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: 10170310
• 负责人: Patrik Schmidle
• 金额: $ 7.49万
• 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/10170310
• 关键词: Acute; Address; Adherence; Adopted; Adverse event; 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; detection limit; detection method; 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; prescription pain reliever; prevent; programs; response; screening; sensor; subcutaneous; substance use; 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，药物滥用障碍 (SUD) 会给人类造成超过 4000 亿美元的经济损失。 美国经济年度报告[1] 最近，海洛因和处方止痛药的滥用已经发生。 成为一个主要的公共卫生问题，与海洛因或海洛因过量相关的死亡人数 过去十年中，处方止痛药数量从 16,000 种左右增加了四倍多 随着服药过量死亡人数的增加和超过 300 万美国公民的死亡人数，从 2006 年增加到 2017 年的 70,000 多人[2]。 全球有超过 1600 万公民患有阿片类药物使用障碍 (OUD)，阿片类药物过量 美国于2017年宣布进入国家紧急状态[3]。 CARI Therapeutics 提议开发一种基于可注射生物传感器的连续监测系统， 大约一粒米大小，植入皮下，检测和监测药物使用情况 这种连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来实现的，但它将提供的数据 医生随着时间的推移了解物质使用模式也将使他们能够更准确地诊断是否存在 此外，它将使医疗保健提供者能够更好地治疗患者。 让他们能够有效地获取患者处方止痛药的持续监测数据 以及街头毒品使用情况，目前的方法无法对药物使用情况进行可靠的测量。 在无法进行筛选测试的情况下，不仅需要时间，也无法检测新药物。 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出药物处方 适当的治疗，然后测量治疗的依从性，从而使其更有效。 特别是，全国范围内阿片类药物滥用流行，过量死亡人数不断增加[2]，而且阿片类药物滥用的风险 随着强效合成阿片类药物的引入，吸毒者的过量用药现象变得更加严重。 需要比目前的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检测物质的创新方法 使用、监测患者并告知治疗方案 目前不存在其他商用解决方案。 可以检测多种物质并随着时间的推移连续测量它们在第一阶段，我们成功了。 基于非酶分析构建了一种微创阿片类药物 BioMote，具有高度选择性、灵敏性、 在溶液和血清中准确且稳定，并对两种类型的阿片类药物表现出出色的催化反应： 在第二阶段，我们将开始 FDA 批准程序（目标 1），延长吗啡和芬太尼的使用寿命。 生物传感器的功能包括合成阿片类药物的检测（目标 2），开发一种可靠且安全的传感器 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 动物和人体测试（目标 4）。