<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/NCT01665066</url>
  </required_header>
  <id_info>
    <org_study_id>KINECIG UNICT 526 /12 (Polosa)</org_study_id>
    <secondary_id>Polosa-Caponnetto 2012</secondary_id>
    <nct_id>NCT01665066</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Profile of Toxic Substances and Nicotine in Electronic Cigarettes</brief_title>
  <acronym>KINECIG</acronym>
  <official_title>Pharmacokinetic Profile of Toxic Substances and Nicotine in Electronic Cigarettes: a Randomised Cross-over Trial KINECIG</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universita degli Studi di Catania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laboratory for Health Protection Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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 serum nicotine levels of different e-Cigarette&#xD;
      strength with usual cigarettes. Serum levels of carcinogenic and toxic substances will be&#xD;
      also compared.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is randomised cross-over trial designed to compare: 1) serum nicotine levels of&#xD;
      four different e-Cigarette strength ; 2) Serum levels of carcinogenic and toxic substances&#xD;
      will be also compared. Participants will be requested to abstain from smoking and alcohol&#xD;
      from 20:00 on the night before each study day and from food and caffeine for at least 1 h&#xD;
      before the session. On arrival at the study centre, carbon monoxide (CO) will be measured in&#xD;
      participants' expired breath. If CO will be less than 15 parts per million (ppm), the&#xD;
      assigned study treatment will be allocated; however, if CO was &gt; 15 ppm or they will report&#xD;
      smoking in the previous 12 h, participants will be rescheduled wherever possible to a&#xD;
      subsequent session.&#xD;
&#xD;
      On the first study day, participants will be randomised to use one of five ordered conditions&#xD;
      (each separated by 3 day): ENDDs (fourth generation) containing nicotine 2,4%; ENDDs (second&#xD;
      generation) containing nicotine 7,4 mg; ENDDs containing nicotine 9 mg; ENDDs nicotine free;&#xD;
      their usual cigarette. Additionally participants will be trained to use an electronic&#xD;
      cigarette. The following tests will be completed at the each visits: Aldehydes; ROM/TOS;&#xD;
      Total thiols; Nicotine; Hydroxypyrene; Cotinine; 1,3-butadiene; Acrylonitrile. After, they&#xD;
      will be cannulated and serial venous blood samples for Aldehydes; ROM/TOS; Total thiols;&#xD;
      Nicotine will be collected at 0.5, 2, 5, 15, 30 and 60 min after being instructed to take 10&#xD;
      puffs. Additionally, levels of carbon monoxide in exhaled breath (eCO) will be measured 0.5,&#xD;
      2, 5, 15, 30 and 60 min after being instructed to take 10 puffs. At 60 min, after being&#xD;
      instructed to take 10 puffs, urine sample for Hydroxypyrene; Cotinine; 1,3-butadiene;&#xD;
      Acrylonitrile will be collected. Participants then will leave the study centre with&#xD;
      instructions to continue their usual daily activities and to use the study product regularly&#xD;
      (for at least 10 hrs) and freely throughout the day. At bedtime and after the puffing chronic&#xD;
      phase, when participants will use the study product regularly for at least 10 hrs, urine&#xD;
      sample for Hydroxypyrene; Cotinine; 1,3-butadiene; Acrylonitrile will be collected.&#xD;
      Participants will be allowed to smoke as they will wish once these measures will be collected&#xD;
      and during the 3-day washout period between each study day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 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>nicotine pharmacokinetic</measure>
    <time_frame>0 sec, 30 second, 2 minutes, 5 minutes, 15 minutes, 30 minutes, 60 minutes</time_frame>
    <description>participants will be cannulated and serial venous blood samples for Nicotine will be collected at 0.5, 2, 5, 15, 30 and 60 min after being instructed to take 10 puffs of cigarette</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum levels of carcinogenic and toxic substances (Aldehydes; ROM/TOS; Total thiols)</measure>
    <time_frame>0 sec, 30 second, 2 minutes, 5 minutes, 15 minutes, 30 minutes, 60 minutes</time_frame>
    <description>Compare serum levels of carcinogenic and toxic substances of &quot;Categoria&quot; electronic cigarettes labelled Original 7,4 mg nicotine , Disposable &quot;Categoria&quot; electronic cigarettes labelled One 2,4% nicotine, Disposable &quot;Categoria&quot; electronic cigarettes labelled nicotine free, electronic cigarettes labelled Ego 9mg nicotine with usual cigarettes.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">15</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>
    <arm_group_label>Own Brand cigarette</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>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 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>Original 7,4 mg 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>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>
    <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>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>
    <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>
  <overall_official>
    <last_name>Riccardo Polosa, MD, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Catania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro per la Prevenzione e Cura del Tabagismo</name>
      <address>
        <city>Catania</city>
        <zip>95124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <results_reference>
    <citation>Goniewicz ML, Kuma T, Gawron M, Knysak J, Kosmider L. Nicotine levels in electronic cigarettes. Nicotine Tob Res. 2013 Jan;15(1):158-66. doi: 10.1093/ntr/nts103. Epub 2012 Apr 22.</citation>
    <PMID>22529223</PMID>
  </results_reference>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>July 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>December 12, 2012</last_update_submitted>
  <last_update_submitted_qc>December 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 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 of Internal Medicine</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/NCT01665066
org study id: KINECIG UNICT 526 /12 (Polosa)
secondary id: Polosa-Caponnetto 2012
nct id: NCT01665066
lead sponsor: 
collaborator: 
has dmc: No
The aim of the present study is to compare serum nicotine levels of different e-Cigarette
      strength with usual cigarettes. Serum levels of carcinogenic and toxic substances will be
      also compared.
