xml: <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/NCT06027840</url>
    </required_header>
    <id_info>
      <org_study_id>2000035713</org_study_id>
      <nct_id>NCT06027840</nct_id>
    </id_info>
    <brief_title>Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use</brief_title>
    <official_title>A Preliminary Test of Concurrent vs. Sequential Cessation of Dual Cigarette and E-cigarette Use on Behavior, Tobacco Toxicant Exposure, and Health Effects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Yale University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Yale University</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this research study is to understand whether concurrent treatment for&#xD;
        cigarettes and e-cigarettes in which an individual quits both products at the same time&#xD;
        (QUIT-C) or sequential treatment in which an individual quits cigarettes first followed by&#xD;
        e-cigarettes is more effective for quitting both products. The study will also compare the&#xD;
        effect of treatment on health-related biomarkers. All participants will receive varenicline,&#xD;
        a medication used to treat tobacco use dependence, counseling, and cessation resources (i.e.,&#xD;
        links to text-based support, self-change booklet). Varenicline helps to reduce cravings for&#xD;
        tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Inclusion/exclusion criteria will be determined via initial online screening and then&#xD;
        confirmed with tele-video/phone call final screening. Non-pregnancy verification will be&#xD;
        ascertained via remote pregnancy test.&#xD;
  &#xD;
        All participants will be asked to provide assessments (as described below) throughout the&#xD;
        sampling process to assess cigarette smoking and e-cigarette use behavior, varenicline use,&#xD;
        and use of cessation resources.&#xD;
  &#xD;
        This is a 12 week, open-label study of varenicline.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <phase>Phase 1</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>Cigarette Abstinence at Week 12- Carbon Monoxide</measure>
      <time_frame>Week 12</time_frame>
      <description>7-day point prevalence cigarette abstinence at Week 12, biochemically verified by breath carbon monoxide</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>E-Cigarette Abstinence at Week 12- Cotinine</measure>
      <time_frame>Week 12</time_frame>
      <description>7-day point prevalence e-cigarette abstinence at Week 12, biochemically verified by urine cotinine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of cigarettes smoked per day</measure>
      <time_frame>Baseline up to week 12</time_frame>
      <description>Number of cigarettes smoked per day assessed by self-report</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent days of e-cigarette usage</measure>
      <time_frame>Baseline up to week 12</time_frame>
      <description>Percent days of e-cigarette usage assessed by self-report</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Biomarkers of tobacco-related harm exposure</measure>
      <time_frame>Baseline up to week 12</time_frame>
      <description>Primary urinary biomarkers of tobacco-related harm exposure will be assessed including NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), a tobacco carcinogen linked to lung cancer risk.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Cigarette Smoking</condition>
    <condition>E-Cigarette Use</condition>
    <condition>Smoking Cessation</condition>
    <arm_group>
      <arm_group_label>QUIT-C (Concurrent)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment in this arm will emphasize concurrent cessation of cigarettes and e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize concurrent cessation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>QUIT-S (Sequential)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Treatment in this arm will focus on cessation of cigarettes followed sequentially by cessation of e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize sequential cessation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Varenicline</intervention_name>
      <description>Varenicline prescription will follow the standard induction period: varenicline 0.5 mg once per day for Days 1-3, varenicline 0.5 mg twice per day for Days 4-7, then varenicline 1 mg twice per day (when varenicline reaches peak efficacy for tobacco cessation). Participants will remain on varenicline for 12 weeks total. Dose adjustments (e.g., reduction to 0.5 mg twice per day if 1 mg is not well tolerated) will be allowed at the discretion of the clinical pharmacist/APRN/physician.</description>
      <arm_group_label>QUIT-C (Concurrent)</arm_group_label>
      <arm_group_label>QUIT-S (Sequential)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Counseling</intervention_name>
