Adherence, MedicationNCT05998876
Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor
An observational study of Adherence, Medication and Opioid Use Disorder, run by Cari Health Inc..
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Adherence, Medication, Opioid Use Disorder
- What is being tested?
- Remote Medication Monitor (RMM) - Prototype and Daily Methadone Dose
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients taking methadone for opioid use disorder
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Patrik Schmidle contact
About this study
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.
Read the 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
- Being tested
- Remote Medication Monitor (RMM) - Prototype, Daily Methadone Dose
- Keywords
- Pharmacokinetics, Differential Pulse Voltammetry, Remote Medication Monitor, Interstitial Fluid
- Medical subject headings
- Medication Adherence, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Medication Monitor (RMM) - PrototypeDevice
Also called RMM
Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
Daily Methadone DoseDrug
Also called Dose Taken
patient takes their prescribed daily dose of methadone
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Remote Medication Monitor (RMM) - Prototype; Drug: Daily Methadone Dose | |
| 12 HRS | Microneedle electrode array placed into dermis for up to 12 hrs. DPV Scans performed at a frequency of 1-20 per hour. Receives: Device: Remote Medication Monitor (RMM) - Prototype; Drug: Daily Methadone Dose | |
| 3 Days | Microneedle electrode array placed into dermis for up to 3 days. DPV Scans performed at a frequency of 1-20 per hour. Receives: Device: Remote Medication Monitor (RMM) - Prototype; Drug: Daily Methadone Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor
Sensitivity of Repeated measurements of methadone levels
Measured: from 3 hours to 3 days.
Specificity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor
Specificity of Repeated measurements of methadone levels
Measured: from 3 hours to 3 days.
Secondary outcomes (3)
Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Liquid Chromatography - Mass Spectroscopy (LC-MS)
Pearson coefficient
Measured: from 3 hours to 3 days
Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Remote Medication Monitor
Pearson coefficient
Measured: from 3 hours to 3 days
Correlation between Liquid Chromatography - Mass Spectroscopy (LC-MS) and Differential Pulse Voltammetry (DPV)
Pearson Coefficient
Measured: from 3 hours to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study startFeb 2024 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, MedicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cari Health Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Bari, MD, Principal investigator, Synergy Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998876
- Sponsor's protocol ID
- IRB005
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor
- ClinicalTrials.gov ID
- NCT05998876
- Acronym / sponsor ID
- IRB005
- Conditions
- Adherence, Medication, Opioid Use Disorder
- Keywords
- Pharmacokinetics, Differential Pulse Voltammetry, Remote Medication Monitor, Interstitial Fluid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cari Health Inc.University, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3-6 HRS | – | Device: Remote Medication Monitor (RMM) - Prototype, Drug: Daily Methadone DoseMicroneedle electrode array placed into dermis for up to 6 hours. DPV Scans performed at a frequency of 1-20 per hour. |
| 12 HRS | – | Device: Remote Medication Monitor (RMM) - Prototype, Drug: Daily Methadone DoseMicroneedle electrode array placed into dermis for up to 12 hrs. DPV Scans performed at a frequency of 1-20 per hour. |
| 3 Days | – | Device: Remote Medication Monitor (RMM) - Prototype, Drug: Daily Methadone DoseMicroneedle electrode array placed into dermis for up to 3 days. DPV Scans performed at a frequency of 1-20 per hour. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients taking methadone for opioid use disorder
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Medication Monitor (RMM) - PrototypeAlso: RMMInserted Microneedle Electrode Array for assaying dermal interstitial fluid. | Device | 12 HRS, 3 Days, 3-6 HRS |
| Daily Methadone DoseAlso: Dose Takenpatient takes their prescribed daily dose of methadone | Drug | 12 HRS, 3 Days, 3-6 HRS |
Primary outcome
Sensitivity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor
Time frame: 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
Time frame: from 3 hours to 3 days.
Specificity of Repeated measurements of methadone levels
3 secondary outcomes
Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Liquid Chromatography - Mass Spectroscopy (LC-MS)
Time frame: from 3 hours to 3 days
Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Remote Medication Monitor
Time frame: from 3 hours to 3 days
Correlation between Liquid Chromatography - Mass Spectroscopy (LC-MS) and Differential Pulse Voltammetry (DPV)
Time frame: from 3 hours to 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Cari Health WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrik Schmidle contact
Mohammad Bari, MD principal investigator
Synergy Research Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Adherence, Medication and Opioid Use Disorder, run by Cari Health Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Foster P Carr, MD (6192343725, drcarr@carihealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor (time frame: from 3 hours to 3 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.