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| ID | Type | Description | Link |
|---|---|---|---|
| 4R44DA058474-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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To train a machine learning model/algorithm for an evaluation of the use of biometric data captured at the wrist for the identification of acute opioid use events and the quantification of opioid withdrawal in opioid dependent individuals.
The goal of this real-world, multi-center, outpatient study is to train a machine learning model/algorithm utilizing patient-specific physiological parameters from the OpiAID Strength Band Platformâ„¢ can accurately detect MOUD events during the induction phase with an 80% classification success when comparing the True Positive Rate against the False Positive Rate as plotted on a Receiver Operator Curve. In addition to MOUD detection, machine learning will be used to quantify participant withdrawal level from physiological parameters. To demonstrate that withdrawal quantification performs as well or better than current measures used for this purpose the correlation between quantified withdrawal and time since last opioid dose (TSLD) will be computed and compared against the association between SOWS and TSLD in a non-inferiority analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm 14 day monitoring period | Experimental | The goal of this real-world, multi-center, outpatient study is to train a machine learning model/algorithm utilizing patient-specific physiological parameters from the OpiAID Strength Band Platformâ„¢ can accurately detect MOUD events during the induction phase with a predefined classification success when comparing the True Positive Rate against the False Positive Rate as plotted on a Receiver Operator Curve. In addition to MOUD detection, machine learning will be used to quantify participant withdrawal level from physiological parameters. To demonstrate that withdrawal quantification performs as well or better than current measures used for this purpose the correlation between quantified withdrawal and time since last opioid dose (TSLD) will be computed and compared against the association between SOWS and TSLD in a non-inferiority analysis. Prescribing physician must determine appropriate starting dose (titration expected over 2-6 weeks) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Train and evaluate the accuracy and reliability of the Strength Band Platform in identifying acute opioid dosing events from time-stamped biometric data collected from wrist-worn devices. | Device | Subjects will be fitted with the wearable device (Samsung Galaxy Watch) for the purpose of data communication and will be instructed to wear the device continuously, except when charging the watch, showering or any activity in which submersion in water is required. Participants will wear the device for 14 days. Study subjects will be responsible for:
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| Measure | Description | Time Frame |
|---|---|---|
| Classification | Accurate algorithm-based classification of acute opioid dosing events in patients receiving treatment for opioid use disorder. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trace Brookins | Contact | 919.355.8221 | trace@opiaid.tech | |
| David Reeser | Contact | 484.824.2248 | david@opiaid.tech |
| Name | Affiliation | Role |
|---|---|---|
| David MacQueen, PhD | OpiAID | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Horizon | Recruiting | Wilmington | North Carolina | 28409 | United States |
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| Community Medical Services | Recruiting | Austin | Texas | 78745 | United States |
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| Community Medical Services | Recruiting | Austin | Texas | 78753 | United States |
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| Community Medical Services | Recruiting | Cedar Park | Texas | 78613 | United States |
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