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/NCT05981573</url>
    </required_header>
    <id_info>
      <org_study_id>1358643</org_study_id>
      <nct_id>NCT05981573</nct_id>
    </id_info>
    <brief_title>Assessment of Methadone Dose Taken Using Electrochemistry</brief_title>
    <official_title>Assessment of Methadone Dose Taken Using Electrochemistry</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>
        Proof of concept: Pilot Study&#xD;
  &#xD;
        A Pilot, proof of concept, observational study with a long-term goal to develop a minimally&#xD;
        invasive wearable Remote Medication Monitor (RMM) that provides continuous, real-time data on&#xD;
        methadone levels in interstitial fluid (ISF). An RMM could be used as a medication adherence&#xD;
        monitor and would allow for the physician, counselor, patient, or family member to remotely&#xD;
        verify that a physician-prescribed dose has been taken.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The investigator will conduct a non-randomized, non-blinded, feasibility study at a single&#xD;
        center in the United States. The study will include up to 20 subjects of an equal number of&#xD;
        male and female adults (ages 18-70) who have a prescription for methadone for chronic pain.&#xD;
        In Aim 1, the investigator will determine if an RMM can assess the status of taking a&#xD;
        prescribed dose of methadone, using biosamples (i.e., ISF, blood) collected from subjects and&#xD;
        tested in a laboratory setup. Biosample collections and pharmacokinetic monitoring will take&#xD;
        up to 6 consecutive hours. By completing this aim, the investigator will determine if a&#xD;
        physician is able to recognize the peak and trough of a methadone dose using ex vivo&#xD;
        Differential Pulse Voltammetry (DPV).&#xD;
  &#xD;
        In Aim 2, the investigator will determine if an RMM can continuously assess the status of&#xD;
        taking a prescribed dose of methadone over time, by inserting the intradermal microneedle&#xD;
        sensing elements into the subjects' skin. The electronics for the RMM prototypes will consist&#xD;
        of commercially available benchtop potentiostats like the PalmSens Sensit BT&#xD;
        (https://www.palmsens.com/product/palmsens4/) or CH Instruments 660D&#xD;
        (https://www.chinstruments.com/) and will not be in direct contact with the skin. Biosample&#xD;
        collections (i.e., ISF, blood) and pharmacokinetic monitoring will occur over a 6-hour&#xD;
        period. By completing this aim, the investigator will determine if a physician is able to&#xD;
        recognize the pharmacokinetic profile of a taken dose of methadone. The physician will see a&#xD;
        dosing curve display generated from intradermal microneedle sensing elements that are worn&#xD;
        continuously on the skin. Completion of Aims 1-2 will require two separate visits.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">February 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2023</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>Methadone Concentration in ISF before and after a dose</measure>
      <time_frame>1 day</time_frame>
      <description>measure dermal interstitial fluid with LC-MS for methadone before and after a daily dose</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Methadone Concentration in blood before and after a dose</measure>
      <time_frame>1 day</time_frame>
      <description>measure blood for methadone with LC-MS before and after a daily dose</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Concentration of Methadone in ISF with LC-MS versus Electrochemical Assay</measure>
      <time_frame>2 days</time_frame>
      <description>measure ISF with two procedures (Liquid Chromatography - Mass Spectroscopy and Differential Pulse Voltammetry.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Concentration of Methadone in blood with LC-MS versus Electrochemical Assay</measure>
      <time_frame>2 days</time_frame>
      <description>measure blood with two procedures (Liquid Chromatography - Mass Spectroscopy and Differential Pulse Voltammetry.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pearson Correlation of Methadone between ISF and Blood</measure>
      <time_frame>2 days</time_frame>
      <description>measure blood and ISF methadone with LC-MS and determine pearson correlation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pearson Correlation between DPV and LC-MS ISF Methadone</measure>
      <time_frame>2 days</time_frame>
      <description>measure ISF for methadone by LC-MS and DPV and determine Pearson correlation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pearson Correlation between DPV and LC-MS ISF EDDP</measure>
