Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor

August 11, 2023 updated by: Cari Health Inc.
CARI Health aims to develop a methadone dose taken sensor that provides real-time data on interstitial fluid (ISF) levels that could be used as a methadone adherence monitor for daily doses. Use of such a monitor would allow for the physician, counselor, patient, and family member to remotely verify that a physician prescribed dose has been taken. Such a verification system can allow methadone clinics greater flexibility in the provision of take-home doses and thus retain more patients in the clinic.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Three specific phases and 9 aims are proposed for first-in-human studies of a remote medication monitor for dose taken in patients taking methadone for opiate use disorder.

Phase 1 detection over 3-6 hours (N=10)

Aim 1: Detect methadone and one or more of its metabolites in interstitial fluid (ISF) with differential pulse voltammetry (DPV) Aim 2: Correlate in vitro blood-based LC-MS and DPV Scans with Intradermal Microneedle based DPV Scans Aim 3: Accurately identify that a dose of methadone has been taken Aim 4: Determine the frequency and severity of any adverse events up to 6 hours.

Phase 2 detection over 12 hours (N=15)

Aim 5. Quantitate methadone and one or more of its metabolites in ISF with DPV over 12 hrs.

Aim 6: Determine the frequency and severity of any adverse events up to 12 hours

Phase 3 detection over 3 days N=20 ( 15 single dosed subjects, 5 split dosed subjects )

Aim 7. Quantitate methadone and one or more of its metabolites in ISF with DPV over 3 days.

Aim 8. Accurately identify a dose or half a dose has been taken Aim 9: Determine the frequency and severity of any adverse events up to 3 days

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients taking methadone for opioid use disorder

Description

Inclusion criteria for methadone group includes:

Age 18-70. A prescription for liquid methadone at a dose of 10mg or more. Taken methadone as prescribed in the last 2 days. Has been prescribed at least 3 take homes

Exclusion criteria for methadone group includes:

Age <18 or >70. A condition preventing or complicating ISF collection. Conditions may include dermatological (skin) condition, immunodeficiency, bleeding diathesis, recent blood donation, anemia, cancer, congestive heart failure, or tuberculosis. Any active severe depression (e.g., suicidal ideation) or mania symptoms.

Pregnancy, or intending to become pregnant during the course of the study. Patients determined to be unstable for enrollment or take homes by the Outpatient Treatment Program (OTP).

Under a conservatorship.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
3-6 HRS
Microneedle electrode array placed into dermis for up to 6 hours. DPV Scans performed at a frequency of 1-20 per hour.
Device: Remote Medication Monitor (RMM) - Prototype
Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
Other Names:
  • RMM
Drug: Daily Methadone Dose
patient takes their prescribed daily dose of methadone
Other Names:
  • Dose Taken
12 HRS
Microneedle electrode array placed into dermis for up to 12 hrs. DPV Scans performed at a frequency of 1-20 per hour.
Device: Remote Medication Monitor (RMM) - Prototype
Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
Other Names:
  • RMM
Drug: Daily Methadone Dose
patient takes their prescribed daily dose of methadone
Other Names:
  • Dose Taken
3 Days
Microneedle electrode array placed into dermis for up to 3 days. DPV Scans performed at a frequency of 1-20 per hour.
Device: Remote Medication Monitor (RMM) - Prototype
Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
Other Names:
  • RMM
Drug: Daily Methadone Dose
patient takes their prescribed daily dose of methadone
Other Names:
  • Dose Taken

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor
Time Frame: from 3 hours to 3 days.
Sensitivity of Repeated measurements of methadone levels
from 3 hours to 3 days.
Specificity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor
Time Frame: from 3 hours to 3 days.
Specificity of Repeated measurements of methadone levels
from 3 hours to 3 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Liquid Chromatography - Mass Spectroscopy (LC-MS)
Time Frame: from 3 hours to 3 days
Pearson coefficient
from 3 hours to 3 days
Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Remote Medication Monitor
Time Frame: from 3 hours to 3 days
Pearson coefficient
from 3 hours to 3 days
Correlation between Liquid Chromatography - Mass Spectroscopy (LC-MS) and Differential Pulse Voltammetry (DPV)
Time Frame: from 3 hours to 3 days
Pearson Coefficient
from 3 hours to 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cari Health Inc.

Investigators

  • Principal Investigator: Mohammad Bari, MD, Synergy Research Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

August 6, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

August 21, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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