<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/NCT03294356</url>
  </required_header>
  <id_info>
    <org_study_id>CSD170304</org_study_id>
    <nct_id>NCT03294356</nct_id>
  </id_info>
  <brief_title>CSD170304: Study to Assess Nicotine Uptake in Smokers From Electronic and Combustible Cigarettes</brief_title>
  <official_title>CSD170304: An Unblinded, Parallel, Randomized Study to Assess Nicotine Uptake in Smokers From Electronic and Combustible Cigarettes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RAI Services Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Covance</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>RAI Services Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of five&#xD;
      different marketed electronic cigarettes, or one combustible cigarette (CC). Furthermore, to&#xD;
      measure overall product liking by subjects to assess potential willingness to seek out the&#xD;
      Electronic Cigarette (EC) again in the future.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single-center, randomized, open-label, parallel study during which up to 210&#xD;
      healthy adult subjects, consisting of 35 subjects per product group, will be enrolled.&#xD;
      Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The&#xD;
      study will involve the use of five different marketed ECs or one CC in tobacco consumers who&#xD;
      are exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e.,&#xD;
      intermittent EC users).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2017</start_date>
  <completion_date type="Actual">November 2, 2017</completion_date>
  <primary_completion_date type="Actual">November 2, 2017</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cmax (Maximum baseline-adjusted nicotine plasma concentration)</measure>
    <time_frame>-5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes</time_frame>
    <description>To assess nicotine uptake with the start of a 10-minute ad libitum Investigational Product (IP) use period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUCnic0-60</measure>
    <time_frame>-5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes</time_frame>
    <description>Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 60 minutes after the start of a 10-minute ad libitum IP use period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>-5, -0.5, 3, 5, 8, 10, 12, 15 Minutes</time_frame>
    <description>Maximum baseline-adjusted plasma nicotine concentration from time zero to 15 minutes after the start of IP use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCnic0-15</measure>
    <time_frame>-5, -0.5, 3, 5, 8, 10, 12, 15 Minutes</time_frame>
    <description>Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 15 minutes after the start of IP use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PLoverall</measure>
    <time_frame>13 Minutes</time_frame>
    <description>Overall product liking (PL) is an additional measure of how much the subject likes the product, and is indicative of their potential willingness to seek out use of the product again at a later point in time; measured 13 minutes after the start of IP use.</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">210</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>FT210771 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 day at-home use of electronic cigarette FT210771 followed by a 2 day in-clinic period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FT210751 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 day at-home use of electronic cigarette FT210751 followed by a 2 day in-clinic period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6T30134157764 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 day at-home use of electronic cigarette 6T30134157764 followed by a 2 day in-clinic period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>G41A7C071 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 day at-home use of electronic cigarette G41A7C071 followed by a 2 day in-clinic period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>M011161212 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 day at-home use of electronic cigarette M011161212 followed by a 2 day in-clinic period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FT21002 Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 day at-home use of combustible cigarette FT21002 followed by a 2 day in-clinic period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FT210771</intervention_name>
    <description>An electronic cigarette</description>
    <arm_group_label>FT210771 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FT210751</intervention_name>
    <description>An electronic cigarette</description>
    <arm_group_label>FT210751 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>6T30134157764</intervention_name>
    <description>An electronic cigarette</description>
    <arm_group_label>6T30134157764 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>G41A7C071</intervention_name>
    <description>An electronic cigarette</description>
    <arm_group_label>G41A7C071 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>M011161212</intervention_name>
    <description>An electronic cigarette</description>
    <arm_group_label>M011161212 Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>FT21002</intervention_name>
    <description>A combustible cigarette</description>
    <arm_group_label>FT21002 Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) and&#xD;
             complete questionnaires written in English.&#xD;
&#xD;
          2. Generally healthy males and females, 21 to 60 years of age, inclusive, at Screening&#xD;
             Visit.&#xD;
&#xD;
          3. Subjects must meet one (a or b) of the following tobacco use conditions:&#xD;
&#xD;
               1. Exclusive cigarette smoker who self-reports smoking ≥ 10 cigarettes per day for&#xD;
                  at least 6 months prior to Screening Visit. Brief periods of abstinence more than&#xD;
                  30 days prior to Screening due to illness, quit attempt, or clinical study&#xD;
                  participation will be allowed at the discretion of the Principal Investigator&#xD;
                  (PI).&#xD;
&#xD;
               2. Dual user of CCs and ECs who self-reports:&#xD;
&#xD;
             i. Smoking ≥ 10 cigarettes per day for at least 6 months prior to Screening Visit.&#xD;
             Brief periods of abstinence more than 30 days prior to Screening due to illness, quit&#xD;
             attempt, or clinical study participation will be allowed at the discretion of the PI;&#xD;
             and ii. Using a nicotine-containing &quot;cig-a-like&quot; EC or a tank system EC either daily&#xD;
