<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/NCT01735487</url>
  </required_header>
  <id_info>
    <org_study_id>CogEcig</org_study_id>
    <nct_id>NCT01735487</nct_id>
  </id_info>
  <brief_title>CogEcig: Cognitive Functioning and Electronic Cigarette</brief_title>
  <acronym>CogEcig</acronym>
  <official_title>Electronic Cigarette and Cognitive Functioning: (CogEcig)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universita degli Studi di Catania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universita degli Studi di Catania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to compare cognitive scores (attention, executive function&#xD;
      and working memory) of different e-Cigarette strength with usual cigarettes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is randomised cross-over trial designed to compare: 1) Cognitive performances&#xD;
      levels for four different e-Cigarette strength. Participants will be requested to abstain&#xD;
      from smoking and alcohol from 20:00 on the night before each study day and from food and&#xD;
      caffeine for at least 1 h before the session. On arrival at the study centre, carbon monoxide&#xD;
      (CO) will be measured in participants' expired breath. If CO will be &gt;15 parts per million&#xD;
      (ppm), the assigned study treatment will be allocated; however, if CO was &gt;15 ppm or they&#xD;
      will report smoking in the previous 12 h, participants will be rescheduled wherever possible&#xD;
      to a subsequent session.&#xD;
&#xD;
      On the first study day, participants will be randomised to use one of five ordered&#xD;
      conditions: Electronic Nicotine Delivery Device (ENDD) (fourth generation) containing&#xD;
      nicotine 2,4%; Electronic Nicotine Delivery Device (ENDD (second generation) containing&#xD;
      nicotine 7,4 mg; Electronic Nicotine Delivery Device (ENDD containing nicotine 9 mg;&#xD;
      Electronic Nicotine Delivery Device (ENDD nicotine free; their usual cigarette. Additionally&#xD;
      participants will be trained to use an electronic cigarette. The following tests will be&#xD;
      completed at the each visits: Continuous Performance Test - AX version (CPT-AX), Wisconsin&#xD;
      card sorting test( WCST), Working memory test (N-BACK).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cognitive Performances</measure>
    <time_frame>35 minutes</time_frame>
    <description>Compare cognitive performances in subjects who smoke &quot;Categoria&quot; electronic cigarettes labelled Original 7,4 mg nicotine , &quot;Categoria&quot; electronic cigarettes labelled One 2,4% nicotine, &quot;Categoria&quot; electronic cigarettes labelled &quot;Mint&quot; nicotine free, electronic cigarettes labelled Ego 9 mg nicotine with usual cigarettes.</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Tobacco Abuse Smoke</condition>
  <arm_group>
    <arm_group_label>Own Brand cigarette</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Smoke Own Brand cigarette, 15 puff of cigarette.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>One High 2,4% nicotine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Original 7,4 mg nicotine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nicotine Free</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Smoke electronic cigarette nicotine free (15 puff)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EGO 9mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Smoke electronic cigarette EGO for a day (15 puff)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Own Brand cigarette</intervention_name>
    <description>Smoke, 15 puff of, Own Brand cigarettes;</description>
    <arm_group_label>EGO 9mg</arm_group_label>
    <arm_group_label>Nicotine Free</arm_group_label>
    <arm_group_label>One High 2,4% nicotine</arm_group_label>
    <arm_group_label>Original 7,4 mg nicotine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>one high 2,4% nicotine</intervention_name>
    <description>Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine</description>
    <arm_group_label>EGO 9mg</arm_group_label>
    <arm_group_label>Nicotine Free</arm_group_label>
    <arm_group_label>Original 7,4 mg nicotine</arm_group_label>
    <arm_group_label>Own Brand cigarette</arm_group_label>
    <other_name>Categoria electronic cigarette one high 2,4% nicotine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>original 7,4 mg nicotine</intervention_name>
    <description>Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine</description>
    <arm_group_label>EGO 9mg</arm_group_label>
    <arm_group_label>Nicotine Free</arm_group_label>
    <arm_group_label>One High 2,4% nicotine</arm_group_label>
    <arm_group_label>Own Brand cigarette</arm_group_label>
    <other_name>Categoria electronic cigarette 7,4 mg nicotine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>nicotine free</intervention_name>
    <description>smoke, 15 puff, of electronic cigarette nicotine free</description>
    <arm_group_label>EGO 9mg</arm_group_label>
    <arm_group_label>One High 2,4% nicotine</arm_group_label>
    <arm_group_label>Original 7,4 mg nicotine</arm_group_label>
    <arm_group_label>Own Brand cigarette</arm_group_label>
    <other_name>categoria electronic cigarette nicotine free &quot;mint&quot;.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ego 9mg</intervention_name>
    <description>smoke, 15 puff, of electronic cigarette Ego 9 mg</description>
    <arm_group_label>Nicotine Free</arm_group_label>
    <arm_group_label>One High 2,4% nicotine</arm_group_label>
    <arm_group_label>Own Brand cigarette</arm_group_label>
    <other_name>electronic cigarette Ego 9 mg nicotine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  20 regular smokers (smoking ≥ 15 factory-made cigarettes per day for at least the past&#xD;
             10 years and not currently attempting to quit smoking or wishing to do so in the next&#xD;
             30 days, CO &gt; 10 parts per million ) will be recruited from the local Hospital staff&#xD;
             in Catania, Italy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  people who reported recent myocardial infarction, angina pectoris or other serious&#xD;
             medical conditions (diabetes mellitus, severe allergies, poorly controlled asthma or&#xD;
             other airways disease, poorly controlled psychiatric disorders or current chemical&#xD;
             dependence other than nicotine) and&#xD;
&#xD;
          -  pregnancy,&#xD;
&#xD;
          -  breastfeeding,&#xD;
&#xD;
          -  blood pressure &gt; 180 mm Hg systolic and/or 100 mm Hg diastolic,&#xD;
&#xD;
          -  weight &lt; 45 or &gt; 120 kg, or&#xD;
&#xD;
          -  current use of any other smoking cessation medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centro per la Prevenzione e Cura del Tabagimso</name>
      <address>
        <city>Catania</city>
        <zip>95124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>November 23, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>December 17, 2012</last_update_submitted>
  <last_update_submitted_qc>December 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universita degli Studi di Catania</investigator_affiliation>
    <investigator_full_name>Riccardo Polosa</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nicotine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01735487
org study id: CogEcig
nct id: NCT01735487
lead sponsor: 
has dmc: No
The aim of the present study is to compare cognitive scores (attention, executive function
      and working memory) of different e-Cigarette strength with usual cigarettes.
