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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at below P25 for all trials

Timeline

Completed

Started Aug 2024

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

First Submitted

Initial submission to the registry

July 28, 2023

Completed

11 days until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed

1.1 years until next milestone

Study Start

First participant enrolled

August 26, 2024

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed

Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

1.5 years

First QC Date

July 28, 2023

Last Update Submit

February 11, 2025

Conditions

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

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (15)

LC-MS based Proteome analysis of dermal interstitial fluid in non opioid use disordered patients
Measure the dermal interstitial fluid proteome using LC-MS in subjects without opioid use disorder
1 day
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 Electrochemical Assay
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
measure blood with two procedures (Liquid Chromatography - Mass Spectroscopy and Differential Pulse Voltammetry.
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 DPV and LC-MS ISF Methadone
measure ISF for methadone by LC-MS and DPV and determine Pearson correlation
2 days
Pearson Correlation between DPV and LC-MS ISF EDDP
measure ISF for EDDP by LC-MS and DPV and determine Pearson correlation
2 days
Pearson Correlation between DPV and LC-MS blood EDDP
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
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
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
measure EMDP in ISF before and after daily dose of methadone
1 day
EMDP concentration in blood before and after daily dose of methadone
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
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
Calculate methadone to EDDP ratio of ISF and Blood and determine Pearson Correlation using DPV
2 days

Study Arms (3)

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.

Diagnostic Test: Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivoDrug: Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivoDevice: ISF Extraction Device 2

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.

Device: ISF Extraction Device 2

Interventions

Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivoDIAGNOSTIC_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 2Visit 3

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

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

Also known as: In vivo Continuous molecular monitoring

Visit 2Visit 3

ISF Extraction Device 2DEVICE

Up to 15 minute periods of continuous ISF collection for analysis

Also known as: Ascilion

Visit 1Visit 2Visit 3

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Chronic pain patients that have been prescribed at least 10mg of methadone per day.

You may qualify if:

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.

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
+4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Cari Health Inc.lead

Study Sites (1)

Synergy

Lemon Grove, California, 91945, United States

RECRUITING

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: 37395135BACKGROUND
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: 36642790BACKGROUND
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: 36748807BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

interstitial fluid and fingerstick blood

MeSH Terms

Conditions

Chronic PainDrug Metabolism, Poor, CYP2D6-Related

Interventions

Methadone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

KetonesOrganic Chemicals

Study Officials

Charmaine Semenluk, MD
Synergy Research Inc.
PRINCIPAL INVESTIGATOR

Central Study Contacts

Foster P Carr, MD

CONTACT

6192343725 drcarr@carihealth.com

Torsten Feibig, PhD

CONTACT

torsten@carihealth.com

Study Design

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

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 8, 2023

Study Start

August 26, 2024

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

February 13, 2025

Record last verified: 2025-02

Locations

US(1)

Assessment of Methadone Dose Taken

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (15)

Study Arms (3)

Visit 2

Visit 3

Visit 1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

Related Links

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (15)

Study Arms (3)

Visit 2

Visit 3

Visit 1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

Related Links

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations