Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
NCT Number: NCT06487533
Acronym: Closed-Loop
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Opioid Withdrawal|Opioid Use Disorder
Interventions: DEVICE: EmbracePlus Smartwatch|DEVICE: Corti Sensor
Sponsor: Spark Biomedical, Inc.
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2025-05
Locations: Hazelden Betty Ford Foundation, Center City, Minnesota, 55012, United States|Battelle Memorial Institute, Columbus, Ohio, 43201, United States

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.

Primary Outcome Measures: 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
Other Outcome Measures: 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), 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