xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05998876</url>
    </required_header>
    <id_info>
      <org_study_id>IRB005</org_study_id>
      <nct_id>NCT05998876</nct_id>
    </id_info>
    <brief_title>Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor</brief_title>
    <official_title>Assessing Dose Taken in Opioid Use Disordered Patients With an Electrochemical Sensor</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cari Health Inc.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cari Health Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        CARI Health aims to develop a methadone dose taken sensor that provides real-time data on&#xD;
        interstitial fluid (ISF) levels that could be used as a methadone adherence monitor for daily&#xD;
        doses. Use of such a monitor would allow for the physician, counselor, patient, and family&#xD;
        member to remotely verify that a physician prescribed dose has been taken. Such a&#xD;
        verification system can allow methadone clinics greater flexibility in the provision of&#xD;
        take-home doses and thus retain more patients in the clinic.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Three specific phases and 9 aims are proposed for first-in-human studies of a remote&#xD;
        medication monitor for dose taken in patients taking methadone for opiate use disorder.&#xD;
  &#xD;
        Phase 1 detection over 3-6 hours (N=10)&#xD;
  &#xD;
        Aim 1: Detect methadone and one or more of its metabolites in interstitial fluid (ISF) with&#xD;
        differential pulse voltammetry (DPV) Aim 2: Correlate in vitro blood-based LC-MS and DPV&#xD;
        Scans with Intradermal Microneedle based DPV Scans Aim 3: Accurately identify that a dose of&#xD;
        methadone has been taken Aim 4: Determine the frequency and severity of any adverse events up&#xD;
        to 6 hours.&#xD;
  &#xD;
        Phase 2 detection over 12 hours (N=15)&#xD;
  &#xD;
        Aim 5. Quantitate methadone and one or more of its metabolites in ISF with DPV over 12 hrs.&#xD;
  &#xD;
        Aim 6: Determine the frequency and severity of any adverse events up to 12 hours&#xD;
  &#xD;
        Phase 3 detection over 3 days N=20 ( 15 single dosed subjects, 5 split dosed subjects )&#xD;
  &#xD;
        Aim 7. Quantitate methadone and one or more of its metabolites in ISF with DPV over 3 days.&#xD;
  &#xD;
        Aim 8. Accurately identify a dose or half a dose has been taken Aim 9: Determine the&#xD;
        frequency and severity of any adverse events up to 3 days&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 2024</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Sensitivity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor</measure>
      <time_frame>from 3 hours to 3 days.</time_frame>
      <description>Sensitivity of Repeated measurements of methadone levels</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Specificity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor</measure>
      <time_frame>from 3 hours to 3 days.</time_frame>
      <description>Specificity of Repeated measurements of methadone levels</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Liquid Chromatography - Mass Spectroscopy (LC-MS)</measure>
      <time_frame>from 3 hours to 3 days</time_frame>
      <description>Pearson coefficient</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Remote Medication Monitor</measure>
      <time_frame>from 3 hours to 3 days</time_frame>
      <description>Pearson coefficient</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation between Liquid Chromatography - Mass Spectroscopy (LC-MS) and Differential Pulse Voltammetry (DPV)</measure>
      <time_frame>from 3 hours to 3 days</time_frame>
      <description>Pearson Coefficient</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">45</enrollment>
    <condition>Adherence, Medication</condition>
    <condition>Opioid Use Disorder</condition>
    <arm_group>
      <arm_group_label>3-6 HRS</arm_group_label>
      <description>Microneedle electrode array placed into dermis for up to 6 hours. DPV Scans performed at a frequency of 1-20 per hour.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>12 HRS</arm_group_label>
      <description>Microneedle electrode array placed into dermis for up to 12 hrs. DPV Scans performed at a frequency of 1-20 per hour.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>3 Days</arm_group_label>
      <description>Microneedle electrode array placed into dermis for up to 3 days. DPV Scans performed at a frequency of 1-20 per hour.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Remote Medication Monitor (RMM) - Prototype</intervention_name>
      <description>Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.</description>
      <arm_group_label>12 HRS</arm_group_label>
      <arm_group_label>3 Days</arm_group_label>
      <arm_group_label>3-6 HRS</arm_group_label>
      <other_name>RMM</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Daily Methadone Dose</intervention_name>
