<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/NCT02202499</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-17654</org_study_id>
    <nct_id>NCT02202499</nct_id>
  </id_info>
  <brief_title>Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence</brief_title>
  <official_title>Translating Extinction Research to Improve Pharmacotherapy for Tobacco Dependence: Intervention Development and Feasibility Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>James and Esther King Biomedical Research Program</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>H. Lee Moffitt Cancer Center and Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this Pilot feasibility study is to find out the effect of different behavioral&#xD;
      treatments along with different duration of a drug called varenicline, on smoking behavior&#xD;
      and quitting smoking. Varenicline, also known as Chantix™, is an FDA-approved medication that&#xD;
      has been shown to help people quit smoking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following the initial telephone screening, eligible participants will be scheduled for a&#xD;
      screening evaluation session.&#xD;
&#xD;
      Following the screening evaluation, participants who pass the medical screening and meet all&#xD;
      other inclusion criteria will be scheduled for their first assessment and then randomized to&#xD;
      receive standard varenicline (SV), extended varenicline (EV), or extended varenicline plus&#xD;
      facilitated extinction (EV + FE). The randomization list will be generated by the study&#xD;
      statistician. It will be stratified by gender and will employ a variable block randomization&#xD;
      that will guarantee that the arms are balanced when a given block is filled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2014</start_date>
  <completion_date type="Actual">June 14, 2019</completion_date>
  <primary_completion_date type="Actual">December 11, 2015</primary_completion_date>
  <phase>Early 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Participant Retention</measure>
    <time_frame>End of post treatment follow-up period of 3 months - approximately 28 weeks</time_frame>
    <description>Practicality: Number of participants completing 3 month post treatment follow-up. Feasibility: Ability to recruit and retain sufficient numbers of the target population, which would be essential in conducting a future randomized clinical trial (RCT).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction Questionnaire (CSQ) Results</measure>
    <time_frame>One month post treatment - approximately 20 weeks</time_frame>
    <description>Acceptability: Mean score of Client Satisfaction Questionnaire (CSQ) version 8 by Attkison &amp; Greenfield. Questionnaire scores client satisfaction with a scale of 1-4 per question, 1 being very dissatisfied and 4 being very satisfied. Score total range is 8-32. A total score of 32 would be the highest possible Client Satisfaction Score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Intervention Adherence - Medication</measure>
    <time_frame>One month post treatment - approximately 20 weeks</time_frame>
    <description>Percent of participants still using varenicline at time of analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Intervention Adherence - Cigarettes Per Day (CPD)</measure>
    <time_frame>During last week of treatment, week 16</time_frame>
    <description>Average Cigarettes per Day across group, during last week of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Peak Craving Score Per Group</measure>
    <time_frame>Across 4 pre-quit weeks</time_frame>
    <description>Peak craving per day by treatment group, scored using an 11-point Likert scale 0-10. 0 was &quot;none&quot;, 5 &quot;medium&quot; and 10 &quot;very high/strong&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Smoking Satisfaction Score Per Group</measure>
    <time_frame>Across 4 pre-quit weeks</time_frame>
    <description>Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10. 0 was &quot;none&quot;, 5 &quot;medium&quot; and 10 &quot;very high&quot;</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">86</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Tobacco Dependence</condition>
  <arm_group>
    <arm_group_label>Extended Varenicline + Facilitated Extinction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Extended Varenicline plus Facilitated Extinction (EV+FE). Participants in the EV+FE condition will receive varenicline for a 4-week run-in period while continuing to smoke. In addition, the EV+FE condition will receive counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided. All groups will undergo periodic laboratory assessments and surveys.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Varenicline (SV)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the Standard Varenicline (SV) condition will receive varenicline for the usual 1-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Extended Varenicline (EV)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants in the Extended Varenicline (EV) condition will receive varenicline for a 4-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Varenicline</intervention_name>
    <description>All participants will take the following dose of varenicline: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day through week 16 of the study. Arm descriptions show specific details for each group.</description>
    <arm_group_label>Extended Varenicline (EV)</arm_group_label>
    <arm_group_label>Extended Varenicline + Facilitated Extinction</arm_group_label>
