Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder (Closed-Loop)

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.

Study Overview

• Status: Recruiting
• Conditions: Opioid Use Disorder; Opioid Withdrawal
• Intervention / Treatment: Device: EmbracePlus Smartwatch; Device: Corti Sensor

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Brooke Le
• Study Contact Backup: Name: Caroline Benner; Phone Number: (210) 624-8046; Email: clinicaltrials@sparkbiomedical.com

Study Locations

• United States
  • Minnesota
    • Center City, Minnesota, United States, 55012
      • Recruiting
      • Hazelden Betty Ford Foundation
      • Contact: Tara Cantwell, MPH; Email: tcantwell@hazeldenbettyford.org
      • Contact: Laurie Zganjar; Email: research@butlercenterresearch.org
      • Principal Investigator: Quyen Ngo, PhD
  • Ohio
    • Columbus, Ohio, United States, 43201
      • Active, not recruiting
      • Battelle Memorial Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Participants between 18 and 50 years of age with a history of dependence on prescription or non-prescription opioids

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Opioid Use Disorder; Participants with a history of dependence on prescription or non-prescription opioids

Device: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	The primary safety endpoint will be the proportion of participants who experience one or more adverse events.	Daily throughout the 14-day inpatient detoxification treatment
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.	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.	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.	Daily throughout the 14-day inpatient detoxification treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Duration	Correlation of sleep duration and quality with opioid withdrawal symptoms as well as cravings	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	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)	Daily throughout the 14-day inpatient detoxification treatment
Wearable Sensors Compliance	Compliance to wearing wearable sensors (EmbracePlus Smartwatch and Corti Sensor)	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.	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.	Daily throughout the 14-day inpatient detoxification treatment

Collaborators and Investigators

• Sponsor: Spark Biomedical, Inc.
• Collaborators: National Institute on Drug Abuse (NIDA); National Institutes of Health (NIH); Battelle Memorial Institute; Hazelden Betty Ford Foundation; The HEAL Initiative
• Investigators: Principal Investigator: Navid Khodaparast, PhD, Chief Science Officer; Study Director: Melanie McWade, PhD, Senior Director of Clinical Operations; Study Chair: Carlos Tirado, MD, Medical Monitor

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: June 27, 2024
• First Posted (Actual): July 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Autonomic Nervous System; Opioid; Cravings; Detoxification; Physiological Signals
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: SBM-OWP-09; 1R43DA059448 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No