Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
NCT ID: NCT06487533
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2025-02-19
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Opioid Use Disorder
Participants with a history of dependence on prescription or non-prescription opioids
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
50 Years
ALL
No
Sponsors
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Battelle Memorial Institute
OTHER
Hazelden Betty Ford Foundation
UNKNOWN
National Institutes of Health (NIH)
NIH
Spark Biomedical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Navid Khodaparast, PhD
Role: STUDY_CHAIR
Chief Science Officer
Melanie McWade, PhD
Role: STUDY_DIRECTOR
Senior Director of Clinical Operations
Carlos Tirado, MD
Role: STUDY_CHAIR
Medical Monitor
Locations
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Hazelden Betty Ford Foundation
Center City, Minnesota, United States
Battelle Memorial Institute
Columbus, Ohio, United States
Countries
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Central Contacts
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Brooke Le
Role: CONTACT
Facility Contacts
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Quyen Ngo, PhD
Role: primary
Tara Cantwell, MPH
Role: backup
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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SBM-OWP-09
Identifier Type: -
Identifier Source: org_study_id