<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/NCT02244918</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00001602</org_study_id>
    <secondary_id>AD-1310-08709</secondary_id>
    <nct_id>NCT02244918</nct_id>
  </id_info>
  <brief_title>Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers</brief_title>
  <official_title>Informing Tobacco Treatment Guidelines for African American Non-Daily Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The researchers are testing if counseling alone or counseling plus over-the-counter nicotine&#xD;
      replacement therapies (NRT), like the patch,gum, or lozenge, helps African American non-daily&#xD;
      smokers quit smoking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Non-daily smokers represent a growing number of racial/ethnic minority smokers. 1 out of 4&#xD;
      African Americans are non-daily smokers. African Americans seem to have a harder time&#xD;
      quitting and have greater medical problems related to smoking even at lighter usage rates&#xD;
      compared to Whites.&#xD;
&#xD;
      Current tobacco treatment guidelines target daily smokers. There are no guidelines for&#xD;
      non-daily smokers. This study will allow the researchers to explore treatment options for&#xD;
      African American non-daily smokers and find out if some treatments work better than others.&#xD;
&#xD;
      Participation in this study will last about 6 months. Over this course of time, participants&#xD;
      will be asked to visit the study location 3 times and will talk with a member of the study&#xD;
      team on the phone 4 times.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2015</start_date>
  <completion_date type="Actual">March 15, 2018</completion_date>
  <primary_completion_date type="Actual">November 1, 2017</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>Smoking Abstinence</measure>
    <time_frame>Week 12</time_frame>
    <description>Biochemically confirmed 30-day point prevalence abstinence at Week 12 using urine anabasine and anatabine, with the recommended cut-off of 2 ng/ml to differentiate smokers from non-smokers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Smoking Abstinence</measure>
    <time_frame>Week 26</time_frame>
    <description>Biochemically confirmed 30-day point prevalence abstinence at Week 26 using urinary cotinine, with the recommended cut-off of 50 ng/ml to differentiate smokers from non-smokers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of Urinary Cotinine</measure>
    <time_frame>Weeks 0, 26</time_frame>
    <description>Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol)</measure>
    <time_frame>Weeks 0, 12</time_frame>
    <description>Measured by a change in NNAL (4-(methyl nitrosamine)-1-(3-pyridyl)-1-butanol),a biochemical marker of tobacco-specific carcinogen exposure. Levels assessed by urine sample from each participant and Weeks 0 and 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Days Abstinent</measure>
    <time_frame>Week 0-26</time_frame>
    <description>Number of days abstinent from baseline through week 26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cigarettes Used</measure>
    <time_frame>Weeks 0-26</time_frame>
    <description>Cigarettes used in the past 30 days from baseline through week 26</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">278</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Counseling Plus NRT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy(NRT) (like the patch, gum or lozenge) of their choice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine Replacement Therapy</intervention_name>
    <description>Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.</description>
    <arm_group_label>Counseling Plus NRT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking Cessation Counseling</intervention_name>
    <arm_group_label>Counseling</arm_group_label>
    <arm_group_label>Counseling Plus NRT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  African American adults who are interested in quitting and whose smoking patterns meet&#xD;
             criteria for non-daily smoking as determined by eligibility screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable&#xD;
             to complete study procedures as determined by eligibility screening&#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>Nikki Nollen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swope Health Central</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <results_first_submitted>November 7, 2018</results_first_submitted>
  <results_first_submitted_qc>December 20, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 9, 2019</results_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</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>Nicotine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT02244918/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Counseling Plus Nicotine Replacement Therapy</title>
          <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks.In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.&#xD;
Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.</description>
        </group>
        <group group_id="P2">
          <title>Counseling</title>
          <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="185"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Week 12</title>
              <participants_list>
                <participants group_id="P1" count="160"/>
                <participants group_id="P2" count="83"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="185"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Counseling Plus Nicotine Replacement Therapy</title>
          <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.&#xD;
Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.</description>
        </group>
        <group group_id="B2">
          <title>Counseling</title>
          <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks.</description>
        </group>
        <group group_id="B3">
          <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="185"/>
            <count group_id="B2" value="93"/>
            <count group_id="B3" value="278"/>
          </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="48.6" spread="1.6"/>
                    <measurement group_id="B2" value="49" spread="11.8"/>
                    <measurement group_id="B3" value="48.7" spread="11.7"/>
