CARI HEALTH INC — Department of Health and Human Services STTR Phase I: NIDA

Description

PROJECT ABSTRACT There are two big challenges to reducing the number of substance use disorders SUDs in the United States Almost of the million people who suffer from SUDs are never professionally diagnosed and never seek treatment and treatment for the small minority that does seek help is not very effective with relapse rates estimated to be between and within the first year after treatment depending on the substance that is being misused The Clinical Addiction Recovery Institute C A R I a Mentor on the Go LLC company aims to address both of those challenges by developing a continuous monitoring system based on an injectable subcutaneously implanted biosensor approximately the size of a grain of rice that can detect and monitor substance use byproducts in the interstitial fluid The C A R I system for detecting and monitoring substance misuse will integrate wearable sensor technology with an already developed mobile smartphone application that will enable physicians to more easily detect monitor and treat substance misuse Currently no other solutions exist that can detect multiple substances and measure them continuously over time This Phase I project will focus on the detection of an opioid substance and will test the hypothesis that a minimally invasive injectable biosensor with a minimum lifetime of one month can successfully measure a biomarker needed to detect opioid use Aim of this project will develop a low power electrochemical injectable biosensor that can communicate wirelessly with a wearable device and smartphone while Aim will involve the selection and development of an electrochemical opioid assay for use in the biosensor The results from these studies will provide not only the proof of concept that opioid use can be detected in interstitial fluid but also the basis for the implantable biosensor component of the proposed C A R I system which will be a vast improvement over the intermittent monitoring data that is currently available via self reporting urine screening and blood testing When fully developed the proposed C A R I system will enable clinicians to be more precise with dosing and safety planning for opioid use treatment thereby lowering relapse rates and improving treatment outcomes for patients PROJECT NARRATIVE There is no effective standard commercial method for detecting opioid use over a period of time and the ineffective nature of current substance use detection and monitoring tools which at present consist of self reporting and intermittent point in time testing of urine or blood samples none of which capture substance use over time nor allow for detection of newer synthetic opioids has contributed to a growing opioid use epidemic This initial Phase I project proposes to develop a minimally invasive injectable biosensor that can measure a biomarker needed to detect opioid use This biosensor will be the first stage in the development of a continuous detection and monitoring solution that can eventually detect mild moderate or severe substance use and will provide treating clinicians with objective continuous substance use data over time which they can use to screen for at risk patients dose medication more precisely conduct more effective safety planning and prevent medication diversion for each patient which would ultimately reduce relapse rates and improve overall treatment effectiveness