<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/NCT02210754</url>
  </required_header>
  <id_info>
    <org_study_id>Galileo</org_study_id>
    <nct_id>NCT02210754</nct_id>
  </id_info>
  <brief_title>Characterization of Nicotine Exposure and Urge-to-Smoke Following Use of Electronic and Conventional Cigarettes</brief_title>
  <official_title>Characterization of Nicotine Exposure and Urge-to-Smoke Following a Single Controlled Administration and Short-Term Ad Lib Use of Electronic Cigarettes and Conventional Cigarettes in Adult Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lorillard Tobacco Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lorillard Tobacco Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial was the initial characterization of the blu™ products being studied, with the&#xD;
      purpose of gaining an understanding of the exposure to nicotine and craving reduction&#xD;
      attained following use of blu™ e-cigarettes by adult smokers. Two types of exposures were&#xD;
      utilized: a single controlled administration and a short-term ad lib use. As smoking&#xD;
      behaviors vary from smoker to smoker, a controlled administration allows for some&#xD;
      standardization of nicotine &quot;dose&quot; for each of the study products to better understand their&#xD;
      uptake characteristics as well as urge reduction achieved under controlled conditions.&#xD;
      Further evaluation under ad lib product use conditions provides insight into product&#xD;
      self-administration behaviors that will allow subjects to achieve acceptable levels of urge&#xD;
      reduction. Comparisons were made to evaluate differences between blu™ formulations as well as&#xD;
      to the market-leading conventional cigarette, Marlboro Gold King Size (&quot;Marlboro cigarette').&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a randomized, partially single-blinded, 6-period crossover study of 24 subjects.&#xD;
&#xD;
      The primary objectives of this study were to:&#xD;
&#xD;
        1. characterize the rate and extent of nicotine exposure following a single controlled&#xD;
           administration and ad lib use of blu™ e-cigarettes,&#xD;
&#xD;
        2. characterize smoking urge following a single controlled administration and ad lib use of&#xD;
           blu™ e cigarettes.&#xD;
&#xD;
      The secondary objectives of this study were to:&#xD;
&#xD;
        1. Compare the pharmacokinetic (PK) profile of nicotine between selected blu™ formulations&#xD;
           and between the blu™ products and Marlboro cigarettes following a single controlled&#xD;
           administration and ad lib use of each study product.&#xD;
&#xD;
        2. Compare changes in smoking urge within and between selected blu™ formulations and&#xD;
           between the blu™ products and Marlboro cigarettes following a single controlled&#xD;
           administration and ad lib use of each study product.&#xD;
&#xD;
        3. Compare the changes in exhaled carbon monoxide (CO) within and between selected blu™&#xD;
           formulations and between the blu™ products and Marlboro cigarettes following use of each&#xD;
           study product.&#xD;
&#xD;
        4. Assess the tolerability of each study product following short-term use.&#xD;
&#xD;
      Subjects were provided blu™ Classic Tobacco and Magnificent Menthol products containing 2.4%&#xD;
      nicotine, glycerin vehicle for 1 week prior to participation in the study to familiarize&#xD;
      themselves with the use of the products. Subjects were confined to the clinic for the entire&#xD;
      study duration and abstained from use of nicotine containing products for a period of at&#xD;
      least 36 hours prior to each product administration. Each product administration included a&#xD;
      controlled product administration and a 1 hour ad lib use of the study products. The&#xD;
      controlled product administration consisted of 50 inhalations of the assigned e-cigarette&#xD;
      product (5-second inhalations at 30-second intervals) or smoking one Marlboro cigarette&#xD;
      (30-second intervals with the subjects' normal inhalation duration) with inhalations&#xD;
      monitored by the clinical staff. The start of the ad lib product use was 30 minutes following&#xD;
      the start of the controlled product use. During ad lib use, subjects were allowed to&#xD;
      self-administer the e-cigarette product as desired for the entire hour and were responsible&#xD;
      for maintaining their own inhalation counts. During the ad lib cigarette product use,&#xD;
      subjects requested the product from the staff as desired and maintained their own inhalation&#xD;
      counts.&#xD;
&#xD;
      Pharmacokinetics: Blood samples for the measurement of plasma nicotine concentrations were&#xD;
      taken by direct venipuncture at 10 minutes prior to, and 5, 10, 15, 20, 25, 30, 45, 60, 75,&#xD;
      and 90 minutes following the start of the controlled product administration.&#xD;
      Non-compartmental PK parameters such as Peak Plasma Concentration and Area under the Plasma&#xD;
      Concentration versus time curve were calculated from the plasma nicotine concentration-time&#xD;
      data.&#xD;
&#xD;
      Pharmacodynamics: Smoking urge was assessed using a 100 mm visual analog scale (VAS).&#xD;
      Assessments occurred within 1 minute prior to the -10 (pre-product administration), 5, 15,&#xD;
      25, 30, 60, and 90-minute PK blood draws. The following non-compartmental Pharmacodynamic&#xD;
      parameters were calculated from the smoking urge change-from-baseline data: Emax0-30,&#xD;
      Emaxreduction0-30, AUEC0-30, tEmax0-30, AUEC30-90, and E90.&#xD;
&#xD;
      Other Measurements: Exhaled CO measurements occurred at approximately 20 minutes prior to the&#xD;
      start of the controlled product use and at approximately 15 minutes following the end of the&#xD;
      ad lib product use.&#xD;
&#xD;
      Tolerability: Adverse events, physical examinations, vital signs, ECGs, and laboratory safety&#xD;
      tests were assessed to evaluate enrolment criteria and subject safety during the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Profile nicotine pharmacokinetics following use of e-cigs and regular cigarettes</measure>
    <time_frame>6 months</time_frame>
    <description>Measure plasma nicotine PK outcome measures such as Peak Plasma Concentration and Area under the Plasma Concentration versus time curve.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess smoking urge scores on the Visual Analog Scale following use of electronic and regular cigarettes</measure>
    <time_frame>6 months</time_frame>
