<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/NCT02224391</url>
  </required_header>
  <id_info>
    <org_study_id>2013-0999</org_study_id>
    <secondary_id>NCI-2015-00609</secondary_id>
    <secondary_id>2013-0999</secondary_id>
    <nct_id>NCT02224391</nct_id>
  </id_info>
  <brief_title>Smartphone-Delivered Attentional Bias Modification Training in Helping Patients Quit Smoking</brief_title>
  <official_title>Smartphone-Delivered Attentional Bias Modification Training for Quitting Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized clinical trial studies how well a smartphone-delivered attentional bias&#xD;
      modification training works in helping patients quit smoking. Smartphone-delivered&#xD;
      attentional bias modification training may help patients quit smoking by reducing the&#xD;
      attentional bias (the tendency of one's perception to be affected by their recurring&#xD;
      thoughts) towards smoking cues that developed over time as a result of conditioning processes&#xD;
      through which smoking cues become important.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the feasibility of smartphone-delivered, in-home attentional bias&#xD;
      modification (ABM) to reduce attentional bias (AB) to smoking cues and to reduce smoking&#xD;
      behavior in the short- and long-term.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients receive ABM training over 30 minutes through a smartphone on days 1-14.&#xD;
      Patients then receive nicotine patches for up to 8 weeks.&#xD;
&#xD;
      ARM II: Patients undergo sham training on days 1-14. Patients then receive nicotine patches&#xD;
      for up to 8 weeks.&#xD;
&#xD;
      After completion of study treatment, patients are followed up on days 15, 29, 43, 57, and 72.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2016</start_date>
  <completion_date type="Actual">March 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 15, 2021</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Dot-probe Task</measure>
    <time_frame>Up to 8 weeks post-training</time_frame>
    <description>Modified dot-probe task evaluated by using 2 (group: ABM vs. sham) X 3 (session: baseline, 1-day post-training, and 8-weeks post-training) linear mixed model using RT difference scores (neutral-cigarette) as the dependent measures and subject as the random effect.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Smoking Stroop Task</measure>
    <time_frame>Up to 8 weeks post-training</time_frame>
    <description>The Stroop task will consist of three blocks, with a 5-s rest period between blocks: (a) practice (40 trials), (b) neutral words (80 trials), and (c) smoking words (80 trials). The score will be calculated by taking the mean RT difference between the smoking and neutral words on trials with correct responses within the response window.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cigarette Per Day (CPD)</measure>
    <time_frame>Up to 8 weeks post-training</time_frame>
    <description>Mean number of cigarettes per day smoked for the seven days preceding each time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Expired Carbon Monoxide (CO)</measure>
    <time_frame>Up to 8 weeks post-training</time_frame>
    <description>Mean expired carbon monoxide, in ppm (parts per million), at each time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary Cotinine</measure>
    <time_frame>Up to 8 weeks post-training</time_frame>
    <description>Mean urinary cotinine, measured in ng/mL, at each time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fagerström Test for Nicotine Dependence (FTND)</measure>
    <time_frame>Up to 8 weeks post-training</time_frame>
    <description>The Fagerström Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. Mean Fagerström Test for Nicotine Dependence (FTND) questionnaire score at each time point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wisconsin Smoking Withdrawal Scale (WSWS) - Craving</measure>
    <time_frame>Up to 8 weeks post-training</time_frame>
    <description>Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">311</enrollment>
  <condition>Current Every Day Smoker</condition>
  <arm_group>
    <arm_group_label>Arm I (ABM training)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (sham training)</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Computer-Assisted Smoking Cessation Intervention</intervention_name>
    <description>Receive ABM training via a smartphone</description>
    <arm_group_label>Arm I (ABM training)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Arm I (ABM training)</arm_group_label>
    <arm_group_label>Arm II (sham training)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nicotine Patch</intervention_name>
    <description>Given via transdermal patch</description>
    <arm_group_label>Arm I (ABM training)</arm_group_label>
    <arm_group_label>Arm II (sham training)</arm_group_label>
    <other_name>NicoDerm CQ</other_name>
    <other_name>Nicotine Skin Patch</other_name>
    <other_name>Nicotine Transdermal Patch</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (ABM training)</arm_group_label>
    <arm_group_label>Arm II (sham training)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham Intervention</intervention_name>
    <description>Undergo sham training</description>
    <arm_group_label>Arm II (sham training)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Smoke an average of 5 or more cigarettes or little cigars per day (CPD) prior to&#xD;
             telephone screen&#xD;
&#xD;
          -  Produce an expired carbon monoxide (CO) level greater than or equal to 6 parts per&#xD;
             million (ppm) or a NicAlert reading of &gt; 2&#xD;
&#xD;
          -  Have a working telephone&#xD;
&#xD;
          -  Interested in quitting smoking in the next 30 days&#xD;
&#xD;
          -  Fluency in spoken and written English&#xD;
&#xD;
          -  Must sign the picture consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking psychotropic, anticonvulsive, or narcotic medication&#xD;
&#xD;
          -  Meet criteria for a current major depressive episode or suicidality&#xD;
&#xD;
          -  Have a history of neurological illness or closed head injury&#xD;
&#xD;
          -  Report uncorrected vision problems&#xD;
&#xD;
          -  Involved in current smoking cessation activity&#xD;
&#xD;
          -  Testing positive on a urine drug screen for drugs of abuse/potential abuse&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding&#xD;
&#xD;
          -  Considered by the investigator to be an unsuitable or unstable candidate (e.g., due to&#xD;
             cognitive impairment)&#xD;
&#xD;
          -  Shares the same address as a currently enrolled participant&#xD;
&#xD;
          -  Unwilling to alter or remove hairstyle, hair extensions, or wig during the clinic&#xD;
             visits to allow for correct electroencephalography (EEG) sensor placement&#xD;
&#xD;
          -  Reports diagnosis of seizure disorder&#xD;
&#xD;
          -  Unwilling to use nicotine replacement therapy (NRT) patches&#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>Jason Robinson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <results_first_submitted>June 14, 2022</results_first_submitted>
  <results_first_submitted_qc>August 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 28, 2022</results_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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 3, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/91/NCT02224391/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>246 participants were randomized</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Arm I: Attention Bias Modification (ABM) Training</title>
          <description>Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