    <arm_group_label>Standard Varenicline (SV)</arm_group_label>
    <other_name>Chantix™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Counseling and Support Materials</intervention_name>
    <description>Counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided.</description>
    <arm_group_label>Extended Varenicline + Facilitated Extinction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Assessments</intervention_name>
    <description>The first laboratory assessment will consist of completion of questionnaires and a cue-reactivity test. The second laboratory assessment will be scheduled for the end of the week before the participant's quit date. It will involve completion of questionnaires and another cue reactivity test. A follow-up session conducted by research staff will occur one month after the target quit date to collect information about each participant's current smoking status, smoking rate, varenicline use, and opinion about the treatment. A second follow-up session will be conducted by telephone and will occur three months after the target quit date, at the end of varenicline use. At the end of the study, participants will be asked to complete a brief survey asking basic information, similar to the questions during the screening period.</description>
    <arm_group_label>Extended Varenicline (EV)</arm_group_label>
    <arm_group_label>Extended Varenicline + Facilitated Extinction</arm_group_label>
    <arm_group_label>Standard Varenicline (SV)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age&#xD;
&#xD;
          -  Smoke at least 10 cigarettes daily for the past year&#xD;
&#xD;
          -  Expired-air carbon monoxide (CO) &gt; 8 ppm&#xD;
&#xD;
          -  Medically eligible to receive varenicline&#xD;
&#xD;
          -  Score at least a 5 on the Contemplation Ladder (Biener &amp; Abrams 1991), a measure of&#xD;
             motivation to quit smoking.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Are pregnant or lactating&#xD;
&#xD;
          -  Have renal dysfunction&#xD;
&#xD;
          -  Have a history of seizures&#xD;
&#xD;
          -  Are medically at risk in the judgment of the study physician&#xD;
&#xD;
          -  Have ever used varenicline&#xD;
&#xD;
          -  Have used other smoking cessation medications within the past three months&#xD;
&#xD;
          -  Have current psychiatric disorders (i.e. major depression, bipolar, and/or psychotic&#xD;
             disorders)&#xD;
&#xD;
          -  Have substance use disorder as determined by a psychiatric screener (Mini&#xD;
             International Neuropsychiatric Interview [MINI]; Sheehan et al 2015).&#xD;
&#xD;
          -  We must limit the number of participants from the same street address to 1.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Brandon, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Lee Moffitt Cancer Center and Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center and Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <results_first_submitted>October 26, 2017</results_first_submitted>
  <results_first_submitted_qc>July 24, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 25, 2019</results_first_posted>
  <last_update_submitted>November 24, 2020</last_update_submitted>
  <last_update_submitted_qc>November 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pharmacotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varenicline</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Daily cigarette smokers were recruited from the community for a smoking cessation intervention study, from July 2014 through August 2015, by Moffitt Cancer Center in Tampa, Florida.</recruitment_details>
      <pre_assignment_details>86 interested parties were consented, 1 later declined, 23 did not meet criteria. 62 were eligible, 3 discontinued due to factors unrelated to study, 1 failed to attend first assessment. 58 parties participated in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Extended Varenicline + Facilitated Extinction</title>
          <description>Active Comparator: Extended Varenicline + Facilitated Extinction.</description>
        </group>
        <group group_id="P2">
          <title>Standard Varenicline</title>
          <description>Active Comparator: Standard Varenicline (SV).</description>
        </group>
        <group group_id="P3">
          <title>Extended Varenicline</title>
          <description>Active Comparator: Extended Varenicline (EV).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Cancer diagnosis</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Moved from area</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Declined before randomization</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Auto accident</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Extended Varenicline + Facilitated Extinction</title>
          <description>Active Comparator: Extended Varenicline + Facilitated Extinction.</description>
        </group>
        <group group_id="B2">
          <title>Standard Varenicline</title>
          <description>Active Comparator: Standard Varenicline (SV).</description>
        </group>
        <group group_id="B3">
          <title>Extended Varenicline</title>
          <description>Active Comparator: Extended Varenicline (EV).</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="19"/>
            <count group_id="B4" value="58"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.2" spread="50.5"/>
                    <measurement group_id="B2" value="51.9" spread="11.0"/>
                    <measurement group_id="B3" value="48.4" spread="11.4"/>