      <time_frame>2 days</time_frame>
      <description>measure ISF for EDDP by LC-MS and DPV and determine Pearson correlation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pearson Correlation between DPV and LC-MS blood EDDP</measure>
      <time_frame>2 days</time_frame>
      <description>measure blood for EDDP by LC-MS and DPV and determine Pearson correlation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EDDP concentration in ISF before and after daily dose of methadone</measure>
      <time_frame>1 day</time_frame>
      <description>measure ISF for EDDP by LC-MS before and after daily dose of methadone</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EDDP concentration in blood before and after daily dose of methadone</measure>
      <time_frame>1 day</time_frame>
      <description>measure blood for EDDP by LC-MS before and after daily dose of methadone</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EMDP concentration in ISF before and after daily dose of methadone</measure>
      <time_frame>1 day</time_frame>
      <description>measure EMDP in ISF before and after daily dose of methadone</description>
    </primary_outcome>
    <primary_outcome>
      <measure>EMDP concentration in blood before and after daily dose of methadone</measure>
      <time_frame>1 day</time_frame>
      <description>measure EMDP in blood by LC-MS before and after daily dose of methadone</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pearson Correlation of Methadone to Metabolite Ratio ( MMR ) between ISF and Blood using LC-MS</measure>
      <time_frame>2 days</time_frame>
      <description>Calculate methadone to EDDP ratio of ISF and Blood and determine Pearson Correlation using LC-MS</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pearson Correlation of Methadone to Metabolite Ratio ( MMR ) between ISF and Blood using DPV</measure>
      <time_frame>2 days</time_frame>
      <description>Calculate methadone to EDDP ratio of ISF and Blood and determine Pearson Correlation using DPV</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Methadone Toxicity</condition>
    <condition>Methadone Overdose</condition>
    <condition>Pain, Chronic</condition>
    <condition>Drug Metabolism, Poor, CYP2D6-Related</condition>
    <condition>Metabolism Medication Toxicity</condition>
    <arm_group>
      <arm_group_label>Visit Day 1</arm_group_label>
      <description>AIM 1 : Determine if an RMM can assess the status of taking a prescribed dose of methadone. To complete this aim, the peak and trough concentrations of a witnessed methadone dose will be assessed in ISF collected through the surface of the skin using existing ISF extraction methods and assessed outside the body via differential pulse voltammetry (DPV). We hypothesize that the peak and trough blood samples will correlate with the level of methadone in collected ISF.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Visit Day 2</arm_group_label>
      <description>AIM 2 : Determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time. To complete this aim, the pharmacokinetic profile of a witnessed methadone dose will be assessed in ISF continuously from the surface of the skin using the RMM for up to 6 hours. We hypothesize that a clinician can recognize a dose taken from the continuous and real-time RMM measurements made in live ISF.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ISF extraction device 1</intervention_name>
      <description>FDA approved microneedle attached to blotter paper tested for ability to extract 1ul of interstitial fluid</description>
      <arm_group_label>Visit Day 1</arm_group_label>
      <arm_group_label>Visit Day 2</arm_group_label>
      <other_name>Samplimy</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo</intervention_name>
      <description>Measurement of Methadone and its metabolites in interstitial fluid with Liquid Chromatography - Mass Spectroscopy (LC-MS) and Electrochemical Assay</description>
      <arm_group_label>Visit Day 1</arm_group_label>
      <other_name>dose taken peak-trough test</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo</intervention_name>
      <description>Measurement of Methadone and its metabolites in ISF with LC-MS and DPV</description>
      <arm_group_label>Visit Day 2</arm_group_label>
      <other_name>In vivo Differential Pulse Voltammetery ( DPV )</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Measurement of Methadone in ISF before and after taking prescribed dose</intervention_name>
      <description>Measurement of methadone in ISF using DPV ex vivo versus in vivo . (Accuracy comparison - sensitivity, specificity, level of detection, and standard deviations )</description>
      <arm_group_label>Visit Day 1</arm_group_label>
      <arm_group_label>Visit Day 2</arm_group_label>
