About this trial
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 criteria
Qualifiers
Age 18-70
A prescription for methadone for chronic pain at a dose of 10mg or more for at least one week.
Taking methadone as prescribed during the last 4 days before consent to participate in the study.
Disqualifiers
Age <18 or >70
A condition preventing or complicating ISF collection
dermatological (skin) condition
immunodeficiency
Trial design
Treatments tested in this trial
- Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo
- Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo
- ISF Extraction Device 2