    <description>Smoking urge was assessed using a 100 mm visual analog scale (VAS). Assessments occurred within 1 minute prior to the -10 (pre-product administration), 5, 15, 25, 30, 60, and 90-minute PK blood draws on Days 1, 3, 5, 7, 9, and 11. The 30-minute assessment was intended to coincide with the start of the ad lib product use. The following non-compartmental pharmacodynamic parameters were calculated from the smoking urge change-from-baseline data: Maximum smoking urge reduction and change-from-baseline from time zero to 30 minutes, area under the effect curve (smoking urge change-from-baseline) from time 0 to 30 minutes and 30 to 90 minutes,time of the maximum (positive or negative) smoking urge change-from-baseline from time 0 to 30 minutes and Observed smoking urge change-from-baseline at 90 minutes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Evaluation of the Number of Participants with Adverse Effects, Vital Signs, and Concomitant Medications</measure>
    <time_frame>6 months</time_frame>
    <description>AE seriousness, severity, and relationship to study product were assessed.</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>E-cigarette 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E-cigarette 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/propylene glycol (PG) vehicle)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E-cigarette 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E-cigarette 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E-cigarette 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combustible Cigarette</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Marlboro Cigarette</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle)</intervention_name>
    <description>electronic cigarettes</description>
    <arm_group_label>Combustible Cigarette</arm_group_label>
    <arm_group_label>E-cigarette 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle)</intervention_name>
    <description>electronic cigarettes</description>
    <arm_group_label>Combustible Cigarette</arm_group_label>
    <arm_group_label>E-cigarette 1</arm_group_label>
    <arm_group_label>E-cigarette 3</arm_group_label>
    <arm_group_label>E-cigarette 5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle)</intervention_name>
    <description>electronic cigarettes</description>
    <arm_group_label>Combustible Cigarette</arm_group_label>
    <arm_group_label>E-cigarette 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle)</intervention_name>
    <description>electronic cigarettes</description>
    <arm_group_label>Combustible Cigarette</arm_group_label>
    <arm_group_label>E-cigarette 5</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)</intervention_name>
    <description>electronic cigarettes</description>
    <arm_group_label>Combustible Cigarette</arm_group_label>
    <arm_group_label>E-cigarette 2</arm_group_label>
    <arm_group_label>E-cigarette 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Marlboro Cigarette</intervention_name>
    <description>cigarettes</description>
    <arm_group_label>E-cigarette 1</arm_group_label>
    <arm_group_label>E-cigarette 2</arm_group_label>
    <arm_group_label>E-cigarette 3</arm_group_label>
    <arm_group_label>E-cigarette 4</arm_group_label>
    <arm_group_label>E-cigarette 5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adult male and female smokers&#xD;
&#xD;
          -  21 to 65 years of age, inclusive, at Screening.&#xD;
&#xD;
          -  Smoker for at least 12 months prior to Check-in&#xD;
&#xD;
          -  Currently smoked an average of 10 or more manufactured cigarettes per day (no&#xD;
             restriction on brand-style, king size [ approx. 83 - 85 mm] and 100s [approximately 98&#xD;
             - 100 mm] only)&#xD;
&#xD;
          -  A history of e-cigarette use was allowed.&#xD;
&#xD;
          -  Females of childbearing potential agreed to use a PI-approved method of contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of tobacco- or nicotine-containing products other than manufactured cigarettes and&#xD;
             e-cigarettes (e.g., roll-your-own cigarettes, bidis, snuff, snus, tablets, inhalers,&#xD;
             pipes, cigars, chewing tobacco, nicotine replacement therapies [e.g., gum, patches,&#xD;
             lozenges, nasal spray, or inhalers]) within 28 days prior to Day 1 product&#xD;
             administration or during the study.&#xD;
&#xD;
          -  Use of any prescription smoking cessation treatments, including, but not limited to,&#xD;
             varenicline (Chantix®) or buproprion (Zyban®) within 3 months prior to Day 1 product&#xD;
             administration and throughout the study.&#xD;
&#xD;
          -  Known hypersensitivity to menthol, glycerol, or propylene glycol (PG).&#xD;
&#xD;
          -  Exhaled CO ≤ 10 ppm at Screening.&#xD;
&#xD;
          -  Self-reported puffers (i.e., smokers who draw smoke from the cigarette into the mouth&#xD;
             and throat but do not inhale).&#xD;
&#xD;
          -  Use of medications known to interact with cytochrome P450 2A6 (including, but not&#xD;
             limited to, amiodarone, desipramine, isoniazid, ketoconazole, miconazole,&#xD;
             phenobarbital, rifampin, tranylcypromine, and methoxsalen) within 3 months prior to&#xD;
             Day 1 product administration.&#xD;
&#xD;
          -  History of drug or alcohol abuse within 24 months of Day 1 product administration&#xD;
&#xD;
          -  Female subjects who were pregnant, lactating, or intended to become pregnant from&#xD;
             Screening through completion of study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael R. Gartner, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Celerion</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Celerion</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nicotine</keyword>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Pharmacodynamics</keyword>
  <keyword>blu e-cigs</keyword>
  <keyword>Tolerability</keyword>
  <keyword>Safety</keyword>
  <keyword>Smoke urge</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Menthol</mesh_term>
    <mesh_term>Nicotine</mesh_term>
    <mesh_term>Glycerol</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/NCT02210754
org study id: Galileo
nct id: NCT02210754
lead sponsor: 
has dmc: No
This trial was the initial characterization of the blu™ products being studied, with the
      purpose of gaining an understanding of the exposure to nicotine and craving reduction
      attained following use of blu™ e-cigarettes by adult smokers. Two types of exposures were
      utilized: a single controlled administration and a short-term ad lib use. As smoking
      behaviors vary from smoker to smoker, a controlled administration allows for some
      standardization of nicotine "dose" for each of the study products to better understand their
      uptake characteristics as well as urge reduction achieved under controlled conditions.
      Further evaluation under ad lib product use conditions provides insight into product
      self-administration behaviors that will allow subjects to achieve acceptable levels of urge
      reduction. Comparisons were made to evaluate differences between blu™ formulations as well as
      to the market-leading conventional cigarette, Marlboro Gold King Size ("Marlboro cigarette').
This was a randomized, partially single-blinded, 6-period crossover study of 24 subjects.

