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NCT Number: NCT06837571

Methadone Dose Monitoring With a Remote Medication Monitor

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.

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Key information

Conditions

Methadone Toxicity Chronic Pain Drug Metabolism, Poor, CYP2D6-Related Metabolism Medication Toxicity Methadone Overdose Neurologic Manifestations Pain Pain, Chronic Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Synergy

Lemon Grove, California, 91945, United States

Location contact

Charmaine Semenluk, MD

PRINCIPAL_INVESTIGATOR

Ryan Woodman

CONTACT

Woody Woodman

CONTACT

About this study

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.

In Aim 1, the investigators will determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time, by inserting the dermal ISF sensing elements into the subjects' abdominal 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 dermal ISF dialysis fluid sampling using an external fiberoptic sensor system that is worn continuously on the abdomen similar to continuous glucose monitors.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-70
  • A prescription for methadone 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.

Exclusion criteria

  • Age <18 or >70
  • A condition preventing or complicating ISF collection
  • dermatological (skin) condition
  • immunodeficiency
  • recent blood donation
  • anemia
  • end stage renal disease
  • liver cirrhosis
  • cancer
  • congestive heart failure
  • bleeding diathesis
  • tuberculosis (TB)
  • Any active severe depression
  • suicidal ideation
  • mania symptoms
  • Pregnancy
  • Intending to become pregnant during the course of the study
  • Enrolled in a substance use disorder treatment program
  • Under a conservatorship.

Treatment and study plan

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

Other names: dose taken peak-trough test

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

Other names: In vivo Continuous molecular monitoring

ISF Extraction Device 2

Device

Up to 15 minute periods of continuous ISF collection for analysis

Other names: Ascilion

Primary outcomes

  1. Methadone Concentration in ISF before and after a dose

    Time frame: 1 day

    measure dermal interstitial fluid with LC-MS for methadone before and after a daily dose

  2. Methadone Concentration in blood before and after a dose

    Time frame: 1 day

    measure blood for methadone with LC-MS before and after a daily dose

  3. Concentration of Methadone in ISF with LC-MS versus Fluorescent Aptamer Switch

    Time frame: 2 days

    measure ISF with two procedures (Liquid Chromatography - Mass Spectroscopy and Fluoroscopy

  4. Concentration of Methadone in blood with LC-MS versus Fluorescent Aptamer Switch

    Time frame: 2 days

    measure blood with two procedures (Liquid Chromatography - Mass Spectroscopy and Fluoroscopy

  5. Pearson Correlation of Methadone between ISF and Blood

    Time frame: 2 days

    measure blood and ISF methadone with LC-MS and determine pearson correlation

  6. Pearson Correlation between Fluoroscopy and LC-MS ISF Methadone

    Time frame: 2 days

    measure ISF for methadone by LC-MS and Fluoroscopy and determine Pearson correlation

Study contacts

Contact information is provided by the study sponsor or research team.

Foster P Carr, MD

CONTACT

[email protected]

6192343725

Sponsors and collaborators

Lead sponsor

Cari Health Inc.

Other

Registry information

Official study title

Assessment of Methadone Dose Taken

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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