NCT06837571|Not Yet RecruitingFDA Drug
Methadone Dose Monitoring With a Remote Medication Monitor
Assessment of Methadone Dose Taken
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Assessment of Methadone Dose Taken
Sponsor study identifier
observational
30
1 country
1
Study Start
April 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 15, 2025
Actual (reported)February 20, 2025
Actual (reported)April 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Methadone Concentration in ISF before and after a dose
measure dermal interstitial fluid with LC-MS for methadone before and after a daily dose
1 day
Methadone Concentration in blood before and after a dose
measure blood for methadone with LC-MS before and after a daily dose
1 day
Concentration of Methadone in ISF with LC-MS versus Fluorescent Aptamer Switch
measure ISF with two procedures (Liquid Chromatography - Mass Spectroscopy and Fluoroscopy
2 days
AIM 2 : Determine if an RMM can assess the status of taking a prescribed dose of methadone. To complete this aim, the peak and trough concentrations of a witnessed methadone dose will be assessed in dermal ISF collected through the surface of the skin using existing ISF extraction methods and assessed outside the body via with and dermal ISF dialysis tube and external aptamer switch based fiberoptic sensor continuously for 6 hours. Methadone and protein binding factors are independently assessed in the collected ISF samples using (LC-MS and Lateral Flow Assays). We hypothesize that the methadone peak and trough levels in the blood samples will correlate with the levels of methadone in ISF. The Investigators hypothesize that the methadone peak and trough levels in the blood samples will correlate with the levels of methadone in ISF.
AIM 3: Determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time. To complete this aim, the pharmacokinetic profile of a witnessed methadone dose will be assessed in ISF dialysate continuously from the surface of the skin using the RMM for up to 12 hours (Aim 3a) and over 3 days (Aim 3b). Methadone will also be assessed over these three time points in the continuously collected ISF samples using LC-MS and Lateral Flow Assays. The Investigators hypothesize that a clinician can recognize a dose taken from the RMM generated measurements of dialyzed ISF.
Measurement of Methadone and its metabolites in interstitial fluid with Liquid Chromatography - Mass Spectroscopy (LC-MS) and Aptamer based Assay
Patients taking at least 10mg of methadone per day for chronic pain or opioid use disorder,
Synergy
Lemon Grove, California, 91945, United States
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.
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.
interstitial fluid and fingerstick blood
Charmaine Semenluk, MD
Synergy Research Inc.
First Submitted
February 15, 2025
First Posted
February 20, 2025
Study Start
April 26, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2025
Estimated (date passed)Group Integrative Breathwork for Chronic Pain
Concentration of Methadone in blood with LC-MS versus Fluorescent Aptamer Switch
measure blood with two procedures (Liquid Chromatography - Mass Spectroscopy and Fluoroscopy
2 days
Pearson Correlation of Methadone between ISF and Blood
measure blood and ISF methadone with LC-MS and determine pearson correlation
2 days
Pearson Correlation between Fluoroscopy and LC-MS ISF Methadone
measure ISF for methadone by LC-MS and Fluoroscopy and determine Pearson correlation
2 days
Measurement of Methadone and its metabolites in ISF with LC-MS and RMM
Up to 15 minute periods of continuous ISF collection for analysis
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 20, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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