Project Summary This proposed Phase I/Phase II FastTrack STTR project is intended to lead to the demonstration of a breathalyzer instrument capable of detecting and quantitatively measuring drugs (i.e. cannabinoids and opioids) in exhaled breath (EB). Prior work on the detection of these drugs in EB by means of liquid chromatography and mass spectrometry (LC/MS) demonstrated that these compounds can be quantitatively detected, but LC/MS is slow, expensive and requires highly skilled personnel to implement. What is needed is a simple and inexpensive method for rapidly measuring the amount of drugs in EB. If such a method becomes available it can be used by law enforcement and in doctors' offices, hospital emergency rooms, ambulances and companies seeking to screen employees for drug abuse. N2 Biomedical proposes to develop a method for quantitatively detecting the presence of drugs in EB by means of Differential Mobility Spectrometry (DMS) developed at Draper Laboratories. DMS is a robust, data-rich, ultra- trace, chemical detection technology that has been proven for numerous applications including air quality cabin monitoring on the International Space Station, chemical warfare agent detection, explosives detection, and drinking water analysis. Recently Draper has applied this device to breath analysis for the detection of lung diseases. A clinical study is currently underway and initial results are promising. This project involves transferring technology developed by Draper for lung infection detection to the detection of psychoactive drugs in exhaled breath. Phase I of the proposed program will investigate the DMS signatures of cannabinoids in the laboratory and define the DMS device’s limits of detection. A small pilot study will also be performed to demonstrate feasibility for using breath analysis as a proxy for the concentration of cannabinoids in the blood. During Phase II DMS signatures of the opioids morphine and fentanyl will be characterized and a 50 subject clinical trial will be performed to obtain breath/blood concentration correlations for THC (cannabinoid), morphine and fentanyl and also to levels of impairment. A plan for bringing this device to market will be implemented based on feedback obtained from local law enforcement obtained throughout the course of the program and an FDA regulatory strategy will be identified. Successful completion of this project will demonstrate that this DMS device can be used as a rapid, non-invasive broad spectrum drug detection tool for law enforcement as well as emergency medical personnel.

Project Narrative Driving under the influence of psychoactive drugs is a major public safety concern justified by the increasing number of states in the US legalizing the medical and recreational use of marijuana and the opioid crisis that continues to devastate the nation. This Phase I/Phase II STTR proposal seeks to apply breath analysis technology, proven to diagnose serious lung diseases, to the detection of psychoactive drugs: in particular marijuana, morphine and fentanyl. Successful completion of this project will demonstrate a rapid, non-invasive broad spectrum drug detection tool for law enforcement as well as emergency medical personnel.