Pain, Chronic Clinical Trial
Official title:
Assessment of Methadone Dose Taken Using Electrochemistry
NCT number | NCT05981573 |
Other study ID # | 1358643 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | September 2024 |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | September 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Synergy | Lemon Grove | California |
Lead Sponsor | Collaborator |
---|---|
Cari Health Inc. |
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Methadone Concentration in blood before and after a dose | measure blood for methadone with LC-MS before and after a daily dose | 1 day | |
Primary | 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 | |
Primary | 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 | |
Primary | Pearson Correlation of Methadone between ISF and Blood | measure blood and ISF methadone with LC-MS and determine pearson correlation | 2 days | |
Primary | Pearson Correlation between DPV and LC-MS ISF Methadone | measure ISF for methadone by LC-MS and DPV and determine Pearson correlation | 2 days | |
Primary | Pearson Correlation between DPV and LC-MS ISF EDDP | measure ISF for EDDP by LC-MS and DPV and determine Pearson correlation | 2 days | |
Primary | Pearson Correlation between DPV and LC-MS blood EDDP | measure blood for EDDP by LC-MS and DPV and determine Pearson correlation | 2 days | |
Primary | 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 | |
Primary | 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 | |
Primary | EMDP concentration in ISF before and after daily dose of methadone | measure EMDP in ISF before and after daily dose of methadone | 1 day | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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