A Study to Train a Machine Learning Algorithm for an Evaluation of the Use of Biometric Data Capt⦠(NCT07405398) | Clinical Trial Compass
RecruitingNot Applicable
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
United States420 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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Inclusion Criteria:
* Male or female
* Age ā„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 Criteria:
* 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