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NOT YET RECRUITING
NCT06837571

Methadone Dose Monitoring With a Remote Medication Monitor

Sponsor: Cari Health Inc.

View on ClinicalTrials.gov

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.

Official title: Assessment of Methadone Dose Taken

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2025-04-26

Completion Date

2025-06

Last Updated

2025-02-20

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo

Measurement of Methadone and its metabolites in interstitial fluid with Liquid Chromatography - Mass Spectroscopy (LC-MS) and Aptamer based Assay

DRUG

Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo

Measurement of Methadone and its metabolites in ISF with LC-MS and RMM

DEVICE

ISF Extraction Device 2

Up to 15 minute periods of continuous ISF collection for analysis

Locations (1)

Synergy

Lemon Grove, California, United States