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.

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.