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NCT Number: NCT06487533

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

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.

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Key information

Conditions

Opioid Withdrawal Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Use Disorder Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hazelden Betty Ford Foundation, Center City, Minnesota, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant has a recent history of opioid dependence; prescription or non-prescription
  • Participant is currently taking, or plans to initiate, medications for opioid use disorder (MOUD)
  • Participant is between 18 and 50 years of age
  • Participant is English proficient
  • Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
  • Participant is willing to wear wearable sensors for 14 days

Exclusion criteria

  • Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
  • Participant has a history of epileptic seizures
  • Participant has a history of neurological diseases or traumatic brain injury
  • Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
  • 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
  • Females who are pregnant or lactating
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)

    Time frame: 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.

  2. Clinical Opioid Withdrawal Scale (COWS)

    Time frame: 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.

  3. Opioid Craving Visual Analog Scale (OC-VAS)

    Time frame: 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.

  4. Adverse Events

    Time frame: 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.

Other outcomes

  1. Sleep Duration

    Time frame: Daily throughout the 14-day inpatient detoxification treatment

    Correlation of sleep duration and quality with opioid withdrawal symptoms as well as cravings

  2. Stress Monitoring and Assessment Tool (SMART)

    Time frame: Daily throughout the 14-day inpatient detoxification treatment

    Correlation of stress score, as measured by the SMART, with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.

  3. Therapy Compliance

    Time frame: Daily throughout the 14-day inpatient detoxification treatment

    Correlation of compliance to recovery-related therapies (e.g. group therapy, individual counseling) with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.

  4. Drug Screening

    Time frame: Once daily on screening/baseline day, study day 7, and study day 14 (14-day time frame)

    Proportion of participants testing positive for Amphetamines, Buprenorphine, Benzodiazepines, Cocaine, Ethyl Glucuronide, Fentanyl, Synthetic Marijuana, Ecstasy, Methamphetamines, Methadone, Opiates / Morphine, Oxycodone, Cannabinoid (Marijuana), Xylazine, and Tramadol or any combination

  5. Medication Use

    Time frame: Daily throughout the 14-day inpatient detoxification treatment

    Medication use and timing (medication name, dosage, and indication)

  6. Wearable Sensors Compliance

    Time frame: Daily throughout the 14-day inpatient detoxification treatment

    Compliance to wearing wearable sensors (EmbracePlus Smartwatch and Corti Sensor)

Study contacts

Contact information is provided by the study sponsor or research team.

Brooke Le

CONTACT

Caroline Benner

CONTACT

[email protected]

(210) 624-8046

Sponsors and collaborators

Lead sponsor

Spark Biomedical, Inc.

Industry

Collaborators

  • Battelle Memorial Institute
  • Hazelden Betty Ford Foundation
  • National Institute on Drug Abuse (NIDA)
  • National Institutes of Health (NIH)
  • The HEAL Initiative

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 5, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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