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

项目总结/摘要 在美国，超过200万人患有阿片类药物使用障碍（OUD）。总的来说，至少有一半的 寻求治疗的人群复发，每年造成75 000多人过量死亡。目的 SBIR快速通道应用程序的一个目的是创建一个受监管的设备，以客观地监测线索诱导的渴望 (CIC)阿片类药物使用障碍（OUD）患者。由环境触发导致的CIC是一大因素 在OUD药物使用和复发中，但目前没有标准工具来测量它。 软件与脑电图（EEG）系统接口，以量化事件相关性 由阿片样物质线索引起的潜在（ERP）脑反应（例如，包含药瓶图像）类似于大脑 由自然食欲线索引起的反应（例如，可口的食物）。第一阶段的具体目标包括 将NeuromarkR™与高度便携和可用的EEG系统集成，该系统已被食品安全局批准。 和美国药品监督管理局（FDA），并进行临床可用性和实验室测试。第二阶段的具体目标 包括评价CIC神经情感特征（CIC-NAP）与阿片样物质渴求和其它OUD 通过临床试验的结果。作为中心焦点，CIC-NAP生物标志物将通过其预测 临床结果，如最近和预期的药物使用，以及其他变量。的安全性和疗效 结果将包含在预期的II类重新分类申请中，该申请将提交给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.