R44DA058474
Project Grant
Overview
Grant Description
Development of the Opioid Strength Band Platform - Project Summary
Opioid misuse has reached epidemic levels in the U.S., claiming the lives of more than 104,000 people in the twelve months up to February 2022 alone. Opioids are highly addictive and are accompanied by severe withdrawal symptoms such as anxiety, generalized pain, insomnia, and flu-like symptoms that contribute to relapse.
Opioid overdose, misuse, and dependence result in an estimated $35B in health care costs, $14B in criminal justice costs, and $92B in lost productivity each year in the U.S. Medications for Opioid Use Disorder (MOUD), which combines behavioral counseling with agonist drug therapies such as buprenorphine or methadone to manage withdrawal, is an evidence-based, whole-patient approach to treating opioid dependence. It has been shown to decrease opioid use and deaths from overdose and increase social functioning and treatment retention.
However, establishing the correct initial dose of an opioid agonist to administer during the MOUD induction phase is difficult; low doses may fail to alleviate withdrawal symptoms and increase the risk of relapse, while high doses may fail to reduce the risk of overdose. Such factors present a barrier to patient retention through the MOUD induction phase, and providers currently lack methods for patient monitoring that could inform improved dosing protocols.
OpiAid, Inc is addressing this unmet need with the Strength Band Platform, an innovative AI-based digital platform that enables patient monitoring throughout the MOUD induction period. Patient biometrics are captured via a wearable device with a multi-sensor array and are used by our proprietary algorithm to detect relapse and withdrawal during MOUD induction. This first-of-its-kind technology aims to enable physicians to implement just-in-time interventions to enhance patient retention, prevent relapse, and improve the management of withdrawal symptoms.
Our pilot studies have shown that our platform can gather and synthesize the biometric data needed for composite quantification and timely identification of acute opioid use and withdrawal. However, our work was done using a research-grade device, the Empatica E4, whose price point and limited adoption may hinder marketability. Building upon this work, we intend to expand our platform to accommodate commercially available and widely adopted devices like the Whoop Strap 4.0 and Fitbit Charge 5.
Further, we plan to conduct a large clinical trial to evaluate the performance of the Strength Band Platform in real-world settings. Successful completion of this project will confirm the utility of OpiAid's Strength Band Platform for detecting relapse and withdrawal, and for enhancing clinicians' ability to deliver quality, sustainable care for patients with opioid dependency.
Opioid misuse has reached epidemic levels in the U.S., claiming the lives of more than 104,000 people in the twelve months up to February 2022 alone. Opioids are highly addictive and are accompanied by severe withdrawal symptoms such as anxiety, generalized pain, insomnia, and flu-like symptoms that contribute to relapse.
Opioid overdose, misuse, and dependence result in an estimated $35B in health care costs, $14B in criminal justice costs, and $92B in lost productivity each year in the U.S. Medications for Opioid Use Disorder (MOUD), which combines behavioral counseling with agonist drug therapies such as buprenorphine or methadone to manage withdrawal, is an evidence-based, whole-patient approach to treating opioid dependence. It has been shown to decrease opioid use and deaths from overdose and increase social functioning and treatment retention.
However, establishing the correct initial dose of an opioid agonist to administer during the MOUD induction phase is difficult; low doses may fail to alleviate withdrawal symptoms and increase the risk of relapse, while high doses may fail to reduce the risk of overdose. Such factors present a barrier to patient retention through the MOUD induction phase, and providers currently lack methods for patient monitoring that could inform improved dosing protocols.
OpiAid, Inc is addressing this unmet need with the Strength Band Platform, an innovative AI-based digital platform that enables patient monitoring throughout the MOUD induction period. Patient biometrics are captured via a wearable device with a multi-sensor array and are used by our proprietary algorithm to detect relapse and withdrawal during MOUD induction. This first-of-its-kind technology aims to enable physicians to implement just-in-time interventions to enhance patient retention, prevent relapse, and improve the management of withdrawal symptoms.
Our pilot studies have shown that our platform can gather and synthesize the biometric data needed for composite quantification and timely identification of acute opioid use and withdrawal. However, our work was done using a research-grade device, the Empatica E4, whose price point and limited adoption may hinder marketability. Building upon this work, we intend to expand our platform to accommodate commercially available and widely adopted devices like the Whoop Strap 4.0 and Fitbit Charge 5.
