<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/NCT03029819</url>
  </required_header>
  <id_info>
    <org_study_id>K23AT008442</org_study_id>
    <secondary_id>K23AT008442</secondary_id>
    <nct_id>NCT03029819</nct_id>
  </id_info>
  <brief_title>iQuit Mindfully: Text Messaging for Smoking Cessation</brief_title>
  <official_title>iQuit Mindfully: A Randomized Controlled Trial of Mindfulness-based Smoking Cessation Enhanced With Mobile Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georgia State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Complementary and Integrative Health (NCCIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Catholic University of America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>George Washington University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Georgia State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate text messaging as a way to enhance&#xD;
      mindfulness-based treatment for smoking cessation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a pilot investigation of mindfulness-based smoking cessation treatment&#xD;
      incorporating between-session text messaging (&quot;iQuit Mindfully&quot;). Participants will be&#xD;
      randomly assigned to one of two groups: Mindfulness-based Addiction Treatment (MBAT) or iQuit&#xD;
      Mindfully (MBAT with the addition of between-session text messages).&#xD;
&#xD;
      All participants will receive in-person group treatment based on the 8-week MBAT protocol in&#xD;
      addition to nicotine patch therapy and self-help materials. Participants assigned to iQuit&#xD;
      Mindfully will receive additional support via text messaging. Assessments will occur at&#xD;
      baseline, at each of the weekly in-person visits, at end of treatment, and at 1-month&#xD;
      follow-up. Feasibility, smoking abstinence, mindfulness practice, and indicators of tobacco&#xD;
      dependence and psychological well-being will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">October 3, 2017</completion_date>
  <primary_completion_date type="Actual">August 10, 2017</primary_completion_date>
  <phase>N/A</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking Abstinence</measure>
    <time_frame>End of Treatment (8 weeks)</time_frame>
    <description>Number of participants who abstained from smoking (based on self-reported 7-day abstinence, which is biochemically verified by expired carbon monoxide &lt;6 parts per million (ppm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant Engagement</measure>
    <time_frame>Over the 8-week treatment period</time_frame>
    <description>Number of participants who respond to interactive text messages</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Ratings</measure>
    <time_frame>End of Treatment (8 weeks)</time_frame>
    <description>Perceived Text Message Helpfulness (minimum value 1 [&quot;not at all helpful&quot;], maximum value 10 [&quot;extremely helpful&quot;], higher scores mean better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attrition</measure>
    <time_frame>End of treatment (8 weeks)</time_frame>
    <description>Number of participants who do not attend end-of-treatment session</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Cigarettes Smoked Per Day</measure>
    <time_frame>End of treatment (8 weeks)</time_frame>
    <description>Self-reported number of cigarettes smoked per day (questionnaire)</description>
  </other_outcome>
  <other_outcome>
    <measure>Weekly Mindfulness Practice</measure>
    <time_frame>Throughout treatment period (8 weeks)</time_frame>
    <description>Self-reported average weekly mindfulness practice (questionnaire)</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-reported Mindfulness and Psychological Functioning</measure>
    <time_frame>End of treatment (8 weeks)</time_frame>
    <description>Mindfulness, affect, self-efficacy, dependence, and withdrawal symptoms (questionnaire)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Cigarette Smoking</condition>
  <arm_group>
    <arm_group_label>Mindfulness-based Addiction Treatment (MBAT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nicotine patch; self-help guide; MBAT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>iQuit Mindfully</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nicotine patch; self-help guide; MBAT; text messaging</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-based Addiction Treatment</intervention_name>
    <description>Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).</description>
    <arm_group_label>Mindfulness-based Addiction Treatment (MBAT)</arm_group_label>
    <arm_group_label>iQuit Mindfully</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>iQuit Mindfully</intervention_name>
    <description>iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.</description>
    <arm_group_label>iQuit Mindfully</arm_group_label>
    <other_name>Mindfulness-based text messaging for smoking cessation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-Help guide</intervention_name>
    <description>Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).</description>
    <arm_group_label>Mindfulness-based Addiction Treatment (MBAT)</arm_group_label>
    <arm_group_label>iQuit Mindfully</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine Patch</intervention_name>
    <description>Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</description>
    <arm_group_label>Mindfulness-based Addiction Treatment (MBAT)</arm_group_label>
    <arm_group_label>iQuit Mindfully</arm_group_label>
    <other_name>Generic Nicotine Patch</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18-65 years&#xD;
&#xD;
          -  current smoker with history of &gt;5 cigarettes/day for past year (and expired carbon&#xD;
             monoxide &gt;6 parts per million [ppm])&#xD;
&#xD;
          -  motivated to quit within next 30 days&#xD;
&#xD;
          -  valid home address in the greater Atlanta, Georgia area&#xD;
&#xD;
          -  functioning telephone number&#xD;
&#xD;
          -  own a mobile phone with text messaging capacity&#xD;
&#xD;
          -  can speak, read, and write in English&#xD;
&#xD;
          -  at least a sixth-grade level of health literacy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication for nicotine patch&#xD;
&#xD;
          -  active substance abuse/dependence&#xD;
&#xD;
          -  regular use of tobacco products other than cigarettes&#xD;
&#xD;
          -  current use of tobacco cessation medications&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
&#xD;
          -  household member enrolled in the study&#xD;
&#xD;
          -  current diagnosis of schizophrenia or bipolar disorder, or use of antipsychotic&#xD;
             medications&#xD;
&#xD;
