<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/NCT02184104</url>
  </required_header>
  <id_info>
    <org_study_id>13-02648-FB</org_study_id>
    <secondary_id>1R03DA035347-01A1</secondary_id>
    <nct_id>NCT02184104</nct_id>
  </id_info>
  <brief_title>Caffeine Disposition After Inhalation</brief_title>
  <official_title>Pharmacokinetics and Pharmacodynamics of a 100 mg Caffeine Dose After Oral Consumption of an Energy Drink or Inhalation Using the Aeroshot Administration Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tennessee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Tennessee</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine how fast caffeine gets into your body with a&#xD;
      product called Aeroshot™. Aeroshot™ is a lipstick sized device that you slide open and then&#xD;
      put your mouth over the opening and inhale. A fine powder containing 100 mg of caffeine is&#xD;
      deposited on your tongue and the inside of your mouth. Caffeine will be absorbed through the&#xD;
      membranes in your mouth or swallowed and then absorbed in your stomach. We will compare the&#xD;
      absorption of caffeine after using the Aeroshot™ with the absorption after drinking an energy&#xD;
      drink by taking 15 blood samples over 8 hours and measuring the caffeine levels in your&#xD;
      blood. You will also be asked to fill out some scales to measure the effects you feel after&#xD;
      the caffeine dose. We hypothesize that caffeine absorption after inhalation will be faster&#xD;
      than after an energy drink.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2014</start_date>
  <completion_date type="Actual">March 20, 2017</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Caffeine plasma concentration</measure>
    <time_frame>0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes and 2, 3, 4, 6, 8 hours</time_frame>
    <description>These are the collection times of blood samples relative to when the caffeine dose was consumed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Caffeine effects</measure>
    <time_frame>0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours</time_frame>
    <description>Subjects will complete seven analog scales to assess the effects that they feel after the caffeine dose.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Cardiovascular effects</measure>
    <time_frame>0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours</time_frame>
    <description>The heart rate and blood pressure will be recorded at the time of each blood collection.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Aeroshot</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A single 100 mg caffeine dose administered using the Aeroshot device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Energy Drink</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A single 100 mg caffeine dose administered as an oral solution.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Caffeine</intervention_name>
    <arm_group_label>Aeroshot</arm_group_label>
    <arm_group_label>Energy Drink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteer&#xD;
&#xD;
          -  non-smoker&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Take chronic medication&#xD;
&#xD;
          -  Co-existing diseases&#xD;
&#xD;
          -  Platelet count less than 100,000/uL (per microliter)&#xD;
&#xD;
          -  Acute or chronic psychiatric condition&#xD;
&#xD;
          -  Consume more than 300 mg of caffeine per day&#xD;
&#xD;
          -  Participated in another study within last 30 days or donated blood in last 6 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven C. Laizure, Pharm.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tennessee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Tennessee Health Science Center</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38163</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>caffeine</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>pharmacodynamics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caffeine</mesh_term>
  </intervention_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/NCT02184104
org study id: 13-02648-FB
secondary id: 1R03DA035347-01A1
nct id: NCT02184104
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine how fast caffeine gets into your body with a
      product called Aeroshot™. Aeroshot™ is a lipstick sized device that you slide open and then
      put your mouth over the opening and inhale. A fine powder containing 100 mg of caffeine is
      deposited on your tongue and the inside of your mouth. Caffeine will be absorbed through the
      membranes in your mouth or swallowed and then absorbed in your stomach. We will compare the
      absorption of caffeine after using the Aeroshot™ with the absorption after drinking an energy
      drink by taking 15 blood samples over 8 hours and measuring the caffeine levels in your
      blood. You will also be asked to fill out some scales to measure the effects you feel after
      the caffeine dose. We hypothesize that caffeine absorption after inhalation will be faster
      than after an energy drink.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Caffeine plasma concentration
time frame: 0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes and 2, 3, 4, 6, 8 hours
description: These are the collection times of blood samples relative to when the caffeine dose was consumed.
measure: Caffeine effects
time frame: 0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours
description: Subjects will complete seven analog scales to assess the effects that they feel after the caffeine dose.
measure: Cardiovascular effects
time frame: 0, 1, 2, 5, 10, 15, 20, 30, 40, 60 minutes, and 2, 3, 4, 6, 8 hours
description: The heart rate and blood pressure will be recorded at the time of each blood collection.
arm group label: Aeroshot
arm group type: Active Comparator
description: A single 100 mg caffeine dose administered using the Aeroshot device.
arm group label: Energy Drink
arm group type: Active Comparator
description: A single 100 mg caffeine dose administered as an oral solution.
intervention type: Dietary Supplement
intervention name: Caffeine
arm group label: Aeroshot
arm group label: Energy Drink
criteria: 
gender: All
minimum age: 21 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Steven C. Laizure, Pharm.D.
role: Principal Investigator
affiliation: University of Tennessee
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Aspiration
mesh term: Caffeine
sharing ipd: No