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

NCT06487533 | Recruiting

• 2 other identifiers: SBM-OWP-091R43DA059448
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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 Use Disorder; Opioid Withdrawal

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Other Outcomes (6)

• Sleep Duration

  Daily throughout the 14-day inpatient detoxification treatment

• Stress Monitoring and Assessment Tool (SMART)

  Daily throughout the 14-day inpatient detoxification treatment

• Therapy Compliance

  Daily throughout the 14-day inpatient detoxification treatment

Study Arms (1)

Opioid Use Disorder

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

Device: EmbracePlus Smartwatch; Device: Corti Sensor

Interventions

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.

Opioid Use Disorder

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.

Opioid Use Disorder

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Spark Biomedical, Inc.: lead
• Battelle Memorial Institute: collaborator
• Hazelden Betty Ford Foundation: collaborator
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• The HEAL Initiative: collaborator

Study Sites (2)

Hazelden Betty Ford Foundation

Center City, Minnesota, 55012, United States

RECRUITING

Battelle Memorial Institute

Columbus, Ohio, 43201, United States

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine samples will also be collected for drug screens. Biomarkers collected will include cortisol, melatonin, interleukin-6 (IL-6), and Tumor Necrosis Factor alpha (TNF-α levels).

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Navid Khodaparast, PhD

  Chief Science Officer

  PRINCIPAL INVESTIGATOR

• Melanie McWade, PhD

  Senior Director of Clinical Operations

  STUDY DIRECTOR

• Carlos Tirado, MD

  Medical Monitor

  STUDY CHAIR

Central Study Contacts

Caroline Benner

CONTACT

(210) 624-8046; clinicaltrials@sparkbiomedical.com

Brooke Le

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 5, 2024
• Study Start: February 19, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (2)