          -  clinically significant depressive symptoms&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire A Spears, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Georgia State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgia State University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Vidrine JI, Spears CA, Heppner WL, Reitzel LR, Marcus MT, Cinciripini PM, Waters AJ, Li Y, Nguyen NT, Cao Y, Tindle HA, Fine M, Safranek LV, Wetter DW. Efficacy of mindfulness-based addiction treatment (MBAT) for smoking cessation and lapse recovery: A randomized clinical trial. J Consult Clin Psychol. 2016 Sep;84(9):824-838. doi: 10.1037/ccp0000117.</citation>
    <PMID>27213492</PMID>
  </reference>
  <reference>
    <citation>Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.</citation>
    <PMID>18617085</PMID>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <results_first_submitted>September 4, 2018</results_first_submitted>
  <results_first_submitted_qc>December 5, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 17, 2018</results_first_posted>
  <last_update_submitted>December 14, 2018</last_update_submitted>
  <last_update_submitted_qc>December 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Georgia State University</investigator_affiliation>
    <investigator_full_name>Claire Spears</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </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>December 15, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03029819/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mindfulness-based Addiction Treatment (MBAT)</title>
          <description>Nicotine patch; self-help guide; MBAT&#xD;
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).&#xD;
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).&#xD;
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</description>
        </group>
        <group group_id="P2">
          <title>iQuit Mindfully</title>
          <description>Nicotine patch; self-help guide; MBAT; text messaging&#xD;
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).&#xD;
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.&#xD;
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).&#xD;
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="33"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Removed due to disruptive behavior</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>A total of 72 participants were enrolled in the study. However, one participant was removed due to disruptive behavior in the in-person group treatment, for a final analytic sample of 71 (33 in MBAT and 38 in iQuit Mindfully).</population>
      <group_list>
        <group group_id="B1">
          <title>Mindfulness-based Addiction Treatment (MBAT)</title>
          <description>Nicotine patch; self-help guide; MBAT&#xD;
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).&#xD;
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).&#xD;
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</description>
        </group>
        <group group_id="B2">
          <title>iQuit Mindfully</title>
          <description>Nicotine patch; self-help guide; MBAT; text messaging&#xD;
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).&#xD;
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.&#xD;
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).&#xD;
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</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="33"/>
            <count group_id="B2" value="38"/>
            <count group_id="B3" value="71"/>
          </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="45.6" spread="12.0"/>
                    <measurement group_id="B2" value="45.6" spread="12.4"/>
                    <measurement group_id="B3" value="45.6" spread="12.0"/>
                  </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="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="68"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline cigarettes per day</title>
          <units>Cigarettes per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.8" spread="9.3"/>
                    <measurement group_id="B2" value="14.4" spread="9.4"/>
                    <measurement group_id="B3" value="16.5" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Smoking Abstinence</title>
        <description>Number of participants who abstained from smoking (based on self-reported 7-day abstinence, which is biochemically verified by expired carbon monoxide &lt;6 parts per million (ppm)</description>
        <time_frame>End of Treatment (8 weeks)</time_frame>
        <population>Available data for smoking abstinence were analyzed because coding missing data as smoking can severely bias results. Accordingly, the overall number of participants analyzed for smoking abstinence was 55.</population>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Addiction Treatment (MBAT)</title>
            <description>Nicotine patch; self-help guide; MBAT&#xD;
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).&#xD;
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).&#xD;
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</description>
          </group>
          <group group_id="O2">
            <title>iQuit Mindfully</title>
            <description>Nicotine patch; self-help guide; MBAT; text messaging&#xD;
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).&#xD;
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.&#xD;
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).&#xD;
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</description>
          </group>
        </group_list>
        <measure>
          <title>Smoking Abstinence</title>
          <description>Number of participants who abstained from smoking (based on self-reported 7-day abstinence, which is biochemically verified by expired carbon monoxide &lt;6 parts per million (ppm)</description>
          <population>Available data for smoking abstinence were analyzed because coding missing data as smoking can severely bias results. Accordingly, the overall number of participants analyzed for smoking abstinence was 55.</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="24"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.52</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Engagement</title>
        <description>Number of participants who respond to interactive text messages</description>
        <time_frame>Over the 8-week treatment period</time_frame>
        <population>Only participants in the iQuit Mindfully condition were included in this analysis because MBAT participants did not receive text messages.</population>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Addiction Treatment (MBAT)</title>
            <description>Nicotine patch; self-help guide; MBAT&#xD;
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).&#xD;
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).&#xD;
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</description>
          </group>
          <group group_id="O2">
            <title>iQuit Mindfully</title>
            <description>Nicotine patch; self-help guide; MBAT; text messaging&#xD;
Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation.&#xD;
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.&#xD;
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline.&#xD;
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Engagement</title>
          <description>Number of participants who respond to interactive text messages</description>
          <population>Only participants in the iQuit Mindfully condition were included in this analysis because MBAT participants did not receive text messages.</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="0"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Participant Ratings</title>
        <description>Perceived Text Message Helpfulness (minimum value 1 [&quot;not at all helpful&quot;], maximum value 10 [&quot;extremely helpful&quot;], higher scores mean better outcome)</description>
        <time_frame>End of Treatment (8 weeks)</time_frame>
        <population>Only participants in the iQuit Mindfully condition were included in this analysis because those in MBAT did not receive text messages.</population>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Addiction Treatment (MBAT)</title>
            <description>Nicotine patch; self-help guide; MBAT&#xD;
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).&#xD;
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).&#xD;
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</description>
          </group>
          <group group_id="O2">
            <title>iQuit Mindfully</title>
            <description>Nicotine patch; self-help guide; MBAT; text messaging&#xD;
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation.&#xD;
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.&#xD;
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline.&#xD;
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</description>
          </group>
        </group_list>
        <measure>
          <title>Participant Ratings</title>
          <description>Perceived Text Message Helpfulness (minimum value 1 [&quot;not at all helpful&quot;], maximum value 10 [&quot;extremely helpful&quot;], higher scores mean better outcome)</description>
          <population>Only participants in the iQuit Mindfully condition were included in this analysis because those in MBAT did not receive text messages.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="8.0" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Attrition</title>
        <description>Number of participants who do not attend end-of-treatment session</description>
        <time_frame>End of treatment (8 weeks)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Addiction Treatment (MBAT)</title>
            <description>Nicotine patch; self-help guide; MBAT&#xD;
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).&#xD;
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).&#xD;
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</description>
          </group>
          <group group_id="O2">
            <title>iQuit Mindfully</title>
            <description>Nicotine patch; self-help guide; MBAT; text messaging&#xD;
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation.&#xD;
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.&#xD;
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline.&#xD;
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</description>
          </group>
        </group_list>
        <measure>
          <title>Attrition</title>
          <description>Number of participants who do not attend end-of-treatment session</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="33"/>
                <count group_id="O2" value="38"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Cigarettes Smoked Per Day</title>
        <description>Self-reported number of cigarettes smoked per day (questionnaire)</description>
        <time_frame>End of treatment (8 weeks)</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Weekly Mindfulness Practice</title>
        <description>Self-reported average weekly mindfulness practice (questionnaire)</description>
        <time_frame>Throughout treatment period (8 weeks)</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Self-reported Mindfulness and Psychological Functioning</title>
        <description>Mindfulness, affect, self-efficacy, dependence, and withdrawal symptoms (questionnaire)</description>
        <time_frame>End of treatment (8 weeks)</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Reported over the period of treatment (8 weeks) and 1 month follow-up, for a total of 12 weeks.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Mindfulness-based Addiction Treatment (MBAT)</title>
          <description>Nicotine patch; self-help guide; MBAT&#xD;
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).&#xD;
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).&#xD;
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</description>
        </group>
        <group group_id="E2">
          <title>iQuit Mindfully</title>
          <description>Nicotine patch; self-help guide; MBAT; text messaging&#xD;
Mindfulness-based Addiction Treatment: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).&#xD;
iQuit Mindfully: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.&#xD;
Self-Help guide: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008).&#xD;
Nicotine Patch: Patch therapy (beginning the week before quit day) for participants who smoke &gt;10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.</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="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="39"/>
              </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="7" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Mild nicotine patch side effects</sub_title>
                <description>Mild nicotine patch side effects (itching, nausea, abnormal dreams, nervousness)</description>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="33"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="39"/>
              </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>
    <point_of_contact>
      <name_or_title>Claire Spears</name_or_title>
      <organization>Georgia State University School of Public Health</organization>
      <phone>4044139335</phone>
      <email>cspears@gsu.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/NCT03029819
org study id: K23AT008442
secondary id: K23AT008442
nct id: NCT03029819
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate text messaging as a way to enhance
      mindfulness-based treatment for smoking cessation.
This study is a pilot investigation of mindfulness-based smoking cessation treatment
      incorporating between-session text messaging ("iQuit Mindfully"). Participants will be
      randomly assigned to one of two groups: Mindfulness-based Addiction Treatment (MBAT) or iQuit
      Mindfully (MBAT with the addition of between-session text messages).

      All participants will receive in-person group treatment based on the 8-week MBAT protocol in
      addition to nicotine patch therapy and self-help materials. Participants assigned to iQuit
      Mindfully will receive additional support via text messaging. Assessments will occur at
      baseline, at each of the weekly in-person visits, at end of treatment, and at 1-month
      follow-up. Feasibility, smoking abstinence, mindfulness practice, and indicators of tobacco
      dependence and psychological well-being will be assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Smoking Abstinence
time frame: End of Treatment (8 weeks)
description: Number of participants who abstained from smoking (based on self-reported 7-day abstinence, which is biochemically verified by expired carbon monoxide <6 parts per million (ppm)
measure: Participant Engagement
time frame: Over the 8-week treatment period
description: Number of participants who respond to interactive text messages
measure: Participant Ratings
time frame: End of Treatment (8 weeks)
description: Perceived Text Message Helpfulness (minimum value 1 ["not at all helpful"], maximum value 10 ["extremely helpful"], higher scores mean better outcome)
measure: Attrition
time frame: End of treatment (8 weeks)
description: Number of participants who do not attend end-of-treatment session
measure: Number of Cigarettes Smoked Per Day
time frame: End of treatment (8 weeks)
description: Self-reported number of cigarettes smoked per day (questionnaire)
measure: Weekly Mindfulness Practice
time frame: Throughout treatment period (8 weeks)
description: Self-reported average weekly mindfulness practice (questionnaire)
measure: Self-reported Mindfulness and Psychological Functioning
time frame: End of treatment (8 weeks)
description: Mindfulness, affect, self-efficacy, dependence, and withdrawal symptoms (questionnaire)
arm group label: Mindfulness-based Addiction Treatment (MBAT)
arm group type: Active Comparator
description: Nicotine patch; self-help guide; MBAT
arm group label: iQuit Mindfully
arm group type: Experimental
description: Nicotine patch; self-help guide; MBAT; text messaging
intervention type: Behavioral
intervention name: Mindfulness-based Addiction Treatment
description: Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
arm group label: Mindfulness-based Addiction Treatment (MBAT)
arm group label: iQuit Mindfully
intervention type: Behavioral
intervention name: iQuit Mindfully
description: iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
arm group label: iQuit Mindfully
other name: Mindfulness-based text messaging for smoking cessation
intervention type: Behavioral
intervention name: Self-Help guide
description: Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).
arm group label: Mindfulness-based Addiction Treatment (MBAT)
arm group label: iQuit Mindfully
intervention type: Drug
intervention name: Nicotine Patch
description: Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
arm group label: Mindfulness-based Addiction Treatment (MBAT)
arm group label: iQuit Mindfully
other name: Generic Nicotine Patch
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Claire A Spears, Ph.D.
role: Principal Investigator
affiliation: Georgia State University
facility: 
country: United States
citation: Vidrine JI, Spears CA, Heppner WL, Reitzel LR, Marcus MT, Cinciripini PM, Waters AJ, Li Y, Nguyen NT, Cao Y, Tindle HA, Fine M, Safranek LV, Wetter DW. Efficacy of mindfulness-based addiction treatment (MBAT) for smoking cessation and lapse recovery: A randomized clinical trial. J Consult Clin Psychol. 2016 Sep;84(9):824-838. doi: 10.1037/ccp0000117.
PMID: 27213492
citation: Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.
PMID: 18617085
responsible party type: Principal Investigator
investigator affiliation: Georgia State University
investigator full name: Claire Spears
investigator title: Assistant Professor
mesh term: Nicotine
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 