                    <measurement group_id="B4" value="50.5" spread="10.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Rate of Participant Retention</title>
        <description>Practicality: Number of participants completing 3 month post treatment follow-up. Feasibility: Ability to recruit and retain sufficient numbers of the target population, which would be essential in conducting a future randomized clinical trial (RCT).</description>
        <time_frame>End of post treatment follow-up period of 3 months - approximately 28 weeks</time_frame>
        <population>All participants who completed 3 month post treatment follow up, regardless of study arm</population>
        <group_list>
          <group group_id="O1">
            <title>Extended Varenicline + Facilitated Extinction</title>
            <description>All participants who received Extended Varenicline + Facilitated Extinction</description>
          </group>
          <group group_id="O2">
            <title>Standard Vareniclline</title>
            <description>All participants who received Standard Varenicline (SV)</description>
          </group>
          <group group_id="O3">
            <title>Extended Varenicline</title>
            <description>All participants who received Extended Varenicline</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Participant Retention</title>
          <description>Practicality: Number of participants completing 3 month post treatment follow-up. Feasibility: Ability to recruit and retain sufficient numbers of the target population, which would be essential in conducting a future randomized clinical trial (RCT).</description>
          <population>All participants who completed 3 month post treatment follow up, regardless of study arm</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Client Satisfaction Questionnaire (CSQ) Results</title>
        <description>Acceptability: Mean score of Client Satisfaction Questionnaire (CSQ) version 8 by Attkison &amp; Greenfield. Questionnaire scores client satisfaction with a scale of 1-4 per question, 1 being very dissatisfied and 4 being very satisfied. Score total range is 8-32. A total score of 32 would be the highest possible Client Satisfaction Score.</description>
        <time_frame>One month post treatment - approximately 20 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Extended Varenicline + Facilitated Extinction</title>
            <description>All participants who received Extended Varenicline +Facilitated Extinction</description>
          </group>
          <group group_id="O2">
            <title>Standard Vareniclline</title>
            <description>All participants who received Standard Varenicline</description>
          </group>
          <group group_id="O3">
            <title>Extended Varenicline</title>
            <description>All participants who received Extended Varenicline</description>
          </group>
        </group_list>
        <measure>
          <title>Client Satisfaction Questionnaire (CSQ) Results</title>
          <description>Acceptability: Mean score of Client Satisfaction Questionnaire (CSQ) version 8 by Attkison &amp; Greenfield. Questionnaire scores client satisfaction with a scale of 1-4 per question, 1 being very dissatisfied and 4 being very satisfied. Score total range is 8-32. A total score of 32 would be the highest possible Client Satisfaction Score.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.33" lower_limit="23" upper_limit="32"/>
                    <measurement group_id="O2" value="30.80" lower_limit="27" upper_limit="32"/>
                    <measurement group_id="O3" value="30.47" lower_limit="25" upper_limit="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Intervention Adherence - Medication</title>
        <description>Percent of participants still using varenicline at time of analysis.</description>
        <time_frame>One month post treatment - approximately 20 weeks</time_frame>
        <population>All participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Extended Varenicline + Facilitated Extinction</title>
            <description>Active Comparator: Extended Varenicline + Facilitated Extinction.</description>
          </group>
          <group group_id="O2">
            <title>Standard Varenicline</title>
            <description>Active Comparator: Standard Varenicline (SV).</description>
          </group>
          <group group_id="O3">
            <title>Extended Varenicline</title>
            <description>Active Comparator: Extended Varenicline (EV).</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Intervention Adherence - Medication</title>
          <description>Percent of participants still using varenicline at time of analysis.</description>
          <population>All participants.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="80"/>
                    <measurement group_id="O3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Intervention Adherence - Cigarettes Per Day (CPD)</title>
        <description>Average Cigarettes per Day across group, during last week of treatment.</description>
        <time_frame>During last week of treatment, week 16</time_frame>
        <population>All participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Extended Varenicline + Facilitated Extinction</title>
            <description>Active Comparator: Extended Varenicline + Facilitated Extinction.</description>
          </group>
          <group group_id="O2">
            <title>Standard Varenicline</title>
            <description>Active Comparator: Standard Varenicline (SV).</description>
          </group>
