Status:
RECRUITING
Assessment of Methadone Dose Taken
Lead Sponsor:
Cari Health Inc.
Conditions:
Methadone Toxicity
Methadone Overdose
Eligibility:
All Genders
18-70 years
Brief Summary
Proof of concept: Pilot Study A Pilot, proof of concept, observational study with a long-term goal to develop a minimally invasive wearable Remote Medication Monitor (RMM) that provides continuous, r...
Detailed Description
The investigator will conduct a non-randomized, non-blinded, feasibility study at a single center in the United States. The study will include up to 20 subjects of an equal number of male and female a...
Eligibility Criteria
Inclusion
- Age 18-70
- A prescription for methadone for chronic pain at a dose of 10mg or more for at least one week.
- Taking methadone as prescribed during the last 4 days before consent to participate in the study.
Exclusion
- Age \<18 or \>70
- A condition preventing or complicating ISF collection
- dermatological (skin) condition
- immunodeficiency
- recent blood donation
- anemia
- end stage renal disease
- liver cirrhosis
- cancer
- congestive heart failure
- bleeding diathesis
- tuberculosis (TB)
- Any active severe depression
- suicidal ideation
- mania symptoms
- Pregnancy
- Intending to become pregnant during the course of the study
- Enrolled in a substance use disorder treatment program
- Under a conservatorship.
Key Trial Info
Start Date :
August 26 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05981573
Start Date
August 26 2024
End Date
April 1 2026
Last Update
February 13 2025
Active Locations (1)
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1
Synergy
Lemon Grove, California, United States, 91945