A wearable device for continuous monitoring of methadone

用于连续监测美沙酮的可穿戴设备

• 批准号: 10787069
• 负责人: Farshad Tehrani
• 金额: $ 31.98万
• 依托单位: ACTIOX LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10787069
• 关键词: Address; Adult; Affect; Alcohols; Animals; Architecture; Biochemical; Biological Markers; Caregivers; Caring; Cause of Death; Centers for Disease Control and Prevention (U.S.); Cessation of life; Chemicals; Chemistry; Clinical Research; Communities; Coupled; Custom; Detection; Development; Devices; Dose; Electrodes; Electron Transport; Electronics; Engineering; Ensure; Epidemic; FDA approved; Family; Feasibility Studies; Feedback; Fentanyl; Foreign Bodies; Glucose; Goals; Health Care Costs; Health Personnel; Health Professional; Heroin; In Vitro; Individual; Intercellular Fluid; Levodopa; Life; Malignant Neoplasms; Marketing; Measurement; Measures; Medical; Membrane; Methadone; Methods; Modification; Monitor; Morphine; Motion; Nanostructures; Needles; Noise; Noscapine; Opiate Addiction; Opioid; Overdose; Patients; Performance; Pharmaceutical Preparations; Phase; Physiological; Physiology; Polymers; Population; Porosity; Privatization; Propofol; Public Health; Quality of life; Reagent; Relapse; Reproducibility; Risk Reduction; Sampling; Secure; Serum; Signal Transduction; Skin; Small Business Innovation Research Grant; Societies; Specificity; Sterilization; Suicide; Surface; System; Technology; Temperature; Testing; Therapeutic; Time; Visualization; Withdrawal Symptom; appropriate dose; automobile accident; biomaterial compatibility; cloud platform; coronavirus disease; cytotoxicity; design; dosage; drug craving; falls; human subject; improved; in vivo; individual patient; innovation; innovative technologies; inter-individual variation; invention; meter; methadone treatment; minimally invasive; mobile application; monitoring device; nanomolar; operation; opioid overdose; opioid use disorder; opioid withdrawal; overdose risk; oxidation; precision medicine; prevent; psychostimulant; relapse prevention; response; sensor; statistics; synthetic opioid; wearable device; wearable sensor technology; wireless; wireless transmission

Opioid overdose is a significant public health problem that has been escalating in recent years. Based on the statistics from the Centers for Disease Control and Prevention (CDC), the number of overdose-related deaths surpassed 100,000 from April 2020 to April 2021. This is a significant increase in overdose cases related to natural and semi-synthetic opioids, synthetic opioids, and psychostimulants. Alarmingly, in the one-year period leading up to April 2021, fentanyl was the top cause of death for adults between 18 and 45 years old, surpassing fatalities caused by car accidents, suicide, COVID, and cancer. Methadone is a well-established medication that has been used for decades to treat opioid use disorder (OUD). However, there is currently no continuous monitoring device that can provide real-time information on methadone levels in the body. This gap in monitoring can result in patients not receiving optimal doses of methadone, leading to relapse or overdose. To address this problem, we propose a wearable device for continuous monitoring of methadone. Our proposed device is a minimally invasive microneedle technology that can be worn on the skin. This device will continuously monitor methadone levels in the body, providing real-time feedback to patients and healthcare professionals. The device is small, discreet, and easy to use, making it ideal for use in various settings. The proposed SBIR project aims to leverage our innovative microneedle technology to develop a wearable device that can continuously monitor therapeutic levels of methadone in the interstitial fluid for a week. In order to achieve this, the team will perform systematic optimization studies on the surface architecture of the sensor to enable highly sensitive, stable, and selective methadone sensing performance. Aim 1 constitutes in-vitro feasibility studies to find the best chemical modification strategy with high sensitivity. Aim 2 will involve extending the stability of the sensor to one week of continuous operation. Aim 3 will assess the selectivity, reproducibility, and shelf life of the developed MN-based methadone sensors in serum samples and involves further developments in the electronics and the accompanying app of the device. Upon successful completion of Phase I, Phase II will focus on demonstrating the utility and establishing reliability of the sensor via extensive clinical studies in both animals and in human subjects. The device will not only provide accurate and personalized dosing of methadone but also help in mitigating OUD by alerting patients and healthcare professionals when levels of methadone fall below or rise above therapeutic levels. This will enable healthcare providers to adjust the methadone dose in real-time, ensuring that patients receive optimal dosages to prevent relapse and overdose. The proposed wearable device for continuous monitoring of methadone is a crucial innovation that will help to address the problem of opioid overdose. The device will provide accurate and personalized dosing of methadone, help to mitigate OUD, and can be used among different populations. Our proposed device has the potential to improve the quality of life of patients, reduce healthcare costs, and ultimately save lives.

阿片类药物过量是近年来一直在升级的重大公共卫生问题。基于 疾病控制与预防中心（CDC）的统计数据，与用药相关的死亡人数 从2020年4月到2021年4月，超过了100,000个。这是与 天然和半合成阿片类药物，合成阿片类药物和精神刺激药。令人震惊的是，在一年的时间里 直到2021年4月，芬太尼是18至45岁的成年人死亡的主要原因，超过 由汽车事故，自杀，联盟和癌症造成的死亡人数。美沙酮是一种公认​​的药物 数十年来已用于治疗阿片类药物使用障碍（OUD）。但是，目前没有连续的 监视可以提供有关美沙酮水平的实时信息的监视设备。监视的差距 可能导致患者未接受最佳剂量美沙酮，导致复发或过量。解决这个问题 问题，我们提出了一种可穿戴设备，用于连续监测美沙酮。我们提出的设备是 可以穿在皮肤上的微创微针技术。该设备将不断监视 美沙酮体内水平，为患者和医疗保健专业人员提供实时反馈。设备 小，谨慎且易于使用，非常适合在各种设置中使用。拟议的SBIR项目目标 利用我们的创新微针技术来开发可穿戴设备，可以连续监视 间质液中美沙酮的治疗水平一周。为了实现这一目标，团队将表演 对传感器表面结构的系统优化研究，使高度敏感，稳定和 选择性美沙酮传感性能。 AIM 1构成了体外可行性研究，以找到最佳的化学物质 具有高灵敏度的修改策略。 AIM 2将涉及将传感器的稳定性扩展到一个星期 连续操作。 AIM 3将评估开发的基于MN的选择性，可重复性和保质期 美沙酮传感器在血清样品中，涉及电子设备的进一步发展 随附设备的应用程序。成功完成第一阶段后，第二阶段将专注于展示 通过在动物和人类中广泛的临床研究来建立传感器的效用和建立传感器的可靠性 主题。该设备不仅可以提供美沙酮的准确和个性化剂量，而且还可以帮助 当美沙酮水平低于或上升时，通过警告患者和医疗保健专业人员来缓解OUD 高于治疗水平。这将使医疗保健提供者能够实时调整美沙酮剂量， 确保患者接受最佳剂量以防止复发和过量。提议的可穿戴设备 为了连续监测美沙酮是一种关键的创新，它将有助于解决阿片类药物的问题 过量。该设备将提供美沙酮的准确和个性化剂量，帮助减轻Oud，并 可以在不同人群中使用。我们提出的设备有可能提高生活质量 患者，降低医疗保健成本，并最终挽救生命。