      <description>Tobacco Treatment Service clinicians will deliver weekly counseling sessions, monitor participants for adverse events, and record participants' weekly cigarette and e-cigarette use. At the first counseling session clinicians will review medication proper use instructions, and potential side effects and strategies to address them at the first counseling session. Study medication refills will be distributed at 4-week intervals. Sessions will focus on quit plan preparation, supportive and practical cessation counseling, resetting quit dates, and relapse prevention.</description>
      <arm_group_label>QUIT-C (Concurrent)</arm_group_label>
      <arm_group_label>QUIT-S (Sequential)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Guided Self-Change Booklets</intervention_name>
      <description>The booklet includes information on how to reduce and quit both cigarettes and e-cigarettes on their own, how to prevent relapse, how to set a quit date, and how to enroll in text-based support resources.</description>
      <arm_group_label>QUIT-C (Concurrent)</arm_group_label>
      <arm_group_label>QUIT-S (Sequential)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  English literate&#xD;
  &#xD;
            -  Report cigarette smoking, and e-cigarette use for at least the past 3 months&#xD;
  &#xD;
            -  Smoke 5 or more cigarettes per day&#xD;
  &#xD;
            -  Report e-cigarette use for at least 14 days in the past month&#xD;
  &#xD;
            -  Interested in quitting both products in the next month and willing to set a quit date.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Vulnerable Populations: Investigators will not be enrolling vulnerable populations,&#xD;
               specifically pregnant women, children, prisoners, or institutionalized individuals&#xD;
  &#xD;
            -  Investigators also will not enroll participants incapable of providing their own&#xD;
               consent. The rationale will be provided to the individual as well as his or her family&#xD;
               members. Referrals for further evaluation, including urgent or emergent evaluation,&#xD;
               will be made as needed and clinically warranted.&#xD;
  &#xD;
            -  Investigators will exclude anyone currently using any smoking cessation services&#xD;
               and/or FDA pharmacotherapies.&#xD;
  &#xD;
            -  Verification of Non-Pregnancy: Females ages &lt;55 will be given a commercially available&#xD;
               pregnancy test to verify non-pregnancy. A female of child-bearing age that is&#xD;
               currently pregnant or breastfeeding or report an unwillingness to use effective birth&#xD;
               control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, or barrier&#xD;
               method such as condoms with spermicide) for the duration of the study will not be&#xD;
               enrolled.&#xD;
  &#xD;
            -  Individuals using other tobacco or nicotine products besides cigarettes and&#xD;
               e-cigarettes &gt; once per week in the last 30 days will be excluded.&#xD;
  &#xD;
            -  Investigators will exclude individuals with medical contraindications for varenicline&#xD;
               use (i.e., severe renal impairment and unstable cardiac history)&#xD;
  &#xD;
            -  Medical Conditions: Investigators will not enroll anyone with a current, serious&#xD;
               uncontrolled medical/psychiatric condition (e.g., a condition that required a&#xD;
               hospitalization or intensive outpatient treatment in the past year) based on review by&#xD;
               Study Physician that would increase risk of severe adverse events and/or interfere&#xD;
               with study participation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lisa Fucito, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Yale University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lisa Fucito, PhD</last_name>
      <phone>203-200-1470</phone>
      <email>lisa.fucito@yale.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Madilyn Augustine</last_name>
      <phone>(203) 430-4714</phone>
      <email>madilyn.augustine@yale.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Yale University</name>
        <address>
          <city>New Haven</city>
          <state>Connecticut</state>
          <zip>06520</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Varenicline</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06027840
  org study id: 2000035713
  nct id: NCT06027840
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The purpose of this research study is to understand whether concurrent treatment for
        cigarettes and e-cigarettes in which an individual quits both products at the same time
        (QUIT-C) or sequential treatment in which an individual quits cigarettes first followed by
        e-cigarettes is more effective for quitting both products. The study will also compare the
        effect of treatment on health-related biomarkers. All participants will receive varenicline,
        a medication used to treat tobacco use dependence, counseling, and cessation resources (i.e.,
        links to text-based support, self-change booklet). Varenicline helps to reduce cravings for
        tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products.
