Clinical trial NCT05998876: Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor
Official title: Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Adherence, Medication
Opioid Use Disorder
Keywords: Pharmacokinetics
Differential Pulse Voltammetry
Remote Medication Monitor
Interstitial Fluid
Lead sponsor: Cari Health Inc.
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients taking methadone for opioid use disorder

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

Eligibility 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.

Primary outcomes:
measure: Sensitivity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor
timeFrame: from 3 hours to 3 days.
measure: Specificity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor
timeFrame: from 3 hours to 3 days.
Secondary outcomes:
measure: Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Liquid Chromatography - Mass Spectroscopy (LC-MS)
timeFrame: from 3 hours to 3 days
measure: Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Remote Medication Monitor
timeFrame: from 3 hours to 3 days
measure: Correlation between Liquid Chromatography - Mass Spectroscopy (LC-MS) and Differential Pulse Voltammetry (DPV)
timeFrame: from 3 hours to 3 days
Other outcomes:
Locations:
Study officials:
affiliation: Synergy Research Inc.
name: Mohammad Bari, MD
role: PRINCIPAL_INVESTIGATOR
References: