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.
Public Health Relevance Statement: Project Narrative Neurotype Inc. is creating the first regulated device to monitor Cue-Induced drug Craving (CIC) in Opioid Use Disorder (OUD) patients. NeuromarkR™ reveals CIC for drug craving and relapse, which has previously gone unmeasured in clinics, enabling clinicians to target therapies and benchmark treatment performance. The company's next steps are to integrate this technology with a highly scalable, regulated EEG device so that clinical trials can be conducted to demonstrate safety and effectiveness, necessary requirements for approval from the FDA.
Project Terms: Affect; Outpatient Care; outpatient treatment; Ambulatory Care; Desire for food; Appetite; Brain; Brain Nervous System; Encephalon; Clinical Trials; Cues; Data Collection; Statistical Data Interpretation; Statistical Data Analyses; Statistical Data Analysis; statistical analysis; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Electroencephalography; EEG; Electroencephalogram; Visual evoked cortical potential; Visual Evoked Potentials; Visual Evoked Response; Feedback; Food; Goals; Hospitals; Laboratories; Marketing; Methods; Persons; United States National Institutes of Health; NIH; National Institutes of Health; Outpatients; Out-patients; Patients; Drug Prescriptions; Drug Prescribing; medication prescription; prescribed medication; Psychotherapy; Relapse; Research; Risk; Safety; Computer software; Software; Tablets; Technology; Testing; Time; Toy; United States; United States Food and Drug Administration; Food and Drug Administration; USFDA; Urine; Work; Measures; improved; Clinical; Phase; Link; Training; Stimulus; Individual; Opiates; Opioid; drug use; Drug usage; Funding; event related potential; Event-Related Potentials; Letters; Therapeutic; tool; Diagnostic; programs; Stream; Clinic; System; Benchmarking; Best Practice Analysis; benchmark; drug craving; meetings; meeting; Performance; Agreement; Patient Self-Report; Self-Report; Devices; relapse prevention; disease recurrence prevention; prevent relapse; recurrence prevention; Emotional; craving; response; portability; pill; Provider; Effectiveness; Data; Clinical Trials Design; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Validation; validations; Monitor; point of care; Image; imaging; drug relapse; Clinical assessments; Outcome; Population; prospective; Affective; usability; bio-markers; biologic marker; biomarker; Biological Markers; nondrug; non-drug; overdose fatalities; overdose death; targeted drug therapy; targeted drug treatments; targeted therapeutic; targeted therapeutic agents; targeted therapy; targeted treatment; cognitive regulation; cognitive reappraisal; I-Corps; Innovation Corps; opiate use disorder; opioid use disorder; stratified patient; patient stratification; opiate consumption; opiate drug use; opiate intake; opiate use; opioid consumption; opioid drug use; opioid intake; opioid use; clinical outcome prediction; predictor of clinical outcome; predict clinical outcome; Drug Screening; psychostimulant use disorder; stimulant use disorder; Primary Care
