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

Part of paid clinical trials in Center City, Minnesota.

Sponsor
Spark Biomedical, Inc.
Study ID
NCT06487533
Status
Recruiting
Apply to this trial

Conditions

  • Opioid Use Disorder
  • Opioid Withdrawal

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • EmbracePlus Smartwatch — DEVICE
    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.
  • Corti Sensor — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Feb 19, 2025
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Opioid Use Disorder
    Participants with a history of dependence on prescription or non-prescription opioids

Primary Outcome Measure

Short Opioid Withdrawal Scale Gossop (SOWS-Gossop) [ Time Frame: Daily throughout the 14-day inpatient detoxification treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hazelden Betty Ford FoundationCenter CityMinnesota55012
Laurie Zganjar
[email protected]
Tara Cantwell, MPH
[email protected]
Quyen Ngo, PhD (PRINCIPAL_INVESTIGATOR)
Battelle Memorial InstituteColumbusOhio43201-

Find similar trials in Center City, MN

By research site
Hazelden Betty Ford Foundation· Center City, MNBattelle Memorial Institute· Columbus, OH

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