Recruiting

Methadone

Sponsor:

Cari Health Inc.

Code:

NCT05981573

Conditions

Methadone Toxicity

Methadone Overdose

Pain, Chronic

Drug Metabolism, Poor, CYP2D6-Related

Metabolism Medication Toxicity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo

Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo

ISF Extraction Device 2

Study Details

Brief summary:

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.

Conditions

Methadone Toxicity

Methadone Overdose

Pain, Chronic

Drug Metabolism, Poor, CYP2D6-Related

Metabolism Medication Toxicity

Study ID

NCT05981573

Start date

Aug 26, 2024

Status verified date

Feb, 2025

Completion date

Apr, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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

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

ISF Extraction Device 2

Up to 15 minute periods of continuous ISF collection for analysis

Primary outcome measure

  • LC-MS based Proteome analysis of dermal interstitial fluid in non opioid use disordered patients [ Time Frame: 1 day ]
  • Methadone Concentration in ISF before and after a dose [ Time Frame: 1 day ]
  • Methadone Concentration in blood before and after a dose [ Time Frame: 1 day ]
  • Concentration of Methadone in ISF with LC-MS versus Electrochemical Assay [ Time Frame: 2 days ]
  • Concentration of Methadone in blood with LC-MS versus Electrochemical Assay [ Time Frame: 2 days ]
  • Pearson Correlation of Methadone between ISF and Blood [ Time Frame: 2 days ]
  • Pearson Correlation between DPV and LC-MS ISF Methadone [ Time Frame: 2 days ]
  • Pearson Correlation between DPV and LC-MS ISF EDDP [ Time Frame: 2 days ]
  • Pearson Correlation between DPV and LC-MS blood EDDP [ Time Frame: 2 days ]
  • EDDP concentration in ISF before and after daily dose of methadone [ Time Frame: 1 day ]
  • EDDP concentration in blood before and after daily dose of methadone [ Time Frame: 1 day ]
  • EMDP concentration in ISF before and after daily dose of methadone [ Time Frame: 1 day ]
  • EMDP concentration in blood before and after daily dose of methadone [ Time Frame: 1 day ]
  • Pearson Correlation of Methadone to Metabolite Ratio ( MMR ) between ISF and Blood using LC-MS [ Time Frame: 2 days ]
  • Pearson Correlation of Methadone to Metabolite Ratio ( MMR ) between ISF and Blood using DPV [ Time Frame: 2 days ]

Central Contacts and Locations

Central contacts

Foster P Carr, MD

6192343725drcarr@carihealth.com

Torsten Feibig, PhD

torsten@carihealth.com

Locations

Synergy

Recruiting

Lemon Grove, California, United States, 91945

Principal Investigator:

Charmaine Semenluk, MD

More Information

Sponsor

Cari Health Inc.

Last update posted

Feb 13, 2025

Last verified

Feb, 2025

Keywords

  • Pharmacokinetics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cari Health Inc. on 2025-02-13.