Assessment of Methadone Dose Taken
Cari Health Inc.
30 participants
Aug 26, 2024
OBSERVATIONAL
Conditions
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, real-time data on methadone levels in interstitial fluid (ISF). An RMM could be used as a medication adherence monitor and would allow for the physician, counselor, patient, or family member to remotely verify that a physician-prescribed dose has been taken.
Eligibility
Inclusion Criteria3
- 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 Criteria19
- 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.
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Interventions
Measurement of Methadone and its metabolites in interstitial fluid with Liquid Chromatography - Mass Spectroscopy (LC-MS) and Aptamer based Assay
Measurement of Methadone and its metabolites in ISF with LC-MS and RMM
Up to 15 minute periods of continuous ISF collection for analysis
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05981573