Brain Solutions, LLC — Department of Health and Human Services STTR Phase I: NIDA

Description

Intoxication from marijuana MJ impairs psychomotor performance and at least doubles the risk of motor vehicle accidents The ongoing wave of legalization of MJ has brought increasing prevalence of driving while intoxicated with MJ However there is no quantitative biologic test that can accurately determine whether an individual is acutely impaired from MJ intoxication Assays of the primary intoxicating substance in MJ THC in body fluids has a high false negative rate as THC is cleared from blood within minutes long before impairment is resolved And assays of THC metabolites yield a high false positive rate because clearance of these metabolites can take weeks Thus there is now no nor is there likely to ever be a test of blood breath or body fluids that can accurately detect MJ intoxication In response to this significant knowledge gap this project aims to develop an accurate portable method for detection of impairment due to MJ intoxication using functional near infrared spectroscopy fNIRS fNIRS is a non invasive safe brain imaging technique that capitalizes on differences in the light absorption spectra of deoxygenated and oxygenated hemoglobin Hb that allows the measurement of relative changes in Hb concentration that reflect brain activity fNIRS can be performed in natural environments at low cost and thus can be used in real world settings In Phase I we will develop an algorithm for individual level detection of impairment from THC using fNIRS measurements To do so we will assess the effect of oral THC or placebo on fNIRS measurements self reported intoxication and impairment as defined by the gold standard field sobriety test conducted by a Drug Recognition Expert DRE in healthy MJ users fNIRS assessments will examine the effect of THC exposure on resting state and task based activation in the prefrontal cortex the extent to which impairment in psychomotor functioning with THC administration correlates with THC induced change in hemodynamic responses detected with fNIRS and the sensitivity and specificity and area under the ROC curve of fNIRS measurements and field sobriety test determinants of impairment Milestone Should machine learning applications to the data generate an algorithm that predicts impairment with andgt accuracy compared with a gold standard field sobriety test we will proceed to Phase II In Phase II we will conduct fNIRS testing in individuals under THC placebo as in Phase I and in individuals in a THC plus alcohol placebo condition in order to further refine the algorithm for MJ impairment detection such that fNIRS detection concurs with field sobriety testing with andgt specificity It is anticipated that this level of specificity could be used in legal definitions of impairment This will warrant commercialization which will be followed by prototype development and field testing An accurate quantitative biological test that is user friendly and enables law enforcement to detect impairment from MJ has the potential to dramatically change practice of law enforcement across the country and the world and thus has enormous commercial potential as outlined in the Commercialization Plan and in accompanying letters of support The goal of this project is to develop test and refine a method to accurately and reliably detect marijuana MJ impairment using a portable user friendly non invasive brain based modality MJ doubles the chance of motor vehicle accidents yet there now exists no valid biologically based method to detect whether an individual is acutely impaired from MJ The development of a reliable quantitative biological marker that enables law enforcement officers to screen individuals whom they suspect are impaired from MJ will have highly significant public health importance and enormous commercial potential