Methadone Dose Monitoring With a Remote Medication Monitor

NCT06837571 | Not Yet Recruiting FDA Drug

• 1 other identifier: IRB3RMM
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (6)

• Methadone Concentration in ISF before and after a dose

  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

  measure blood for methadone with LC-MS before and after a daily dose

  1 day

• Concentration of Methadone in ISF with LC-MS versus Fluorescent Aptamer Switch

  measure ISF with two procedures (Liquid Chromatography - Mass Spectroscopy and Fluoroscopy

  2 days

• Concentration of Methadone in blood with LC-MS versus Fluorescent Aptamer Switch

  measure blood with two procedures (Liquid Chromatography - Mass Spectroscopy and Fluoroscopy

  2 days

• Pearson Correlation of Methadone between ISF and Blood

  measure blood and ISF methadone with LC-MS and determine pearson correlation

  2 days

• Pearson Correlation between Fluoroscopy and LC-MS ISF Methadone

  measure ISF for methadone by LC-MS and Fluoroscopy and determine Pearson correlation

  2 days

Study Arms (2)

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.

Device: ISF Extraction Device 2

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.

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; Device: ISF Extraction Device 2

Interventions

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

Measurement of Methadone and its metabolites in interstitial fluid with Liquid Chromatography - Mass Spectroscopy (LC-MS) and Aptamer based Assay

Also known as: dose taken peak-trough test

Visit 2

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

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

Also known as: In vivo Continuous molecular monitoring

Visit 2

ISF Extraction Device 2 DEVICE

Up to 15 minute periods of continuous ISF collection for analysis

Also known as: Ascilion

Visit 1; Visit 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients taking at least 10mg of methadone per day for chronic pain or opioid use disorder,

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cari Health Inc.: lead

Study Sites (1)

Synergy

Lemon Grove, California, 91945, United States

Location

Related Publications (3)

• Friedel M, Werbovetz B, Drexelius A, Watkins Z, Bali A, Plaxco KW, Heikenfeld J. Continuous molecular monitoring of human dermal interstitial fluid with microneedle-enabled electrochemical aptamer sensors. Lab Chip. 2023 Jul 12;23(14):3289-3299. doi: 10.1039/d3lc00210a.

  PMID: 37395135 BACKGROUND

• Gomes NO, Raymundo-Pereira PA. On-Site Therapeutic Drug Monitoring of Paracetamol Analgesic in Non-Invasively Collected Saliva for Personalized Medicine. Small. 2023 Mar;19(12):e2206753. doi: 10.1002/smll.202206753. Epub 2023 Jan 15.

  PMID: 36642790 BACKGROUND

• Ribet F, Bendes A, Fredolini C, Dobielewski M, Bottcher M, Beck O, Schwenk JM, Stemme G, Roxhed N. Microneedle Patch for Painless Intradermal Collection of Interstitial Fluid Enabling Multianalyte Measurement of Small Molecules, SARS-CoV-2 Antibodies, and Protein Profiling. Adv Healthc Mater. 2023 May;12(13):e2202564. doi: 10.1002/adhm.202202564. Epub 2023 Feb 21.

  PMID: 36748807 BACKGROUND

Related Links

• Cari Health Website

Biospecimen

Retention: SAMPLES WITHOUT DNA

interstitial fluid and fingerstick blood

MeSH Terms

Conditions

Chronic Pain; Drug Metabolism, Poor, CYP2D6-Related

Interventions

Methadone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals

Study Officials

• Charmaine Semenluk, MD

  Synergy Research Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Foster P Carr, MD

CONTACT

6192343725; drcarr@carihealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 20, 2025
• Study Start: April 26, 2025
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)