Methadone Dose Monitoring With a Remote Medication Monitor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-26

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Methadone Toxicity Methadone Overdose Pain, Chronic Drug Metabolism, Poor, CYP2D6-Related Metabolism Medication Toxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Visit 1

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.

ISF Extraction Device 2

Intervention Type DEVICE

Up to 15 minute periods of continuous ISF collection for analysis

Visit 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.

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DRUG

Measurement of Methadone and its metabolites in ISF with LC-MS and RMM

ISF Extraction Device 2

Intervention Type DEVICE

Up to 15 minute periods of continuous ISF collection for analysis

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DRUG

ISF Extraction Device 2

Up to 15 minute periods of continuous ISF collection for analysis

Intervention Type DEVICE

Other Intervention Names

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dose taken peak-trough test In vivo Continuous molecular monitoring Ascilion

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No