Cue-induced drug craving monitoring for opioid use disorder with visual evoked potentials

视觉诱发电位提示诱导的阿片类药物使用障碍监测

• 批准号: 10787065
• 负责人: Scott Burwell
• 金额: $ 32.9万
• 依托单位: NEUROTYPE INC.
• 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 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10787065
• 关键词: Affect; Affective; Agreement; Ambulatory Care; Benchmarking; Biological Markers; Brain; Clinic; Clinical; Clinical Trials; Clinical Trials Design; Clinical assessments; Computer software; Cues; Data; Data Collection; Desire for food; Devices; Diagnostic; Drug Prescriptions; Drug Screening; Drug usage; Effectiveness; Electroencephalography; Emotional; Event-Related Potentials; Feedback; Food; Funding; Goals; Hospitals; Image; Individual; Innovation Corps; Laboratories; Letters; Link; Marketing; Measures; Methods; Monitor; Opioid; Outcome; Outpatients; Patient Self-Report; Patients; Performance; Persons; Pharmaceutical Preparations; Phase; Population; Primary Care; Provider; Psychotherapy; Relapse; Research; Risk; Safety; Small Business Innovation Research Grant; Statistical Data Interpretation; Stimulus; Stream; System; Tablets; Technology; Testing; Therapeutic; Time; Toy; Training; United States; United States Food and Drug Administration; United States National Institutes of Health; Urine; Validation; Visual evoked cortical potential; Work; cognitive reappraisal; craving; drug craving; drug relapse; improved; meetings; non-drug; opioid use; opioid use disorder; overdose death; patient stratification; pill; point of care; portability; predict clinical outcome; programs; prospective; relapse prevention; response; stimulant use disorder; targeted treatment; tool; usability

Project Summary / Abstract More than 2 million people in the United States have an Opioid Use Disorder (OUD). Overall, at least half of the treatment-seeking population relapse, contributing to over 75,000 overdose deaths annually. The purpose of this SBIR Fast-Track application is to create a regulated device to objectively monitor Cue-Induced Craving (CIC) in Opioid Use Disorder (OUD) patients. CIC, which is caused by environmental triggers, is a major factor in OUD drug use and relapse but currently, there are no standard tools to measure it. The NeuromarkR™ software interfaces with electroencephalogram (EEG) systems to quantify the extent to which Event-Related Potential (ERP) brain responses elicited by opioid cues (e.g., image containing a pill bottle) resemble brain responses elicited by naturally appetitive cues (e.g., palatable foods). The Phase I specific aims include integrating NeuromarkR™ with a highly portable and usable EEG system that is already cleared by the Food and Drug Administration (FDA), and conducting clinical usability and bench testing. The Phase II specific aims include evaluating a CIC Neuro-Affective Profile (CIC-NAP) with respect to opioid craving and other OUD outcomes through clinical trials. Of central focus, the CIC-NAP biomarker will be evaluated by its prediction of clinical outcomes such as recent and prospective drug use, among other variables. The safety and efficacy results will be included in an anticipated Class II De Novo request that will be submitted to the FDA.

项目摘要 /摘要 在美国，超过200万人患有阿片类药物使用障碍（OUD）。总体而言，至少一半 寻求治疗的人群接力，每年导致超过75,000例过量死亡。目的 此SBIR快速轨道应用程序是创建一个受监管的设备，以客观监视提示引起的渴望 （CIC）阿片类药物使用障碍（OUD）患者。 CIC是由环境触发器引起的，是一个主要因素 在OUD毒品使用和缓解方面，目前没有标准工具来衡量它。 Neuromarkr™ 软件与脑电图（EEG）系统界面，以量化事件相关的程度 电位（ERP）大脑反应是由阿片类药物提示引起的（例如，含有药丸的图像）类似于大脑 自然食用线索引起的反应（例如，可口的食物）。第一阶段的特定目的包括 将Neuromarkr™与已被食物清除的高度便携式和可用的脑电图整合在一起 和药物管理（FDA），以及进行临床可用性和基准测试。第二阶段特定的目的 包括评估有关阿片类药物渴望和其他OUD的CIC神经影响概况（CIC-NAP） 通过临床试验进行结果。 CIC-NAP生物标志物将通过其预测来评估CIC-NAP生物标志物 临床结果，例如最近的和前瞻性吸毒，以及其他变量。安全性和效率 结果将包括在预期的第二类请求中，该请求将提交给FDA。