<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/NCT03242161</url>
  </required_header>
  <id_info>
    <org_study_id>2017P001502</org_study_id>
    <nct_id>NCT03242161</nct_id>
  </id_info>
  <brief_title>Development of LabPatch-alcohol as a Noninvasive Skin Patch to Detect Blood Alcohol Concentrations</brief_title>
  <official_title>Development of LabPatch-alcohol: A Wearable Biosensor for Detecting Alcohol in Interstitial Fluid</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mclean Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mclean Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to test LabPatch-alcohol, a wearable, non-invasive biosensor Band-Aid&#xD;
      like patch that is designed to detect real-time changes in interstitial alcohol&#xD;
      concentrations in human subjects. The changes in interstitial alcohol concentrations will be&#xD;
      compared to blood alcohol concentrations to determine the patch's validity against the gold&#xD;
      standard.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nanotechnology has the potential to become a powerful tool in addiction medicine. The&#xD;
      potential utility for passive, non-invasive wearable alcohol monitors is great and could play&#xD;
      a major role in public safety as well as in both research, clinical, and treatment settings.&#xD;
      Clinitech, LLC has developed LabPatch, an electronic bandage that continuously and&#xD;
      imperceptibly samples interstitial fluid from the skin surface and measures relevant&#xD;
      biomarkers in the fluid. The patch uses novel nanowire technology to sample the interstitial&#xD;
      fluid from just underneath the skin and then uses an electrochemical reaction to measure&#xD;
      either glucose or alcohol concentration. The participants' interstitial alcohol concentration&#xD;
      (IAC) will be measured via LabPatch-alcohol at the same time points as blood samples so that&#xD;
      a direct comparison can be made. Thus, the LabPatch-alcohol will be tested as the&#xD;
      participant's BAC rises and falls through the legally intoxicated concentration (0.08%), and&#xD;
      the goal is to match measures obtained via the prototype LabPatch-alcohol with whole blood&#xD;
      alcohol concentrations. The LabPatch operational circuit lies on the underside of the&#xD;
      bandage. The circuit surface is placed in contact with the skin by the application of the&#xD;
      elastic adhesive bandage with a contact tension that provides modest pressure, as in the case&#xD;
      of a conventional wound bandage. The temperature of the skin is measured electrically and the&#xD;
      consistency of temperature is used to verify good contact and to monitor continued contact.&#xD;
      The entire process takes 3-5 seconds to collect the sample, a pause for 1 sec and then 3&#xD;
      additional seconds to conduct the analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">May 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2022</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All participants assigned to have a lab patch-alcohol applied to skin and then receive a single dose of alcohol and then the patch measures how much alcohol appears in interstitial fluid. This is compared to the blood alcohol concentrations.</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Interstitial and Blood Alcohol Concentrations</measure>
    <time_frame>Both samples will be collected at baseline and at 2.5 to 5 minute intervals for up to 2.5 hrs after a 0.9 g/kg dose of alcohol.</time_frame>
    <description>Interstitial (from the skin surface) alcohol concentrations will be obtained via the LabPatch band-aid while at the same time blood samples will be collected in an attempt to correlate the two. The LabPatch-alcohol is a completely noninvasive device and the goal is to determine is precision against the gold standard--blood alcohol concentrations.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">8</enrollment>
  <condition>Alcohol Intoxication</condition>
  <arm_group>
    <arm_group_label>LabPatch-alcohol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All subjects will be administered alcohol and then monitored by a non-invasive alcohol sensor</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>LabPatch-alcohol</intervention_name>
    <description>a wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time changes in interstitial alcohol concentrations in human subjects after they have consumed alcohol</description>
    <arm_group_label>LabPatch-alcohol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is capable of understanding and complying with the protocol&#xD;
&#xD;
          -  Good physical and mental health (normal physical exam, ECG, blood and urine&#xD;
             chemistries, including absences of history or laboratory evidence of diabetes)&#xD;
&#xD;
          -  Body Mass Index between 18-30, inclusive&#xD;
&#xD;
          -  Age 21-50 years (age will be verified by driver's license or other valid form of&#xD;
             identification)&#xD;
&#xD;
          -  Have used alcohol, on average, between 5-15 drinks per week over the past 6 months.&#xD;
&#xD;
          -  Have a stable living situation with current postal address&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Meets criteria for current alcohol or substance use disorders (Past alcohol or&#xD;
             substance use disorders greater than 3 years ago is acceptable)&#xD;
&#xD;
          -  Concurrent diagnosis of Axis I disorder&#xD;
&#xD;
          -  bMaintained on an antipsychotic or antidepressant medication; taking prescription&#xD;
             medications except certain short-term anti-fungal agents and some tropical creams for&#xD;
             dermal conditions&#xD;
&#xD;
          -  Heavy alcohol drinkers (greater than 15 drinks per week)&#xD;
&#xD;
          -  Tobacco use greater than 5 cigarettes per day&#xD;
&#xD;
