Assessment of Methadone Dose Taken

Part of paid clinical trials in Lemon Grove, California.

Sponsor
Cari Health Inc.
Study ID
NCT05981573
Status
Recruiting
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Conditions

  • Drug Metabolism, Poor, CYP2D6-Related
  • Metabolism Medication Toxicity
  • Methadone Overdose
  • Methadone Toxicity
  • Pain, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Aug 26, 2024
Status verified
Feb 2025
Primary completion
Mar 31, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Visit 2
    AIM 2 : Determine if an RMM can assess the status of taking a prescribed dose of methadone. To complete this aim, the peak and trough concentrations of a witnessed methadone dose will be assessed in ISF collected through the surface of the skin using existing ISF extraction methods and assessed outside the body via Lateral Flow Immunoassay for up to 6 hours. Methadone metabolites and protein binding factors may be assessed in the collected ISF samples using (LC-MS). We hypothesize that the methadone peak and trough levels as well as the metabolites in the blood samples will correlate with the levels of methadone in ISF. The Investigators hypothesize that the methadone peak and trough levels as well as the metabolites in the blood samples will correlate with the levels of methadone in ISF.
  • Arm: Visit 3
    AIM 3: Determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time. To complete this aim, the pharmacokinetic profile of a witnessed methadone dose will be assessed in ISF continuously from the surface of the skin using the RMM for up to 12 hours (Aim 3a) and over 3 days (Aim 3b). Methadone metabolites will also be assessed over these three time points in the continuously collected ISF samples using LC-MS. The Investigators hypothesize that a clinician can recognize a dose taken and the methadone metabolites from the RMM generated measurements in the ISF.
  • Arm: Visit 1
    Aim 1: Characterize dermal interstitial fluid (ISF) in healthy adults with Liquid Chromatography-Mass Spectroscopy (LC-MS) based proteomics. To complete this aim, the dermal interstitial fluid will be extracted from the surface of the skin of healthy adults over a period up to 3 hours. The participants may also have continuous monitoring of their interstitial fluid using the RMM. We hypothesize that the protein content of ISF will be 50% the level of normal human serum levels and contain potential protein biomarkers of disease status.

Primary Outcome Measure

LC-MS based Proteome analysis of dermal interstitial fluid in non opioid use disordered patients [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
SynergyLemon GroveCalifornia91945
Woody Woodman
Ryan Woodman
Charmaine Semenluk, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Synergy· Lemon Grove, CA

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