RecruitingNCT06487533

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

Sponsor

Spark Biomedical, Inc.

Enrollment

20 participants

Start Date

Feb 19, 2025

Study Type

OBSERVATIONAL

Conditions

Opioid Withdrawal

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.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria6

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 Criteria7

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

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Interventions

DEVICEEmbracePlus 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.

DEVICECorti 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.