Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor
- Conditions
- Opioid Use DisorderAdherence, Medication
- Interventions
- Device: Remote Medication Monitor (RMM) - PrototypeDrug: Daily Methadone Dose
- Registration Number
- NCT05998876
- Lead Sponsor
- Cari Health Inc.
- 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
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 45
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 12 HRS Daily Methadone Dose Microneedle electrode array placed into dermis for up to 12 hrs. DPV Scans performed at a frequency of 1-20 per hour. 3-6 HRS Remote Medication Monitor (RMM) - Prototype Microneedle electrode array placed into dermis for up to 6 hours. DPV Scans performed at a frequency of 1-20 per hour. 3 Days Daily Methadone Dose Microneedle electrode array placed into dermis for up to 3 days. DPV Scans performed at a frequency of 1-20 per hour. 12 HRS Remote Medication Monitor (RMM) - Prototype Microneedle electrode array placed into dermis for up to 12 hrs. DPV Scans performed at a frequency of 1-20 per hour. 3-6 HRS Daily Methadone Dose Microneedle electrode array placed into dermis for up to 6 hours. DPV Scans performed at a frequency of 1-20 per hour. 3 Days Remote Medication Monitor (RMM) - Prototype Microneedle electrode array placed into dermis for up to 3 days. DPV Scans performed at a frequency of 1-20 per hour.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Correlation between Liquid Chromatography - Mass Spectroscopy (LC-MS) and Differential Pulse Voltammetry (DPV) 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 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