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Assessment of Methadone Dose Taken

ConditionsMethadone ToxicityMethadone OverdosePain, ChronicDrug Metabolism, Poor, CYP2D6-RelatedMetabolism Medication Toxicity
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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 population

Chronic pain patients that have been prescribed at least 10mg of methadone per day.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo

    Diagnostic test

    Measurement of Methadone and its metabolites in interstitial fluid with Liquid Chromatography - Mass Spectroscopy (LC-MS) and Aptamer based Assay

  • Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo

    Drug

    Measurement of Methadone and its metabolites in ISF with LC-MS and RMM

  • ISF Extraction Device 2

    Device

    Up to 15 minute periods of continuous ISF collection for analysis

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Visit 23 interventions
Group B: Visit 33 interventions
Group C: Visit 11 intervention

Trial outcomes

Primary outcomes

1

LC-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
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cari Health Inc.

Lead sponsor

Source ClinicalTrials.gov
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