          <group group_id="O3">
            <title>Extended Varenicline</title>
            <description>Active Comparator: Extended Varenicline (EV).</description>
          </group>
        </group_list>
        <measure>
          <title>Average Intervention Adherence - Cigarettes Per Day (CPD)</title>
          <description>Average Cigarettes per Day across group, during last week of treatment.</description>
          <population>All participants.</population>
          <units>cigarettes per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.58" spread="5.85"/>
                    <measurement group_id="O2" value="14.95" spread="9.06"/>
                    <measurement group_id="O3" value="11.05" spread="6.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Peak Craving Score Per Group</title>
        <description>Peak craving per day by treatment group, scored using an 11-point Likert scale 0-10. 0 was &quot;none&quot;, 5 &quot;medium&quot; and 10 &quot;very high/strong&quot;</description>
        <time_frame>Across 4 pre-quit weeks</time_frame>
        <population>All participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Extended Varenicline + Facilitated Extinction</title>
            <description>Active Comparator: Extended Varenicline + Facilitated Extinction.</description>
          </group>
          <group group_id="O2">
            <title>Standard Varenicline</title>
            <description>Active Comparator: Standard Varenicline (SV).</description>
          </group>
          <group group_id="O3">
            <title>Extended Varenicline</title>
            <description>Active Comparator: Extended Varenicline (EV).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Peak Craving Score Per Group</title>
          <description>Peak craving per day by treatment group, scored using an 11-point Likert scale 0-10. 0 was &quot;none&quot;, 5 &quot;medium&quot; and 10 &quot;very high/strong&quot;</description>
          <population>All participants.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.64" spread="0.56"/>
                    <measurement group_id="O2" value="6.34" spread="0.49"/>
                    <measurement group_id="O3" value="4.56" spread="0.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Smoking Satisfaction Score Per Group</title>
        <description>Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10. 0 was &quot;none&quot;, 5 &quot;medium&quot; and 10 &quot;very high&quot;</description>
        <time_frame>Across 4 pre-quit weeks</time_frame>
        <population>All participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Extended Varenicline + Facilitated Extinction</title>
            <description>Active Comparator: Extended Varenicline + Facilitated Extinction.</description>
          </group>
          <group group_id="O2">
            <title>Standard Varenicline</title>
            <description>Active Comparator: Standard Varenicline (SV).</description>
          </group>
          <group group_id="O3">
            <title>Extended Varenicline</title>
            <description>Active Comparator: Extended Varenicline (EV).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Smoking Satisfaction Score Per Group</title>
          <description>Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10. 0 was &quot;none&quot;, 5 &quot;medium&quot; and 10 &quot;very high&quot;</description>
          <population>All participants.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.37" spread="0.64"/>
                    <measurement group_id="O2" value="5.22" spread="067"/>
                    <measurement group_id="O3" value="2.59" spread="0.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>15 weeks</time_frame>
      <desc>Adverse Events collected after start of Varenicline until end of treatment (15 weeks)</desc>
      <group_list>
        <group group_id="E1">
          <title>Extended Varenicline + Facilitated Extinction</title>
          <description>Active Comparator: Extended Varenicline + Facilitated Extinction.</description>
        </group>
        <group group_id="E2">
          <title>Standard Varenicline</title>
          <description>Active Comparator: Standard Varenicline (SV).</description>
        </group>
        <group group_id="E3">
          <title>Extended Varenicline</title>
          <description>Active Comparator: Extended Varenicline (EV).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (4.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac Disorders - Other</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Esophageal Ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Gallblader Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Vascular access complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Joint range of motion decreased lumbar spine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Thomas Brandon</name_or_title>
      <organization>H. Lee Moffitt Cancer Center and Research Institute</organization>
      <phone>813-745-1750</phone>
      <email>thomas.brandon@moffitt.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02202499
org study id: MCC-17654
nct id: NCT02202499
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this Pilot feasibility study is to find out the effect of different behavioral
      treatments along with different duration of a drug called varenicline, on smoking behavior
      and quitting smoking. Varenicline, also known as Chantix™, is an FDA-approved medication that
      has been shown to help people quit smoking.
Following the initial telephone screening, eligible participants will be scheduled for a
      screening evaluation session.

