<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/NCT03750825</url>
  </required_header>
  <id_info>
    <org_study_id>HS-18-00744</org_study_id>
    <nct_id>NCT03750825</nct_id>
  </id_info>
  <brief_title>Are Smokers Switching to Vaping at Lower Risk for Cancer? (Electronic Cigarettes and Cancer Risk)</brief_title>
  <official_title>Are Smokers Switching to Vaping at Lower Risk for Cancer?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will address a growing public health concern, namely, the health risks or&#xD;
      benefits of e-cig use relative to cigarette smoking. The investigators will use biomarkers of&#xD;
      early effects of relevance to cancer to determine the carcinogenic potential of e-cig use&#xD;
      relative to cigarette smoking in oral epithelium, which is a target tissue for&#xD;
      smoking-associated cancer. The study population will consist of one group of smokers who are&#xD;
      interested in switching to e-cig use (Grp 1), one group of smokers who do not intend to&#xD;
      change their smoking habits (Grp 2), and one group of non-users who would like to maintain&#xD;
      their nonsmoking non-vaping status (Grp 3); The total number of participants in this project&#xD;
      is 150 (n = 50, each group). The investigators will use an integrative 'multi-omics' approach&#xD;
      complemented with single-locus/gene validation analyses to detect temporal changes in the&#xD;
      genome, epigenome, and transcriptome relevant to cancer in the oral cells of the participants&#xD;
      as the intervention progresses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Electronic cigarettes (e-cig) are increasingly popular among adult smokers and adolescent&#xD;
      never smokers. Chemical analyses of e-cig vapor and liquid have shown the presence of many of&#xD;
      the same carcinogens as those found in cigarette smoke, albeit in generally lower&#xD;
      concentrations. However, the carcinogenic potential of e-cig has not been investigated in&#xD;
      e-cig users (otherwise known as 'vapers'). The investigators will investigate the&#xD;
      cancer-causing potential of e-cig use as compared to cigarette smoking by quantifying&#xD;
      molecular changes linked to risk of cancer in smokers who switch to e-cig use vs. those who&#xD;
      maintain their smoking habits. Leveraging a source population for ongoing studies on e-cig,&#xD;
      the investigators will recruit smokers who are interested in switching to e-cig use, and two&#xD;
      control groups of non-vapers, including smokers and nonsmokers who do not intend to change&#xD;
      their smoking and nonsmoking status, respectively (n = 50, each group). Smokers consenting to&#xD;
      switch completely to e-cig will be assigned to a 3-month intervention with a standard e-cig&#xD;
      with fully described product characteristics. Control groups will maintain their&#xD;
      smoking/nonsmoking habits during the intervention. At weekly intervals, the investigators&#xD;
      will verify participants' compliance through personal interviews, CO breath tests, cotinine&#xD;
      quantification, and vaping/smoking topography measurements. The investigators will use a&#xD;
      non-invasive brushing technique to collect oral cells from the inside of the cheeks of all&#xD;
      participants at baseline and every 2 weeks, afterwards. The investigators will use an&#xD;
      integrative 'multi-omics' approach complemented with single-locus/gene validation analyses to&#xD;
      detect temporal changes in the genome, epigenome, and transcriptome relevant to cancer in the&#xD;
      oral cells of the participants as the intervention progresses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 1, 2021</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Genetic changes</measure>
    <time_frame>3 months</time_frame>
    <description>Number and location of DNA damage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Epigenetic changes</measure>
    <time_frame>3 months</time_frame>
    <description>Number of epigenetic marks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gene expression</measure>
    <time_frame>Every 2 weeks for 3 months</time_frame>
    <description>Relative gene expression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DNA methylation</measure>
    <time_frame>Every 2 weeks for 3 months</time_frame>
    <description>Pattern and distribution of aberrant DNA methylation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Histone modifications</measure>
    <time_frame>Every 2 weeks for 3 months</time_frame>
    <description>Pattern and distribution of histone marks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mutation</measure>
    <time_frame>Every 2 weeks for 3 months</time_frame>
    <description>Frequency and location of mutations</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Cigarette Smoking</condition>
  <arm_group>
    <arm_group_label>Vapers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Smokers will switch to NIDA Standard Research E-cigarette (SREC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smokers</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Smokers will continue to smoke.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nonsmokers non-vapers</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control nonsmokers non-vapers will continue to refrain from smoking or vaping.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NIDA Standard Research E-cigarette (SREC)</intervention_name>
    <description>Smokers will switch to NIDA Standard Research E-cigarette (SREC).</description>
    <arm_group_label>Vapers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being male or female between the ages of 22-55;&#xD;
&#xD;
          -  Being able to read and write in English and understand and give informed consent;&#xD;
&#xD;
          -  Giving consent to strictly follow the study protocol throughout the study;&#xD;
&#xD;
          -  Not planning to move, take an extended vacation, or undergo surgery during the study;&#xD;
&#xD;
          -  Reporting smoking of &gt; 5 manufactured cigarettes per day for at least 1 year&#xD;
             (applicable to participants who will undergo intervention with e-cig (Grp 1) or&#xD;
             continue to smoke (Grp 2) only); and&#xD;
&#xD;
          -  Presenting with an expired air CO measurement of &gt; 7 parts per million (ppm) at&#xD;
             baseline (applicable to participants who will undergo intervention with e-cig (Grp 1)&#xD;
