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

项目摘要/摘要 美国有200多万人患有阿片类药物使用障碍(OUD)。总体而言，至少有一半 寻求治疗的人群复发，每年导致超过7.5万人过量死亡。目的 这个SBIR Fast-Track应用程序的目的是创建一种受监管的设备，以客观地监控提示诱导的渴望 (CIC)阿片类药物使用障碍(OUD)患者。由环境诱因引起的CIC是一个主要因素 毒品的使用和复发，但目前还没有标准的工具来衡量。NeuromarkR™ 软件与脑电(EEG)系统接口，以量化事件相关的程度 由阿片类线索(例如，包含药瓶的图像)引发的潜在(ERP)大脑反应类似于大脑 由自然的食欲提示(例如，可口的食物)引起的反应。第一阶段的具体目标包括 将NeuromarkR™与高度便携和可用的脑电系统集成在一起，该系统已被The Food批准 和药品管理局(FDA)，并进行临床可用性和试验台测试。第二阶段的具体目标 包括评估CIC神经情感特征(CIC-NAP)有关阿片类药物渴求和其他不良反应 通过临床试验的结果。对于中心焦点，CIC-NAP生物标记物将通过其预测 临床结果，如最近和未来的药物使用，以及其他变量。安全性和有效性 结果将包括在预期的II类新请求中，该请求将提交给FDA。

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.