<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/NCT03749876</url>
  </required_header>
  <id_info>
    <org_study_id>TRDRP Award #580582</org_study_id>
    <nct_id>NCT03749876</nct_id>
  </id_info>
  <brief_title>A Study of Unfiltered Cigarettes Among Committed Smokers</brief_title>
  <official_title>A Randomized Cross-over Clinical Trial of Unfiltered Cigarettes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Diego State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>California State University, San Marcos</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tobacco Related Disease Research Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>San Diego State University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study is an open-label, randomized, 9-week, two-sequence, two-treatment, cross-over&#xD;
      clinical trial of 40 adult filtered cigarette smokers who switch to unfiltered cigarettes&#xD;
      There will be a 1-week baseline period, 2 weeks of smoking filtered or unfiltered cigarettes&#xD;
      (determined at time of randomization), and a 3-week washout period, followed by post-washout&#xD;
      baseline week, and a crossover to 2 weeks of smoking the opposite condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This innovative research project will assess the acceptability among committed smokers of&#xD;
      switching to unfiltered cigarettes from filtered cigarettes and compare the measurement of&#xD;
      exposure to nicotine and carcinogens after such a switch from filtered to unfiltered&#xD;
      cigarettes. Such research will inform regulatory policy regarding the possibility of banning&#xD;
      filters from the U.S. cigarette market. This high-impact pilot project is a randomized,&#xD;
      cross-over clinical trial among smokers to measure changes in their puffing behavior,&#xD;
      carcinogen exposures, nicotine exposure, and attitudes toward smoking unfiltered cigarettes&#xD;
      if they were to no longer able to buy filtered cigarettes. The overall objective for this&#xD;
      pilot trial is to collect preliminary data to inform design of a larger clinical trial in&#xD;
      assessing changes in attitudes toward smoking unfiltered cigarettes; smoking topography; and&#xD;
      urinary cotinine, urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), and volatile&#xD;
      organic compound (VOC) excretion resulting from switching from filtered to unfiltered&#xD;
      cigarettes among a sample of committed smokers.&#xD;
&#xD;
      Aim 1. Determine smokers' satisfaction, and attitudes towards smoking cigarettes if they were&#xD;
      to switch from smoking filtered to unfiltered cigarettes. The investigators hypothesize that&#xD;
      smokers who smoke unfiltered cigarettes will have less satisfaction with their smoking&#xD;
      compared with smoking filtered cigarettes.&#xD;
&#xD;
      Aim 2. Measure changes in smoking topography and cigarettes smoked per day among smokers who&#xD;
      change to unfiltered cigarettes for two weeks compared with these measures while smoking&#xD;
      filtered cigarettes. The investigators hypothesize that smokers who smoke unfiltered&#xD;
      cigarettes for two weeks will change their topography such that they will inhale less deeply&#xD;
      and frequently and will smoke fewer cigarettes per day.&#xD;
&#xD;
      Aim 3. Measure changes in urinary cotinine, NNAL, and VOC excretion among smokers who smoke&#xD;
      unfiltered cigarettes for two weeks compared to smoking filtered cigarettes.&#xD;
&#xD;
      The investigators hypothesize that smokers who smoke unfiltered cigarettes for two weeks will&#xD;
      have lower urinary cotinine, NNAL, and VOC excretion compared with filtered cigarettes.&#xD;
&#xD;
      The results from this trial can inform a larger clinical trial that can be submitted to the&#xD;
      National Institutes of Health/Food and Drug Administration to develop evidence on the&#xD;
      potentially positive impact of removing plastic filters from commercial cigarettes. It will&#xD;
      allow us to develop sound scientific methods to assess the topography of smoking and&#xD;
      excretion of cotinine, tobacco-specific nitrosamines, and VOCs by smokers who smoke&#xD;
      cigarettes with and without filters. This new knowledge may lead the Food and Drug&#xD;
      Administration or specific states to consider banning the sale of filtered cigarettes because&#xD;
      filters make it easier for young people to start smoking, unjustifiably discourage smokers&#xD;
      from quitting, and contaminate the environment with non-biodegradable, toxic waste.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>
    <intervention_model_description>Participants receive one of two alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>The research staff performing the statistical analyses of the outcomes of interest will be masked from knowing the individuals' randomized treatment assignments, as will the principal investigator.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in mean flow rate (mL/s)</measure>
    <time_frame>9 weeks</time_frame>
    <description>Mean flow rate, in mL per second, measures the flow of air through the CReSS as participants smoke cigarettes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of puffs per cigarette</measure>
