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Assessment of Methadone Dose Taken

NCT05981573 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-02-13

No results posted yet for this study

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.

Conditions

  • Methadone Toxicity
  • Methadone Overdose
  • Pain, Chronic
  • Drug Metabolism, Poor, CYP2D6-Related
  • Metabolism Medication Toxicity

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

Sponsors & Collaborators

  • Cari Health Inc.

    lead OTHER

Principal Investigators

  • Charmaine Semenluk, MD · Synergy Research Inc.

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-26
Primary Completion
2026-03-31
Completion
2026-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05981573 on ClinicalTrials.gov