                  </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="94"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="141"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>African American, Non-Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="185"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="278"/>
                  </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="185"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="278"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cohabitation Status, Married or living with a partner</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employed Full-time</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education level of less than High School graduate</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Has health insurance</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="146"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>&lt; or = 100% Poverty Level</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Own a Home</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.3" spread="8.7"/>
                    <measurement group_id="B2" value="31.7" spread="9.8"/>
                    <measurement group_id="B3" value="31.5" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Days smoked cigarettes in the last 30</title>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.2" spread="8.0"/>
                    <measurement group_id="B2" value="22.8" spread="8.0"/>
                    <measurement group_id="B3" value="23.1" spread="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of cigarettes used on days smoked</title>
          <units>cigarettes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.8" spread="3.6"/>
                    <measurement group_id="B2" value="4.4" spread="3.2"/>
                    <measurement group_id="B3" value="4.7" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Smoking Abstinence</title>
        <description>Biochemically confirmed 30-day point prevalence abstinence at Week 12 using urine anabasine and anatabine, with the recommended cut-off of 2 ng/ml to differentiate smokers from non-smokers.</description>
        <time_frame>Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Counseling Plus Nicotine Replacement Therapy</title>
            <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.&#xD;
Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.</description>
          </group>
          <group group_id="O2">
            <title>Counseling</title>
            <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Smoking Abstinence</title>
          <description>Biochemically confirmed 30-day point prevalence abstinence at Week 12 using urine anabasine and anatabine, with the recommended cut-off of 2 ng/ml to differentiate smokers from non-smokers.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Smoking Abstinence</title>
        <description>Biochemically confirmed 30-day point prevalence abstinence at Week 26 using urinary cotinine, with the recommended cut-off of 50 ng/ml to differentiate smokers from non-smokers.</description>
        <time_frame>Week 26</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Counseling Plus Nicotine Replacement Therapy</title>
            <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.&#xD;
Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.</description>
          </group>
          <group group_id="O2">
            <title>Counseling</title>
            <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Smoking Abstinence</title>
          <description>Biochemically confirmed 30-day point prevalence abstinence at Week 26 using urinary cotinine, with the recommended cut-off of 50 ng/ml to differentiate smokers from non-smokers.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Concentration of Urinary Cotinine</title>
        <description>Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26.</description>
        <time_frame>Weeks 0, 26</time_frame>
        <population>Number analyzed at the week 26 follow-up time point reflects the number of participants who returned for this visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Counseling Plus Nicotine Replacement Therapy</title>
            <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.&#xD;
Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.</description>
          </group>
          <group group_id="O2">
            <title>Counseling</title>
            <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Concentration of Urinary Cotinine</title>
          <description>Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26.</description>
          <population>Number analyzed at the week 26 follow-up time point reflects the number of participants who returned for this visit.</population>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Nicotine Exposure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1538.3" spread="1622.0"/>
                    <measurement group_id="O2" value="1905.3" spread="1695.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26 Nicotine Exposure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="128"/>
                    <count group_id="O2" value="74"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1513.2" spread="1779.0"/>
                    <measurement group_id="O2" value="1649.3" spread="1443.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol)</title>
        <description>Measured by a change in NNAL (4-(methyl nitrosamine)-1-(3-pyridyl)-1-butanol),a biochemical marker of tobacco-specific carcinogen exposure. Levels assessed by urine sample from each participant and Weeks 0 and 12.</description>
        <time_frame>Weeks 0, 12</time_frame>
        <population>The number of participants analyzed at follow-up time-points reflects only those who returned at that point.</population>
        <group_list>
          <group group_id="O1">
            <title>Counseling Plus Nicotine Replacement Therapy</title>
            <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.&#xD;
Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.</description>
          </group>
          <group group_id="O2">
            <title>Counseling</title>
            <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol)</title>
          <description>Measured by a change in NNAL (4-(methyl nitrosamine)-1-(3-pyridyl)-1-butanol),a biochemical marker of tobacco-specific carcinogen exposure. Levels assessed by urine sample from each participant and Weeks 0 and 12.</description>
          <population>The number of participants analyzed at follow-up time-points reflects only those who returned at that point.</population>
          <units>pg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Carcinogen Exposure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.9" spread="121.0"/>
                    <measurement group_id="O2" value="97.1" spread="97.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 Carcinogen Exposure</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="158"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.6" spread="55.2"/>
                    <measurement group_id="O2" value="49.3" spread="47.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Days Abstinent</title>
        <description>Number of days abstinent from baseline through week 26.</description>
        <time_frame>Week 0-26</time_frame>
        <population>The number of participants analyzed at follow-up time-points reflects only those who returned at that point.</population>
        <group_list>
          <group group_id="O1">
            <title>Counseling Plus Nicotine Replacement Therapy</title>
            <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.&#xD;
Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.</description>
          </group>
          <group group_id="O2">
            <title>Counseling</title>
            <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Days Abstinent</title>
          <description>Number of days abstinent from baseline through week 26.</description>
          <population>The number of participants analyzed at follow-up time-points reflects only those who returned at that point.</population>
          <units>days abstinent in the past 30 days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline days abstinent from all tobacco</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" spread="6.4"/>
                    <measurement group_id="O2" value="10.4" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4 days abstinent from all tobacco</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" spread="9.0"/>
                    <measurement group_id="O2" value="12.8" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8 days abstinent from all tobacco</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.8" spread="9.0"/>
                    <measurement group_id="O2" value="19.8" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12 days abstinent from all tobacco</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.8" spread="10.7"/>
                    <measurement group_id="O2" value="14.8" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26 days abstinent from all tobacco</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.2" spread="11.2"/>
                    <measurement group_id="O2" value="15.1" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cigarettes Used</title>
        <description>Cigarettes used in the past 30 days from baseline through week 26</description>
        <time_frame>Weeks 0-26</time_frame>
        <population>The number of participants analyzed at follow-up time-points reflects only those who returned at that point.</population>
        <group_list>
          <group group_id="O1">
            <title>Counseling Plus Nicotine Replacement Therapy</title>
            <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks.In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.&#xD;
Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.</description>
          </group>
          <group group_id="O2">
            <title>Counseling</title>
            <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Cigarettes Used</title>
          <description>Cigarettes used in the past 30 days from baseline through week 26</description>
          <population>The number of participants analyzed at follow-up time-points reflects only those who returned at that point.</population>
          <units>Cigarettes used in the past 30 days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="185"/>
                <count group_id="O2" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="185"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.4" spread="102.1"/>
                    <measurement group_id="O2" value="85.8" spread="72.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.2" spread="58.5"/>
                    <measurement group_id="O2" value="57.9" spread="51.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.9" spread="52.3"/>
                    <measurement group_id="O2" value="53.3" spread="64.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="160"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.1" spread="69.4"/>
                    <measurement group_id="O2" value="49.0" spread="56.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="132"/>
                    <count group_id="O2" value="75"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.9" spread="81.0"/>
                    <measurement group_id="O2" value="48.7" spread="57.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected for 12 weeks.</time_frame>
      <desc>At each assessment point, participants were asked to report any new or worsening symptoms.</desc>
      <group_list>
        <group group_id="E1">
          <title>Counseling Plus Nicotine Replacement Therapy</title>
          <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks.In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy (like the patch, gum or lozenge) of their choice.&#xD;
Nicotine Replacement Therapy: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.</description>
        </group>
        <group group_id="E2">
          <title>Counseling</title>
          <description>Participants will attend 5 smoking cessation counseling sessions over 12 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <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="185"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="161" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="83" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Irregular or fast heart beat</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Disturbed hearing or vision</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Cold Sweats or increased sweating</sub_title>
                <counts group_id="E1" subjects_affected="72" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Blisters in the mouth, increased saliva, or other problems with the mouth, tooth or jaw</sub_title>