      <description>patient takes their prescribed daily dose of methadone</description>
      <arm_group_label>12 HRS</arm_group_label>
      <arm_group_label>3 Days</arm_group_label>
      <arm_group_label>3-6 HRS</arm_group_label>
      <other_name>Dose Taken</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients taking methadone for opioid use disorder&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion criteria for methadone group includes:&#xD;
  &#xD;
          Age 18-70. A prescription for liquid methadone at a dose of 10mg or more. Taken methadone&#xD;
          as prescribed in the last 2 days. Has been prescribed at least 3 take homes&#xD;
  &#xD;
          Exclusion criteria for methadone group includes:&#xD;
  &#xD;
          Age &lt;18 or &gt;70. A condition preventing or complicating ISF collection. Conditions may&#xD;
          include dermatological (skin) condition, immunodeficiency, bleeding diathesis, recent blood&#xD;
          donation, anemia, cancer, congestive heart failure, or tuberculosis. Any active severe&#xD;
          depression (e.g., suicidal ideation) or mania symptoms.&#xD;
  &#xD;
          Pregnancy, or intending to become pregnant during the course of the study. Patients&#xD;
          determined to be unstable for enrollment or take homes by the Outpatient Treatment Program&#xD;
          (OTP).&#xD;
  &#xD;
          Under a conservatorship.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mohammad Bari, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Synergy Research Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Foster P Carr, MD</last_name>
      <phone>6192343725</phone>
      <email>drcarr@carihealth.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Patrik Schmidle</last_name>
      <email>patrik@carihealth.com</email>
    </overall_contact_backup>
    <link>
      <url>http://www.carihealth.com</url>
      <description>Cari Health Website</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pharmacokinetics</keyword>
    <keyword>Differential Pulse Voltammetry</keyword>
    <keyword>Remote Medication Monitor</keyword>
    <keyword>Interstitial Fluid</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Opioid-Related Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Methadone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05998876
  org study id: IRB005
  nct id: NCT05998876
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  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.
  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
  observational model: Cohort
  time perspective: Prospective
  measure: Sensitivity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor
  time frame: from 3 hours to 3 days.
  description: Sensitivity of Repeated measurements of methadone levels
  measure: Specificity of detection of methadone levels in Interstitial Fluid using an electrochemical sensor
  time frame: from 3 hours to 3 days.
  description: Specificity of Repeated measurements of methadone levels
  measure: 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
  description: Pearson coefficient
  measure: Correlation between Blood and ISF levels of Methadone and Methadone Metabolites assayed with Remote Medication Monitor
  time frame: from 3 hours to 3 days
  description: Pearson coefficient
  measure: Correlation between Liquid Chromatography - Mass Spectroscopy (LC-MS) and Differential Pulse Voltammetry (DPV)
  time frame: from 3 hours to 3 days
  description: Pearson Coefficient
  arm group label: 3-6 HRS
  description: Microneedle electrode array placed into dermis for up to 6 hours. DPV Scans performed at a frequency of 1-20 per hour.
  arm group label: 12 HRS
  description: Microneedle electrode array placed into dermis for up to 12 hrs. DPV Scans performed at a frequency of 1-20 per hour.
  arm group label: 3 Days
  description: Microneedle electrode array placed into dermis for up to 3 days. DPV Scans performed at a frequency of 1-20 per hour.
  intervention type: Device
  intervention name: Remote Medication Monitor (RMM) - Prototype
  description: Inserted Microneedle Electrode Array for assaying dermal interstitial fluid.
  arm group label: 12 HRS
  arm group label: 3 Days
  arm group label: 3-6 HRS
  other name: RMM
  intervention type: Drug
  intervention name: Daily Methadone Dose
  description: patient takes their prescribed daily dose of methadone
  arm group label: 12 HRS
  arm group label: 3 Days
  arm group label: 3-6 HRS
  other name: Dose Taken
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mohammad Bari, MD
  role: Principal Investigator
  affiliation: Synergy Research Inc.
  last name: Foster P Carr, MD
  phone: 6192343725
  email: drcarr@carihealth.com
  last name: Patrik Schmidle
  email: patrik@carihealth.com
  url: http://www.carihealth.com
  description: Cari Health Website
  responsible party type: Sponsor
  mesh term: Opioid-Related Disorders
  mesh term: Methadone
  sharing ipd: Undecided