      <other_name>Comparing in vitro and in vivo approaches to determining a dose taken</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ISF Extraction Device 2</intervention_name>
      <description>2 hour periods of continuous ISF collection for analysis</description>
      <arm_group_label>Visit Day 2</arm_group_label>
      <other_name>Kiffik</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Chronic pain patients that have been prescribed at least 10mg of methadone per day.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-70&#xD;
  &#xD;
            -  A prescription for methadone for chronic pain at a dose of 10mg or more for at least&#xD;
               one week.&#xD;
  &#xD;
            -  Taking methadone as prescribed during the last 4 days before consent to participate in&#xD;
               the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt;18 or &gt;70&#xD;
  &#xD;
            -  A condition preventing or complicating ISF collection&#xD;
  &#xD;
            -  dermatological (skin) condition&#xD;
  &#xD;
            -  immunodeficiency&#xD;
  &#xD;
            -  recent blood donation&#xD;
  &#xD;
            -  anemia&#xD;
  &#xD;
            -  end stage renal disease&#xD;
  &#xD;
            -  liver cirrhosis&#xD;
  &#xD;
            -  cancer&#xD;
  &#xD;
            -  congestive heart failure&#xD;
  &#xD;
            -  bleeding diathesis&#xD;
  &#xD;
            -  tuberculosis (TB)&#xD;
  &#xD;
            -  Any active severe depression&#xD;
  &#xD;
            -  suicidal ideation&#xD;
  &#xD;
            -  mania symptoms&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Intending to become pregnant during the course of the study&#xD;
  &#xD;
            -  Enrolled in a substance use disorder treatment program&#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>No</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>Torsten Feibig, PhD</last_name>
      <email>torsten@carihealth.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Synergy</name>
        <address>
          <city>Lemon Grove</city>
          <state>California</state>
          <zip>91945</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Woody Woodman</last_name>
      </contact>
      <contact_backup>
        <last_name>Ryan Woodman</last_name>
      </contact_backup>
      <investigator>
        <last_name>Mohammad Bari, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.carihealth.com</url>
      <description>Cari Health Website</description>
    </link>
    <link>
      <url>http://www.kiffik.com</url>
      <description>Kiffik Website</description>
    </link>
    <reference>
      <citation>Friedel M, Werbovetz B, Drexelius A, Watkins Z, Bali A, Plaxco KW, Heikenfeld J. Continuous molecular monitoring of human dermal interstitial fluid with microneedle-enabled electrochemical aptamer sensors. Lab Chip. 2023 Jul 12;23(14):3289-3299. doi: 10.1039/d3lc00210a.</citation>
      <PMID>37395135</PMID>
    </reference>
    <reference>
      <citation>Gomes NO, Raymundo-Pereira PA. On-Site Therapeutic Drug Monitoring of Paracetamol Analgesic in Non-Invasively Collected Saliva for Personalized Medicine. Small. 2023 Mar;19(12):e2206753. doi: 10.1002/smll.202206753. Epub 2023 Jan 15.</citation>
      <PMID>36642790</PMID>
    </reference>
    <reference>
      <citation>Ribet F, Bendes A, Fredolini C, Dobielewski M, Bottcher M, Beck O, Schwenk JM, Stemme G, Roxhed N. Microneedle Patch for Painless Intradermal Collection of Interstitial Fluid Enabling Multianalyte Measurement of Small Molecules, SARS-CoV-2 Antibodies, and Protein Profiling. Adv Healthc Mater. 2023 May;12(13):e2202564. doi: 10.1002/adhm.202202564. Epub 2023 Feb 21.</citation>
      <PMID>36748807</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pharmacokinetics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Chronic Pain</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Methadone</mesh_term>
    </intervention_browse>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 14, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT05981573/Prot_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 14, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT05981573/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05981573
  org study id: 1358643
  nct id: NCT05981573
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  Proof of concept: Pilot Study
  
        A Pilot, proof of concept, observational study with a long-term goal to develop a minimally
        invasive wearable Remote Medication Monitor (RMM) that provides continuous, real-time data on
        methadone levels in interstitial fluid (ISF). An RMM could be used as a medication adherence
        monitor and would allow for the physician, counselor, patient, or family member to remotely
        verify that a physician-prescribed dose has been taken.
