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RecruitingNCT05981573

Assessment of Methadone Dose Taken

Sponsor

Cari Health Inc.

Enrollment

30 participants

Start Date

Aug 26, 2024

Study Type

OBSERVATIONAL

Conditions

Pain, ChronicDrug Metabolism, Poor, CYP2D6-RelatedMethadone ToxicityMethadone OverdoseMetabolism Medication Toxicity

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying ISF Extraction Device 2, Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo, and others for people with drug metabolism, poor, cyp2d6-related, metabolism medication toxicity, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTMeasurement 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

DRUGMeasurement 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

DEVICEISF Extraction Device 2

Up to 15 minute periods of continuous ISF collection for analysis

Locations(1)

Synergy

Lemon Grove, California, United States

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NCT05981573

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