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Cue-induced drug craving monitoring for opioid use disorder with visual evoked potentials

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44DA059517-01
Agency Tracking Number: R44DA059517
Amount: $328,963.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIDA
Solicitation Number: DA23-021
Solicitation Year: 2023
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-09-30
Award End Date (Contract End Date): 2024-08-31
Small Business Information
4610 E LAKE ST
Minneapolis, MN 55406
United States
DUNS: 117177174
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (651) 431-0574
Business Contact
Phone: (651) 431-0574
Research Institution

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 NeuromarkRâ„¢
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 NeuromarkRâ„¢ 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.

* Information listed above is at the time of submission. *

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