        </group>
        <group group_id="P2">
          <title>Arm II: Sham Training</title>
          <description>Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 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="124"/>
                <participants group_id="P2" count="122"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="92"/>
                <participants group_id="P2" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="24"/>
              </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="26"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arm I: Attention Bias Modification (ABM) Training</title>
          <description>Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
        </group>
        <group group_id="B2">
          <title>Arm II: Sham Training</title>
          <description>Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 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="124"/>
            <count group_id="B2" value="122"/>
            <count group_id="B3" value="246"/>
          </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="47.27" spread="10.13"/>
                    <measurement group_id="B2" value="45.28" spread="11.65"/>
                    <measurement group_id="B3" value="46.28" spread="10.93"/>
                  </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="45"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="79"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="157"/>
                  </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="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="216"/>
                  </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>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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </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="34"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="172"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </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="124"/>
                    <measurement group_id="B2" value="122"/>
                    <measurement group_id="B3" value="246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years of education</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.35" spread="1.86"/>
                    <measurement group_id="B2" value="13.72" spread="2"/>
                    <measurement group_id="B3" value="13.53" spread="1.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants Employed</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="179"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fagerström Test for Nicotine Dependence (FTND) total score</title>
          <description>The Fagerström Test for Nicotine Dependence (FTND), yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.82" spread="2.14"/>
                    <measurement group_id="B2" value="4.96" spread="2.11"/>
                    <measurement group_id="B3" value="4.89" spread="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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="18.14" spread="8.87"/>
                    <measurement group_id="B2" value="18.48" spread="9.27"/>
                    <measurement group_id="B3" value="18.31" spread="9.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Modified Dot-probe Task</title>
        <description>Modified dot-probe task evaluated by using 2 (group: ABM vs. sham) X 3 (session: baseline, 1-day post-training, and 8-weeks post-training) linear mixed model using RT difference scores (neutral-cigarette) as the dependent measures and subject as the random effect.</description>
        <time_frame>Up to 8 weeks post-training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I: Attention Bias Modification (ABM) Training</title>
            <description>Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Arm II: Sham Training</title>
            <description>Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Dot-probe Task</title>
          <description>Modified dot-probe task evaluated by using 2 (group: ABM vs. sham) X 3 (session: baseline, 1-day post-training, and 8-weeks post-training) linear mixed model using RT difference scores (neutral-cigarette) as the dependent measures and subject as the random effect.</description>
          <units>milliseconds</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.49" spread="0.99"/>
                    <measurement group_id="O2" value="7.49" spread="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-day post-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.42" spread="1.04"/>
                    <measurement group_id="O2" value="9.85" spread="1.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-weeks post-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.94" spread="1.19"/>
                    <measurement group_id="O2" value="9.48" spread="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Smoking Stroop Task</title>
        <description>The Stroop task will consist of three blocks, with a 5-s rest period between blocks: (a) practice (40 trials), (b) neutral words (80 trials), and (c) smoking words (80 trials). The score will be calculated by taking the mean RT difference between the smoking and neutral words on trials with correct responses within the response window.</description>
        <time_frame>Up to 8 weeks post-training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I: Attention Bias Modification (ABM) Training</title>
            <description>Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Arm II: Sham Training</title>
            <description>Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Smoking Stroop Task</title>
          <description>The Stroop task will consist of three blocks, with a 5-s rest period between blocks: (a) practice (40 trials), (b) neutral words (80 trials), and (c) smoking words (80 trials). The score will be calculated by taking the mean RT difference between the smoking and neutral words on trials with correct responses within the response window.</description>
          <units>milisecond</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.57" spread="4.11"/>
                    <measurement group_id="O2" value="4.94" spread="4.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-day post-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.38" spread="4.31"/>
                    <measurement group_id="O2" value="3.73" spread="4.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-weeks post-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.59" spread="4.94"/>
                    <measurement group_id="O2" value="10.97" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cigarette Per Day (CPD)</title>
        <description>Mean number of cigarettes per day smoked for the seven days preceding each time point.</description>
        <time_frame>Up to 8 weeks post-training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I: Attention Bias Modification (ABM) Training</title>
            <description>Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Arm II: Sham Training</title>
            <description>Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Cigarette Per Day (CPD)</title>
          <description>Mean number of cigarettes per day smoked for the seven days preceding each time point.</description>
          <units>number of cigerettes</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.1" spread="0.8"/>
                    <measurement group_id="O2" value="18.45" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-day post-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.94" spread="0.82"/>
                    <measurement group_id="O2" value="14.78" spread="0.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-weeks post-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.29" spread="0.9"/>
