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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要美国有超过 200 万人患有阿片类药物使用障碍 (OUD)，其中至少有一半人患有阿片类药物使用障碍 (OUD)。寻求治疗的人群复发，每年导致超过 75,000 人因服药过量死亡。该 SBIR 快速通道应用程序的主要目的是创建一个受监管的设备来客观地监控提示诱发的渴望阿片类药物使用障碍 (OUD) 患者中的 CIC 是由环境触发因素引起的一个主要因素。 OUD 药物使用和复发的影响，但目前没有标准工具来衡量 NeuromarkR™。软件与脑电图（EEG）系统接口，以量化事件相关的程度阿片类药物线索（例如包含药瓶的图像）引起的潜在 (ERP) 大脑反应类似于大脑由自然食欲线索（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™ 与高度便携且可用的 EEG 系统集成，该系统已获得食品和药物管理局的批准和药物管理局 (FDA)，并进行临床可用性和台架测试。包括评估关于阿片类药物渴望和其他 OUD 的 CIC 神经情感概况 (CIC-NAP) CIC-NAP 生物标志物将通过其预测进行评估。临床结果，例如近期和未来的药物使用情况以及其他变量。结果将包含在预期的 II 类 De Novo 请求中，该请求将提交给 FDA。