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Набор скоро начнётся NCT06837571

Methadone Dose Monitoring With a Remote Medication Monitor

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

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 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.
Кому может быть актуально
Состояния в реестре: Methadone Toxicity, Methadone Overdose, Pain, Chronic, Drug Metabolism, Poor, CYP2D6-Related. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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.

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.

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

  • 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 Fluorescent Aptamer Switch [Срок оценки: 2 days]
  • Concentration of Methadone in blood with LC-MS versus Fluorescent Aptamer Switch [Срок оценки: 2 days]
  • Pearson Correlation of Methadone between ISF and Blood [Срок оценки: 2 days]
  • Pearson Correlation between Fluoroscopy and LC-MS ISF Methadone [Срок оценки: 2 days]

Критерии участия

Критерии включения

  • 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.

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: NCT06837571 · IRB3RMM

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