Methadone Dose Monitoring With a Remote Medication Monitor

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorCari Health Inc.

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 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

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators