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NCT Number: NCT05981573

Assessment of Methadone Dose Taken

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 status: Recruiting

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 for chronic pain. In Aim 1, the investigator will determine if an RMM can assess the status of taking a prescribed dose of methadone, using biosamples (i.e., ISF, blood) collected from subjects and tested in a laboratory setup. Biosample collections and pharmacokinetic monitoring will take up to 6 consecutive hours. By completing this aim, the investigator will determine if a physician is able to recognize the peak and trough of a methadone dose using ex vivo Continuous Monitor.

In Aim 2, the investigator will determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time, by inserting the intradermal microneedle sensing elements into the subjects' 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 intradermal microneedle sensing elements that are worn continuously on the skin. Completion of Aims 1-2 will require two separate visits.

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 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.

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. LC-MS based Proteome analysis of dermal interstitial fluid in non opioid use disordered patients

    Time frame: 1 day

    Measure the dermal interstitial fluid proteome using LC-MS in subjects without opioid use disorder

  2. 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

  3. 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

  4. Concentration of Methadone in ISF with LC-MS versus Electrochemical Assay

    Time frame: 2 days

    measure ISF with two procedures (Liquid Chromatography - Mass Spectroscopy and Differential Pulse Voltammetry.

  5. Concentration of Methadone in blood with LC-MS versus Electrochemical Assay

    Time frame: 2 days

    measure blood with two procedures (Liquid Chromatography - Mass Spectroscopy and Differential Pulse Voltammetry.

  6. Pearson Correlation of Methadone between ISF and Blood

    Time frame: 2 days

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

  7. Pearson Correlation between DPV and LC-MS ISF Methadone

    Time frame: 2 days

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

  8. Pearson Correlation between DPV and LC-MS ISF EDDP

    Time frame: 2 days

    measure ISF for EDDP by LC-MS and DPV and determine Pearson correlation

  9. Pearson Correlation between DPV and LC-MS blood EDDP

    Time frame: 2 days

    measure blood for EDDP by LC-MS and DPV and determine Pearson correlation

  10. EDDP concentration in ISF before and after daily dose of methadone

    Time frame: 1 day

    measure ISF for EDDP by LC-MS before and after daily dose of methadone

  11. EDDP concentration in blood before and after daily dose of methadone

    Time frame: 1 day

    measure blood for EDDP by LC-MS before and after daily dose of methadone

  12. EMDP concentration in ISF before and after daily dose of methadone

    Time frame: 1 day

    measure EMDP in ISF before and after daily dose of methadone

  13. EMDP concentration in blood before and after daily dose of methadone

    Time frame: 1 day

    measure EMDP in blood by LC-MS before and after daily dose of methadone

  14. Pearson Correlation of Methadone to Metabolite Ratio ( MMR ) between ISF and Blood using LC-MS

    Time frame: 2 days

    Calculate methadone to EDDP ratio of ISF and Blood and determine Pearson Correlation using LC-MS

  15. Pearson Correlation of Methadone to Metabolite Ratio ( MMR ) between ISF and Blood using DPV

    Time frame: 2 days

    Calculate methadone to EDDP ratio of ISF and Blood and determine Pearson Correlation using DPV

Study contacts

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

Foster P Carr, MD

CONTACT

[email protected]

6192343725

Torsten Feibig, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cari Health Inc.

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2023
Registry last updated
Feb 13, 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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