Significance: In 2021, more than 75,000 people in the United States died from opioid overdoses. Clinics that treat Opioid Use Disorder (OUD) lack Food and Drug Administration (FDA)-regulated devices that can be prescribed to alleviate cravings and prevent drug use and overdoses. The objective of this SBIR Phase I project is to develop and test a portable neurotherapeutic device that reduces drug craving processes using brain training. Innovation: Craving and drug use following OUD treatment are precipitated by patients' "attention bias" towards people, places, and things associated with prior drug use. For example, encountering a pill bottle may evoke intensified attention towards additional drug-related cues, leading to physiological craving and drug-seeking behavior. Attention Bias Modification (ABM) is a therapeutic approach that trains patients' attention away from triggers for drug use (e.g., pill bottle) and towards natural, non-drug-related scenarios (e.g., prosocial cues), curtailing drug use and overdose. Neurotype Inc. will develop Modit-AB, a neurotherapeutic device that uses closed-loop neurofeedback and mobile electroencephalogram (EEG) headsets to modify drug-related attention biases in OUD. Specific aim 1: in 15 healthy controls and 15 abstinent OUD inpatients, we will evaluate the technical feasibility of 3 types of ABM integrated with real-time neurofeedback using the Modit-AB prototype. Here, the effects of ABM neurofeedback on neurobehavioral measures of attention and attention bias will be evaluated. Specific aim 2: we will assess the expectations, perceptions, and user criques of Modit-AB using a "Future Workshop" co-designing approach with clinicians (n = 10) and patients (n = 20) from participating OUD treatment programs. Clinician and patient feedback will guide device design. Expected outcomes: the technical and commercial feasibility of Modit-AB will be determined by its ability to successfully modify drug-related attention biases and craving processes in patients with OUD at the point of care (e.g., clinic office, waiting room). Finally, we will conduct a pre-submission meeting with the FDA to clarify Modit-AB's regulatory pathway and plan for the SBIR Phase II project. Investigators: Neurotype Inc. and its team of collaborators includes experts in clinical neuroscience, addiction medicine, EEG brain monitoring, product development, software engineering, healthcare, and regulatory matters.
Public Health Relevance Statement: Project Narrative Neurotype Inc. is developing Modit-AB, a novel neurotherapeutic designed to prevent drug craving and drug use in Opioid Use Disorder (OUD). Modit-AB combines promising attention neurofeedback approaches and low-cost mobile brain sensing technologies to train patients' attention away from triggers for drug use (e.g., pill bottle) and towards naturally rewarding environments (e.g., prosocial scenes). Based on Food and Drug Administration and stakeholder feedback, Modit-AB will be sold to OUD treatment programs to support therapy and protect patients from harms such as relapse and overdoses.
Project Terms: Attention; Awareness; Brain; Brain Nervous System; Encephalon; Clinical Trials; Critiques; Cues; Data Collection; Mental Depression; depression; Pharmaceutical Preparations; Drugs; Medication; Pharmaceutic Preparations; drug/agent; Electroencephalography; EEG; Electroencephalogram; Environment; Feedback; Future; Inpatients; Learning; Magnetic Resonance Imaging; MR Imaging; MR Tomography; MRI; MRIs; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; NMR Imaging; NMR Tomography; Nuclear Magnetic Resonance Imaging; Zeugmatography; Medicine; Persons; United States National Institutes of Health; NIH; National Institutes of Health; Neurosciences; Overdose; Patient Education; Patient Instruction; Patient Training; Patients; Perception; Relapse; Research Personnel; Investigators; Researchers; Rewards; Safety; Software Engineering; Computer Software Development; Computer Software Engineering; Suggestion; Task Performances; Technology Assessment; Testing; Time; United States; United States Food and Drug Administration; Food and Drug Administration; USFDA; Measures; Device Designs; health care; Healthcare; improved; Clinical; Phase; Physiologic; Physiological; Training; Stimulus; Visual; Workshop; Educational workshop; Opiates; Opioid; drug use; Drug usage; Patient-Centered Care; Therapeutic; programs; Clinic; Techniques; System; Neurocognitive; drug craving; meetings; meeting; experience; success; drug modification; expectation; novel; Participant; treatment program; drug seeking behavior; Devices; craving; portability; Intervention; Intervention Strategies; interventional strategy; pill; drug addiction prevention; drug use prevention; prevent drug abuse; prevent drug addiction; prevent drug use; drug abuse prevention; Effectiveness; preventing; prevent; Regulatory Pathway; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Monitor; Process; Modification; point of care; cost; neurobehavioral; designing; design; Outcome; innovate; innovative; innovation; addictive disorder; addiction; prototype; nondrug; non-drug; neurofeedback; product development; attentional bias; I-Corps; Innovation Corps; opiate use disorder; opioid use disorder; opiate overdose; opiate related overdose; opioid drug overdose; opioid induced overdose; opioid intoxication; opioid medication overdose; opioid poisoning; opioid related overdose; opioid toxicity; opioid overdose; sensing technology; sensor technology; digital therapeutics; digital therapy; digital treatment; detection system; detection platform; feasibility testing
