Assessment of Methadone Dose Taken
RecruitingNCT05981573
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Assessment of Methadone Dose Taken
- Conditions
- Methadone Toxicity
- Methadone Overdose
- Pain, Chronic
- Drug Metabolism, Poor, CYP2D6-Related
- Metabolism Medication Toxicity
- Interventions
- Diagnostic test: Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo
- Drug: Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo
- Device: ISF Extraction Device 2
- Sponsor
- Cari Health Inc.
- Start date
- 2024-08-26
- Primary completion
- 2026-03
- Sex
- All
- Age range
- from 18 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05981573