          -  History of major head trauma resulting in cognitive impairment or history of seizure&#xD;
             disorder&#xD;
&#xD;
          -  Heavy caffeine use (greater than 500 mg on a regular daily basis)&#xD;
&#xD;
          -  Subject has active hepatitis and/or aspartate aminotransferase (AST), alanine&#xD;
             aminotransferase (ALT) &gt; 3x the upper limit of normal&#xD;
&#xD;
          -  For female volunteers, a positive pregnancy test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott E Lukas, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mclean Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Scott Lukas, PhD</last_name>
    <phone>617-855-2767</phone>
    <email>slukas@mclean.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wendy Tartarini, MA</last_name>
    <phone>617-855-2174</phone>
    <email>wtartarini@mclean.harvard.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>McLean Hospital</name>
      <address>
        <city>Belmont</city>
        <state>Massachusetts</state>
        <zip>02478</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Scott E Lukas, PhD</last_name>
      <phone>617-855-2767</phone>
      <email>slukas@mclean.harvard.edu</email>
    </contact>
    <contact_backup>
      <last_name>Wendy Tartarini, MA</last_name>
      <phone>617-855-2174</phone>
      <email>wtartarini@mclean.harvard.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>July 28, 2020</last_update_submitted>
  <last_update_submitted_qc>July 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mclean Hospital</investigator_affiliation>
    <investigator_full_name>Scott Lukas</investigator_full_name>
    <investigator_title>Director, McLean Imaging Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholic Intoxication</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03242161
org study id: 2017P001502
nct id: NCT03242161
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This study is designed to test LabPatch-alcohol, a wearable, non-invasive biosensor Band-Aid
      like patch that is designed to detect real-time changes in interstitial alcohol
      concentrations in human subjects. The changes in interstitial alcohol concentrations will be
      compared to blood alcohol concentrations to determine the patch's validity against the gold
      standard.
Nanotechnology has the potential to become a powerful tool in addiction medicine. The
      potential utility for passive, non-invasive wearable alcohol monitors is great and could play
      a major role in public safety as well as in both research, clinical, and treatment settings.
      Clinitech, LLC has developed LabPatch, an electronic bandage that continuously and
      imperceptibly samples interstitial fluid from the skin surface and measures relevant
      biomarkers in the fluid. The patch uses novel nanowire technology to sample the interstitial
      fluid from just underneath the skin and then uses an electrochemical reaction to measure
      either glucose or alcohol concentration. The participants' interstitial alcohol concentration
      (IAC) will be measured via LabPatch-alcohol at the same time points as blood samples so that
      a direct comparison can be made. Thus, the LabPatch-alcohol will be tested as the
      participant's BAC rises and falls through the legally intoxicated concentration (0.08%), and
      the goal is to match measures obtained via the prototype LabPatch-alcohol with whole blood
      alcohol concentrations. The LabPatch operational circuit lies on the underside of the
      bandage. The circuit surface is placed in contact with the skin by the application of the
      elastic adhesive bandage with a contact tension that provides modest pressure, as in the case
      of a conventional wound bandage. The temperature of the skin is measured electrically and the
      consistency of temperature is used to verify good contact and to monitor continued contact.
      The entire process takes 3-5 seconds to collect the sample, a pause for 1 sec and then 3
      additional seconds to conduct the analysis.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All participants assigned to have a lab patch-alcohol applied to skin and then receive a single dose of alcohol and then the patch measures how much alcohol appears in interstitial fluid. This is compared to the blood alcohol concentrations.
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Interstitial and Blood Alcohol Concentrations
time frame: Both samples will be collected at baseline and at 2.5 to 5 minute intervals for up to 2.5 hrs after a 0.9 g/kg dose of alcohol.
description: Interstitial (from the skin surface) alcohol concentrations will be obtained via the LabPatch band-aid while at the same time blood samples will be collected in an attempt to correlate the two. The LabPatch-alcohol is a completely noninvasive device and the goal is to determine is precision against the gold standard--blood alcohol concentrations.
arm group label: LabPatch-alcohol
arm group type: Experimental
description: All subjects will be administered alcohol and then monitored by a non-invasive alcohol sensor
intervention type: Diagnostic Test
intervention name: LabPatch-alcohol
description: a wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time changes in interstitial alcohol concentrations in human subjects after they have consumed alcohol
arm group label: LabPatch-alcohol
criteria: 
gender: All
minimum age: 21 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Scott E Lukas, PhD
role: Principal Investigator
affiliation: Mclean Hospital
last name: Scott Lukas, PhD
phone: 617-855-2767
email: slukas@mclean.harvard.edu
last name: Wendy Tartarini, MA
phone: 617-855-2174
email: wtartarini@mclean.harvard.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mclean Hospital
investigator full name: Scott Lukas
investigator title: Director, McLean Imaging Center
mesh term: Alcoholic Intoxication
sharing ipd: No