    <time_frame>9 weeks</time_frame>
    <description>Measured by the CReSS device as participants smoke cigarettes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in duration of each cigarette puff (in seconds)</measure>
    <time_frame>9 weeks</time_frame>
    <description>Measured by the CReSS device as participants smoke cigarettes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in inter-puff interval in seconds</measure>
    <time_frame>9 weeks</time_frame>
    <description>The time between puffs on the cigarette, measured by the CReSS device as participants smoke cigarettes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in volume of each puff (mL)</measure>
    <time_frame>9 weeks</time_frame>
    <description>Measured by the CReSS device as participants smoke cigarettes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in total smoke intake (mL)</measure>
    <time_frame>9 weeks</time_frame>
    <description>Measured by the CReSS device as participants smoke cigarettes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urinary biomarker measurements</measure>
    <time_frame>9 weeks</time_frame>
    <description>Target analytes are creatinine (the main proximate metabolite of nicotine), total (free + conjugated) 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (tNNAL, a carcinogenic tobacco-specific n-nitrosamine metabolite specific to tobacco smoke exposure), and a set of eight volatile organic compounds (VOCs, potentially toxic by-products of tobacco combustion). VOC concentrations will be measured at baseline in this study to account for possible additional sources of VOC exposure (assuming subjects' additional exposure remains consistent). VOCs will be measured as their urinary metabolites; i.e., mercapturic acid derivatives. The target parent VOCs are ethylene oxide, 1,3 butadiene, crotonaldehyde, acrolein, benzene, acrylamide, acrylonitrile, and propylene oxide. The biomarkers' urine concentration will be normalized to creatinine. Baseline midstream urine samples of at least 30 mL will be collected at baseline, post-washout, and at the end of each study cigarette period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cigarette satisfaction: mCEQ</measure>
    <time_frame>9 weeks</time_frame>
    <description>Satisfaction with test cigarettes will be assessed using the 12-item modified Cigarette Evaluation Scale (mCEQ). This validated tool uses visual analog scales to assess subjective ratings: general acceptability (&quot;bad&quot; to &quot;very good&quot;), smoking need (&quot;not at all&quot; to &quot;very strong&quot;), smoking satisfaction (&quot;not at all&quot; to &quot;very good&quot;), harshness (&quot;not at all&quot; to &quot;very strong&quot;) and pleasantness of smoke taste (&quot;not tasty at all&quot; to &quot;very tasty&quot;). Open-ended questions will also be asked regarding subject's experience smoking unfiltered cigarettes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in answers to Stanford Perceptions Survey of Youth questions</measure>
    <time_frame>9 weeks</time_frame>
    <description>Qualitative questions assessing knowledge abut cigarette filters, behaviors if filtered cigarettes were no longer available, and support for policy related to filtered cigarettes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in perceptions of cigarette harshness</measure>
    <time_frame>9 weeks</time_frame>
    <description>As measured by a visual analog scale of 0 (not harsh at all) to 100 (extremely harsh)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in perceptions of cigarette draw</measure>
    <time_frame>9 weeks</time_frame>
    <description>As measured by a visual analog scale of 0 (very hard to draw smoke) to 100 (very easy to draw smoke)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Cigarette Smoking</condition>
  <condition>Tobacco Smoking</condition>
  <arm_group>
    <arm_group_label>Study Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study Group 1 will begin the first treatment period with the provided Unfiltered Cigarettes intervention for two weeks, followed by a three-week wash-out period, before switching to the provided Filtered Cigarette intervention for two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study Group 2 will begin the first treatment period with the provided Filtered Cigarettes intervention for two weeks, followed by a three-week wash-out period, before switching to the provided Unfiltered Cigarette intervention for two weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Unfiltered Cigarettes</intervention_name>
    <description>Participants will be given unfiltered Pall Mall or Camel cigarettes to smoke for two weeks according to the brand they smoked prior to the start of the study. They will agree to smoke the cigarettes using a monitoring device (CReSS) that measures puffing behavior on five (5) days during each of the two weeks. They will also collect their cigarette butts on all days as a measure of smoking behaviors.</description>
    <arm_group_label>Study Group 1</arm_group_label>
    <arm_group_label>Study Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Filtered Cigarettes</intervention_name>
    <description>Participants will be given filtered Pall Mall or Camel cigarettes to smoke for two weeks according to the brand they smoked prior to the start of the study. They will agree to smoke the cigarettes using a monitoring device (CReSS) that measures puffing behavior on five (5) days during each of the two weeks. They will also collect their cigarette butts on all days as a measure of smoking behaviors.</description>
    <arm_group_label>Study Group 1</arm_group_label>
    <arm_group_label>Study Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Are non-institutionalized, and&#xD;
&#xD;
          -  Able to provide informed consent, and&#xD;
&#xD;
          -  Are ages 21 to 65, and&#xD;
&#xD;
          -  Smoke at least 25 days per month, and&#xD;
&#xD;
          -  Smoke at least 5 cigarettes per day on the days they smoke, and&#xD;
&#xD;
          -  Have been smoking cigarettes for at least 1 year, and&#xD;
&#xD;
          -  Have smoked exclusively Camel or Pall Mall cigarettes over the past two weeks, or are&#xD;
             willing to do so for the two weeks prior to, and for seven weeks during, the study,&#xD;
             and&#xD;
&#xD;
          -  Are fluent in English, and&#xD;
&#xD;
          -  Have regular access to a telephone, and&#xD;
&#xD;
          -  Have smoked only filtered cigarettes for the past year, and&#xD;
&#xD;
          -  Have access to transportation to California State University, San Marcos (CSUSM), and&#xD;
&#xD;
          -  Report primary (≥50% of the time) smoking of cigarettes, allowing for secondary use of&#xD;
             other tobacco products, and&#xD;
&#xD;
          -  Agree to the terms of the trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Do not meet one or more of the above inclusion criteria, or&#xD;
&#xD;
          -  Self-report uncontrolled diabetes (i.e., diagnosed with diabetes, and it is not being&#xD;
             managed by a physician), or&#xD;
&#xD;
          -  Present to the enrollment visit with a systolic blood pressure greater than 160 mm Hg&#xD;
             or a diastolic blood pressure greater than 105 mm Hg, or&#xD;
&#xD;
          -  Self-report involvement in another clinical trial, or&#xD;
&#xD;
          -  Self-report hospitalization for psychiatric issues or had a heart-related event (e.g.&#xD;
             heart attack) at enrollment or within the past 30 days, or&#xD;
&#xD;
          -  Self-report attempts to quit or cut down on smoking in past 30 days, or&#xD;
&#xD;
          -  Self-report use of pharmacotherapy to aid smoking cessation within the past 30 days,&#xD;
             or&#xD;
&#xD;
          -  Are breastfeeding, pregnant, or may become pregnant during the next six months, or&#xD;
&#xD;
          -  Are planning to move out of San Diego in the next 9 weeks, or&#xD;
&#xD;
          -  Do not meet expected expired carbon monoxide (CO) measurements of smokers (Expired CO&#xD;
             measurements&gt;10 parts per million (ppm) will confirm status as a current smoker of at&#xD;
             &gt;5 cigarettes/day on the initial visit), or&#xD;
&#xD;
          -  Are deemed mentally unstable (i.e., psychotic, under influence of drugs or alcohol, or&#xD;
             unable to comprehend the call or meeting) or physically unfit (i.e, physically unwell)&#xD;
             to participate in the study based on the researcher's determination at the enrollment&#xD;
             visit&#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>Eyal Oren, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Diego State University School of Public Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kimberly Pulvers, Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>California State University, San Marcos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>California State University San Marcos</name>
      <address>
        <city>San Marcos</city>
        <state>California</state>
        <zip>92096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>October 20, 2020</last_update_submitted>
  <last_update_submitted_qc>October 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>San Diego State University</investigator_affiliation>
    <investigator_full_name>Eyal Oren</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Cigarette filters</keyword>
  <keyword>Cigarette smoking</keyword>
  <keyword>Unfiltered cigarettes</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual participant data (IPD), including a data dictionary, will be shared with the study's Data Safety and Monitoring Board (DSMB), or potentially with other collaborators in the future. It is not yet determined if there will be a plan to make the IPD available.</ipd_description>
  </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/NCT03749876
org study id: TRDRP Award #580582
nct id: NCT03749876
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is an open-label, randomized, 9-week, two-sequence, two-treatment, cross-over
      clinical trial of 40 adult filtered cigarette smokers who switch to unfiltered cigarettes
      There will be a 1-week baseline period, 2 weeks of smoking filtered or unfiltered cigarettes
      (determined at time of randomization), and a 3-week washout period, followed by post-washout
      baseline week, and a crossover to 2 weeks of smoking the opposite condition.
