Methadone Dose Monitoring With a Remote Medication Monitor

Not yet recruiting

• Conditions: Methadone Toxicity; Methadone Overdose; Pain, Chronic; Drug Metabolism, Poor, CYP2D6-Related; Metabolism Medication Toxicity
• Interventions: Device: ISF Extraction Device 2; Diagnostic Test: Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo; Drug: Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo

• Registration Number: NCT06837571
• Lead Sponsor: Cari Health Inc.

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.

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.

In Aim 1, the investigators will determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time, by inserting the dermal ISF sensing elements into the subjects' abdominal 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 dermal ISF dialysis fluid sampling using an external fiberoptic sensor system that is worn continuously on the abdomen similar to continuous glucose monitors.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-15
• Study First Submitted QC: 2025-02-15
• Last Update Submitted: 2025-02-15
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Study Start: 2025-04-26
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age 18-70
• A prescription for methadone 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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Visit 1	ISF Extraction Device 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 dermal ISF collected through the surface of the skin using existing ISF extraction methods and assessed outside the body via with and dermal ISF dialysis tube and external aptamer switch based fiberoptic sensor continuously for 6 hours. Methadone and protein binding factors are independently assessed in the collected ISF samples using (LC-MS and Lateral Flow Assays). We hypothesize that the methadone peak and trough levels in the blood samples will correlate with the levels of methadone in ISF. The Investigators hypothesize that the methadone peak and trough levels in the blood samples will correlate with the levels of methadone in ISF.
Visit 2	Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo	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 dialysate continuously from the surface of the skin using the RMM for up to 12 hours (Aim 3a) and over 3 days (Aim 3b). Methadone will also be assessed over these three time points in the continuously collected ISF samples using LC-MS and Lateral Flow Assays. The Investigators hypothesize that a clinician can recognize a dose taken from the RMM generated measurements of dialyzed ISF.
Visit 2	Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo	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 dialysate continuously from the surface of the skin using the RMM for up to 12 hours (Aim 3a) and over 3 days (Aim 3b). Methadone will also be assessed over these three time points in the continuously collected ISF samples using LC-MS and Lateral Flow Assays. The Investigators hypothesize that a clinician can recognize a dose taken from the RMM generated measurements of dialyzed ISF.
Visit 2	ISF Extraction Device 2	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 dialysate continuously from the surface of the skin using the RMM for up to 12 hours (Aim 3a) and over 3 days (Aim 3b). Methadone will also be assessed over these three time points in the continuously collected ISF samples using LC-MS and Lateral Flow Assays. The Investigators hypothesize that a clinician can recognize a dose taken from the RMM generated measurements of dialyzed ISF.

Primary Outcome Measures

Name	Time	Method
Methadone Concentration in ISF before and after a dose	1 day	measure dermal interstitial fluid with LC-MS for methadone before and after a daily dose
Methadone Concentration in blood before and after a dose	1 day	measure blood for methadone with LC-MS before and after a daily dose
Concentration of Methadone in ISF with LC-MS versus Fluorescent Aptamer Switch	2 days	measure ISF with two procedures (Liquid Chromatography - Mass Spectroscopy and Fluoroscopy
Concentration of Methadone in blood with LC-MS versus Fluorescent Aptamer Switch	2 days	measure blood with two procedures (Liquid Chromatography - Mass Spectroscopy and Fluoroscopy
Pearson Correlation of Methadone between ISF and Blood	2 days	measure blood and ISF methadone with LC-MS and determine pearson correlation
Pearson Correlation between Fluoroscopy and LC-MS ISF Methadone	2 days	measure ISF for methadone by LC-MS and Fluoroscopy and determine Pearson correlation

Trial Locations

Locations (1)

Synergy; 🇺🇸 Lemon Grove, California, United States