      The primary objectives of this study were to:

        1. characterize the rate and extent of nicotine exposure following a single controlled
           administration and ad lib use of blu™ e-cigarettes,

        2. characterize smoking urge following a single controlled administration and ad lib use of
           blu™ e cigarettes.

      The secondary objectives of this study were to:

        1. Compare the pharmacokinetic (PK) profile of nicotine between selected blu™ formulations
           and between the blu™ products and Marlboro cigarettes following a single controlled
           administration and ad lib use of each study product.

        2. Compare changes in smoking urge within and between selected blu™ formulations and
           between the blu™ products and Marlboro cigarettes following a single controlled
           administration and ad lib use of each study product.

        3. Compare the changes in exhaled carbon monoxide (CO) within and between selected blu™
           formulations and between the blu™ products and Marlboro cigarettes following use of each
           study product.

        4. Assess the tolerability of each study product following short-term use.

      Subjects were provided blu™ Classic Tobacco and Magnificent Menthol products containing 2.4%
      nicotine, glycerin vehicle for 1 week prior to participation in the study to familiarize
      themselves with the use of the products. Subjects were confined to the clinic for the entire
      study duration and abstained from use of nicotine containing products for a period of at
      least 36 hours prior to each product administration. Each product administration included a
      controlled product administration and a 1 hour ad lib use of the study products. The
      controlled product administration consisted of 50 inhalations of the assigned e-cigarette
      product (5-second inhalations at 30-second intervals) or smoking one Marlboro cigarette
      (30-second intervals with the subjects' normal inhalation duration) with inhalations
      monitored by the clinical staff. The start of the ad lib product use was 30 minutes following
      the start of the controlled product use. During ad lib use, subjects were allowed to
      self-administer the e-cigarette product as desired for the entire hour and were responsible
      for maintaining their own inhalation counts. During the ad lib cigarette product use,
      subjects requested the product from the staff as desired and maintained their own inhalation
      counts.

