Methadone Dose Monitoring With a Remote Medication Monitor

Part of paid clinical trials in Lemon Grove, California.

Sponsor
Cari Health Inc.
Study ID
NCT06837571
Status
Not Yet 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
Apr 26, 2025
Status verified
Feb 2025
Primary completion
May 31, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Visit 1
    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 dermal ISF collected through the surface of the skin using existing ISF extraction methods and assessed outside the body via with and dermal ISF dialysis tube and external aptamer switch based fiberoptic sensor continuously for 6 hours. Methadone and protein binding factors are independently assessed in the collected ISF samples using (LC-MS and Lateral Flow Assays). We hypothesize that the methadone peak and trough levels in the blood samples will correlate with the levels of methadone in ISF. The Investigators hypothesize that the methadone peak and trough levels in the blood samples will correlate with the levels of methadone in ISF.
  • Arm: Visit 2
    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 dialysate continuously from the surface of the skin using the RMM for up to 12 hours (Aim 3a) and over 3 days (Aim 3b). Methadone will also be assessed over these three time points in the continuously collected ISF samples using LC-MS and Lateral Flow Assays. The Investigators hypothesize that a clinician can recognize a dose taken from the RMM generated measurements of dialyzed ISF.

Primary Outcome Measure

Methadone Concentration in ISF before and after a dose [ Time Frame: 1 day ]

Central Contacts

Locations (1)

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

Find similar trials in Lemon Grove, CA

By research site
Synergy· Lemon Grove, CA

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