Pilot Study to Evaluate a Wearable Remote Medication Monitor for Tracking Methadone Levels in Adults with Chronic Pain

What this Trial Is About

Researchers are conducting a pilot observational study to develop a minimally invasive wearable Remote Medication Monitor RMM that continuously and in real time measures methadone levels in the interstitial fluid ISF. This study aims to evaluate whether such a device can monitor medication adherence by showing if prescribed methadone doses have been taken. The study involves adults aged 18 to 70 who are prescribed methadone for chronic pain. The study consists of multiple aims involving biosample collection and pharmacokinetic monitoring. In Aim 1, biosamples of ISF and blood will be collected over up to 6 hours to assess if the RMM can detect methadone dose timing using ex vivo methods. Aim 2 involves inserting intradermal microneedle sensors into the skin to continuously monitor methadone levels via the RMM over 6 hours. Later aims include longer monitoring periods of up to 3 days to observe methadone and its metabolites in ISF. Participants will attend up to three visits involving ISF and blood sample collections, wearing the RMM device, and pharmacokinetic monitoring. Researchers will analyze methadone concentrations and metabolite levels using advanced laboratory techniques such as Liquid Chromatography-Mass Spectroscopy. The primary outcomes include correlations between methadone measurements in ISF and blood to evaluate the devices monitoring capabilities. The study is expected to run until April 2026.

Assessment of Methadone Dose Taken