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.
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.
Study Type
OBSERVATIONAL
Enrollment
30
Measurement of Methadone and its metabolites in interstitial fluid with Liquid Chromatography - Mass Spectroscopy (LC-MS) and Aptamer based Assay
Measurement of Methadone and its metabolites in ISF with LC-MS and RMM
Up to 15 minute periods of continuous ISF collection for analysis
Synergy
Lemon Grove, California, United States
RECRUITINGLC-MS based Proteome analysis of dermal interstitial fluid in non opioid use disordered patients
Measure the dermal interstitial fluid proteome using LC-MS in subjects without opioid use disorder
Time frame: 1 day
Methadone Concentration in ISF before and after a dose
measure dermal interstitial fluid with LC-MS for methadone before and after a daily dose
Time frame: 1 day
Methadone Concentration in blood before and after a dose
measure blood for methadone with LC-MS before and after a daily dose
Time frame: 1 day
Concentration of Methadone in ISF with LC-MS versus Electrochemical Assay
measure ISF with two procedures (Liquid Chromatography - Mass Spectroscopy and Differential Pulse Voltammetry.
Time frame: 2 days
Concentration of Methadone in blood with LC-MS versus Electrochemical Assay
measure blood with two procedures (Liquid Chromatography - Mass Spectroscopy and Differential Pulse Voltammetry.
Time frame: 2 days
Pearson Correlation of Methadone between ISF and Blood
measure blood and ISF methadone with LC-MS and determine pearson correlation
Time frame: 2 days
Pearson Correlation between DPV and LC-MS ISF Methadone
measure ISF for methadone by LC-MS and DPV and determine Pearson correlation
Time frame: 2 days
Pearson Correlation between DPV and LC-MS ISF EDDP
measure ISF for EDDP by LC-MS and DPV and determine Pearson correlation
Time frame: 2 days
Pearson Correlation between DPV and LC-MS blood EDDP
measure blood for EDDP by LC-MS and DPV and determine Pearson correlation
Time frame: 2 days
EDDP concentration in ISF before and after daily dose of methadone
measure ISF for EDDP by LC-MS before and after daily dose of methadone
Time frame: 1 day
EDDP concentration in blood before and after daily dose of methadone
measure blood for EDDP by LC-MS before and after daily dose of methadone
Time frame: 1 day
EMDP concentration in ISF before and after daily dose of methadone
measure EMDP in ISF before and after daily dose of methadone
Time frame: 1 day
EMDP concentration in blood before and after daily dose of methadone
measure EMDP in blood by LC-MS before and after daily dose of methadone
Time frame: 1 day
Pearson Correlation of Methadone to Metabolite Ratio ( MMR ) between ISF and Blood using LC-MS
Calculate methadone to EDDP ratio of ISF and Blood and determine Pearson Correlation using LC-MS
Time frame: 2 days
Pearson Correlation of Methadone to Metabolite Ratio ( MMR ) between ISF and Blood using DPV
Calculate methadone to EDDP ratio of ISF and Blood and determine Pearson Correlation using DPV
Time frame: 2 days
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