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

ConditionsOpioid Withdrawal Opioid Use Disorder

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-50

SponsorSpark Biomedical, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.
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.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Opioid Use Disorder2 interventions

Trial outcomes

Primary outcomes

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