Continuous molecular monitoring of human dermal interstitial fluid with microneedle-enabled electrochemical aptamer sensors.
Mark Friedel, Benjamin Werbovetz, Amy Drexelius...
https://pubmed.ncbi.nlm.nih.gov/37395135Actively Recruiting
Age: 18Years - 70Years
All Genders
ID05981573
Assessment of Methadone Dose Taken Using a Remote Medication Monitor in Adults With Chronic Pain
Led by Cari Health Inc. · Updated on 2025-02-13
30
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a pilot observational study to develop a minimally invasive wearable Remote Medication Monitor (RMM) that continuously and in real time measures methadone levels in the interstitial fluid (ISF). This study aims to evaluate whether such a device can monitor medication adherence by showing if prescribed methadone doses have been taken. The study involves adults aged 18 to 70 who are prescribed methadone for chronic pain. The study consists of multiple aims involving biosample collection and pharmacokinetic monitoring. In Aim 1, biosamples of ISF and blood will be collected over up to 6 hours to assess if the RMM can detect methadone dose timing using ex vivo methods. Aim 2 involves inserting intradermal microneedle sensors into the skin to continuously monitor methadone levels via the RMM over 6 hours. Later aims include longer monitoring periods of up to 3 days to observe methadone and its metabolites in ISF. Participants will attend up to three visits involving ISF and blood sample collections, wearing the RMM device, and pharmacokinetic monitoring. Researchers will analyze methadone concentrations and metabolite levels using advanced laboratory techniques such as Liquid Chromatography-Mass Spectroscopy. The primary outcomes include correlations between methadone measurements in ISF and blood to evaluate the device's monitoring capabilities. The study is expected to run until April 2026.
CONDITIONS
Brief Title
Assessment of Methadone Dose Taken
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- 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
You will not qualify if you...
- Age younger than 18 or older than 70 years
- Any condition preventing or complicating interstitial fluid collection
- Any skin (dermatological) condition
- Immunodeficiency
- Recent blood donation
- Anemia
- End stage renal disease
- Liver cirrhosis
- Cancer
- Congestive heart failure
- Bleeding disorder
- Tuberculosis (TB)
- Any active severe depression
- Suicidal thoughts
- Mania symptoms
- Pregnancy or intending to become pregnant during the study
- Enrolled in a substance use disorder treatment program
- Under a conservatorship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Diagnostic Evaluation
Duration - Up to 3 hours per visit
Participants have dermal interstitial fluid extracted and analyzed using proteomics and other laboratory techniques over a period of up to 3 hours to characterize the fluid.
1 visit
Monitoring
Duration - Up to 6 hours per visit
Participants undergo biosample collections and pharmacokinetic monitoring over up to 6 consecutive hours to assess methadone concentrations before and after a dose using remote medication monitoring and laboratory analysis.
2 separate visits
Long-term Monitoring
Duration - Up to 3 days
Participants wear intradermal microneedle sensing devices continuously on the skin for up to 3 days to assess methadone pharmacokinetics over time with ongoing biosample collections.
1 extended visit with continuous monitoring
Trial Site Locations
Total: 1 location
1
Synergy
Lemon Grove, California, United States, 91945
Actively Recruiting
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Research Team
F
Foster P Carr, MD
T
Torsten Feibig, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
On-Site Therapeutic Drug Monitoring of Paracetamol Analgesic in Non-Invasively Collected Saliva for Personalized Medicine.
Nathalia O Gomes, Paulo A Raymundo-Pereira
https://pubmed.ncbi.nlm.nih.gov/36642790Microneedle Patch for Painless Intradermal Collection of Interstitial Fluid Enabling Multianalyte Measurement of Small Molecules, SARS-CoV-2 Antibodies, and Protein Profiling.
Federico Ribet, Annika Bendes, Claudia Fredolini...
https://pubmed.ncbi.nlm.nih.gov/36748807