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| ID | Type | Description | Link |
|---|---|---|---|
| 1R43DA059448 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Battelle Memorial Institute | OTHER |
| Hazelden Betty Ford Foundation | UNKNOWN |
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid Use Disorder | Participants with a history of dependence on prescription or non-prescription opioids |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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| 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 |
| Stress Monitoring and Assessment Tool (SMART) |
Inclusion Criteria
Exclusion Criteria
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Participants between 18 and 50 years of age with a history of dependence on prescription or non-prescription opioids
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Benner | Contact | (210) 624-8046 | clinicaltrials@sparkbiomedical.com | |
| Brooke Le | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Navid Khodaparast, PhD | Chief Science Officer | Principal Investigator |
| Melanie McWade, PhD | Senior Director of Clinical Operations | Study Director |
| Carlos Tirado, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hazelden Betty Ford Foundation | Recruiting | Center City | Minnesota | 55012 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 2, 2024 | Sep 11, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| NIH |
| The HEAL Initiative | UNKNOWN |
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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).
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| 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. |
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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 |
| 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 |
| Medical Monitor |
| Study Chair |
| Battelle Memorial Institute | Active, not recruiting | Columbus | Ohio | 43201 | United States |