Assessment of Methadone Dose Taken

February 11, 2025 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 Continuous Monitor.

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.

Study Type

Observational

Enrollment (Estimated)

30

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:
          • Charmaine Semenluk, 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 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.
Device: ISF Extraction Device 2
Up to 15 minute periods of continuous ISF collection for analysis
Other Names:
  • Ascilion
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 Aptamer based Assay
Other Names:
  • dose taken peak-trough test
Drug: 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
Other Names:
  • In vivo Continuous molecular monitoring
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.
Device: ISF Extraction Device 2
Up to 15 minute periods of continuous ISF collection for analysis
Other Names:
  • Ascilion
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 Aptamer based Assay
Other Names:
  • dose taken peak-trough test
Drug: 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
Other Names:
  • In vivo Continuous molecular monitoring
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.
Device: ISF Extraction Device 2
Up to 15 minute periods of continuous ISF collection for analysis
Other Names:
  • Ascilion

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
LC-MS based Proteome analysis of dermal interstitial fluid in non opioid use disordered patients
Time Frame: 1 day
Measure the dermal interstitial fluid proteome using LC-MS in subjects without opioid use disorder
1 day

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: Charmaine Semenluk, 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 (Actual)

August 26, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

April 1, 2026

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)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

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.

Clinical Trials on Pain, Chronic

Clinical Trials on ISF Extraction Device 2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe