Assessment of Methadone Dose Taken Using Electrochemistry

February 8, 2024 updated by: Cari Health Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 for chronic pain. In Aim 1, the investigator will determine if an RMM can assess the status of taking a prescribed dose of methadone, using biosamples (i.e., ISF, blood) collected from subjects and tested in a laboratory setup. Biosample collections and pharmacokinetic monitoring will take up to 6 consecutive hours. By completing this aim, the investigator will determine if a physician is able to recognize the peak and trough of a methadone dose using ex vivo Differential Pulse Voltammetry (DPV).

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. The electronics for the RMM prototypes will consist of commercially available benchtop potentiostats like the PalmSens Sensit BT (https://www.palmsens.com/product/palmsens4/) or CH Instruments 660D (https://www.chinstruments.com/) and will not be in direct contact with the 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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Lemon Grove, California, United States, 91945
        • Recruiting
        • Synergy
        • Contact:
          • Woody Woodman
        • Contact:
          • Ryan Woodman
        • Principal Investigator:
          • Mohammad Bari, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Chronic pain patients that have been prescribed at least 10mg of methadone per day.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Visit Day 1
AIM 1 : 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 differential pulse voltammetry (DPV). We hypothesize that the peak and trough blood samples will correlate with the level of methadone in collected ISF.
Device: ISF extraction device 1
FDA approved microneedle attached to blotter paper tested for ability to extract 1ul of interstitial fluid
Other Names:
  • Samplimy
Diagnostic test: 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 Electrochemical Assay
Other Names:
  • dose taken peak-trough test
Drug: Measurement of Methadone in ISF before and after taking prescribed dose
Measurement of methadone in ISF using DPV ex vivo versus in vivo . (Accuracy comparison - sensitivity, specificity, level of detection, and standard deviations )
Other Names:
  • Comparing in vitro and in vivo approaches to determining a dose taken
Visit Day 2
AIM 2 : 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 6 hours. We hypothesize that a clinician can recognize a dose taken from the continuous and real-time RMM measurements made in live ISF.
Device: ISF extraction device 1
FDA approved microneedle attached to blotter paper tested for ability to extract 1ul of interstitial fluid
Other Names:
  • Samplimy
Drug: Measurement of Methadone in ISF before and after taking prescribed dose
Measurement of methadone in ISF using DPV ex vivo versus in vivo . (Accuracy comparison - sensitivity, specificity, level of detection, and standard deviations )
Other Names:
  • Comparing in vitro and in vivo approaches to determining a dose taken
Device: 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 DPV
Other Names:
  • In vivo Differential Pulse Voltammetery ( DPV )
Device: ISF Extraction Device 2
2 hour periods of continuous ISF collection for analysis
Other Names:
  • Kiffik

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Methadone Concentration in ISF before and after a dose
Time Frame: 1 day
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
Time Frame: 1 day
measure blood for methadone with LC-MS before and after a daily dose
1 day
Concentration of Methadone in ISF with LC-MS versus Electrochemical Assay
Time Frame: 2 days
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
Time Frame: 2 days
measure blood with two procedures (Liquid Chromatography - Mass Spectroscopy and Differential Pulse Voltammetry.
2 days
Pearson Correlation of Methadone between ISF and Blood
Time Frame: 2 days
measure blood and ISF methadone with LC-MS and determine pearson correlation
2 days
Pearson Correlation between DPV and LC-MS ISF Methadone
Time Frame: 2 days
measure ISF for methadone by LC-MS and DPV and determine Pearson correlation
2 days
Pearson Correlation between DPV and LC-MS ISF EDDP
Time Frame: 2 days
measure ISF for EDDP by LC-MS and DPV and determine Pearson correlation
2 days
Pearson Correlation between DPV and LC-MS blood EDDP
Time Frame: 2 days
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
Time Frame: 1 day
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
Time Frame: 1 day
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
Time Frame: 1 day
measure EMDP in ISF before and after daily dose of methadone
1 day
EMDP concentration in blood before and after daily dose of methadone
Time Frame: 1 day
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
Time Frame: 2 days
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
Time Frame: 2 days
Calculate methadone to EDDP ratio of ISF and Blood and determine Pearson Correlation using DPV
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cari Health Inc.

Collaborators

Samplimy Medical AB

Investigators

  • Principal Investigator: Mohammad Bari, MD, Synergy Research Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

July 31, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1358643

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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