  Inclusion/exclusion criteria will be determined via initial online screening and then
        confirmed with tele-video/phone call final screening. Non-pregnancy verification will be
        ascertained via remote pregnancy test.
  
        All participants will be asked to provide assessments (as described below) throughout the
        sampling process to assess cigarette smoking and e-cigarette use behavior, varenicline use,
        and use of cessation resources.
  
        This is a 12 week, open-label study of varenicline.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Cigarette Abstinence at Week 12- Carbon Monoxide
  time frame: Week 12
  description: 7-day point prevalence cigarette abstinence at Week 12, biochemically verified by breath carbon monoxide
  measure: E-Cigarette Abstinence at Week 12- Cotinine
  time frame: Week 12
  description: 7-day point prevalence e-cigarette abstinence at Week 12, biochemically verified by urine cotinine
  measure: Number of cigarettes smoked per day
  time frame: Baseline up to week 12
  description: Number of cigarettes smoked per day assessed by self-report
  measure: Percent days of e-cigarette usage
  time frame: Baseline up to week 12
  description: Percent days of e-cigarette usage assessed by self-report
  measure: Biomarkers of tobacco-related harm exposure
  time frame: Baseline up to week 12
  description: Primary urinary biomarkers of tobacco-related harm exposure will be assessed including NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol), a tobacco carcinogen linked to lung cancer risk.
  arm group label: QUIT-C (Concurrent)
  arm group type: Experimental
  description: Treatment in this arm will emphasize concurrent cessation of cigarettes and e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize concurrent cessation.
  arm group label: QUIT-S (Sequential)
  arm group type: Experimental
  description: Treatment in this arm will focus on cessation of cigarettes followed sequentially by cessation of e-cigarettes. All participants will receive 12-weeks of varenicline, weekly individual counseling, and access to cessation resources including a guided self-change booklet and links to free text-based support. Counseling and cessation resources will emphasize sequential cessation.
  intervention type: Drug
  intervention name: Varenicline
  description: Varenicline prescription will follow the standard induction period: varenicline 0.5 mg once per day for Days 1-3, varenicline 0.5 mg twice per day for Days 4-7, then varenicline 1 mg twice per day (when varenicline reaches peak efficacy for tobacco cessation). Participants will remain on varenicline for 12 weeks total. Dose adjustments (e.g., reduction to 0.5 mg twice per day if 1 mg is not well tolerated) will be allowed at the discretion of the clinical pharmacist/APRN/physician.
  arm group label: QUIT-C (Concurrent)
  arm group label: QUIT-S (Sequential)
  intervention type: Behavioral
  intervention name: Counseling
  description: Tobacco Treatment Service clinicians will deliver weekly counseling sessions, monitor participants for adverse events, and record participants' weekly cigarette and e-cigarette use. At the first counseling session clinicians will review medication proper use instructions, and potential side effects and strategies to address them at the first counseling session. Study medication refills will be distributed at 4-week intervals. Sessions will focus on quit plan preparation, supportive and practical cessation counseling, resetting quit dates, and relapse prevention.
  arm group label: QUIT-C (Concurrent)
  arm group label: QUIT-S (Sequential)
  intervention type: Behavioral
  intervention name: Guided Self-Change Booklets
  description: The booklet includes information on how to reduce and quit both cigarettes and e-cigarettes on their own, how to prevent relapse, how to set a quit date, and how to enroll in text-based support resources.
  arm group label: QUIT-C (Concurrent)
  arm group label: QUIT-S (Sequential)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lisa Fucito, PhD
  role: Principal Investigator
  affiliation: Yale University
  last name: Lisa Fucito, PhD
  phone: 203-200-1470
  email: lisa.fucito@yale.edu
  last name: Madilyn Augustine
  phone: (203) 430-4714
  email: madilyn.augustine@yale.edu
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Varenicline
  sharing ipd: No