Status:
UNKNOWN
Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor
Lead Sponsor:
Cari Health Inc.
Conditions:
Adherence, Medication
Opioid Use Disorder
Eligibility:
All Genders
18-70 years
Brief Summary
CARI Health aims to develop a methadone dose taken sensor that provides real-time data on interstitial fluid (ISF) levels that could be used as a methadone adherence monitor for daily doses. Use of su...
Detailed Description
Three specific phases and 9 aims are proposed for first-in-human studies of a remote medication monitor for dose taken in patients taking methadone for opiate use disorder. Phase 1 detection over 3-6...
Eligibility Criteria
Inclusion
- Inclusion criteria for methadone group includes:
- Age 18-70. A prescription for liquid methadone at a dose of 10mg or more. Taken methadone as prescribed in the last 2 days. Has been prescribed at least 3 take homes
- Exclusion criteria for methadone group includes:
- Age \<18 or \>70. A condition preventing or complicating ISF collection. Conditions may include dermatological (skin) condition, immunodeficiency, bleeding diathesis, recent blood donation, anemia, cancer, congestive heart failure, or tuberculosis. Any active severe depression (e.g., suicidal ideation) or mania symptoms.
- Pregnancy, or intending to become pregnant during the course of the study. Patients determined to be unstable for enrollment or take homes by the Outpatient Treatment Program (OTP).
- Under a conservatorship.
Exclusion
Key Trial Info
Start Date :
February 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05998876
Start Date
February 1 2024
End Date
June 1 2024
Last Update
August 21 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.