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: 10612243
• 负责人: Patrik Schmidle
• 金额: $ 111.86万
• 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 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10612243
• 关键词: BioMote; Opioid; Use; Disorder; OUD

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，物质使用障碍（SUD）给美国造成的经济损失超过4000亿美元。 美国经济按年计算[1]。最近，滥用海洛因和处方止痛药， 成为一个主要的公共卫生问题，与海洛因或 处方止痛药在过去十年中增加了四倍多， 2006年至2017年超过70，000 [2]。随着吸毒过量死亡人数的上升，超过300万美国公民和 全世界有超过1600万人患有阿片类药物使用障碍（OUD），阿片类药物过量是 2017年，美国宣布进入国家紧急状态[3]。 CARI Therapeutics提出开发一种基于可注射生物传感器的连续监测系统， 大约米粒大小，皮下植入，检测和监测物质的使用， 间质液中的产物。这种持续监测系统不仅有可能改善 通过检测更多的高危患者来提高目前的筛查能力，但它将提供的数据 随着时间的推移，医生对物质使用模式的研究也将使他们能够更准确地诊断 和物质使用障碍的严重程度。此外，它将允许医疗保健提供者更多地治疗患者， 通过让他们获得患者处方止痛药的连续监测数据， 以及街头毒品的使用。目前的方法既不能可靠的物质使用测量， 在筛选试验不可用的情况下，也不能检测到新的病原体。不仅迫切需要 简化检测物质使用障碍所需的数据，但使医生能够推荐或开处方， 适当的治疗，然后测量坚持治疗，从而使其更有效。在 特别是，全国阿片类药物滥用流行，过量死亡人数增加[2]， 随着高效合成阿片类药物的引入， 需要比目前尿液药物筛查更好的检测方法[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新方法来检测物质 使用、监测患者并告知治疗方案。目前没有其他商业上可用的解决方案 它可以检测多种物质，并随着时间的推移不断测量它们。在第一阶段，我们成功地 建立了一个微创阿片类药物BioMote基于非酶测定，具有高度选择性，敏感性， 准确，在溶液和血清中稳定，对两种阿片类药物显示出优异的催化反应： 吗啡和芬太尼在第二阶段，我们将开始FDA批准程序（目标1），延长寿命， 生物传感器的功能，包括合成阿片类药物的检测（目标2），开发一种可靠和安全的 展开和拔出程序（目标3），并确认器械的准确性、安全性和可靠性 动物和人体试验（目标4）。