             or at least weekly for at least 3 months prior to Screening Visit.&#xD;
&#xD;
          4. Willing to be confined overnight and abstain from tobacco- and nicotine-containing&#xD;
             product use (with the exception of study IP use) for 12 hours prior to IP use through&#xD;
             Study Discharge.&#xD;
&#xD;
          5. Willing to use assigned IP during the study according to protocol.&#xD;
&#xD;
          6. Expired breath carbon monoxide (ECO) level is ≥ 10 parts per million (ppm) at the&#xD;
             Screening Visit and Study Day 1.&#xD;
&#xD;
          7. Positive urine cotinine test at the Screening Visit and Study Day 1.&#xD;
&#xD;
          8. No intent to quit smoking or vaping from Screening to Study Day 2.&#xD;
&#xD;
          9. Females of childbearing age must be willing to use a form of contraception acceptable&#xD;
             to the PI from the time of signing informed consent until Study Discharge, or be&#xD;
             surgically sterile for at least 90 days prior to the Screening Visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of clinically significant or unstable/uncontrolled acute or chronic medical&#xD;
             condition at the Screening Visit, as determined by the PI, that would preclude a&#xD;
             subject from participating safely in the study (e.g.,, uncontrolled hypertension,&#xD;
             chronic lung disease, cardiac disease, neurological disease, or psychiatric disorders)&#xD;
             based on safety assessments such as clinical laboratory tests, pregnancy tests,&#xD;
             medical history, and physical/oral examinations.&#xD;
&#xD;
          2. At risk for heart disease, as determined by the PI.&#xD;
&#xD;
          3. Systolic blood pressure of &gt; 160 mmHg or a diastolic blood pressure of &gt; 95 mmHg,&#xD;
             measured after being seated for 5 minutes.&#xD;
&#xD;
          4. Weight of ≤ 110 pounds.&#xD;
&#xD;
          5. Poor peripheral venous access.&#xD;
&#xD;
          6. Use of medicine for treatment of depression, unless on a stable dose for the past 6&#xD;
             months prior to screening and deemed clinically stable by the PI.&#xD;
&#xD;
          7. Current on scheduled treatment(s) for asthma within the past consecutive 12 months&#xD;
             prior to screening. If potential subject is on an as-needed treatment, such as rescue&#xD;
             inhalers, subject may be included at the PI's discretion pending approval from the&#xD;
             Medical Monitor.&#xD;
&#xD;
          8. Any history of cancer, except for primary cancers of skin such as localized basal&#xD;
             cell/squamous cell carcinoma that has been surgically or cryogenically removed.&#xD;
&#xD;
          9. Use of any medication or substance that aids in smoking cessation, including but not&#xD;
             limited to any nicotine replacement therapy (NRT) (e.g., nicotine gum, lozenge,&#xD;
             patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract,&#xD;
             within 30 days prior to the Screening Visit.&#xD;
&#xD;
         10. History or presence of hemophilia or other bleeding disorders.&#xD;
&#xD;
         11. History or presence of clotting disorders with concomitant use of anticoagulants&#xD;
             (e.g., clopidogrel [Plavix®], warfarin [Coumadin®, Jantoven®], aspirin [&gt; 325&#xD;
             mg/day]).&#xD;
&#xD;
         12. Participation in another clinical trial within 30 days prior to the time of consent.&#xD;
             The 30-day window for each subject will be derived from the date of the last study&#xD;
             event in the previous study to the time of consent of the current study.&#xD;
&#xD;
         13. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen&#xD;
             (HBsAg), or hepatitis C virus antibody (anti-HCV).&#xD;
&#xD;
         14. Females who have a positive pregnancy test or who are pregnant, breastfeeding, or&#xD;
             intend to become pregnant during the course of the study.&#xD;
&#xD;
         15. Females ≥ 35 years of age currently using systemic, estrogen-containing contraception&#xD;
             or hormone replacement therapy.&#xD;
&#xD;
         16. A positive urine drug screen without disclosure of prescribed corresponding&#xD;
             concomitant medication(s) at the Screening Visit or on Study Day 1.&#xD;
&#xD;
         17. A positive alcohol breathalyzer result at the Screening Visit or on Study Day 1.&#xD;
&#xD;
         18. Employed by a tobacco or nicotine-manufacturing company, the study site, or handles&#xD;
             tobacco or nicotine-containing products as part of their job.&#xD;
&#xD;
         19. Determined by the PI to be inappropriate for the study, including a subject who is&#xD;
             unable to communicate or unwilling to cooperate with the clinical staff.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Corey Anderson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinical Research Consortium (CRC)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Adams, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central Kentucky Research Associates (CKRA)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Daniel Gruener, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis Clinical Trials (SLCT)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Otto Dueno, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Midwest Clinical Research (MCRC)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William Smith, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>New Orleans Center for Clinical Research (NOCCR)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinical Research Consortium (CRC)</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85283</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Kentucky Research Associates (CKRA)</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Clinical Trials (SLCT)</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midwest Clinical Research (MCRC)</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Orleans Center for Clinical Research (NOCCR)</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>November 9, 2017</last_update_submitted>
  <last_update_submitted_qc>November 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03294356
org study id: CSD170304
nct id: NCT03294356
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To determine the rate and amount of nicotine uptake with 10-minute ad libitum use of five
      different marketed electronic cigarettes, or one combustible cigarette (CC). Furthermore, to
      measure overall product liking by subjects to assess potential willingness to seek out the
      Electronic Cigarette (EC) again in the future.
