Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
Recruiting now
Conditions studied: Opioid Withdrawal, Opioid Use Disorder
In brief
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.
Key facts
- Study ID
- NCT06487533
- Run by
- Spark Biomedical, Inc.
- People needed
- 20
- Starts
- 2025-02-19
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2026-06-02
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hazelden Betty Ford Foundation — Center City, Minnesota, United States (enrolling)
- Battelle Memorial Institute — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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