<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/NCT01714778</url>
  </required_header>
  <id_info>
    <org_study_id>QMUL201208a</org_study_id>
    <nct_id>NCT01714778</nct_id>
  </id_info>
  <brief_title>Toxins and Delivery in e-Cigarette Users</brief_title>
  <acronym>TADEUS</acronym>
  <official_title>Electronic Cigarettes: Potential Toxicant (Acrolein) and Nicotine Delivery in Users</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen Mary University of London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Electronic cigarettes or &quot;e-cigarettes&quot; (EC) may have a potential public health benefit as a&#xD;
      safer alternative to smoking and possibly also as an aid in tobacco dependence treatment.&#xD;
      However, there are concerns about their safety and whether they can deliver nicotine&#xD;
      consistently and in doses necessary for such effects.&#xD;
&#xD;
      To be able to consider the safety of ECs and their potential in harm reduction, data are&#xD;
      needed comparing the exposure to the potential toxicant, acrolein, in smokers of conventional&#xD;
      cigarettes, users of EC, and people who use both products at the same time.&#xD;
&#xD;
      To accurately assess EC nicotine delivery, data are needed from people who use them&#xD;
      regularly, as there is some evidence of higher and faster nicotine absorption in experienced&#xD;
      users compared with naïve users who try them once in an artificial laboratory setting.&#xD;
&#xD;
      This study will provide information on both of these issues. Forty smokers will be given EC&#xD;
      to use, in addition to behavioural support, as part of a stop smoking attempt. Levels of&#xD;
      acrolein and nicotine will be measured before and after 4 weeks of EC use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Change in urinary 3HPMA levels after 4 weeks use of electronic cigarettes.</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in urinary 3HPMA levels (a metabolite of acrolein) after 4 weeks use of electronic cigarettes, in both individuals who have stopped smoking conventional cigarettes and those who are still using them.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in nicotine levels after 4 weeks use of electronic cigarettes (EC)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in blood nicotine levels obtained from using an EC after 4 weeks use of electronic cigarettes (10 participants only).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electronic cigarette acceptability</measure>
    <time_frame>6 months</time_frame>
    <description>Participants' views on electronic cigarettes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of electronic cigarettes</measure>
    <time_frame>6 months</time_frame>
    <description>Participants' use of electronic cigarettes</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>e-Cigarette</arm_group_label>
    <description>Smokers attempting to quit with behavioural support and e-Cigarettes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>e-Cigarette</intervention_name>
    <arm_group_label>e-Cigarette</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Urine is collected for analysis of a metabolite of acrolein (3-HPMA_.&#xD;
&#xD;
      Blood is collected for analysis of nicotine.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Smokers from the community who wish to stop smoking.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Smokers who want help in quitting&#xD;
&#xD;
          -  Aged 18 or over&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding&#xD;
&#xD;
          -  People with any current serious illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Queen Mary University of London</name>
      <address>
        <city>London</city>
        <zip>E12JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>October 23, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>March 12, 2014</last_update_submitted>
  <last_update_submitted_qc>March 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01714778
org study id: QMUL201208a
nct id: NCT01714778
lead sponsor: 
has dmc: No
Electronic cigarettes or "e-cigarettes" (EC) may have a potential public health benefit as a
      safer alternative to smoking and possibly also as an aid in tobacco dependence treatment.
      However, there are concerns about their safety and whether they can deliver nicotine
      consistently and in doses necessary for such effects.

      To be able to consider the safety of ECs and their potential in harm reduction, data are
      needed comparing the exposure to the potential toxicant, acrolein, in smokers of conventional
      cigarettes, users of EC, and people who use both products at the same time.

      To accurately assess EC nicotine delivery, data are needed from people who use them
      regularly, as there is some evidence of higher and faster nicotine absorption in experienced
      users compared with naïve users who try them once in an artificial laboratory setting.

      This study will provide information on both of these issues. Forty smokers will be given EC
      to use, in addition to behavioural support, as part of a stop smoking attempt. Levels of
      acrolein and nicotine will be measured before and after 4 weeks of EC use.
observational model: Cohort
time perspective: Prospective
measure: Change in urinary 3HPMA levels after 4 weeks use of electronic cigarettes.
time frame: 4 weeks
description: Change in urinary 3HPMA levels (a metabolite of acrolein) after 4 weeks use of electronic cigarettes, in both individuals who have stopped smoking conventional cigarettes and those who are still using them.
measure: Change in nicotine levels after 4 weeks use of electronic cigarettes (EC)
time frame: 4 weeks
description: Change in blood nicotine levels obtained from using an EC after 4 weeks use of electronic cigarettes (10 participants only).
measure: Electronic cigarette acceptability
time frame: 6 months
description: Participants' views on electronic cigarettes
measure: Use of electronic cigarettes
time frame: 6 months
description: Participants' use of electronic cigarettes
arm group label: e-Cigarette
description: Smokers attempting to quit with behavioural support and e-Cigarettes.
intervention type: Other
intervention name: e-Cigarette
arm group label: e-Cigarette
Urine is collected for analysis of a metabolite of acrolein (3-HPMA_.

      Blood is collected for analysis of nicotine.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor