NCT05998876

Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 45 (estimated)
• Sponsor: Cari Health Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Conditions

• Adherence, Medication
• Opioid Use Disorder

Interventions

Type	Name	Description
DEVICE	Remote Medication Monitor (RMM) - Prototype	Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
DRUG	Daily Methadone Dose	patient takes their prescribed daily dose of methadone

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-05-01
• Completion: 2024-06-01
• First posted: 2023-08-21
• Last updated: 2023-08-21

Regulatory

• FDA-regulated drug study