Sensing Physiological Symptoms of Opioid Withdrawal and Cravings in Patients With Opioid Use Disorder
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorSpark Biomedical, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- EmbracePlus Smartwatch
- Corti Sensor
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
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
Source ClinicalTrials.gov