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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.
The investigator will conduct a non-randomized, non-blinded, feasibility study at a single center in the United States. The study will include up to 20 subjects of an equal number of male and female adults (ages 18-70) who have a prescription for methadone.
In Aim 1, the investigators will determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time, by inserting the dermal ISF sensing elements into the subjects' abdominal 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 dermal ISF dialysis fluid sampling using an external fiberoptic sensor system that is worn continuously on the abdomen similar to continuous glucose monitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visit 1 | 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. |
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| Visit 2 | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo | Diagnostic Test | Measurement of Methadone and its metabolites in interstitial fluid with Liquid Chromatography - Mass Spectroscopy (LC-MS) and Aptamer based Assay |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients taking at least 10mg of methadone per day for chronic pain or opioid use disorder,
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Foster P Carr, MD | Contact | 6192343725 | drcarr@carihealth.com |
| Name | Affiliation | Role |
|---|---|---|
| Charmaine Semenluk, MD | Synergy Research Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synergy | Lemon Grove | California | 91945 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37395135 | Background | 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. | |
| 36642790 | Background | 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. |
| Label | URL |
|---|---|
| Cari Health Website | View source |
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interstitial fluid and fingerstick blood
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| Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo | Drug | Measurement of Methadone and its metabolites in ISF with LC-MS and RMM |
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| ISF Extraction Device 2 | Device | Up to 15 minute periods of continuous ISF collection for analysis |
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| 36748807 | Background | 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. |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| C563835 | Drug Metabolism, Poor, CYP2D6-Related |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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