Opioid Use Disorder Clinical Trial
Official title:
Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor
NCT number | NCT05998876 |
Other study ID # | IRB005 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 2024 |
Est. completion date | June 2024 |
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.
Status | Not yet recruiting |
Enrollment | 45 |
Est. completion date | June 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Cari Health Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Liquid Chromatography - Mass Spectroscopy (LC-MS) | Pearson coefficient | from 3 hours to 3 days | |
Secondary | Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Remote Medication Monitor | Pearson coefficient | from 3 hours to 3 days | |
Secondary | Correlation between Liquid Chromatography - Mass Spectroscopy (LC-MS) and Differential Pulse Voltammetry (DPV) | Pearson Coefficient | from 3 hours to 3 days |
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