                <counts group_id="E1" subjects_affected="59" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Bowel changes like constipation or diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="70" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="36" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Changes in taste</sub_title>
                <counts group_id="E1" subjects_affected="104" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Heartburn, indigestion, hiccups or burping</sub_title>
                <counts group_id="E1" subjects_affected="88" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Nausea or vomiting</sub_title>
                <counts group_id="E1" subjects_affected="53" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Sore throat</sub_title>
                <counts group_id="E1" subjects_affected="43" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Stomach cramps or pains</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="87" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="105" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="63" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Sleeping Problems</sub_title>
                <counts group_id="E1" subjects_affected="98" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="56" subjects_at_risk="93"/>
              </event>
              <event>
                <sub_title>Tiredness/fatigue</sub_title>
                <counts group_id="E1" subjects_affected="109" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="67" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous, restless, anxious</sub_title>
                <counts group_id="E1" subjects_affected="103" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="56" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Difficulty concentrating or confusion.mental weakness</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Breathing Problems</sub_title>
                <counts group_id="E1" subjects_affected="59" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Redness/swelling/rash/irritation on the skin</sub_title>
                <counts group_id="E1" subjects_affected="36" subjects_at_risk="185"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="93"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>
    <limitations_and_caveats>Findings may not generalize to non-daily smokers of other racial/ethnic groups. Low rates of cessation overall limited the potential for analyses of differential effects in sub-populations.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Nicole Nollen</name_or_title>
      <organization>University of Kansas Medical Center</organization>
      <phone>913-588-3784</phone>
      <email>nnollen@kumc.edu</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/NCT02244918
org study id: STUDY00001602
secondary id: AD-1310-08709
nct id: NCT02244918
lead sponsor: 
collaborator: 
has dmc: No
The researchers are testing if counseling alone or counseling plus over-the-counter nicotine
      replacement therapies (NRT), like the patch,gum, or lozenge, helps African American non-daily
      smokers quit smoking.
Non-daily smokers represent a growing number of racial/ethnic minority smokers. 1 out of 4
      African Americans are non-daily smokers. African Americans seem to have a harder time
      quitting and have greater medical problems related to smoking even at lighter usage rates
      compared to Whites.

      Current tobacco treatment guidelines target daily smokers. There are no guidelines for
      non-daily smokers. This study will allow the researchers to explore treatment options for
      African American non-daily smokers and find out if some treatments work better than others.

      Participation in this study will last about 6 months. Over this course of time, participants
      will be asked to visit the study location 3 times and will talk with a member of the study
      team on the phone 4 times.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Smoking Abstinence
time frame: Week 12
description: Biochemically confirmed 30-day point prevalence abstinence at Week 12 using urine anabasine and anatabine, with the recommended cut-off of 2 ng/ml to differentiate smokers from non-smokers.
measure: Smoking Abstinence
time frame: Week 26
description: Biochemically confirmed 30-day point prevalence abstinence at Week 26 using urinary cotinine, with the recommended cut-off of 50 ng/ml to differentiate smokers from non-smokers.
measure: Concentration of Urinary Cotinine
time frame: Weeks 0, 26
description: Measured by urinary cotinine, a biochemical marker of nicotine intake, sampled from participants at weeks 0 and 26.
measure: Urinary Concentration of NNAL (4-(Methyl Nitrosamine)-1-(3-pyridyl)-1-butanol)
time frame: Weeks 0, 12
description: Measured by a change in NNAL (4-(methyl nitrosamine)-1-(3-pyridyl)-1-butanol),a biochemical marker of tobacco-specific carcinogen exposure. Levels assessed by urine sample from each participant and Weeks 0 and 12.
measure: Total Days Abstinent
time frame: Week 0-26
description: Number of days abstinent from baseline through week 26.
measure: Cigarettes Used
time frame: Weeks 0-26
description: Cigarettes used in the past 30 days from baseline through week 26
arm group label: Counseling
arm group type: Active Comparator
description: Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions.
arm group label: Counseling Plus NRT
arm group type: Experimental
description: Participants will go to smoking cessation counseling over 12 weeks. They will be asked to participated in 5 total counseling sessions. In addition to counseling, participants in this group will also take 12 weeks of a nicotine replacement therapy(NRT) (like the patch, gum or lozenge) of their choice.
intervention type: Drug
intervention name: Nicotine Replacement Therapy
description: Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.
arm group label: Counseling Plus NRT
intervention type: Behavioral
intervention name: Smoking Cessation Counseling
arm group label: Counseling
arm group label: Counseling Plus NRT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nikki Nollen, PhD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Nicotine
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Findings may not generalize to non-daily smokers of other racial/ethnic groups. Low rates of cessation overall limited the potential for analyses of differential effects in sub-populations.
point of contact: 