Recruiting

Observational Study

Sponsor:

Spark Biomedical, Inc.

Code:

NCT06487533

Conditions

Opioid Withdrawal

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

EmbracePlus Smartwatch

Corti Sensor

Study Details

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.

Conditions

Opioid Withdrawal

Opioid Use Disorder

Study ID

NCT06487533

Start date

Feb 19, 2025

Status verified date

Jun, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria

1. Participant has a recent history of opioid dependence; prescription or non-prescription
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

1. Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Opioid Use Disorder

Participants with a history of dependence on prescription or non-prescription opioids

Interventions

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.

Primary outcome measure

  • Short Opioid Withdrawal Scale Gossop (SOWS-Gossop) [ Time Frame: Daily throughout the 14-day inpatient detoxification treatment ]
  • Clinical Opioid Withdrawal Scale (COWS) [ Time Frame: Daily throughout the 14-day inpatient detoxification treatment ]
  • Opioid Craving Visual Analog Scale (OC-VAS) [ Time Frame: Daily throughout the 14-day inpatient detoxification treatment ]
  • Adverse Events [ Time Frame: Daily throughout the 14-day inpatient detoxification treatment ]

Central Contacts and Locations

Locations

Hazelden Betty Ford Foundation

Recruiting

Center City, Minnesota, United States, 55012

Contacts

Principal Investigator:

Quyen Ngo, PhD

More Information

Sponsor

Spark Biomedical, Inc.

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Keywords

  • Physiological Signals
  • Opioid
  • Detoxification
  • Cravings
  • Autonomic Nervous System

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spark Biomedical, Inc. on 2026-06-02.