This innovative research project will assess the acceptability among committed smokers of
      switching to unfiltered cigarettes from filtered cigarettes and compare the measurement of
      exposure to nicotine and carcinogens after such a switch from filtered to unfiltered
      cigarettes. Such research will inform regulatory policy regarding the possibility of banning
      filters from the U.S. cigarette market. This high-impact pilot project is a randomized,
      cross-over clinical trial among smokers to measure changes in their puffing behavior,
      carcinogen exposures, nicotine exposure, and attitudes toward smoking unfiltered cigarettes
      if they were to no longer able to buy filtered cigarettes. The overall objective for this
      pilot trial is to collect preliminary data to inform design of a larger clinical trial in
      assessing changes in attitudes toward smoking unfiltered cigarettes; smoking topography; and
      urinary cotinine, urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), and volatile
      organic compound (VOC) excretion resulting from switching from filtered to unfiltered
      cigarettes among a sample of committed smokers.

      Aim 1. Determine smokers' satisfaction, and attitudes towards smoking cigarettes if they were
      to switch from smoking filtered to unfiltered cigarettes. The investigators hypothesize that
      smokers who smoke unfiltered cigarettes will have less satisfaction with their smoking
      compared with smoking filtered cigarettes.

      Aim 2. Measure changes in smoking topography and cigarettes smoked per day among smokers who
      change to unfiltered cigarettes for two weeks compared with these measures while smoking
      filtered cigarettes. The investigators hypothesize that smokers who smoke unfiltered
      cigarettes for two weeks will change their topography such that they will inhale less deeply
      and frequently and will smoke fewer cigarettes per day.

      Aim 3. Measure changes in urinary cotinine, NNAL, and VOC excretion among smokers who smoke
      unfiltered cigarettes for two weeks compared to smoking filtered cigarettes.

      The investigators hypothesize that smokers who smoke unfiltered cigarettes for two weeks will
      have lower urinary cotinine, NNAL, and VOC excretion compared with filtered cigarettes.

      The results from this trial can inform a larger clinical trial that can be submitted to the
      National Institutes of Health/Food and Drug Administration to develop evidence on the
      potentially positive impact of removing plastic filters from commercial cigarettes. It will
      allow us to develop sound scientific methods to assess the topography of smoking and
      excretion of cotinine, tobacco-specific nitrosamines, and VOCs by smokers who smoke
      cigarettes with and without filters. This new knowledge may lead the Food and Drug
      Administration or specific states to consider banning the sale of filtered cigarettes because
      filters make it easier for young people to start smoking, unjustifiably discourage smokers
      from quitting, and contaminate the environment with non-biodegradable, toxic waste.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Participants receive one of two alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study.
primary purpose: Basic Science
masking: Double (Investigator, Outcomes Assessor)
masking description: The research staff performing the statistical analyses of the outcomes of interest will be masked from knowing the individuals' randomized treatment assignments, as will the principal investigator.
measure: Change in mean flow rate (mL/s)
time frame: 9 weeks
description: Mean flow rate, in mL per second, measures the flow of air through the CReSS as participants smoke cigarettes.