Further, we plan to conduct a large clinical trial to evaluate the performance of the Strength Band Platform in real-world settings. Successful completion of this project will confirm the utility of OpiAid's Strength Band Platform for detecting relapse and withdrawal, and for enhancing clinicians' ability to deliver quality, sustainable care for patients with opioid dependency.
Awardee
Funding Goals
NOT APPLICABLE
Grant Program (CFDA)
Awarding / Funding Agency
Place of Performance
Wilmington,
North Carolina
284094704
United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the End Date has been extended from 04/30/24 to 02/28/27 and the total obligations have increased 750% from $319,589 to $2,715,104.
Opiaid was awarded
Project Grant R44DA058474
worth $2,715,104
from National Institute on Drug Abuse in May 2023 with work to be completed primarily in Wilmington North Carolina United States.
The grant
has a duration of 3 years 9 months and
was awarded through assistance program 93.279 Drug Abuse and Addiction Research Programs.
The Project Grant was awarded through grant opportunity Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R43/R44 - Clinical Trial Optional).
SBIR Details
Research Type
SBIR Phase I
Title
Development of the OpiAID strength band platform
Abstract
PROJECT SUMMARY Opioid misuse has reached epidemic levels in the U.S., claiming the lives of more than 104,000 people in the twelve months up to February 2022 alone. Opioids are highly addictive and are accompanied by severe withdrawal symptoms such as anxiety, generalized pain, insomnia, and flu-like symptoms that contribute to relapse. Opioid overdose, misuse, and dependence result in an estimated $35B in health care costs, $14B in criminal justice costs, and $92B in lost productivity each year in the U.S. Medications for opioid use disorder (MOUD), which combines behavioral counseling with agonist drug therapies such as buprenorphine or methadone to manage withdrawal, is an evidence-based, whole-patient approach to treating opioid dependence. It has been shown to decrease opioid use and deaths from overdose and increase social functioning and treatment retention. However, establishing the correct initial dose of an opioid agonist to administer during the MOUD induction phase is difficult; low doses may fail to alleviate withdrawal symptoms and increase the risk of relapse, while high doses may fail to reduce the risk of overdose. Such factors present a barrier to patient retention through the MOUD induction phase, and providers currently lack methods for patient monitoring that could inform improved dosing protocols. OpiAID, Inc is addressing this unmet need with the Strength Band Platform, an innovative AI-based digital platform that enables patient monitoring throughout the MOUD induction period. Patient biometrics are captured via a wearable device with a multi-sensor array and are used by our proprietary algorithm to detect relapse and withdrawal during MOUD induction. This first-of-its-kind technology aims to enable physicians to implement just-in-time interventions to enhance patient retention, prevent relapse, and improve the management of withdrawal symptoms. Our pilot studies have shown that our platform can gather and synthesize the biometric data needed for composite quantification and timely identification of acute opioid use and withdrawal. However, our work was done using a research-grade device, the Empatica E4, whose price point and limited adoption may hinder marketability. Building upon this work, we intend to expand our platform to accommodate commercially available and widely adopted devices like the WHOOP Strap 4.0 and Fitbit Charge 5. Further, we plan to conduct a large clinical trial to evaluate the performance of the Strength Band Platform in real-world settings. Successful completion of this project will confirm the utility of OpiAID’s Strength Band Platform for detecting relapse and withdrawal, and for enhancing clinicians’ ability to deliver quality, sustainable care for patients with opioid dependency.
Topic Code
NIDA
Solicitation Number
DA23-021
Status
(Ongoing)
Last Modified 7/6/26
Period of Performance
5/1/23
Start Date
2/28/27
End Date
Funding Split
$2.7M
Federal Obligation
$0.0
Non-Federal Obligation
$2.7M
Total Obligated
Activity Timeline
Transaction History
Modifications to R44DA058474
Additional Detail
Award ID FAIN
R44DA058474
SAI Number
R44DA058474-950436069
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Small Business
Awarding Office
75N600 NIH National Insitute on Drug Abuse
Funding Office
75N600 NIH National Insitute on Drug Abuse
Awardee UEI
GLP5YD2PDSG4
Awardee CAGE
88A03
Performance District
NC-07
Senators
Thom Tillis
Ted Budd
Ted Budd
Budget Funding
| Federal Account | Budget Subfunction | Object Class | Total | Percentage |
|---|---|---|---|---|
| National Institute on Drug Abuse, National Institutes of Health, Health and Human Services (075-0893) | Health research and training | Grants, subsidies, and contributions (41.0) | $319,589 | 100% |
Modified: 7/6/26