这种连续的监视系统不仅有可能改善 当前的筛查功能通过检测到更多的高风险患者，但它将提供的数据 随着时间的推移，医生使用模式的医生也将使他们能够更准确地诊断出存在 和药物使用障碍的严重程度。此外，它将允许医疗保健提供者对患者进行更多治疗 通过让他们获得患者处方止痛药的连续监测数据有效地有效 以及街头吸毒。当前的方法可以使任何可靠的物质使用测量 时间或检测不可用的筛查测试的新代理。不仅需要 简化检测药物使用障碍所需的数据，但使医生能够推荐或准备 适当的治疗，然后测量对治疗的依从性，从而使其更有效。在 特别是，有一种全国阿片类药物滥用流行病，过量死亡[2]，以及 通过引入高潜在的合成阿片类药物，用户中的用药变得更大 比目前的尿液药物筛查需要更好的检测方法[4]。 一种新颖的，微创的基于生物传感器的方法构成了一种创新的检测底物的新方法 使用，监控患者并为治疗解决方案提供信息。目前尚无其他市售解决方案 可以检测多种物质并随着时间的流逝而连续测量它们。在第一阶段，我们成功 建立了一种基于高度选择性，敏感， 准确且在溶液和血清中稳定，并且对两种类型的绿核酸显示出极好的催化反应： 吗啡和芬太尼。在第二阶段，我们将开始FDA批准过程（AIM 1），扩大寿命和 生物传感器的功能包括检测合成阿片类药物（AIM 2），发展可靠且安全 部署和提取程序（AIM 3），并验证设备在 动物和人类测试（AIM 4）。