             or continue to smoke (Grp 2) only).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having oral infection/inflammation, gum disease, dental decay, immune system&#xD;
             disorders, diabetes, respiratory diseases (e.g., asthma), or kidney diseases;&#xD;
&#xD;
          -  Having any unstable or significant medical condition (e.g., symptomatic heart&#xD;
             conditions) in the past 12 months ;&#xD;
&#xD;
          -  Having body mass index &lt; 18 kg/m2 or &gt; 40 kg/m2&#xD;
&#xD;
          -  Being pregnant or having a baby in the past 12 months;&#xD;
&#xD;
          -  Having uncontrolled mental illness or substance abuse (e.g., alcoholism) or inpatient&#xD;
             treatment for those conditions in the past 12 months;&#xD;
&#xD;
          -  Having used recreational or illicit drugs in the past 3 months;&#xD;
&#xD;
          -  Having used any medication known to induce/inhibit CYP450 2A6 enzyme;&#xD;
&#xD;
          -  Having any known allergy to propylene glycol/vegetable glycerin (applicable&#xD;
             participants who will undergo intervention with e-cig (Grp 1) only); and&#xD;
&#xD;
          -  Having another member of household participating in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmad Besaratinia</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Southern California, Health Sciences Campus</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>April 19, 2023</last_update_submitted>
  <last_update_submitted_qc>April 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Ahmad Besaratinia</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Electronic Nicotine Delivery System</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data (IPD) available to other researchers.</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/NCT03750825
org study id: HS-18-00744
nct id: NCT03750825
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This project will address a growing public health concern, namely, the health risks or
      benefits of e-cig use relative to cigarette smoking. The investigators will use biomarkers of
      early effects of relevance to cancer to determine the carcinogenic potential of e-cig use
      relative to cigarette smoking in oral epithelium, which is a target tissue for
      smoking-associated cancer. The study population will consist of one group of smokers who are
      interested in switching to e-cig use (Grp 1), one group of smokers who do not intend to
      change their smoking habits (Grp 2), and one group of non-users who would like to maintain
      their nonsmoking non-vaping status (Grp 3); The total number of participants in this project
      is 150 (n = 50, each group). The investigators will use an integrative 'multi-omics' approach
      complemented with single-locus/gene validation analyses to detect temporal changes in the
      genome, epigenome, and transcriptome relevant to cancer in the oral cells of the participants
      as the intervention progresses.
Electronic cigarettes (e-cig) are increasingly popular among adult smokers and adolescent
      never smokers. Chemical analyses of e-cig vapor and liquid have shown the presence of many of
      the same carcinogens as those found in cigarette smoke, albeit in generally lower
      concentrations. However, the carcinogenic potential of e-cig has not been investigated in
      e-cig users (otherwise known as 'vapers'). The investigators will investigate the
      cancer-causing potential of e-cig use as compared to cigarette smoking by quantifying
      molecular changes linked to risk of cancer in smokers who switch to e-cig use vs. those who
      maintain their smoking habits. Leveraging a source population for ongoing studies on e-cig,
      the investigators will recruit smokers who are interested in switching to e-cig use, and two
      control groups of non-vapers, including smokers and nonsmokers who do not intend to change
      their smoking and nonsmoking status, respectively (n = 50, each group). Smokers consenting to
      switch completely to e-cig will be assigned to a 3-month intervention with a standard e-cig
      with fully described product characteristics. Control groups will maintain their
      smoking/nonsmoking habits during the intervention. At weekly intervals, the investigators
      will verify participants' compliance through personal interviews, CO breath tests, cotinine
      quantification, and vaping/smoking topography measurements. The investigators will use a
      non-invasive brushing technique to collect oral cells from the inside of the cheeks of all
      participants at baseline and every 2 weeks, afterwards. The investigators will use an
      integrative 'multi-omics' approach complemented with single-locus/gene validation analyses to
      detect temporal changes in the genome, epigenome, and transcriptome relevant to cancer in the
      oral cells of the participants as the intervention progresses.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Genetic changes
time frame: 3 months
description: Number and location of DNA damage
measure: Epigenetic changes
time frame: 3 months
description: Number of epigenetic marks
measure: Gene expression
time frame: Every 2 weeks for 3 months
description: Relative gene expression
measure: DNA methylation
time frame: Every 2 weeks for 3 months
description: Pattern and distribution of aberrant DNA methylation
measure: Histone modifications
time frame: Every 2 weeks for 3 months
description: Pattern and distribution of histone marks
measure: Mutation
time frame: Every 2 weeks for 3 months
description: Frequency and location of mutations
arm group label: Vapers
arm group type: Experimental
description: Smokers will switch to NIDA Standard Research E-cigarette (SREC).
arm group label: Smokers
arm group type: No Intervention
description: Smokers will continue to smoke.
arm group label: Nonsmokers non-vapers
arm group type: No Intervention
description: Control nonsmokers non-vapers will continue to refrain from smoking or vaping.
intervention type: Device
intervention name: NIDA Standard Research E-cigarette (SREC)
description: Smokers will switch to NIDA Standard Research E-cigarette (SREC).
arm group label: Vapers
criteria: 
gender: All
minimum age: 22 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmad Besaratinia
role: Principal Investigator
affiliation: University of Southern California
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Ahmad Besaratinia
investigator title: Professor
sharing ipd: No
ipd description: There is no plan to make individual participant data (IPD) available to other researchers.