NCT05998876|UnknownFDA Drug
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Sponsor study identifier
observational
45
0 countries
N/A
Study Start
February 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 6, 2023
Actual (reported)August 21, 2023
Actual (reported)February 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Sensitivity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor
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
Specificity of Repeated measurements of methadone levels
from 3 hours to 3 days.
Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Liquid Chromatography - Mass Spectroscopy (LC-MS)
from 3 hours to 3 days
Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Remote Medication Monitor
from 3 hours to 3 days
Correlation between Liquid Chromatography - Mass Spectroscopy (LC-MS) and Differential Pulse Voltammetry (DPV)
from 3 hours to 3 days
Microneedle electrode array placed into dermis for up to 6 hours. DPV Scans performed at a frequency of 1-20 per hour.
Microneedle electrode array placed into dermis for up to 12 hrs. DPV Scans performed at a frequency of 1-20 per hour.
Microneedle electrode array placed into dermis for up to 3 days. DPV Scans performed at a frequency of 1-20 per hour.
Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
Patients taking methadone for opioid use disorder
Mohammad Bari, MD
Synergy Research Inc.
First Submitted
August 6, 2023
First Posted
August 21, 2023
Study Start
February 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 2024
Estimated (date passed)Divided or Single Exposure (DOSE) Study
patient takes their prescribed daily dose of methadone
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 21, 2023
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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