                    <measurement group_id="O2" value="7.52" spread="0.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Expired Carbon Monoxide (CO)</title>
        <description>Mean expired carbon monoxide, in ppm (parts per million), at each time point.</description>
        <time_frame>Up to 8 weeks post-training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I: Attention Bias Modification (ABM) Training</title>
            <description>Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Arm II: Sham Training</title>
            <description>Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Expired Carbon Monoxide (CO)</title>
          <description>Mean expired carbon monoxide, in ppm (parts per million), at each time point.</description>
          <units>Parts Per Million</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.41" spread="1.1"/>
                    <measurement group_id="O2" value="22.27" spread="1.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-day post-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.28" spread="1.13"/>
                    <measurement group_id="O2" value="22.95" spread="1.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-day post-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.54" spread="1.24"/>
                    <measurement group_id="O2" value="12.99" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urinary Cotinine</title>
        <description>Mean urinary cotinine, measured in ng/mL, at each time point.</description>
        <time_frame>Up to 8 weeks post-training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I: Attention Bias Modification (ABM) Training</title>
            <description>Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Arm II: Sham Training</title>
            <description>Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Urinary Cotinine</title>
          <description>Mean urinary cotinine, measured in ng/mL, at each time point.</description>
          <units>ng/mL</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.11" spread=".99"/>
                    <measurement group_id="O2" value="7.12" spread=".09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-Day post-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.91" spread=".09"/>
                    <measurement group_id="O2" value="6.99" spread=".09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-Day post-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.16" spread=".12"/>
                    <measurement group_id="O2" value="6.61" spread=".12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fagerström Test for Nicotine Dependence (FTND)</title>
        <description>The Fagerström Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. Mean Fagerström Test for Nicotine Dependence (FTND) questionnaire score at each time point.</description>
        <time_frame>Up to 8 weeks post-training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I: Attention Bias Modification (ABM) Training</title>
            <description>Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Arm II: Sham Training</title>
            <description>Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Fagerström Test for Nicotine Dependence (FTND)</title>
          <description>The Fagerström Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. Mean Fagerström Test for Nicotine Dependence (FTND) questionnaire score at each time point.</description>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.84" spread="0.19"/>
                    <measurement group_id="O2" value="4.96" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-day post-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.34" spread="0.2"/>
                    <measurement group_id="O2" value="4.05" spread="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-weeks post-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.93" spread="0.21"/>
                    <measurement group_id="O2" value="2.65" spread="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Wisconsin Smoking Withdrawal Scale (WSWS) - Craving</title>
        <description>Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal.</description>
        <time_frame>Up to 8 weeks post-training</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm I: Attention Bias Modification (ABM) Training</title>
            <description>Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
          </group>
          <group group_id="O2">
            <title>Arm II: Sham Training</title>
            <description>Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Wisconsin Smoking Withdrawal Scale (WSWS) - Craving</title>
          <description>Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal.</description>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="122"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.9" spread="0.29"/>
                    <measurement group_id="O2" value="9.76" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-day post-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.36" spread="0.3"/>
                    <measurement group_id="O2" value="8.52" spread="0.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>8-weeks post-training</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.92" spread="0.34"/>
                    <measurement group_id="O2" value="6.73" spread="0.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <desc>Per the trial only adverse events potentially related to use of the nicotine patch were reported. Internal Serious Adverse Events (SAE) that are unexpected (not listed in the Informed Consent Document) and are related (possible, probable and definite) must be reported to the IRB within 5 working days. Deaths that are related and occur within 30 days after completion of treatment must be submitted to the IRB within 24 hours.</desc>
      <group_list>
        <group group_id="E1">
          <title>Arm I: Attention Bias Modification (ABM) Training</title>
          <description>Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
        </group>
        <group group_id="E2">
          <title>Arm II: Sham Training</title>
          <description>Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAE (5.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain - cardiac</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colonic obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>CTCAE (5.0)</default_vocab>
        <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="60" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="67" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Stomach pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Mucosal infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Concentration impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="122"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="122"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Jason Robinson, PHD- Associate Professor, Behavioral Science</name_or_title>
      <organization>UT MD Anderson Cancer Center</organization>
      <phone>(713) 792-0919</phone>
      <email>jdrobinson@mdanderson.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02224391
org study id: 2013-0999
secondary id: NCI-2015-00609
secondary id: 2013-0999
nct id: NCT02224391
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This randomized clinical trial studies how well a smartphone-delivered attentional bias
      modification training works in helping patients quit smoking. Smartphone-delivered
      attentional bias modification training may help patients quit smoking by reducing the
      attentional bias (the tendency of one's perception to be affected by their recurring
      thoughts) towards smoking cues that developed over time as a result of conditioning processes
      through which smoking cues become important.
