Significance: Over 2 million Americans have an Opioid Use Disorder (OUD) and relapse following treatment exceeds 60%, underlining a need to understand what works (and what does not) in OUD interventions. Currently, there are no standardized, objective point of care tools to inform treatment providers of patients level of opioid craving and relapse vulnerability, leaving subjective and unclear a treatments effectiveness on reducing craving and protecting against relapse. Such inadequacies contribute to the costly and chronic cycle of relapse, emergency room visits, legal problems, treatment re-admittance, overdose, and possible death experienced by OUD patients. Innovation: Using consumer-grade mobile electroencephalogram (EEG) headsets and proprietary software, Neurotype Inc. proposes development and commercialization of NeuromarkR, a point of care brain-sensing platform that enables detection of EEG cue reactivity correlates of drug craving and prospective indicators of drug use and relapse. NeuromarkR may be used by EEG non- experts (e.g., clinicians, technicians) to quantify biomarker correlates of opioid craving, benchmark treatment effectiveness, and potentially inform treatment decisions. The NeuromarkR platform: 1) acquires patients EEG during viewing of affective (emotion-laden) and opioid-related images, 2) performs fully-automated EEG signal processing and cue reactivity quantification, and 3) generates a digital report of opioid cue reactivity phenotypes which can be measured longitudinally to objectively quantify treatment endpoints (e.g., craving reduction, change in drug cue reactivity). Specific aims: There are two aims of this SBIR Phase I project, including: 1) measurement and longitudinal tracking of craving and EEG cue reactivity phenotypes in treatment-seeking OUD patients over 48 weeks of recovery, and 2) development of our NeuromarkR prototype into a scalable web platform for generating clinical insights and reports at the point of care. Expected outcome: Successful project outcomes include: 1) identification of drug cue reactivity phenotypes (e.g., EEG reactivity to opioid cues that resembles EEG reactivity to naturally rewarding cues) in OUD patients that correlate with recovery outcomes (e.g., treatment completion, prolonged abstinence, reduced craving), and 2) an established web platform that enables broader clinical and research use. Finally, we will obtain feedback from crucial stakeholders (e.g., clinicians, patients) and initiate Q-Submission meetings with the Food and Drug Administration to refine our regulatory plan for the Phase II project. Investigators: Our team includes experts in clinical substance abuse treatment, addiction neuroscience, EEG brain monitoring, software engineering, and health technology startup development expertise.
Public Health Relevance Statement: Project Narrative Neurotype Inc. is researching the science behind drug craving and triggers for relapse in opioid use disorder by commercializing its NeuromarkR platform that combines consumer-grade brain-sensing technology and a mobile tablet to enable quick, affordable, and automated detection of objective biomarkers associated with drug use and future relapse. NeuromarkR is designed to be used by clinicians and technicians in clinical and underserved regions to inform treatment decisions and quantify treatment endpoints.
Project Terms: Abstinence; addiction; Affective; American; Assessment tool; base; Benchmarking; Biological Markers; Brain; care providers; Cessation of life; Chronic; Classification; Clinical; Clinical assessments; Clinical Research; Clinical Trials; clinically relevant; commercialization; Computer software; cost; craving; cue reactivity; Cues; Data; design; Detection; Development; digital; drug craving; drug relapse; Drug usage; Electroencephalogram; Emergency department visit; Emotions; Erotica; experience; Feedback; Food; Funding; Future; Goals; Health; Health Insurance Portability and Accountability Act; Health Personnel; Health Technology; Image; improved; Industry; innovation; insight; Intervention; Laboratories; Legal; Legal patent; Letters; Literature; Measurement; Measures; Medical Device; meetings; Monitor; National Institute of Drug Abuse; Neurosciences; novel therapeutics; Opioid; opioid use; opioid use disorder; Outcome; Overdose; Palate; Patients; Pharmaceutical Preparations; Phase; Phenotype; Physiological Processes; point of care; population based; portability; Process; prospective; prototype; Provider; Recovery; Regulatory Pathway; Relapse; relapse prediction; Reporting; Research; Research Personnel; response; Retreatment; Rewards; Science; Seeds; sensor technology; Severities; signal processing; Small Business Innovation Research Grant; Software Engineering; Source; Standardization; substance abuse treatment; Substance Use Disorder; Tablets; Technology; Time; tool; Translating; Treatment Effectiveness; treatment response; United States Food and Drug Administration; United States National Institutes of Health; web platform; Work
