NCT05981573|RecruitingFDA Drug
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Sponsor study identifier
observational
30
1 country
1
Study Start
August 26, 2024
Actual (reported)Primary Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2026
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.
April 2026
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.
July 28, 2023
Actual (reported)August 8, 2023
Actual (reported)August 26, 2024
Actual (reported)March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
LC-MS based Proteome analysis of dermal interstitial fluid in non opioid use disordered patients
Measure the dermal interstitial fluid proteome using LC-MS in subjects without opioid use disorder
1 day
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
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 ISF collected through the surface of the skin using existing ISF extraction methods and assessed outside the body via Lateral Flow Immunoassay for up to 6 hours. Methadone metabolites and protein binding factors may be assessed in the collected ISF samples using (LC-MS). We hypothesize that the methadone peak and trough levels as well as the metabolites in the blood samples will correlate with the levels of methadone in ISF. The Investigators hypothesize that the methadone peak and trough levels as well as the metabolites 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 continuously from the surface of the skin using the RMM for up to 12 hours (Aim 3a) and over 3 days (Aim 3b). Methadone metabolites will also be assessed over these three time points in the continuously collected ISF samples using LC-MS. The Investigators hypothesize that a clinician can recognize a dose taken and the methadone metabolites from the RMM generated measurements in the ISF.
Measurement of Methadone and its metabolites in interstitial fluid with Liquid Chromatography - Mass Spectroscopy (LC-MS) and Aptamer based Assay
Chronic pain patients that have been prescribed at least 10mg of methadone per day.
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
July 28, 2023
First Posted
August 8, 2023
Study Start
August 26, 2024
Actual (reported)Primary Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
VCOM Pain Free Research Collaborative
Concentration of Methadone in ISF with LC-MS versus Electrochemical Assay
measure ISF with two procedures (Liquid Chromatography - Mass Spectroscopy and Differential Pulse Voltammetry.
2 days
Concentration of Methadone in blood with LC-MS versus Electrochemical Assay
measure blood with two procedures (Liquid Chromatography - Mass Spectroscopy and Differential Pulse Voltammetry.
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 DPV and LC-MS ISF Methadone
measure ISF for methadone by LC-MS and DPV and determine Pearson correlation
2 days
Pearson Correlation between DPV and LC-MS ISF EDDP
measure ISF for EDDP by LC-MS and DPV and determine Pearson correlation
2 days
Pearson Correlation between DPV and LC-MS blood EDDP
measure blood for EDDP by LC-MS and DPV and determine Pearson correlation
2 days
EDDP concentration in ISF before and after daily dose of methadone
measure ISF for EDDP by LC-MS before and after daily dose of methadone
1 day
EDDP concentration in blood before and after daily dose of methadone
measure blood for EDDP by LC-MS before and after daily dose of methadone
1 day
EMDP concentration in ISF before and after daily dose of methadone
measure EMDP in ISF before and after daily dose of methadone
1 day
EMDP concentration in blood before and after daily dose of methadone
measure EMDP in blood by LC-MS before and after daily dose of methadone
1 day
Pearson Correlation of Methadone to Metabolite Ratio ( MMR ) between ISF and Blood using LC-MS
Calculate methadone to EDDP ratio of ISF and Blood and determine Pearson Correlation using LC-MS
2 days
Pearson Correlation of Methadone to Metabolite Ratio ( MMR ) between ISF and Blood using DPV
Calculate methadone to EDDP ratio of ISF and Blood and determine Pearson Correlation using DPV
2 days
Aim 1: Characterize dermal interstitial fluid (ISF) in healthy adults with Liquid Chromatography-Mass Spectroscopy (LC-MS) based proteomics. To complete this aim, the dermal interstitial fluid will be extracted from the surface of the skin of healthy adults over a period up to 3 hours. The participants may also have continuous monitoring of their interstitial fluid using the RMM. We hypothesize that the protein content of ISF will be 50% the level of normal human serum levels and contain potential protein biomarkers of disease status.
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.
Contact the study team to confirm eligibility.
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.
Study Completion
April 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 13, 2025
Record last verified: 2025-02
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Source: ClinicalTrials.gov.
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