RecruitingNot ApplicableNCT07405398

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


Sponsor

OpiAID

Enrollment

420 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 22 Years

Inclusion Criteria3

  • 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

Exclusion Criteria7

  • Sleeve tattoo covering the wrist
  • Subject unable to independently navigate and operate smartwatch applications
  • Subject not proficient with written and spoken English
  • Subject determined likely to be non-compliant by physician/HCP
  • Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
  • History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
  • Subject has diminished decision making capability

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETrain 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.

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: * Wearing the Samsung Galaxy watch daily except when charging the watch, showering or any activity in which submersion in water is required * Charging the Samsung Galaxy watch daily * Answering prompts on the Samsung Galaxy watch * Answering the daily SOWS questionnaire(s)


Locations(4)

Coastal Horizon

Wilmington, North Carolina, United States

Community Medical Services

Austin, Texas, United States

Community Medical Services

Austin, Texas, United States

Community Medical Services

Cedar Park, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07405398