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/NCT05997225</url>
    </required_header>
    <id_info>
      <org_study_id>2023-14980</org_study_id>
      <nct_id>NCT05997225</nct_id>
    </id_info>
    <brief_title>Tobacco Cessation at FDNY</brief_title>
    <official_title>Preventing Lung Cancer Through Tobacco Cessation at FDNY</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Albert Einstein College of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>FDNY World Trade Center Health Program</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Albert Einstein College of Medicine</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        At the Fire Department of the City of New York (FDNY) World Trade Center Health Program, 36%&#xD;
        of participants in the low dose computed tomography (LDCT) lung cancer screening program are&#xD;
        current smokers, despite referral to the free FDNY Tobacco Cessation Program (Standard Care).&#xD;
        Investigators propose testing an Enhanced Care program which includes opt-out enrollment;&#xD;
        tobacco cessation counseling will be individually tailored to LDCT results and treatment with&#xD;
        varenicline starting 4 weeks prior to their target quit date. This randomized trial will&#xD;
        compare enrollment and cessation outcomes in Standard Care vs. Enhanced Care groups of&#xD;
        challenging-to-treat, high-risk smokers.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The overarching goal of this Randomized Controlled trial is to develop and test an effective,&#xD;
        scalable intervention with potential to reach high-risk smokers undergoing CT lung cancer&#xD;
        screening who have not engaged in or succeeded with traditional tobacco treatment approaches.&#xD;
        The investigators will test an Enhanced Care intervention specifically designed to address&#xD;
        multiple challenges to tobacco treatment engagement and success. First, the researchers will&#xD;
        test opt-out enrollment in cessation treatment. The current tobacco treatment default, in&#xD;
        which patients must opt-in to cessation treatment and are only offered counseling and&#xD;
        pharmacotherapy when deemed ready to quit, results in missed opportunities to engage smokers&#xD;
        into treatment. Previous studies of opt-out enrollment in cessation treatment suggest that an&#xD;
        opt-out tobacco treatment strategy substantially increases engagement and cessation rates&#xD;
        compared with traditional opt-in approaches. Second, proactive counseling will leverage the&#xD;
        &quot;reachable, teachable moment&quot; of CT screening to motivate cessation through individually&#xD;
        tailored messaging tied to CT results and lung function spirometry. Using CT results as a&#xD;
        motivational tool has shown promise in pilot studies. The optimal approach and success of&#xD;
        using CT coupled with spirometry results to motivate tobacco cessation remains unknown.&#xD;
        Third, investigators will offer varenicline pre-loading to all enrollees, regardless of study&#xD;
        arm, in which varenicline is initiated 4 weeks prior to target quit date. This approach is&#xD;
        associated with decreased pre-quit tobacco-associated reward and double the rate of&#xD;
        abstinence compared with standard varenicline treatment.&#xD;
  &#xD;
        The investigators thus propose a randomized trial among retired FDNY World Trade Center&#xD;
        Health Program responders participating in the FDNY World Trade Center Health Program CT&#xD;
        screening program to test the effects of Enhanced Care (opt-out enrollment, tailored&#xD;
        counseling based on CT and spirometry results, and varenicline with preloading) against&#xD;
        Standard Care (opt-in enrollment, standard cessation counseling without CT tailoring, and&#xD;
        varenicline with preloading) in the engagement of high-risk smokers in cessation treatment&#xD;
        and the achievement of tobacco abstinence.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <phase>Phase 4</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>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Enrollment</measure>
      <time_frame>28 weeks</time_frame>
      <description>Enrollment is defined as first visit attendance with our tobacco treatment specialist in FDNY's Tobacco Cessation Program: Standard vs. Enhanced Care arms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Retention</measure>
      <time_frame>28 weeks</time_frame>
      <description>Number of participants retained to study end-date</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Varenicline adherence</measure>
      <time_frame>week 16</time_frame>
      <description>Assessed via electronic medication monitoring: pills taken / pills prescribed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Counseling adherence</measure>
      <time_frame>week 28</time_frame>
      <description>Adherence with number of counseling visits attended as a continuous variable</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tobacco abstinence</measure>
