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Recruiting NCT05981573

Assessment of Methadone Dose Taken

— Observational Methadone Toxicity Methadone Overdose Pain, Chronic Drug Metabolism, Poor, CYP2D6-Related

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo, Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo, ISF Extraction Device 2.
Who it may be relevant to
Registry conditions: Methadone Toxicity, Methadone Overdose, Pain, Chronic, Drug Metabolism, Poor, CYP2D6-Related. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

  • Diagnostic test Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo
    Measurement of Methadone and its metabolites in interstitial fluid with Liquid Chromatography - Mass Spectroscopy (LC-MS) and Aptamer based Assay
  • Drug Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo
    Measurement of Methadone and its metabolites in ISF with LC-MS and RMM
  • Device ISF Extraction Device 2
    Up to 15 minute periods of continuous ISF collection for analysis

Primary outcome measures

  • LC-MS based Proteome analysis of dermal interstitial fluid in non opioid use disordered patients [Time frame: 1 day]
  • Methadone Concentration in ISF before and after a dose [Time frame: 1 day]
  • Methadone Concentration in blood before and after a dose [Time frame: 1 day]
  • Concentration of Methadone in ISF with LC-MS versus Electrochemical Assay [Time frame: 2 days]
  • Concentration of Methadone in blood with LC-MS versus Electrochemical Assay [Time frame: 2 days]
  • Pearson Correlation of Methadone between ISF and Blood [Time frame: 2 days]
  • Pearson Correlation between DPV and LC-MS ISF Methadone [Time frame: 2 days]
  • Pearson Correlation between DPV and LC-MS ISF EDDP [Time frame: 2 days]
  • Pearson Correlation between DPV and LC-MS blood EDDP [Time frame: 2 days]
  • EDDP concentration in ISF before and after daily dose of methadone [Time frame: 1 day]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Synergy — Lemon Grove

Publications

  • Friedel M, Werbovetz B, Drexelius A, Watkins Z, Bali A, Plaxco KW, Heikenfeld J. Continuous molecular monitoring of human dermal interstitial fluid with microneedle-enabled electrochemical aptamer sensors. Lab Chip. 2023 Jul 12;23(14):3289-3299. doi: 10.1039/d3lc00210a. PMID 37395135
  • Gomes NO, Raymundo-Pereira PA. On-Site Therapeutic Drug Monitoring of Paracetamol Analgesic in Non-Invasively Collected Saliva for Personalized Medicine. Small. 2023 Mar;19(12):e2206753. doi: 10.1002/smll.202206753. Epub 2023 Jan 15. PMID 36642790
  • Ribet F, Bendes A, Fredolini C, Dobielewski M, Bottcher M, Beck O, Schwenk JM, Stemme G, Roxhed N. Microneedle Patch for Painless Intradermal Collection of Interstitial Fluid Enabling Multianalyte Measurement of Small Molecules, SARS-CoV-2 Antibodies, and Protein Profiling. Adv Healthc Mater. 2023 May;12(13):e2202564. doi: 10.1002/adhm.202202564. Epub 2023 Feb 21. PMID 36748807

Identifiers

NCT: NCT05981573 · 1358643

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