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Develop technology platform to transform the diagnosing monitoring and treating of opioid use disorders

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41DA044905-01
Agency Tracking Number: R41DA044905
Amount: $235,848.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIDA
Solicitation Number: PA16-303
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-08-01
Award End Date (Contract End Date): 2018-10-30
Small Business Information
San Diego, CA 92130-6956
United States
DUNS: 082068934
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (619) 980-5782
Business Contact
Phone: (619) 980-5782
Research Institution
9500 Gilman Drive, Mail Code 0934
LA JOLLA, CA 92093-0934
United States

 Nonprofit College or University

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

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

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

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