      <time_frame>end of treatment (16 weeks)</time_frame>
      <description>7-day point prevalence abstinence biochemically verified by urine cotinine &lt; 30 ng/mL</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">220</enrollment>
    <condition>Tobacco Use</condition>
    <condition>Tobacco Smoking</condition>
    <condition>Tobacco Use Cessation</condition>
    <arm_group>
      <arm_group_label>Enhanced Treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Opt-out counseling enrollment. individually-tailored biofeedback linked to Chest CT and spirometry results.&#xD;
  Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28.&#xD;
  1 mg twice day for 12 weeks after target quit date.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Opt-in counseling enrollment. Standard tobacco cessation counseling.&#xD;
  Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28.&#xD;
  1 mg twice day for 12 weeks after target quit date.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>opt out enrollment, tailored counseling, varenicline started prior to target quit date</intervention_name>
      <description>Participants automatically enrolled in motivational counseling. Tailored counseling includes sharing results of Chest CT results and lung function spirometry tests with participants.</description>
      <arm_group_label>Enhanced Treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>opt in enrollment, non-tailored counseling, varenicline started prior to target quit date</intervention_name>
      <description>Participants must opt-in to receive counseling. Counseling does not include discussion of Chest CT or spirometry results.</description>
      <arm_group_label>Standard Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  self-reported current smoker as of participants' most recent FDNY World Trade Center&#xD;
               Health Program questionnaire&#xD;
  &#xD;
            -  Enrolled in the FDNY World Trade Center Health Program Chest CT program&#xD;
  &#xD;
            -  Previously provided informed consent to World Trade Center Health Program Research&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  use of varenicline in past 30 days&#xD;
  &#xD;
            -  psychiatric instability (exacerbations in prior 3 months; current suicidal ideation or&#xD;
               attempt, psych hospitalizations in past year)&#xD;
  &#xD;
            -  seizures&#xD;
  &#xD;
            -  pregnancy or breast feeding.&#xD;
  &#xD;
            -  alcohol use disorders&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shadi Nahvi, MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Albert Einstein College of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shadi Nahvi, MD, MS</last_name>
      <phone>718 920 5379</phone>
      <email>shadi.nahvi@einsteinmed.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>David Goldfarb, PhD</last_name>
      <phone>718 403 4413</phone>
      <email>david.goldfarb@fdny.nyc.gov</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>FDNY World Trade Center Health Program</name>
        <address>
          <city>Brooklyn</city>
          <state>New York</state>
          <zip>11201</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>David Goldfarb, PhD</last_name>
        <phone>718-403-4413</phone>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Albert Einstein College of Medicine</investigator_affiliation>
      <investigator_full_name>Shadi Nahvi</investigator_full_name>
      <investigator_title>Professor of Medicine, Psychiatry &amp; Behavioral Sciences</investigator_title>
    </responsible_party>
    <keyword>World Trade Center Health Program</keyword>
    <keyword>occupational medicine</keyword>
    <keyword>tobacco cessation</keyword>
    <keyword>lifestyle medicine</keyword>
    <keyword>opt-out treatment</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Varenicline</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Deidentified data set</ipd_description>
    </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/NCT05997225
  org study id: 2023-14980
  nct id: NCT05997225
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  At the Fire Department of the City of New York (FDNY) World Trade Center Health Program, 36%
        of participants in the low dose computed tomography (LDCT) lung cancer screening program are
        current smokers, despite referral to the free FDNY Tobacco Cessation Program (Standard Care).
        Investigators propose testing an Enhanced Care program which includes opt-out enrollment;
        tobacco cessation counseling will be individually tailored to LDCT results and treatment with
        varenicline starting 4 weeks prior to their target quit date. This randomized trial will
        compare enrollment and cessation outcomes in Standard Care vs. Enhanced Care groups of
        challenging-to-treat, high-risk smokers.
  The overarching goal of this Randomized Controlled trial is to develop and test an effective,
        scalable intervention with potential to reach high-risk smokers undergoing CT lung cancer
        screening who have not engaged in or succeeded with traditional tobacco treatment approaches.
