Opioid Use Disorder, Opioid Withdrawal
Conditions
Keywords
Physiological Signals, Opioid, Detoxification, Cravings, Autonomic Nervous System
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.
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.
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.
Sponsors
Spark Biomedical, Inc.
Battelle Memorial Institute
Hazelden Betty Ford Foundation
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
The HEAL Initiative
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Opioid Withdrawal Scale Gossop (SOWS-Gossop) | Daily throughout the 14-day inpatient detoxification treatment | Correlation of opioid withdrawal symptoms, as measured by the SOWS-Gossop, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable. |
| Clinical Opioid Withdrawal Scale (COWS) | Daily throughout the 14-day inpatient detoxification treatment | Correlation of opioid withdrawal symptoms, as measured by the COWS, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable. |
| Opioid Craving Visual Analog Scale (OC-VAS) | Daily throughout the 14-day inpatient detoxification treatment | Correlation of the intensity of opioid cravings, as measured by the OC-VAS, over time with biomarkers using the EmbracePlus Smartwatch and Corti Wearable. |
| Adverse Events | Daily throughout the 14-day inpatient detoxification treatment | The primary safety endpoint will be the proportion of participants who experience one or more adverse events. |
Countries
United States
Contacts
CONTACTCaroline Benner
CONTACTBrooke Le
PRINCIPAL_INVESTIGATORNavid Khodaparast, PhD
Chief Science Officer
STUDY_DIRECTORMelanie McWade, PhD
Senior Director of Clinical Operations
STUDY_CHAIRCarlos Tirado, MD
Medical Monitor
Outcome results
None listed