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NCT06487533Recruiting

Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder

Spark Biomedical, Inc.

Start Date

2/19/2025

Completion Date

5/31/2027

Summary

The primary objective of this trial is to measure changes in physiologic signals to quantify the status of the autonomic nervous system during opioid withdrawal and cravings.

Detailed Description

This is a prospective observational clinical trial in which 20 participants with a history of dependence on prescription or non-prescription opioids will be recruited for collection of physiologic data via wearable sensors during a 14-day inpatient detoxification treatment. The EmbracePlus Smartwatch and Corti Sensor will be worn continuously throughout the 14-day treatment course to detect heart rate, heart rate variability, skin conductance, skin temperature, motion, and cortisol levels.

Eligibility Criteria

Age Range: 18 years to 50 years

Inclusion Criteria 1. Participant has a recent history of opioid dependence; prescription or non-prescription 2. Participant is currently taking, or plans to initiate, medications for opioid use disorder (MOUD) 3. Participant is between 18 and 50 years of age 4. Participant is English proficient 5. Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements 6. Participant is willing to wear wearable sensors for 14 days Exclusion Criteria 1. Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition 2. Participant has a history of epileptic seizures 3. Participant has a history of neurological diseases or traumatic brain injury 4. Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation 5. Subject has significant current suicidal ideation within 30 days prior to Screening as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) completed at Screening, that, in the opinion of the investigator, warrants exclusion from the trial 6. Females who are pregnant or lactating 7. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Interventions

DEVICE

EmbracePlus Smartwatch

DEVICE

Corti Sensor

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Conditions

Opioid WithdrawalOpioid Use Disorder

Locations

Hazelden Betty Ford Foundation

Center City, Minnesota 55012

United States

Battelle Memorial Institute

Columbus, Ohio 43201

United States