Study Results
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Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2024-08-26
2026-04-30
Brief Summary
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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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Detailed Description
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In Aim 2, the investigator will determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time, by inserting the intradermal microneedle sensing elements into the subjects' 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 intradermal microneedle sensing elements that are worn continuously on the skin. Completion of Aims 1-2 will require two separate visits.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Visit 2
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.
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
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
ISF Extraction Device 2
Up to 15 minute periods of continuous ISF collection for analysis
Visit 3
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 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
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
ISF Extraction Device 2
Up to 15 minute periods of continuous ISF collection for analysis
Visit 1
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.
ISF Extraction Device 2
Up to 15 minute periods of continuous ISF collection for analysis
Interventions
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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
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
ISF Extraction Device 2
Up to 15 minute periods of continuous ISF collection for analysis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Cari Health Inc.
OTHER
Responsible Party
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Principal Investigators
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Charmaine Semenluk, MD
Role: PRINCIPAL_INVESTIGATOR
Synergy Research Inc.
Locations
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Synergy
Lemon Grove, California, United States
Countries
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Central Contacts
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Facility Contacts
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Woody Woodman
Role: primary
Ryan Woodman
Role: backup
References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Related Links
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Cari Health Website
Kiffik Website
Other Identifiers
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1358643
Identifier Type: -
Identifier Source: org_study_id
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