Clinical trial NCT06487533: Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
Official title: Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Opioid Withdrawal
Opioid Use Disorder
Keywords: Physiological Signals
Opioid
Detoxification
Cravings
Autonomic Nervous System
Lead sponsor: Spark Biomedical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Battelle Memorial Institute
name: Hazelden Betty Ford Foundation
name: National Institutes of Health (NIH)
First posted: 2024-07-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants between 18 and 50 years of age with a history of dependence on prescription or non-prescription opioids

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.

Eligibility criteria: Inclusion Criteria

1. Participant shows signs of current opioid dependence; prescription or non-prescription
2. Participant is seeking an induction to 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

Primary outcomes:
measure: Short Opioid Withdrawal Scale Gossop (SOWS-Gossop)
timeFrame: Daily throughout the 14-day inpatient detoxification treatment
measure: Clinical Opioid Withdrawal Scale (COWS)
timeFrame: Daily throughout the 14-day inpatient detoxification treatment
measure: Opioid Craving Visual Analog Scale (OC-VAS)
timeFrame: Daily throughout the 14-day inpatient detoxification treatment
measure: Adverse Events
timeFrame: Daily throughout the 14-day inpatient detoxification treatment
Secondary outcomes:
Other outcomes:
measure: Sleep Duration
timeFrame: Daily throughout the 14-day inpatient detoxification treatment
measure: Stress Monitoring and Assessment Tool (SMART)
timeFrame: Daily throughout the 14-day inpatient detoxification treatment
measure: Therapy Compliance
timeFrame: Daily throughout the 14-day inpatient detoxification treatment
measure: Drug Screening
timeFrame: Once daily on screening/baseline day, study day 7, and study day 14 (14-day time frame)
measure: Medication Use
timeFrame: Daily throughout the 14-day inpatient detoxification treatment
measure: Wearable Sensors Compliance
timeFrame: Daily throughout the 14-day inpatient detoxification treatment
Locations:
city: Center City
country: United States
facility: Hazelden Betty Ford Foundation
state: Minnesota
city: Columbus
country: United States
facility: Battelle Memorial Institute
state: Ohio
Study officials:
affiliation: Chief Science Officer
name: Navid Khodaparast, PhD
role: STUDY_CHAIR
affiliation: Senior Director of Clinical Operations
name: Melanie McWade, PhD
role: STUDY_DIRECTOR
affiliation: Medical Monitor
name: Carlos Tirado, MD
role: STUDY_CHAIR
References: