Overview
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.
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.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Age \<18 or \>70
- A condition preventing or complicating ISF collection
- dermatological (skin) condition
- immunodeficiency
- recent blood donation
- anemia
- end stage renal disease
- liver cirrhosis
- cancer
- congestive heart failure
- bleeding diathesis
- tuberculosis (TB)
- Any active severe depression
- suicidal ideation
- mania symptoms
- Pregnancy
- Intending to become pregnant during the course of the study
- Enrolled in a substance use disorder treatment program
- Under a conservatorship.
