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Assessment of Methadone Dose Taken

Recruitingn/aAges 18 Years - 70 YearsAllCari Health Inc.
NCT05981573 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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.
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What it tests

  • 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
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Where

1 site
Synergy
Lemon Grove, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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