measure: Change in number of puffs per cigarette
time frame: 9 weeks
description: Measured by the CReSS device as participants smoke cigarettes
measure: Change in duration of each cigarette puff (in seconds)
time frame: 9 weeks
description: Measured by the CReSS device as participants smoke cigarettes
measure: Change in inter-puff interval in seconds
time frame: 9 weeks
description: The time between puffs on the cigarette, measured by the CReSS device as participants smoke cigarettes
measure: Change in volume of each puff (mL)
time frame: 9 weeks
description: Measured by the CReSS device as participants smoke cigarettes
measure: Change in total smoke intake (mL)
time frame: 9 weeks
description: Measured by the CReSS device as participants smoke cigarettes
measure: Urinary biomarker measurements
time frame: 9 weeks
description: Target analytes are creatinine (the main proximate metabolite of nicotine), total (free + conjugated) 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (tNNAL, a carcinogenic tobacco-specific n-nitrosamine metabolite specific to tobacco smoke exposure), and a set of eight volatile organic compounds (VOCs, potentially toxic by-products of tobacco combustion). VOC concentrations will be measured at baseline in this study to account for possible additional sources of VOC exposure (assuming subjects' additional exposure remains consistent). VOCs will be measured as their urinary metabolites; i.e., mercapturic acid derivatives. The target parent VOCs are ethylene oxide, 1,3 butadiene, crotonaldehyde, acrolein, benzene, acrylamide, acrylonitrile, and propylene oxide. The biomarkers' urine concentration will be normalized to creatinine. Baseline midstream urine samples of at least 30 mL will be collected at baseline, post-washout, and at the end of each study cigarette period.
measure: Cigarette satisfaction: mCEQ
time frame: 9 weeks
description: Satisfaction with test cigarettes will be assessed using the 12-item modified Cigarette Evaluation Scale (mCEQ). This validated tool uses visual analog scales to assess subjective ratings: general acceptability ("bad" to "very good"), smoking need ("not at all" to "very strong"), smoking satisfaction ("not at all" to "very good"), harshness ("not at all" to "very strong") and pleasantness of smoke taste ("not tasty at all" to "very tasty"). Open-ended questions will also be asked regarding subject's experience smoking unfiltered cigarettes.
measure: Change in answers to Stanford Perceptions Survey of Youth questions
time frame: 9 weeks
description: Qualitative questions assessing knowledge abut cigarette filters, behaviors if filtered cigarettes were no longer available, and support for policy related to filtered cigarettes.
measure: Change in perceptions of cigarette harshness
time frame: 9 weeks
description: As measured by a visual analog scale of 0 (not harsh at all) to 100 (extremely harsh)
measure: Change in perceptions of cigarette draw
time frame: 9 weeks
description: As measured by a visual analog scale of 0 (very hard to draw smoke) to 100 (very easy to draw smoke)
arm group label: Study Group 1
arm group type: Active Comparator
description: Study Group 1 will begin the first treatment period with the provided Unfiltered Cigarettes intervention for two weeks, followed by a three-week wash-out period, before switching to the provided Filtered Cigarette intervention for two weeks.
arm group label: Study Group 2
arm group type: Experimental
description: Study Group 2 will begin the first treatment period with the provided Filtered Cigarettes intervention for two weeks, followed by a three-week wash-out period, before switching to the provided Unfiltered Cigarette intervention for two weeks.
intervention type: Other
intervention name: Unfiltered Cigarettes
description: Participants will be given unfiltered Pall Mall or Camel cigarettes to smoke for two weeks according to the brand they smoked prior to the start of the study. They will agree to smoke the cigarettes using a monitoring device (CReSS) that measures puffing behavior on five (5) days during each of the two weeks. They will also collect their cigarette butts on all days as a measure of smoking behaviors.
arm group label: Study Group 1
arm group label: Study Group 2
intervention type: Other
intervention name: Filtered Cigarettes
description: Participants will be given filtered Pall Mall or Camel cigarettes to smoke for two weeks according to the brand they smoked prior to the start of the study. They will agree to smoke the cigarettes using a monitoring device (CReSS) that measures puffing behavior on five (5) days during each of the two weeks. They will also collect their cigarette butts on all days as a measure of smoking behaviors.
arm group label: Study Group 1
arm group label: Study Group 2
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eyal Oren, Ph.D.
role: Principal Investigator
affiliation: San Diego State University School of Public Health
last name: Kimberly Pulvers, Ph.D.
role: Study Director
affiliation: California State University, San Marcos
facility: 
country: United States
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PMID: 24679109
citation: Goniewicz ML, Havel CM, Peng MW, Jacob P 3rd, Dempsey D, Yu L, Zielinska-Danch W, Koszowski B, Czogala J, Sobczak A, Benowitz NL. Elimination kinetics of the tobacco-specific biomarker and lung carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol. Cancer Epidemiol Biomarkers Prev. 2009 Dec;18(12):3421-5. doi: 10.1158/1055-9965.EPI-09-0874.
