Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Device: Remote Medication Monitor (RMM) - Prototype
Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
Other Names:
Drug: Daily Methadone Dose
patient takes their prescribed daily dose of methadone
Other Names:
|
| 12 HRS Microneedle electrode array placed into dermis for up to 12 hrs. DPV Scans performed at a frequency of 1-20 per hour. |
Device: Remote Medication Monitor (RMM) - Prototype
Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
Other Names:
Drug: Daily Methadone Dose
patient takes their prescribed daily dose of methadone
Other Names:
|
| 3 Days Microneedle electrode array placed into dermis for up to 3 days. DPV Scans performed at a frequency of 1-20 per hour. |
Device: Remote Medication Monitor (RMM) - Prototype
Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
Other Names:
Drug: Daily Methadone Dose
patient takes their prescribed daily dose of methadone
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Cari Health Inc.
Investigators
- Principal Investigator: Mohammad Bari, MD, Synergy Research Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- IRB005