  The investigator will conduct a non-randomized, non-blinded, feasibility study at a single
        center in the United States. The study will include up to 20 subjects of an equal number of
        male and female adults (ages 18-70) who have a prescription for methadone for chronic pain.
        In Aim 1, the investigator will determine if an RMM can assess the status of taking a
        prescribed dose of methadone, using biosamples (i.e., ISF, blood) collected from subjects and
        tested in a laboratory setup. Biosample collections and pharmacokinetic monitoring will take
        up to 6 consecutive hours. By completing this aim, the investigator will determine if a
        physician is able to recognize the peak and trough of a methadone dose using ex vivo
        Differential Pulse Voltammetry (DPV).
  
        In Aim 2, the investigator will determine if an RMM can continuously assess the status of
        taking a prescribed dose of methadone over time, by inserting the intradermal microneedle
        sensing elements into the subjects' skin. The electronics for the RMM prototypes will consist
        of commercially available benchtop potentiostats like the PalmSens Sensit BT
        (https://www.palmsens.com/product/palmsens4/) or CH Instruments 660D
        (https://www.chinstruments.com/) and will not be in direct contact with the skin. Biosample
        collections (i.e., ISF, blood) and pharmacokinetic monitoring will occur over a 6-hour
        period. By completing this aim, the investigator will determine if a physician is able to
        recognize the pharmacokinetic profile of a taken dose of methadone. The physician will see a
        dosing curve display generated from intradermal microneedle sensing elements that are worn
        continuously on the skin. Completion of Aims 1-2 will require two separate visits.
  observational model: Cohort
  time perspective: Prospective
  measure: Methadone Concentration in ISF before and after a dose
  time frame: 1 day
  description: measure dermal interstitial fluid with LC-MS for methadone before and after a daily dose
  measure: Methadone Concentration in blood before and after a dose
  time frame: 1 day
  description: measure blood for methadone with LC-MS before and after a daily dose
  measure: Concentration of Methadone in ISF with LC-MS versus Electrochemical Assay
  time frame: 2 days
  description: measure ISF with two procedures (Liquid Chromatography - Mass Spectroscopy and Differential Pulse Voltammetry.
  measure: Concentration of Methadone in blood with LC-MS versus Electrochemical Assay
  time frame: 2 days
  description: measure blood with two procedures (Liquid Chromatography - Mass Spectroscopy and Differential Pulse Voltammetry.
  measure: Pearson Correlation of Methadone between ISF and Blood
  time frame: 2 days
  description: measure blood and ISF methadone with LC-MS and determine pearson correlation
  measure: Pearson Correlation between DPV and LC-MS ISF Methadone
  time frame: 2 days
  description: measure ISF for methadone by LC-MS and DPV and determine Pearson correlation
  measure: Pearson Correlation between DPV and LC-MS ISF EDDP
  time frame: 2 days
  description: measure ISF for EDDP by LC-MS and DPV and determine Pearson correlation
  measure: Pearson Correlation between DPV and LC-MS blood EDDP
  time frame: 2 days
  description: measure blood for EDDP by LC-MS and DPV and determine Pearson correlation
  measure: EDDP concentration in ISF before and after daily dose of methadone
  time frame: 1 day
  description: measure ISF for EDDP by LC-MS before and after daily dose of methadone
  measure: EDDP concentration in blood before and after daily dose of methadone
  time frame: 1 day
  description: measure blood for EDDP by LC-MS before and after daily dose of methadone
  measure: EMDP concentration in ISF before and after daily dose of methadone
  time frame: 1 day
  description: measure EMDP in ISF before and after daily dose of methadone
  measure: EMDP concentration in blood before and after daily dose of methadone
  time frame: 1 day
  description: measure EMDP in blood by LC-MS before and after daily dose of methadone
  measure: Pearson Correlation of Methadone to Metabolite Ratio ( MMR ) between ISF and Blood using LC-MS
  time frame: 2 days
  description: Calculate methadone to EDDP ratio of ISF and Blood and determine Pearson Correlation using LC-MS
  measure: Pearson Correlation of Methadone to Metabolite Ratio ( MMR ) between ISF and Blood using DPV
  time frame: 2 days
  description: Calculate methadone to EDDP ratio of ISF and Blood and determine Pearson Correlation using DPV
  arm group label: Visit Day 1
  description: AIM 1 : Determine if an RMM can assess the status of taking a prescribed dose of methadone. To complete this aim, the peak and trough concentrations of a witnessed methadone dose will be assessed in ISF collected through the surface of the skin using existing ISF extraction methods and assessed outside the body via differential pulse voltammetry (DPV). We hypothesize that the peak and trough blood samples will correlate with the level of methadone in collected ISF.
