<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/NCT03254433</url>
  </required_header>
  <id_info>
    <org_study_id>825425-Supplement</org_study_id>
    <secondary_id>3R01CA206058-02S1</secondary_id>
    <nct_id>NCT03254433</nct_id>
  </id_info>
  <brief_title>Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain (Neuroimaging Supplement)</brief_title>
  <official_title>Behavioral Activation for Smoking Cessation and the Prevention of Post-Cessation Weight Gain (Neuroimaging Supplement)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</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>
      This research study is a sub-study within the Behavioral Activation for Smoking Cessation and&#xD;
      the Prevention of Post-Cessation Weight Gain main study (NCT02906787). Participants who are&#xD;
      eligible for the main study and meet certain MRI (Magnetic Resonance Imaging) related study&#xD;
      criteria (i.e. conditions) may also elect to complete a series of computer tasks inside a&#xD;
      standard, closed MRI scanner to examine changes in brain activity associated with the smoking&#xD;
      cessation counseling that participants will receive in the main study. In total, participants&#xD;
      will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling&#xD;
      session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment&#xD;
      period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This neuroimaging sub-study will examine a sub-set of the main study's (Smoking Cessation and&#xD;
      the Prevention of Post-Cessation Weight Gain) randomized clinical trial participants&#xD;
      (balanced sample between BAS+ and SC). Participants who meet MRI eligibility and elect to&#xD;
      participate in the sub-study will complete two, 1-hour functional magnetic resonance imaging&#xD;
      (fMRI) scans while completing computer tasks inside an MRI scanner. fMRI can identify&#xD;
      mechanisms underlying behavior change beyond self-report and behavioral measures. The&#xD;
      investigators will examine neural responses in three parallel pathways including: cognitive&#xD;
      control, food cue reactivity, and food reinforcement. The project's three aims address: 1)&#xD;
      identifying putative brain mechanisms underlying BAS+ (vs. SC) treatment for smoking&#xD;
      cessation and PCWG; 2) evaluating the relative contribution of treatment-induced changes in&#xD;
      task related brain signal (Food Cue Response, Food Reinforcement/Choice) in prediction of&#xD;
      post treatment food intake; and 3) testing whether BAS+ (vs. SC) induced change in neural&#xD;
      responses to food cues and food reinforcement is a stronger predictor of food intake among&#xD;
      smokers with greater cognitive control. The findings will address why BAS+ may be effective&#xD;
      in managing PCWG and provide insight into which patients are best supported by this&#xD;
      treatment. The investigators will also test whether cognitive control processes moderate the&#xD;
      influence of BAS+ treatment on food intake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 9, 2017</start_date>
  <completion_date type="Actual">September 12, 2019</completion_date>
  <primary_completion_date type="Actual">June 3, 2019</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>
    <intervention_model_description>Participants are randomized to one of two counseling conditions (BAS+ or SC) as part of the main (parent) study.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date</measure>
    <time_frame>12-Week Follow-Up Visit</time_frame>
    <description>Smoking abstinence was assessed and biochemically verified at the 12-week Follow-Up Visit (12 weeks post target quit date). Seven-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) was biochemically verified by a carbon monoxide (CO) reading &lt; 8 parts per million.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline Food Intake (Kcals/Day) at 12 Weeks Post Target Quit Date</measure>
    <time_frame>Baseline,12-Week Follow-Up</time_frame>
    <description>Food intake was assessed via 3 telephone-administered, 24-hour dietary recalls during the week after (or near) the Baseline Visit, Mid-Treatment 3 Visit (week 4), End of Treatment Visit (week 8) and the 12-week Follow-Up Visit. A trained member of the research staff used a multi-pass method with an interactive computerized software program, the ASA24® (Automated Self-Administered 24-hour Recall), to determine total kcal/day (outcome variable).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Pre-treatment fMRI BOLD Signal at End of Treatment</measure>
    <time_frame>Pre-Treatment fMRI Scan (~week -2), End of Treatment fMRI Scan (~week 8)</time_frame>
    <description>T2*-weighted Blood Oxygen-Level-Dependent (BOLD) images will be acquired using a wholebrain, single-shot gradient-echo (GE) echo-planar imaging (EPI) sequence. BOLD images were captured (and subsequently analyzed) while participants complete a Food Cue-Induced Craving, Relative Reinforcing Value of Food, and Working Memory task inside the MRI Scanner.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Smoking Cessation</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>BAS+</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>As part of the main study, participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SC</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>As part of the main study, participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>BAS+</intervention_name>
