NCT05981573

Assessment of Methadone Dose Taken

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Cari Health Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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 adults (ages 18-70) who have a prescription for methadone for chronic pain. In Aim 1, the investigator will determine if an RMM can assess the status of taking a prescribed dose of methadone, using biosamples (i.e., ISF, blood) collected from subjects and tested in a laboratory setup. Biosample collections and pharmacokinetic monitoring will take up to 6 consecutive hours. By completing this aim, the investigator will determine if a physician is able to recognize the peak and trough of a methadone dose using ex vivo Continuous Monitor. In Aim 2, the investigator will determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time, by inserting the intradermal microneedle sensing elements into the subjects' skin. Biosample collections (i.e., ISF, blood) and pharmacokinetic monitoring will occur over a 6-hour period. By completing this aim, the investigator will determine if a physician is able to recognize the pharmacokinetic profile of a taken dose of methadone. The physician will see a dosing curve display generated from intradermal microneedle sensing elements that are worn continuously on the skin. Completion of Aims 1-2 will require two separate visits.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-08-26
• Primary completion: 2026-03-01
• Completion: 2026-04-01
• First posted: 2023-08-08
• Last updated: 2025-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study