Adherence, Medication, Opioid Use Disorder
Conditions
Keywords
Pharmacokinetics, Differential Pulse Voltammetry, Remote Medication Monitor, Interstitial Fluid
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.
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
Interventions
DEVICERemote Medication Monitor (RMM) - Prototype
Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
DRUGDaily Methadone Dose
patient takes their prescribed daily dose of methadone
Sponsors
Cari Health Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor | from 3 hours to 3 days. | Sensitivity of Repeated measurements of methadone levels |
| Specificity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor | from 3 hours to 3 days. | Specificity of Repeated measurements of methadone levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Pearson coefficient |
| Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Remote Medication Monitor | from 3 hours to 3 days | Pearson coefficient |
| Correlation between Liquid Chromatography - Mass Spectroscopy (LC-MS) and Differential Pulse Voltammetry (DPV) | from 3 hours to 3 days | Pearson Coefficient |
Contacts
Primary ContactFoster P Carr, MD
Backup ContactPatrik Schmidle
Outcome results
None listed