An observational study in Opioid Withdrawal and Opioid Use Disorder, sponsored by Spark Biomedical, Inc.. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Spark Biomedical, Inc. · Observational
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.
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.
Participants between 18 and 50 years of age with a history of dependence on prescription or non-prescription opioids
Exclusion Criteria
Participants with a history of dependence on prescription or non-prescription opioids
Device: EmbracePlus Smartwatch · Device: Corti Sensor
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.
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.
Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
Correlation of opioid withdrawal symptoms, as measured by the SOWS-Gossop, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.
Time frame: Daily throughout the 14-day inpatient detoxification treatment
Clinical Opioid Withdrawal Scale (COWS)
Correlation of opioid withdrawal symptoms, as measured by the COWS, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.
Time frame: Daily throughout the 14-day inpatient detoxification treatment
Opioid Craving Visual Analog Scale (OC-VAS)
Correlation of the intensity of opioid cravings, as measured by the OC-VAS, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.
Time frame: Daily throughout the 14-day inpatient detoxification treatment
Adverse Events
The primary safety endpoint will be the proportion of participants who experience one or more adverse events.
Time frame: Daily throughout the 14-day inpatient detoxification treatment
Sleep Duration
Correlation of sleep duration and quality with opioid withdrawal symptoms as well as cravings
Time frame: Daily throughout the 14-day inpatient detoxification treatment
Stress Monitoring and Assessment Tool (SMART)
Correlation of stress score, as measured by the SMART, with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.
Time frame: Daily throughout the 14-day inpatient detoxification treatment
Therapy Compliance
Correlation of compliance to recovery-related therapies (e.g. group therapy, individual counseling) with biomarkers using the EmbracePlus Smartwatch and Corti Wearable.
Time frame: Daily throughout the 14-day inpatient detoxification treatment
Drug Screening
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
Time frame: Once daily on screening/baseline day, study day 7, and study day 14 (14-day time frame)
Medication Use
Medication use and timing (medication name, dosage, and indication)
Time frame: Daily throughout the 14-day inpatient detoxification treatment
Wearable Sensors Compliance
Compliance to wearing wearable sensors (EmbracePlus Smartwatch and Corti Sensor)
Time frame: Daily throughout the 14-day inpatient detoxification treatment
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Spark Biomedical, Inc.