  arm group label: Visit Day 2
  description: AIM 2 : Determine if an RMM can continuously assess the status of taking a prescribed dose of methadone over time. To complete this aim, the pharmacokinetic profile of a witnessed methadone dose will be assessed in ISF continuously from the surface of the skin using the RMM for up to 6 hours. We hypothesize that a clinician can recognize a dose taken from the continuous and real-time RMM measurements made in live ISF.
  intervention type: Device
  intervention name: ISF extraction device 1
  description: FDA approved microneedle attached to blotter paper tested for ability to extract 1ul of interstitial fluid
  arm group label: Visit Day 1
  arm group label: Visit Day 2
  other name: Samplimy
  intervention type: Diagnostic Test
  intervention name: Measurement of Methadone in the Interstitial Fluid (ISF) before and after prescribed dose taken ex vivo
  description: Measurement of Methadone and its metabolites in interstitial fluid with Liquid Chromatography - Mass Spectroscopy (LC-MS) and Electrochemical Assay
  arm group label: Visit Day 1
  other name: dose taken peak-trough test
  intervention type: Device
  intervention name: Measurement of Methadone in the Interstitial Fluid before and after prescribed dose taken in vivo
  description: Measurement of Methadone and its metabolites in ISF with LC-MS and DPV
  arm group label: Visit Day 2
  other name: In vivo Differential Pulse Voltammetery ( DPV )
  intervention type: Drug
  intervention name: Measurement of Methadone in ISF before and after taking prescribed dose
  description: Measurement of methadone in ISF using DPV ex vivo versus in vivo . (Accuracy comparison - sensitivity, specificity, level of detection, and standard deviations )
  arm group label: Visit Day 1
  arm group label: Visit Day 2
  other name: Comparing in vitro and in vivo approaches to determining a dose taken
  intervention type: Device
  intervention name: ISF Extraction Device 2
  description: 2 hour periods of continuous ISF collection for analysis
  arm group label: Visit Day 2
  other name: Kiffik
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  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: Torsten Feibig, PhD
  email: torsten@carihealth.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  url: http://www.carihealth.com
  description: Cari Health Website
  url: http://www.kiffik.com
  description: Kiffik Website
  citation: Friedel M, Werbovetz B, Drexelius A, Watkins Z, Bali A, Plaxco KW, Heikenfeld J. Continuous molecular monitoring of human dermal interstitial fluid with microneedle-enabled electrochemical aptamer sensors. Lab Chip. 2023 Jul 12;23(14):3289-3299. doi: 10.1039/d3lc00210a.
  PMID: 37395135
  citation: Gomes NO, Raymundo-Pereira PA. On-Site Therapeutic Drug Monitoring of Paracetamol Analgesic in Non-Invasively Collected Saliva for Personalized Medicine. Small. 2023 Mar;19(12):e2206753. doi: 10.1002/smll.202206753. Epub 2023 Jan 15.
  PMID: 36642790
  citation: Ribet F, Bendes A, Fredolini C, Dobielewski M, Bottcher M, Beck O, Schwenk JM, Stemme G, Roxhed N. Microneedle Patch for Painless Intradermal Collection of Interstitial Fluid Enabling Multianalyte Measurement of Small Molecules, SARS-CoV-2 Antibodies, and Protein Profiling. Adv Healthc Mater. 2023 May;12(13):e2202564. doi: 10.1002/adhm.202202564. Epub 2023 Feb 21.
  PMID: 36748807
  responsible party type: Sponsor
  mesh term: Chronic Pain
  mesh term: Methadone
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