      Following the screening evaluation, participants who pass the medical screening and meet all
      other inclusion criteria will be scheduled for their first assessment and then randomized to
      receive standard varenicline (SV), extended varenicline (EV), or extended varenicline plus
      facilitated extinction (EV + FE). The randomization list will be generated by the study
      statistician. It will be stratified by gender and will employ a variable block randomization
      that will guarantee that the arms are balanced when a given block is filled.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Rate of Participant Retention
time frame: End of post treatment follow-up period of 3 months - approximately 28 weeks
description: Practicality: Number of participants completing 3 month post treatment follow-up. Feasibility: Ability to recruit and retain sufficient numbers of the target population, which would be essential in conducting a future randomized clinical trial (RCT).
measure: Client Satisfaction Questionnaire (CSQ) Results
time frame: One month post treatment - approximately 20 weeks
description: Acceptability: Mean score of Client Satisfaction Questionnaire (CSQ) version 8 by Attkison & Greenfield. Questionnaire scores client satisfaction with a scale of 1-4 per question, 1 being very dissatisfied and 4 being very satisfied. Score total range is 8-32. A total score of 32 would be the highest possible Client Satisfaction Score.
measure: Rate of Intervention Adherence - Medication
time frame: One month post treatment - approximately 20 weeks
description: Percent of participants still using varenicline at time of analysis.
measure: Average Intervention Adherence - Cigarettes Per Day (CPD)
time frame: During last week of treatment, week 16
description: Average Cigarettes per Day across group, during last week of treatment.
measure: Mean Peak Craving Score Per Group
time frame: Across 4 pre-quit weeks
description: Peak craving per day by treatment group, scored using an 11-point Likert scale 0-10. 0 was "none", 5 "medium" and 10 "very high/strong"
measure: Mean Smoking Satisfaction Score Per Group
time frame: Across 4 pre-quit weeks
description: Smoking satisfaction per day by treatment group, using 11-point Likert scale, 0-10. 0 was "none", 5 "medium" and 10 "very high"
arm group label: Extended Varenicline + Facilitated Extinction
arm group type: Active Comparator
description: Extended Varenicline plus Facilitated Extinction (EV+FE). Participants in the EV+FE condition will receive varenicline for a 4-week run-in period while continuing to smoke. In addition, the EV+FE condition will receive counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided. All groups will undergo periodic laboratory assessments and surveys.
arm group label: Standard Varenicline (SV)
arm group type: Active Comparator
description: Participants in the Standard Varenicline (SV) condition will receive varenicline for the usual 1-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys.
arm group label: Extended Varenicline (EV)
arm group type: Active Comparator
description: Participants in the Extended Varenicline (EV) condition will receive varenicline for a 4-week run-in period while continuing to smoke. All groups will undergo periodic laboratory assessments and surveys.
intervention type: Drug
intervention name: Varenicline
description: All participants will take the following dose of varenicline: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day through week 16 of the study. Arm descriptions show specific details for each group.
arm group label: Extended Varenicline (EV)
arm group label: Extended Varenicline + Facilitated Extinction
arm group label: Standard Varenicline (SV)
other name: Chantix™
intervention type: Other
intervention name: Counseling and Support Materials
description: Counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided.
arm group label: Extended Varenicline + Facilitated Extinction
intervention type: Other
intervention name: Laboratory Assessments
description: The first laboratory assessment will consist of completion of questionnaires and a cue-reactivity test. The second laboratory assessment will be scheduled for the end of the week before the participant's quit date. It will involve completion of questionnaires and another cue reactivity test. A follow-up session conducted by research staff will occur one month after the target quit date to collect information about each participant's current smoking status, smoking rate, varenicline use, and opinion about the treatment. A second follow-up session will be conducted by telephone and will occur three months after the target quit date, at the end of varenicline use. At the end of the study, participants will be asked to complete a brief survey asking basic information, similar to the questions during the screening period.
arm group label: Extended Varenicline (EV)
arm group label: Extended Varenicline + Facilitated Extinction
arm group label: Standard Varenicline (SV)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Thomas Brandon, Ph.D.
role: Principal Investigator
affiliation: H. Lee Moffitt Cancer Center and Research Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
mesh term: Varenicline
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 