PMID: 19959691
citation: Jacob P 3rd, Havel C, Lee DH, Yu L, Eisner MD, Benowitz NL. Subpicogram per milliliter determination of the tobacco-specific carcinogen metabolite 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol in human urine using liquid chromatography-tandem mass spectrometry. Anal Chem. 2008 Nov 1;80(21):8115-21. doi: 10.1021/ac8009005. Epub 2008 Oct 8.
PMID: 18841944
citation: Jain RB. Levels of selected urinary metabolites of volatile organic compounds among children aged 6-11 years. Environ Res. 2015 Oct;142:461-70. doi: 10.1016/j.envres.2015.07.023. Epub 2015 Aug 7.
PMID: 26257031
citation: Goniewicz ML, Gawron M, Smith DM, Peng M, Jacob P 3rd, Benowitz NL. Exposure to Nicotine and Selected Toxicants in Cigarette Smokers Who Switched to Electronic Cigarettes: A Longitudinal Within-Subjects Observational Study. Nicotine Tob Res. 2017 Feb;19(2):160-167. doi: 10.1093/ntr/ntw160. Epub 2016 Aug 17.
PMID: 27613896
citation: Dodder NG, Tai SS, Sniegoski LT, Zhang NF, Welch MJ. Certification of creatinine in a human serum reference material by GC-MS and LC-MS. Clin Chem. 2007 Sep;53(9):1694-9. doi: 10.1373/clinchem.2007.090027. Epub 2007 Jul 27.
PMID: 17660272
citation: Tonstad S, Gustavsson G, Kruse E, Walmsley JM, Westin A. Symptoms of nicotine toxicity in subjects achieving high cotinine levels during nicotine replacement therapy. Nicotine Tob Res. 2014 Sep;16(9):1266-71. doi: 10.1093/ntr/ntu076. Epub 2014 May 22.
PMID: 24852574
citation: Jacob P 3rd, Yu L, Duan M, Ramos L, Yturralde O, Benowitz NL. Determination of the nicotine metabolites cotinine and trans-3'-hydroxycotinine in biologic fluids of smokers and non-smokers using liquid chromatography-tandem mass spectrometry: biomarkers for tobacco smoke exposure and for phenotyping cytochrome P450 2A6 activity. J Chromatogr B Analyt Technol Biomed Life Sci. 2011 Feb 1;879(3-4):267-76. doi: 10.1016/j.jchromb.2010.12.012. Epub 2010 Dec 21.
PMID: 21208832
citation: Benowitz NL, Dains KM, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Progressive commercial cigarette yield reduction: biochemical exposure and behavioral assessment. Cancer Epidemiol Biomarkers Prev. 2009 Mar;18(3):876-83. doi: 10.1158/1055-9965.EPI-08-0731. Epub 2009 Mar 3.
PMID: 19258480
citation: Benowitz NL, Hall SM, Stewart S, Wilson M, Dempsey D, Jacob P 3rd. Nicotine and carcinogen exposure with smoking of progressively reduced nicotine content cigarette. Cancer Epidemiol Biomarkers Prev. 2007 Nov;16(11):2479-85. doi: 10.1158/1055-9965.EPI-07-0393.
PMID: 18006940
responsible party type: Principal Investigator
investigator affiliation: San Diego State University
investigator full name: Eyal Oren
investigator title: Associate Professor
sharing ipd: No
ipd description: Individual participant data (IPD), including a data dictionary, will be shared with the study's Data Safety and Monitoring Board (DSMB), or potentially with other collaborators in the future. It is not yet determined if there will be a plan to make the IPD available.