Next Generation Tools for Onsite Monitoring and Treatment of Drug of Abuse-Dependent Persons

用于对药物滥用者进行现场监测和治疗的下一代工具

• 批准号: 10026090
• 负责人: Robert Mehalso
• 金额: $ 72.18万
• 依托单位: SENSODX II, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10026090
• 关键词: Accounting; Affect; American; Analgesics; Area; Biological Assay; Blinded; Buprenorphine; Caring; Clinical; Cocaine; Computer software; Consumption; Correlation Studies; Custom; Data; Detection; Devices; Disease; Dose; Drug Exposure; Drug Targeting; Ensure; Epidemic; Fentanyl; Focus Groups; Foundations; Gold; Health Services Accessibility; Healthcare; Heroin; Heroin Users; Improve Access; Lab-On-A-Chips; Liquid Chromatography; Liquid substance; Measurement; Measures; Medical; Medicine; Methadone; Methods; Monitor; Morphine; Naltrexone; Opiate Addiction; Opioid; Optics; Oral; Outcome; Overdose; Oxycodone; Patient Monitoring; Patients; Performance; Persons; Pharmaceutical Preparations; Pharmacotherapy; Phase; Pregnancy; Prescription opioid overdose; Price; Privatization; Provider; Recovery; Reference Standards; Research; Resources; Saliva; Sampling; Services; Site; Social Impacts; Specimen; Substance Abuse Detection; System; Technology; Testing; Time; Treatment Efficacy; United States Dept. of Health and Human Services; United States National Institutes of Health; Urine; Validation; Withdrawal Symptom; Work; addiction; aged; base; buprenorphine treatment; care outcomes; clinical efficacy; cocaine use; college; commercialization; cost; design; drug of abuse; drug testing; effective intervention; effective therapy; fetal; heroin use; illicit drug use; improved; instrument; instrumentation; medication-assisted treatment; microdevice; microfluidic technology; mortality; next generation; nonmedical use; opioid abuse; opioid epidemic; opioid misuse; opioid mortality; opioid use; opioid use disorder; opioid user; overdose risk; personalized medicine; phase 1 study; point of care; portability; prescription opioid; prescription opioid abuse; prescription opioid misuse; programs; prototype; response; sensor; tandem mass spectrometry; technology development; tool; treatment program

Abstract Opioid abuse disorder (OAD) affects 2.1 million of Americans annually resulting in overdoses numbering in the tens of thousands and skyrocketing rates of mortality. In addition to its enormous social impact, OAD carries a multi-billion-dollar price tag that includes $78.5 billion, specifically for health care and other costs related to prescription opioid abuse and misuse. Although effective interventions exist, they are highly underutilized – Currently less than 1-in-5 Americans with prescription OUDs receive treatment for their disorder, the $2.8 billion spent accounting for less than 4% of the financial resources consumed by mismanagement of prescription opioid use. As treatment programs expand to meet need, it is critical that they be able to offer comprehensive services to best support patient recovery. Among potential treatment options for OAD, medication-assisted treatment (MAT) for opioid addiction – typically employing methadone, buprenorphine or naltrexone – has been shown to reduce withdrawal symptoms and is associated with reduced overdose risk and improved maternal and fetal outcomes in pregnancy. Since the inception of medication-assisted treatment (MAT) for opioid addiction, drug testing has provided both an objective measure of treatment efficacy and a tool to monitor patient progress, however, current methods are ill-suited for use in drug treatment settings. Liquid chromatography–tandem mass spectrometry (LC–MS-MS) is highly sensitive, but the method is slow to yield results and requires tedious sample processing. Easy to use immunochromatographic test strips (ICS) are gold-standard reference methods for point-of-care settings, but they are non-quantitative and have limited multiplexing capacity. A multiplexing tool is desirable for monitoring MAT because patients with OUD may have multiple opioids in their system over the course of treatment including the primary addictive opioid, treatment opioid, and less desirable substitutes for the addictive opioid of choice. Recognizing this unmet need in addiction treatment settings for a simple, yet sensitive, instrument that can measure multiple opioids in clinical specimens, SensoDx conceptualized a drug of abuse testing-on-a-chip strategy that implements microfluidics technology for high-sensitivity detection of opioids. In previous work (Phase I studies), we developed and clinically tested a triplex assay targeting simultaneous quantitative determination of buprenorphine, cocaine and morphine in oral fluid for use in buprenorphine-assisted treatment. This Phase II project will deliver a set of milestones – an optimized cartridge (precision, cost, size), expanded multiplexing capabilities to detection of seven drugs (buprenorphine, morphine, oxycodone, methadone, heroine, fentanyl, and cocaine), and pilot-scale clinical validation (in patients undergoing MAT) that will form the foundation and proof-of-concept for a prototype SensoDx Drug ScreenTM platform ready for design and fabrication finalization, GLP manufacturing and testing. The efforts will result in the commercial release of analyzer instrumentation, sampling devices and customized disposables for entry into the Lab-on-a- Chip market, valued at $4.23 Billion (in 2016) and expected to grow at a CAGR of 11% by 2022.