The study is randomised cross-over trial designed to compare: 1) serum nicotine levels of
      four different e-Cigarette strength ; 2) Serum levels of carcinogenic and toxic substances
      will be also compared. 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 less than 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
      (each separated by 3 day): ENDDs (fourth generation) containing nicotine 2,4%; ENDDs (second
      generation) containing nicotine 7,4 mg; ENDDs containing nicotine 9 mg; ENDDs 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: Aldehydes; ROM/TOS;
      Total thiols; Nicotine; Hydroxypyrene; Cotinine; 1,3-butadiene; Acrylonitrile. After, they
      will be cannulated and serial venous blood samples for Aldehydes; ROM/TOS; Total thiols;
      Nicotine will be collected at 0.5, 2, 5, 15, 30 and 60 min after being instructed to take 10
      puffs. Additionally, levels of carbon monoxide in exhaled breath (eCO) will be measured 0.5,
      2, 5, 15, 30 and 60 min after being instructed to take 10 puffs. At 60 min, after being
      instructed to take 10 puffs, urine sample for Hydroxypyrene; Cotinine; 1,3-butadiene;
      Acrylonitrile will be collected. Participants then will leave the study centre with
      instructions to continue their usual daily activities and to use the study product regularly
      (for at least 10 hrs) and freely throughout the day. At bedtime and after the puffing chronic
      phase, when participants will use the study product regularly for at least 10 hrs, urine
      sample for Hydroxypyrene; Cotinine; 1,3-butadiene; Acrylonitrile will be collected.
      Participants will be allowed to smoke as they will wish once these measures will be collected
      and during the 3-day washout period between each study day.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: nicotine pharmacokinetic
time frame: 0 sec, 30 second, 2 minutes, 5 minutes, 15 minutes, 30 minutes, 60 minutes
description: participants will be cannulated and serial venous blood samples for Nicotine will be collected at 0.5, 2, 5, 15, 30 and 60 min after being instructed to take 10 puffs of cigarette
measure: Serum levels of carcinogenic and toxic substances (Aldehydes; ROM/TOS; Total thiols)
time frame: 0 sec, 30 second, 2 minutes, 5 minutes, 15 minutes, 30 minutes, 60 minutes
description: Compare serum levels of carcinogenic and toxic substances of "Categoria" electronic cigarettes labelled Original 7,4 mg nicotine , Disposable "Categoria" electronic cigarettes labelled One 2,4% nicotine, Disposable "Categoria" electronic cigarettes labelled nicotine free, electronic cigarettes labelled Ego 9mg 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
arm group label: Own Brand cigarette
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: One High 2,4% nicotine
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: Original 7,4 mg 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: Nicotine Free
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: EGO 9mg
arm group label: Nicotine Free
arm group label: One High 2,4% nicotine
arm group label: Original 7,4 mg 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
last name: Riccardo Polosa, MD, Phd
role: Principal Investigator
affiliation: University of Catania
facility: 
country: Italy
citation: Goniewicz ML, Kuma T, Gawron M, Knysak J, Kosmider L. Nicotine levels in electronic cigarettes. Nicotine Tob Res. 2013 Jan;15(1):158-66. doi: 10.1093/ntr/nts103. Epub 2012 Apr 22.
PMID: 22529223
responsible party type: Principal Investigator
investigator affiliation: Universita degli Studi di Catania
investigator full name: Riccardo Polosa
investigator title: Professor of Internal Medicine
mesh term: Tobacco Use Disorder
mesh term: Nicotine