This will be a single-center, randomized, open-label, parallel study during which up to 210
      healthy adult subjects, consisting of 35 subjects per product group, will be enrolled.
      Subjects will be evaluated for plasma nicotine uptake, as well as overall product liking. The
      study will involve the use of five different marketed ECs or one CC in tobacco consumers who
      are exclusive smokers (i.e., naïve EC users) or dual users of cigarettes and ECs (i.e.,
      intermittent EC users).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cmax (Maximum baseline-adjusted nicotine plasma concentration)
time frame: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes
description: To assess nicotine uptake with the start of a 10-minute ad libitum Investigational Product (IP) use period.
measure: AUCnic0-60
time frame: -5, -0.5, 3, 5, 8, 10, 11, 12, 15, 20, 30, 60 Minutes
description: Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 60 minutes after the start of a 10-minute ad libitum IP use period.
measure: Tmax
time frame: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes
description: Maximum baseline-adjusted plasma nicotine concentration from time zero to 15 minutes after the start of IP use.
measure: AUCnic0-15
time frame: -5, -0.5, 3, 5, 8, 10, 12, 15 Minutes
description: Area under the baseline-adjusted nicotine concentration-versus-time curve from time zero to 15 minutes after the start of IP use.
measure: PLoverall
time frame: 13 Minutes
description: Overall product liking (PL) is an additional measure of how much the subject likes the product, and is indicative of their potential willingness to seek out use of the product again at a later point in time; measured 13 minutes after the start of IP use.
arm group label: FT210771 Group
arm group type: Experimental
description: 7 day at-home use of electronic cigarette FT210771 followed by a 2 day in-clinic period.
arm group label: FT210751 Group
arm group type: Experimental
description: 7 day at-home use of electronic cigarette FT210751 followed by a 2 day in-clinic period.
arm group label: 6T30134157764 Group
arm group type: Experimental
description: 7 day at-home use of electronic cigarette 6T30134157764 followed by a 2 day in-clinic period.
arm group label: G41A7C071 Group
arm group type: Experimental
description: 7 day at-home use of electronic cigarette G41A7C071 followed by a 2 day in-clinic period.
arm group label: M011161212 Group
arm group type: Experimental
description: 7 day at-home use of electronic cigarette M011161212 followed by a 2 day in-clinic period.
arm group label: FT21002 Group
arm group type: Experimental
description: 7 day at-home use of combustible cigarette FT21002 followed by a 2 day in-clinic period.
intervention type: Other
intervention name: FT210771
description: An electronic cigarette
arm group label: FT210771 Group
intervention type: Other
intervention name: FT210751
description: An electronic cigarette
arm group label: FT210751 Group
intervention type: Other
intervention name: 6T30134157764
description: An electronic cigarette
arm group label: 6T30134157764 Group
intervention type: Other
intervention name: G41A7C071
description: An electronic cigarette
arm group label: G41A7C071 Group
intervention type: Other
intervention name: M011161212
description: An electronic cigarette
arm group label: M011161212 Group
intervention type: Other
intervention name: FT21002
description: A combustible cigarette
arm group label: FT21002 Group
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Corey Anderson, MD
role: Principal Investigator
affiliation: Clinical Research Consortium (CRC)
last name: Mark Adams, MD
role: Principal Investigator
affiliation: Central Kentucky Research Associates (CKRA)
last name: Daniel Gruener, MD
role: Principal Investigator
affiliation: St. Louis Clinical Trials (SLCT)
last name: Otto Dueno, MD
role: Principal Investigator
affiliation: Midwest Clinical Research (MCRC)
last name: William Smith, MD
role: Principal Investigator
affiliation: New Orleans Center for Clinical Research (NOCCR)
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No