Wearable Sensors for Opioid Withdrawal Syndrome
(Closed-Loop Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand the body's nervous system response during opioid withdrawal and cravings by measuring changes in physiological signals. Participants will wear sensors for 14 days to help researchers track these changes. The trial seeks individuals who have recently struggled with opioid use and are starting or already taking medications to manage their condition. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could improve future treatments.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications. However, it mentions that participants should be taking or planning to start medications for opioid use disorder, so you may continue those.
What prior data suggests that these devices are safe for measuring autonomic nervous system status during opioid withdrawal?
Previous studies have used the Corti Sensor to track opioid use by monitoring body signals like heart rate and skin response. This wearable device aims to identify high-risk opioid situations, such as increased opioid tolerance. These studies have reported no safety issues, suggesting the device is safe to use.
The EmbracePlus Smartwatch, a medical-grade device, has been used in studies to gather similar information. While researchers continue to study its safety in some situations, no major safety concerns have been reported when it tracks body signals.
Both devices are designed to collect data, not provide treatment, which reduces the risk of side effects. This makes them generally safe for use in clinical trials.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel method for sensing physiological symptoms of opioid withdrawal and cravings in patients with opioid use disorder. Unlike traditional treatments that focus on medication-assisted therapy, like methadone or buprenorphine, this approach aims to provide real-time monitoring of withdrawal symptoms. By leveraging advanced sensor technology, the trial hopes to offer a more personalized and immediate intervention strategy. This could lead to more precise management of opioid use disorder, potentially improving outcomes and offering a new layer of support for individuals struggling with addiction.
What evidence suggests that the Corti Sensor and EmbracePlus Smartwatch are effective for monitoring the autonomic nervous system during opioid withdrawal?
Research shows that wearable devices like the Corti Sensor and EmbracePlus Smartwatch, both studied in this trial, can help manage opioid use disorder. These devices track indicators such as heart rate and skin temperature to monitor the body's reactions during opioid withdrawal and cravings. Studies have found that they can also detect stress by monitoring cortisol, a hormone related to stress. Specifically, the EmbracePlus Smartwatch collects data that can enhance adherence to treatment plans and personalize treatments. This approach offers a way to monitor and potentially improve treatment outcomes for those dealing with opioid addiction.46789
Who Is on the Research Team?
Navid Khodaparast, PhD
Principal Investigator
Chief Science Officer
Melanie McWade, PhD
Principal Investigator
Senior Director of Clinical Operations
Carlos Tirado, MD
Principal Investigator
Medical Monitor
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Inpatient Detoxification Treatment
Participants undergo a 14-day inpatient detoxification treatment with continuous monitoring using wearable sensors
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Corti Sensor
- EmbracePlus Smartwatch
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants with a history of dependence on prescription or non-prescription opioids
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spark Biomedical, Inc.
Lead Sponsor
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
Citations
1.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06487533?term=Craving%20and%20Withdrawal%20&viewType=Table&rank=6Sensing Physiological Symptoms of Opioid Withdrawal and ...
The EmbracePlus Smartwatch and Corti Sensor will be worn continuously throughout the 14-day treatment course to detect heart rate, heart rate variability, skin ...
Digital Biomarker Applications Across the Spectrum of Opioid ...
This review explores the current evidence (and potential) for digital biomarkers monitoring across the spectrum of opioid use.
3.
researchgate.net
researchgate.net/publication/367522090_A_non-invasive_wearable_stress_patch_for_real-time_cortisol_monitoring_using_a_pseudoknot-assisted_aptamer(PDF) A non-invasive wearable stress patch for real-time ...
These data demonstrated that the sensor was well-formed and able to detect Cortisol. The length of the hybridization region significantly ...
Perceptions on wearable sensor-based interventions for ...
The purpose of the parent study was to use physiologic data from a wearable sensor to detect opioid use and identify early signs of opioid ...
Perceptions on wearable sensor-based interventions for ...
The purpose of the parent study was to use physiologic data from a wearable sensor to detect opioid use and identify early signs of opioid ...
Sensing Physiological Symptoms of Opioid Withdrawal and ...
The EmbracePlus Smartwatch and Corti Sensor will be worn continuously throughout the 14-day treatment course to detect heart rate, heart rate variability, skin ...
OpiTrack: A Wearable-based Clinical Opioid Use Tracker with ...
A mobile technology system that can identify high-risk opioid-related events (ie, development of tolerance in the setting of prescription opioid use)
Sensing Physiological Symptoms of Opioid Withdrawal and ...
The primary objective of this trial is to measure changes in physiologic signals to quantify the status of the autonomic nervous system ...
Current and Future Perspective of Devices and Diagnostics ...
The integrated electrochemical sensors measure in vivo opioid levels in real-time closing the treatment loop. A system like this could be extremely useful for ...
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