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

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05998876
• Other study ID #: IRB005
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Cari Health Inc.
• Contact: Foster P Carr, MD
• Phone: 6192343725
• Email: drcarr[@]carihealth.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adherence, Medication
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cari Health Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor	Sensitivity of Repeated measurements of methadone levels	from 3 hours to 3 days.
Primary	Specificity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor	Specificity of Repeated measurements of methadone levels	from 3 hours to 3 days.
Secondary	Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Liquid Chromatography - Mass Spectroscopy (LC-MS)	Pearson coefficient	from 3 hours to 3 days
Secondary	Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Remote Medication Monitor	Pearson coefficient	from 3 hours to 3 days
Secondary	Correlation between Liquid Chromatography - Mass Spectroscopy (LC-MS) and Differential Pulse Voltammetry (DPV)	Pearson Coefficient	from 3 hours to 3 days

External Links

•   Cari Health Website