      Pharmacokinetics: Blood samples for the measurement of plasma nicotine concentrations were
      taken by direct venipuncture at 10 minutes prior to, and 5, 10, 15, 20, 25, 30, 45, 60, 75,
      and 90 minutes following the start of the controlled product administration.
      Non-compartmental PK parameters such as Peak Plasma Concentration and Area under the Plasma
      Concentration versus time curve were calculated from the plasma nicotine concentration-time
      data.

      Pharmacodynamics: Smoking urge was assessed using a 100 mm visual analog scale (VAS).
      Assessments occurred within 1 minute prior to the -10 (pre-product administration), 5, 15,
      25, 30, 60, and 90-minute PK blood draws. The following non-compartmental Pharmacodynamic
      parameters were calculated from the smoking urge change-from-baseline data: Emax0-30,
      Emaxreduction0-30, AUEC0-30, tEmax0-30, AUEC30-90, and E90.

      Other Measurements: Exhaled CO measurements occurred at approximately 20 minutes prior to the
      start of the controlled product use and at approximately 15 minutes following the end of the
      ad lib product use.

      Tolerability: Adverse events, physical examinations, vital signs, ECGs, and laboratory safety
      tests were assessed to evaluate enrolment criteria and subject safety during the study.
allocation: Randomized
intervention model: Crossover Assignment
masking: Single (Participant)
measure: Profile nicotine pharmacokinetics following use of e-cigs and regular cigarettes
time frame: 6 months
description: Measure plasma nicotine PK outcome measures such as Peak Plasma Concentration and Area under the Plasma Concentration versus time curve.
measure: Assess smoking urge scores on the Visual Analog Scale following use of electronic and regular cigarettes
time frame: 6 months
description: Smoking urge was assessed using a 100 mm visual analog scale (VAS). Assessments occurred within 1 minute prior to the -10 (pre-product administration), 5, 15, 25, 30, 60, and 90-minute PK blood draws on Days 1, 3, 5, 7, 9, and 11. The 30-minute assessment was intended to coincide with the start of the ad lib product use. The following non-compartmental pharmacodynamic parameters were calculated from the smoking urge change-from-baseline data: Maximum smoking urge reduction and change-from-baseline from time zero to 30 minutes, area under the effect curve (smoking urge change-from-baseline) from time 0 to 30 minutes and 30 to 90 minutes,time of the maximum (positive or negative) smoking urge change-from-baseline from time 0 to 30 minutes and Observed smoking urge change-from-baseline at 90 minutes.
measure: Evaluation of the Number of Participants with Adverse Effects, Vital Signs, and Concomitant Medications
time frame: 6 months
description: AE seriousness, severity, and relationship to study product were assessed.
arm group label: E-cigarette 1
arm group type: Experimental
description: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle)
arm group label: E-cigarette 2
arm group type: Experimental
description: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/propylene glycol (PG) vehicle)
arm group label: E-cigarette 3
arm group type: Experimental
description: blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle)
arm group label: E-cigarette 4
arm group type: Experimental
description: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle)
arm group label: E-cigarette 5
arm group type: Experimental
description: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)
arm group label: Combustible Cigarette
arm group type: Active Comparator
description: Marlboro Cigarette
intervention type: Other
intervention name: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle)
description: electronic cigarettes
arm group label: Combustible Cigarette
arm group label: E-cigarette 2
intervention type: Other
intervention name: blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle)
description: electronic cigarettes
arm group label: Combustible Cigarette
arm group label: E-cigarette 1
arm group label: E-cigarette 3
arm group label: E-cigarette 5
intervention type: Other
intervention name: blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle)
description: electronic cigarettes
arm group label: Combustible Cigarette
arm group label: E-cigarette 2
intervention type: Other
intervention name: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle)
description: electronic cigarettes
arm group label: Combustible Cigarette
arm group label: E-cigarette 5
intervention type: Other
intervention name: blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)
description: electronic cigarettes
arm group label: Combustible Cigarette
arm group label: E-cigarette 2
arm group label: E-cigarette 4
intervention type: Other
intervention name: Marlboro Cigarette
description: cigarettes
arm group label: E-cigarette 1
arm group label: E-cigarette 2
arm group label: E-cigarette 3
arm group label: E-cigarette 4
arm group label: E-cigarette 5
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael R. Gartner, MD
role: Principal Investigator
affiliation: Celerion
facility: 
country: United States
responsible party type: Sponsor
mesh term: Menthol
mesh term: Nicotine
mesh term: Glycerol