Status:
RECRUITING
Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
Lead Sponsor:
Spark Biomedical, Inc.
Collaborating Sponsors:
Battelle Memorial Institute
Hazelden Betty Ford Foundation
Conditions:
Opioid Withdrawal
Opioid Use Disorder
Eligibility:
All Genders
18-50 years
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 dat...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participant has a recent history of opioid dependence; prescription or non-prescription
- Participant is currently taking, or plans to initiate, medications for opioid use disorder (MOUD)
- Participant is between 18 and 50 years of age
- Participant is English proficient
- Participant is able to provide informed consent and function at an intellectual level sufficient for study requirements
- Participant is willing to wear wearable sensors for 14 days
- Exclusion Criteria
- Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
- Participant has a history of epileptic seizures
- Participant has a history of neurological diseases or traumatic brain injury
- Participant has recent suicide attempt leading to current hospital admission or continued expressed suicidal ideation
- 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
- Females who are pregnant or lactating
- 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
Exclusion
Key Trial Info
Start Date :
February 19 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06487533
Start Date
February 19 2025
End Date
May 31 2026
Last Update
January 8 2026
Active Locations (2)
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1
Hazelden Betty Ford Foundation
Center City, Minnesota, United States, 55012
2
Battelle Memorial Institute
Columbus, Ohio, United States, 43201