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mHealth for Patient Self-Management of Opioid Use Disorder

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 9R42DA054881-02
Agency Tracking Number: R42DA054881
Amount: $2,622,062.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: NIDA
Solicitation Number: PA20-261
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-01
Award End Date (Contract End Date): 2024-08-31
Small Business Information
499 E. High Street #401
Lexington, KY 40507
United States
DUNS: 145377966
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (210) 567-0611
Business Contact
Phone: (210) 567-0611
Research Institution
SAN ANTONIO, TX 78229-3901
United States

 Nonprofit College or University

PROJECT SUMMARY / ABSTRACTThe opioid crisis is an epidemic with devastating health, social, and economic consequences for the United
States. From 1999–2018, almost 450,000 people died from an overdose involving any opioid, including
prescription and illicit opioids. Three million US citizens and 16 million individuals worldwide have had or
currently suffer from opioid use disorder (OUD). The total economic burden of the opioid crisis in the US is
estimated to be more than $200 billion annually.
Treatment for OUD involves medication assisted treatment (MAT) combined with counseling or behavioral
therapy to manage the illness, achieve and sustain better health, and improve quality of life. Rates of recurrent
drug use are high, and access to counseling is limited and costly. While MAT is standard of care and highly
effective at reducing acute morbidity and mortality, there are advantages to treatment approaches tailored to
address an individual patient’s drug use patterns and drug-related medical, psychiatric, and social problems.
While mobile tools exist to support OUD treatment, these products offer only generalized information and not
personalized feedback that is responsive to each person’s current status to support their individual recovery.In Phase I, we developed KIOS, an innovative software platform using nonlinear control theory. KIOS
tracks multiple interacting symptoms (e.g., craving, mood, pain) to map patient trajectories and deliver timely
evidence-based intervention strategies, responding directly to patient-reported needs. Accessible via mobile
devices, KIOS provides patients on demand individualized advice and reinforcement of lifestyle interventions to
improve self-management during MAT. Phase I beta testing demonstrated significant reductions in key
symptoms of OUD and high levels of engagement, usability and patient satisfaction.This project completes development of KIOS as a prescription digital health therapeutic suitable for FDA
approval concomitant to MAT to treat OUD. This innovative tool to help patients manage OUD has the potential
to have a profound impact on public health and achieve significant commercial success. This Phase II STTR
study has three Specific Aims which are designed to attain FDA medical device approval:
Specific Aim 1: Enhance Software Design and Features
Specific Aim 2: Comply with Regulatory Requirements
Specific Aim 3: Evaluate KIOS in a 12-week Randomized Controlled Trial

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

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