BioMote for Opioid Use Disorder (OUD) Recovery

项目摘要 据估计，物质使用障碍(SODS)会给 美国年度经济数据[1]。最近，海洛因和处方止痛药的滥用已经 成为一个主要的公共卫生问题，与海洛因或海洛因过量有关的死亡人数 在过去的十年中，处方止痛药从大约16,000种增加了四倍多 从2006年的70,000多人增加到2017年的70,000人[2]。随着服药过量死亡人数的上升和300多万美国公民和 全世界有1600多万人患有阿片使用障碍(OUD)，阿片类药物过量是 2017年美国宣布全国进入紧急状态[3]。 CARI治疗公司建议开发一种基于可注射生物传感器的连续监测系统， 大约一粒大米的大小，植入皮下检测和监测物质的使用 间质液体中的产物。这一持续监测系统不仅具有改进的潜力 目前的筛查能力是通过检测更多的高危患者，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存在 和药物使用障碍的严重程度。此外，它将允许卫生保健提供者对患者进行更多的治疗 通过让他们访问他们的患者处方止痛药的连续监测数据来有效地 以及街头吸毒。目前的方法都不能使可靠的物质使用测量超过 在没有筛选测试的情况下，也没有时间检测到较新的药物。迫切需要的不仅是 简化检测药物使用障碍所需的数据，但使医生能够建议或开出 适当的治疗，然后衡量治疗的依从性，从而使其更有效。在……里面 特别是，阿片类药物滥用在全国范围内流行，过量死亡人数不断增加[2]， 随着高效合成阿片类药物的引入，吸食过量的情况变得更加严重 需要比目前尿液药物筛查更好的检测方法[4]。 一种新的、微创的、基于生物传感器的方法构成了一种创新的物质检测方法 使用、监测患者并告知治疗解决方案。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 构建了一种基于非酶检测的微创阿片类生物移动，这种检测具有高度选择性，敏感性， 准确，在溶液和血清中稳定，对两种类型的阿片类药物表现出良好的催化反应： 吗啡和芬太尼。在第二阶段，我们将开始FDA批准程序(目标1)，延长生命周期和 生物传感器的功能包括检测合成阿片类药物(目标2)，开发可靠和安全的 部署和提取程序(目标3)，并验证设备的准确性、安全性和可靠性 动物和人体试验(目标4)。

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).