        The investigators will test an Enhanced Care intervention specifically designed to address
        multiple challenges to tobacco treatment engagement and success. First, the researchers will
        test opt-out enrollment in cessation treatment. The current tobacco treatment default, in
        which patients must opt-in to cessation treatment and are only offered counseling and
        pharmacotherapy when deemed ready to quit, results in missed opportunities to engage smokers
        into treatment. Previous studies of opt-out enrollment in cessation treatment suggest that an
        opt-out tobacco treatment strategy substantially increases engagement and cessation rates
        compared with traditional opt-in approaches. Second, proactive counseling will leverage the
        "reachable, teachable moment" of CT screening to motivate cessation through individually
        tailored messaging tied to CT results and lung function spirometry. Using CT results as a
        motivational tool has shown promise in pilot studies. The optimal approach and success of
        using CT coupled with spirometry results to motivate tobacco cessation remains unknown.
        Third, investigators will offer varenicline pre-loading to all enrollees, regardless of study
        arm, in which varenicline is initiated 4 weeks prior to target quit date. This approach is
        associated with decreased pre-quit tobacco-associated reward and double the rate of
        abstinence compared with standard varenicline treatment.
  
        The investigators thus propose a randomized trial among retired FDNY World Trade Center
        Health Program responders participating in the FDNY World Trade Center Health Program CT
        screening program to test the effects of Enhanced Care (opt-out enrollment, tailored
        counseling based on CT and spirometry results, and varenicline with preloading) against
        Standard Care (opt-in enrollment, standard cessation counseling without CT tailoring, and
        varenicline with preloading) in the engagement of high-risk smokers in cessation treatment
        and the achievement of tobacco abstinence.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Enrollment
  time frame: 28 weeks
  description: Enrollment is defined as first visit attendance with our tobacco treatment specialist in FDNY's Tobacco Cessation Program: Standard vs. Enhanced Care arms.
  measure: Retention
  time frame: 28 weeks
  description: Number of participants retained to study end-date
  measure: Varenicline adherence
  time frame: week 16
  description: Assessed via electronic medication monitoring: pills taken / pills prescribed
  measure: Counseling adherence
  time frame: week 28
  description: Adherence with number of counseling visits attended as a continuous variable
  measure: Tobacco abstinence
  time frame: end of treatment (16 weeks)
  description: 7-day point prevalence abstinence biochemically verified by urine cotinine < 30 ng/mL
  arm group label: Enhanced Treatment
  arm group type: Experimental
  description: Opt-out counseling enrollment. individually-tailored biofeedback linked to Chest CT and spirometry results.
  Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28.
  1 mg twice day for 12 weeks after target quit date.
  arm group label: Standard Treatment
  arm group type: Active Comparator
  description: Opt-in counseling enrollment. Standard tobacco cessation counseling.
  Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28.
  1 mg twice day for 12 weeks after target quit date.
  intervention type: Other
  intervention name: opt out enrollment, tailored counseling, varenicline started prior to target quit date
  description: Participants automatically enrolled in motivational counseling. Tailored counseling includes sharing results of Chest CT results and lung function spirometry tests with participants.
  arm group label: Enhanced Treatment
  intervention type: Other
  intervention name: opt in enrollment, non-tailored counseling, varenicline started prior to target quit date
  description: Participants must opt-in to receive counseling. Counseling does not include discussion of Chest CT or spirometry results.
  arm group label: Standard Treatment
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Shadi Nahvi, MD, MS
  role: Principal Investigator
  affiliation: Albert Einstein College of Medicine
  last name: Shadi Nahvi, MD, MS
  phone: 718 920 5379
  email: shadi.nahvi@einsteinmed.edu
  last name: David Goldfarb, PhD
  phone: 718 403 4413
  email: david.goldfarb@fdny.nyc.gov
  facility: 
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Albert Einstein College of Medicine
  investigator full name: Shadi Nahvi
  investigator title: Professor of Medicine, Psychiatry & Behavioral Sciences
  mesh term: Varenicline
  sharing ipd: Undecided
  ipd description: Deidentified data set