NCT06487533

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Spark Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: —

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.

Conditions

• Opioid Withdrawal
• Opioid Use Disorder

Interventions

Type	Name	Description
DEVICE	EmbracePlus Smartwatch	The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data can be wirelessly transmitted to a paired mobile device. The data received are analyzed by EmpaDSP, which computes the user physiological parameters. The Care App is responsible for transmitting raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. The device supports continuous data collection for monitoring of the following physiological parameters: * Peripheral skin temperature * Electrodermal activity * Blood Oxygen Saturation under no motion conditions * Activity associated with movement during sleep. The EmbracePlus Watch has been used in previous human subject research studies for bio-physiological data collection in other medical conditions and have confirmed that there is minimal risk to participants. This device is therefore exempt from any IDE requirements.
DEVICE	Corti Sensor	The Corti Wearable is a sweat sensor that is worn continuously measure cortisol, melatonin, tumor necrosis alpha interleukin-6 (IL-6) in the protein analytes in the sweat of participants via electrochemical impedance spectroscopy. The Corti Wearable comprises a plastic reader and a replaceable polymer sweat-sensing strip with zinc oxide (ZnO) coated electrodes that is worn on the participant's forearm. It is manufactured through a screen-printing technique that allows for an affinity-based interaction between a capture probe antibody and the target molecule generating electrochemical activity. The Cort Wearable has been used in previous human subject research studies for bio-physiological data collection in other medical conditions and have confirmed that there is minimal risk to participants. This device is therefore exempt from any IDE requirements.

Timeline

• Start date: 2025-02-19
• Primary completion: 2027-03-31
• Completion: 2027-05-31
• First posted: 2024-07-05
• Last updated: 2026-04-08

Locations

2 sites across 1 country: United States