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Assessment of Methadone Dose Taken

StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated February 13, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Mar 2025 to Mar 2026v6 Show 6 more changesShow less
    • Trial status: Enrolling by Invitation to Recruiting
    • Study completion date: Apr 2025 to Apr 2026
    • Interventions: ISF Extraction Device 2 (Device), ISF extraction device 1 (Device), Measurement of Methadone in ISF before and after taking prescribed dose… to ISF Extraction Device 2 (Device), Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo…
    • Study description shortened, about 36 words
    • Site details revised
    • Study title shortened, about 2 words
  2. Enrollment target: 20 to 30v5 Show 7 more changesShow less
    • Primary completion date: Aug 2024 to Mar 2025
    • Start date: Jun 2024 to Aug 26, 2024
    • Primary endpoints: 14 to 15
    • Trial status: Recruiting to Enrolling by Invitation
    • Study completion date: Sep 2024 to Apr 2025
    • Site details revised
    • Study arms: 2 to 3
  3. Primary completion date: Dec 2023 to Aug 2024
    • Start date: Oct 2023 to Jun 2024
    • Study completion date: Feb 2024 to Sep 2024
    v4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Nov 2023 to Dec 2023
    • Study completion date: Dec 2023 to Feb 2024
    • Start date: Sep 2023 to Oct 2023
    • Collaborators shortened, about 3 words
  5. Eligibility criteria shortened, about 7 words
    • Study description expanded, about 5 words
    • Collaborators expanded, about 3 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05981573
Lead Sponsor Cari Health Inc.
Conditions
(from sponsor)		 Methadone Toxicity, Methadone Overdose, Pain, Chronic, Drug Metabolism, Poor, CYP2D6-Related, Metabolism Medication Toxicity
Related terms Chronic Pain, Drug Metabolism, Poor, CYP2D6-Related
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov