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A Study to Train a Machine Learning 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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: t
View:

• Male or female Age ≥22 years at signing of informed consent Patients with a DSM-5 diagnosis of OUD who are eligible for MOUD induction with methadone or buprenorphine

Locations
United States
North Carolina
Coastal Horizon
RECRUITING
Wilmington
Texas
Community Medical Services
RECRUITING
Austin
Community Medical Services
RECRUITING
Austin
Community Medical Services
RECRUITING
Cedar Park
Contact Information
Primary
Trace Brookins
trace@opiaid.tech
919.355.8221
Backup
David Reeser
david@opiaid.tech
484.824.2248
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 420
Treatments
Experimental: Single arm 14 day monitoring period
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 Platform™ 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)
Related Therapeutic Areas
Sponsors
Leads: OpiAID
Collaborators: National Institute on Drug Abuse (NIDA)

This content was sourced from clinicaltrials.gov

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