PRIMARY OBJECTIVES:

      I. To determine the feasibility of smartphone-delivered, in-home attentional bias
      modification (ABM) to reduce attentional bias (AB) to smoking cues and to reduce smoking
      behavior in the short- and long-term.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients receive ABM training over 30 minutes through a smartphone on days 1-14.
      Patients then receive nicotine patches for up to 8 weeks.

      ARM II: Patients undergo sham training on days 1-14. Patients then receive nicotine patches
      for up to 8 weeks.

      After completion of study treatment, patients are followed up on days 15, 29, 43, 57, and 72.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Modified Dot-probe Task
time frame: Up to 8 weeks post-training
description: Modified dot-probe task evaluated by using 2 (group: ABM vs. sham) X 3 (session: baseline, 1-day post-training, and 8-weeks post-training) linear mixed model using RT difference scores (neutral-cigarette) as the dependent measures and subject as the random effect.
measure: Smoking Stroop Task
time frame: Up to 8 weeks post-training
description: The Stroop task will consist of three blocks, with a 5-s rest period between blocks: (a) practice (40 trials), (b) neutral words (80 trials), and (c) smoking words (80 trials). The score will be calculated by taking the mean RT difference between the smoking and neutral words on trials with correct responses within the response window.
measure: Cigarette Per Day (CPD)
time frame: Up to 8 weeks post-training
description: Mean number of cigarettes per day smoked for the seven days preceding each time point.
measure: Expired Carbon Monoxide (CO)
time frame: Up to 8 weeks post-training
description: Mean expired carbon monoxide, in ppm (parts per million), at each time point.
measure: Urinary Cotinine
time frame: Up to 8 weeks post-training
description: Mean urinary cotinine, measured in ng/mL, at each time point.
measure: Fagerström Test for Nicotine Dependence (FTND)
time frame: Up to 8 weeks post-training
description: The Fagerström Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. Mean Fagerström Test for Nicotine Dependence (FTND) questionnaire score at each time point.
measure: Wisconsin Smoking Withdrawal Scale (WSWS) - Craving
time frame: Up to 8 weeks post-training
description: Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. Participants rate each item on a scale of 0-4 (0=Strongly disagree, 1=Disagree, 2=Feel neutral, 3=Agree, 4=Strongly agree). The subscale to each item is determined on how high they agree on the scale. Mean Wisconsin Smoking Withdrawal Scale (WSWS) - Craving subscale score at each time point. For some items, the subscale is determined on how low they agreed. Each score is determined by the mean of each item that applies. Higher means indicate greater withdrawal.
arm group label: Arm I (ABM training)
arm group type: Experimental
description: Patients receive ABM training over 30 minutes through a smartphone on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
arm group label: Arm II (sham training)
arm group type: Sham Comparator
description: Patients undergo sham training on days 1-14. Patients then receive nicotine patches for up to 8 weeks.
intervention type: Behavioral
intervention name: Computer-Assisted Smoking Cessation Intervention
description: Receive ABM training via a smartphone
arm group label: Arm I (ABM training)
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Arm I (ABM training)
arm group label: Arm II (sham training)
intervention type: Drug
intervention name: Nicotine Patch
description: Given via transdermal patch
arm group label: Arm I (ABM training)
arm group label: Arm II (sham training)
other name: NicoDerm CQ
other name: Nicotine Skin Patch
other name: Nicotine Transdermal Patch
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (ABM training)
arm group label: Arm II (sham training)
intervention type: Other
intervention name: Sham Intervention
description: Undergo sham training
arm group label: Arm II (sham training)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jason Robinson, MD
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center
responsible party type: Sponsor
mesh term: Nicotine
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 