抽象的 阿片类药物滥用障碍（OAD）每年影响210万美国人 数以万计的死亡率飙升。除了其巨大的社会影响外，OAD还带有 数十亿美元的价格标签，包括785亿美元，专门用于医疗保健和其他与 尽管存在有效的干预措施，但它们被高度未被充分利用 - 目前，少于5名美国人的处方Ouds因其疾病而接受治疗，这是28亿美元 花费不到处方OID的错误所消耗的财务资源的4％ 使用。随着治疗计划的扩展到满足需求，至关重要的是他们能够提供全面的服务 为了最好地支持患者康复。在OAD的潜在治疗选择中，药物辅助治疗 （MAT）对于阿片类药物成瘾 - 通常使用Meadadone，丁丙诺啡或纳曲酮 - 已显示出 减轻戒断症状，​​与减少药物的风险和改善的母乳和胎儿有关 怀孕的结果。自从药物辅助治疗（MAT）用于阿片类药物，药物以来 测试既提供了对治疗效率的客观测量，又提供了监测患者进度的工具， 但是，当前的方法不适合用于药物治疗环境。液相色谱 - 潮流质量 光谱法（LC – MS-MS）高度敏感，但是该方法得出的结果很慢，需要乏味的样品 加工。易于使用的免疫色谱测试条（ICS）是金标准参考方法 护理点设置，但它们是非定量的，并且多重能力有限。多路复用工具是 希望监视垫子，因为OUD患者的系统中可能有多种阿片类药物 治疗过程，包括主要添加剂阿片类药物，治疗阿片类药物以及不太理想的替代品 其他选择的阿片类药物。认识到成瘾治疗环境中的这种未满足的需求 敏感的仪器可以测量临床标本中多种阿片类药物，Sensodx概念化了一种药物 滥用片策略策略，该策略实现了微流体技术，以进行高敏性检测 阿片类药物。在先前的工作（第一阶段研究）中，我们开发并在临床上测试了三重测定的靶向 简单定量测定口服流体中丁丙诺啡，可卡因和吗啡 丁丙诺啡辅助治疗。该第二阶段项目将提供一组里程碑 - 优化的墨盒 （精度，成本，大小），扩展的多重能力检测七种药物（丁丙诺啡，吗啡， 羟考酮，方法adone，女主人公，芬太尼和可卡因）和试验尺度临床验证（在接受的患者中 垫子）将构成原型Sensodx药物屏幕平台准备的基础和概念验证 用于设计和制造最终确定，GLP制造和测试。努力将导致广告 释放分析仪仪器，采样设备和定制的处置，以进入实验室 芯片市场的价值为42.3亿美元（2016年），预计到2022年的复合年增长率为11％。