Assessment of Methadone Dose Taken

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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
• Препарат 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
• Устройство ISF Extraction Device 2
  Up to 15 minute periods of continuous ISF collection for analysis

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Synergy — Lemon Grove

Публикации

• 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

Идентификаторы

NCT: NCT05981573 · 1358643

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