Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor
1 other identifier
observational
45
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2024
Shorter than P25 for all trials
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
First Submitted
Initial submission to the registry
August 6, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedAugust 21, 2023
August 1, 2023
3 months
August 6, 2023
August 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Secondary Outcomes (3)
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
Study Arms (3)
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.
12 HRS
Microneedle electrode array placed into dermis for up to 12 hrs. DPV Scans performed at a frequency of 1-20 per hour.
3 Days
Microneedle electrode array placed into dermis for up to 3 days. DPV Scans performed at a frequency of 1-20 per hour.
Interventions
Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
patient takes their prescribed daily dose of methadone
Eligibility Criteria
Patients taking methadone for opioid use disorder
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cari Health Inc.lead
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohammad Bari, MD
Synergy Research Inc.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2023
First Posted
August 21, 2023
Study Start
February 1, 2024
Primary Completion
May 1, 2024
Study Completion
June 1, 2024
Last Updated
August 21, 2023
Record last verified: 2023-08