Development and validation of a novel point-of-care technology for rapid non-targeted identification of emerging opioid and other drug threats

开发和验证一种新型即时护理技术，用于快速非靶向识别新出现的阿片类药物和其他药物威胁

• 批准号: 10775250
• 负责人: Drew Alexander Hall
• 金额: $ 64.03万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10775250
• 关键词: Address; American; Anesthetics; Applied Research; Authorization documentation; Automobile Driving; Benzodiazepines; Biological Assay; Biosensor; COVID-19; Canada; Cities; Client; Cocaine; Complex; Country; Development; Disease Outbreaks; Drug Controls; Drug usage; Drug user; Effectiveness; Epidemic; Exercise; Federal Government; Fentanyl; Forensic Medicine; Grant; Health; Heroin; Human; Improve Access; Individual; Intervention; Investigation; Ketamine; Legal; Machine Learning; Marketing; Mass Spectrum Analysis; Medical Examiners; Methamphetamine; Morphine; Nature; Norfentanyl; North America; Opioid; Overdose; Overdose reduction; Overdose reversal; Performance; Persons; Pharmaceutical Preparations; Plasma; Point of Care Technology; Point-of-Care Systems; Policies; Population; Populations at Risk; Psychotropic Drugs; Quality-Adjusted Life Years; Research Infrastructure; Risk; Risk Behaviors; Sampling; Services; Specimen; Spectroscopy, Fourier Transform Infrared; Stimulant; System; Technical Expertise; Technology; Testing; Time; United States; Urine; Validation; Work; assay development; authority; carfentanil; cost; detection method; drug market; ecstasy; experience; high risk; instrument; interest; machine learning algorithm; meetings; mortality; multidisciplinary; new technology; novel; overdose prevention; overdose risk; point of care; prevent; preventive intervention; public health emergency; reagent testing; repository; scale up; service providers; substance use; synthetic opioid; technology development; test strip; tool

ABSTRACT The North American overdose crisis remains at epidemic levels, with over 1 million lives lost over the past decade. This crisis is primarily driven by the emergence of high- potency opioids such as fentanyl, in unregulated (“street”) drug markets. However, the volatility of these markets has also led to the emergence of other even more potent opioids such as carfentanil and nitazene-class opioids, along with adulterants such as benzodiazepines. These emerging drug threats produce complex overdose presentations and difficulties in overdose reversal, all of which contribute to overdose mortality. Drug checking services, which provide individuals with analytic information regarding the presence of compounds in drugs of unknown composition, are increasingly employed in North America to prevent overdose mortality during the era of high-potency synthetic opioid contamination. However, current efforts to implement and expand access to drug checking services are hampered, primarily because current available technologies have logistical, technical, and cost-related barriers that impede their feasibility as point-of-care interventions. This is exacerbated by the need for ongoing assay development to ensure that drug checking technologies can continue to accurately detect and identify novel high-potency drug threats in North American drug markets. Meeting these needs is critical to advance the effectiveness of drug checking at the population level, particularly for drug checking service providers, individuals who use drugs, and medical examiners undertaking forensic investigations of overdose mortality. The aim of the current project is therefore to develop and validate a novel point-of-care technology, known as DoseCheck, for rapid non-targeted identification of emerging drug threats. Specifically, we will: 1) validate the DoseCheck system’s capacity to differentiate between and within classes of opioid, stimulant, depressant, and anesthetic compounds in non-targeted analyses of unregulated drugs; 2) undertake timed exercises to evaluate the capacity of our team to rapidly adapt the DoseCheck system to detect and differentiate a novel emerging drug threat; and 3) test the capacity of the DoseCheck system to identify and differentiate distinct opioid metabolites within human biomatrices. Achieving these aims will generate high impact and highly translational findings that will support the expansion of adaptive, analytically sophisticated, and low-cost point-of-care drug checking services and thereby contribute to a reduction in overdose mortality.

抽象的 北美服药过量危机仍处于流行病水平，超过100万人丧生 这场危机主要是由高风险的出现造成的。 芬太尼等强效阿片类药物在不受监管的（“街头”）毒品市场上销售。 这些市场的波动也导致了其他更强大的市场的出现 阿片类药物，例如卡芬太尼和硝氮类阿片类药物，以及掺杂剂，例如 这些新出现的药物威胁会导致复杂的药物过量。 药物过量逆转的表现和困难，所有这些都会导致药物过量 死亡率药物检查服务，为个人提供分析信息。 关于未知成分药物中化合物的存在，越来越多的人 在北美用于预防高效力时代的过量死亡 然而，目前实施和扩大合成阿片类药物污染的努力。 获得药物检查服务受到阻碍，主要是因为目前可用 技术存在阻碍其实现的后勤、技术和成本相关障碍 作为现场护理干预措施的可行性因持续的需要而加剧。 检测开发以确保药物检查技术能够继续 准确检测和识别北美毒品中的新型高效毒品威胁 满足这些需求对于提高药品检查的有效性至关重要。 人口水平，尤其是药物检查服务提供者、使用药物的个人 药物和法医对过量死亡的法医调查提出质疑。 因此，当前项目的目标是开发和验证一种新颖的护理点 称为 DoseCheck 的技术，用于快速非靶向识别新兴药物 具体来说，我们将： 1) 验证 DoseCheck 系统区分威胁的能力。 阿片类药物、兴奋剂、镇静剂和麻醉剂化合物之间和类别之内 对不受监管的药物进行非靶向分析；2) 进行定时练习以进行评估 我们团队快速调整 DoseCheck 系统以检测和 区分新出现的药物威胁；3) 测试 DoseCheck 的能力 识别和区分人类生物基质中不同阿片类代谢物的系统。 实现这些目标将产生高影响力和高度转化的发现，这些发现将 支持扩展适应性强、分析复杂且低成本的护理点 药物检查服务，从而有助于降低用药过量死亡率。