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

Recruiting

• Conditions: Opioid Use Disorder; Opioid Withdrawal
• Interventions: Device: EmbracePlus Smartwatch; Device: Corti Sensor

• Registration Number: NCT06487533
• Lead Sponsor: Spark Biomedical, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2024-06-27
• Study First Submitted QC: 2024-06-27
• Study First Posted: 2024-07-05
• Study Start: 2024-11-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-08
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-05
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Opioid Use Disorder	EmbracePlus Smartwatch	Participants with a history of dependence on prescription or non-prescription opioids
Opioid Use Disorder	Corti Sensor	Participants with a history of dependence on prescription or non-prescription opioids

Primary Outcome Measures

Name	Time	Method
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)	Daily throughout the 14-day inpatient detoxification treatment	Correlation of opioid withdrawal symptoms, as measured by the SOWS-Gossop, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.
Opioid Craving Visual Analog Scale (OC-VAS)	Daily throughout the 14-day inpatient detoxification treatment	Correlation of the intensity of opioid cravings, as measured by the OC-VAS, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.
Adverse Events	Daily throughout the 14-day inpatient detoxification treatment	The primary safety endpoint will be the proportion of participants who experience one or more adverse events.
Clinical Opioid Withdrawal Scale (COWS)	Daily throughout the 14-day inpatient detoxification treatment	Correlation of opioid withdrawal symptoms, as measured by the COWS, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.

Trial Locations

Locations (2)

Hazelden Betty Ford Foundation; 🇺🇸 Center City, Minnesota, United States

Battelle Memorial Institute; 🇺🇸 Columbus, Ohio, United States