The study is randomised cross-over trial designed to compare: 1) Cognitive performances
      levels for four different e-Cigarette strength. Participants will be requested to abstain
      from smoking and alcohol from 20:00 on the night before each study day and from food and
      caffeine for at least 1 h before the session. On arrival at the study centre, carbon monoxide
      (CO) will be measured in participants' expired breath. If CO will be >15 parts per million
      (ppm), the assigned study treatment will be allocated; however, if CO was >15 ppm or they
      will report smoking in the previous 12 h, participants will be rescheduled wherever possible
      to a subsequent session.

      On the first study day, participants will be randomised to use one of five ordered
      conditions: Electronic Nicotine Delivery Device (ENDD) (fourth generation) containing
      nicotine 2,4%; Electronic Nicotine Delivery Device (ENDD (second generation) containing
      nicotine 7,4 mg; Electronic Nicotine Delivery Device (ENDD containing nicotine 9 mg;
      Electronic Nicotine Delivery Device (ENDD nicotine free; their usual cigarette. Additionally
      participants will be trained to use an electronic cigarette. The following tests will be
      completed at the each visits: Continuous Performance Test - AX version (CPT-AX), Wisconsin
      card sorting test( WCST), Working memory test (N-BACK).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Cognitive Performances
time frame: 35 minutes
description: Compare cognitive performances in subjects who smoke "Categoria" electronic cigarettes labelled Original 7,4 mg nicotine , "Categoria" electronic cigarettes labelled One 2,4% nicotine, "Categoria" electronic cigarettes labelled "Mint" nicotine free, electronic cigarettes labelled Ego 9 mg nicotine with usual cigarettes.
arm group label: Own Brand cigarette
arm group type: Active Comparator
description: Smoke Own Brand cigarette, 15 puff of cigarette.
arm group label: One High 2,4% nicotine
arm group type: Experimental
description: Smoke electronic cigarette One High 2,4% nicotine for a day, 15 puff of e-cigarette.
arm group label: Original 7,4 mg nicotine
arm group type: Experimental
description: Smoke electronic cigarette Original 7,4 mg nicotine for a day. 15 puff of e-cigarette.
arm group label: Nicotine Free
arm group type: Placebo Comparator
description: Smoke electronic cigarette nicotine free (15 puff)
arm group label: EGO 9mg
arm group type: Experimental
description: Smoke electronic cigarette EGO for a day (15 puff)
intervention type: Other
intervention name: Own Brand cigarette
description: Smoke, 15 puff of, Own Brand cigarettes;
arm group label: EGO 9mg
arm group label: Nicotine Free
arm group label: One High 2,4% nicotine
arm group label: Original 7,4 mg nicotine
intervention type: Other
intervention name: one high 2,4% nicotine
description: Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
arm group label: EGO 9mg
arm group label: Nicotine Free
arm group label: Original 7,4 mg nicotine
arm group label: Own Brand cigarette
other name: Categoria electronic cigarette one high 2,4% nicotine
intervention type: Other
intervention name: original 7,4 mg nicotine
description: Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
arm group label: EGO 9mg
arm group label: Nicotine Free
arm group label: One High 2,4% nicotine
arm group label: Own Brand cigarette
other name: Categoria electronic cigarette 7,4 mg nicotine
intervention type: Other
intervention name: nicotine free
description: smoke, 15 puff, of electronic cigarette nicotine free
arm group label: EGO 9mg
arm group label: One High 2,4% nicotine
arm group label: Original 7,4 mg nicotine
arm group label: Own Brand cigarette
other name: categoria electronic cigarette nicotine free "mint".
intervention type: Other
intervention name: Ego 9mg
description: smoke, 15 puff, of electronic cigarette Ego 9 mg
arm group label: Nicotine Free
arm group label: One High 2,4% nicotine
arm group label: Own Brand cigarette
other name: electronic cigarette Ego 9 mg nicotine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Universita degli Studi di Catania
investigator full name: Riccardo Polosa
investigator title: Professor
mesh term: Tobacco Use Disorder
mesh term: Nicotine