    <description>The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.</description>
    <arm_group_label>BAS+</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SC</intervention_name>
    <description>Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.</description>
    <arm_group_label>SC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible to participate in the main study (See NCT02906787)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of claustrophobia.&#xD;
&#xD;
          -  Being left-handed.&#xD;
&#xD;
          -  Lifetime history of stroke.&#xD;
&#xD;
          -  Having a cochlear implant or wearing bilateral hearing aids.&#xD;
&#xD;
          -  History of notable head trauma. Although notable head trauma is typically defined as&#xD;
             being knocked unconscious for a period of three minutes or longer, notable head trauma&#xD;
             will be evaluated on a case-by-case basis by the appropriate personnel prior to an&#xD;
             eligibility decision considering exceptions can be made based on the nature and&#xD;
             severity of the trauma.&#xD;
&#xD;
          -  History of brain or spinal tumor.&#xD;
&#xD;
          -  Pacemakers, certain metallic implants or objects, or presence of metal in the eye as&#xD;
             contraindicated for MRI.&#xD;
&#xD;
          -  Any circumstances (e.g., exclusionary metal implants, certain dental work, and/or&#xD;
             physical impairments) and/or conditions that may interfere with MRI and MRI-related&#xD;
             study visit procedures. All potential exclusionary circumstances and/or conditions&#xD;
             will be evaluated on a case-by-case basis by the appropriate personnel prior to an&#xD;
             eligibility decision.&#xD;
&#xD;
          -  History of gunshot wounds. Injuries from BB guns will be evaluated on a case-by-case&#xD;
             basis by the appropriate personnel prior to an eligibility decision.&#xD;
&#xD;
          -  History of epilepsy and/or recurrent or uncontrolled seizures.&#xD;
&#xD;
          -  Weight greater than 250 lbs at Intake Visit or self-reported at phone screen. If a&#xD;
             participant weighs less than or equal to 250 lbs at Intake, but presents with a weight&#xD;
             greater than 250 lbs at either Scan 1 and/or Scan 2, the participant may be permitted&#xD;
             to proceed with the scan as long as the participant's weight does not exceed 300 lbs.&#xD;
&#xD;
          -  A positive urine drug screen (UDS) for cocaine, opiates, amphetamines,&#xD;
             methamphetamines, phencyclidine (PCP), ecstasy (MDMA), barbiturates, benzodiazepines,&#xD;
             methadone, and/or oxycodone at either Scan Visit. Depending on the substance and&#xD;
             circumstances, a subject may be deemed ineligible for the main study at the discretion&#xD;
             of the Principal Investigator as well.&#xD;
&#xD;
          -  A Breath Alcohol Reading greater than 0.010 at either Scan Visit. Depending on the&#xD;
             circumstances, the Principal Investigator may permit the participant to remain in the&#xD;
             sub-study and reschedule a neuroimaging scan to another day.&#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>Janet Audrain-McGovern, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <results_first_submitted>October 28, 2022</results_first_submitted>
  <results_first_submitted_qc>February 24, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 24, 2023</results_first_posted>
  <last_update_submitted>February 24, 2023</last_update_submitted>
  <last_update_submitted_qc>February 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pennsylvania</investigator_affiliation>
    <investigator_full_name>Janet Audrain-McGovern</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Neuroimaging</keyword>
  <keyword>Smoking Cessation</keyword>
  <keyword>Weight Loss</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</mesh_term>
    <mesh_term>Weight Gain</mesh_term>
  </condition_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>August 14, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03254433/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 11, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT03254433/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Behavioral Activation (BAS+)</title>
          <description>As part of the main study, participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).&#xD;
BAS+: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.</description>
        </group>
        <group group_id="P2">
          <title>Standard Counseling (SC)</title>
          <description>As part of the main study, participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).&#xD;
SC: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Enrolled in fMRI Sub-study</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Scan 1</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Scan 2</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed EOT</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 12-week Follow up</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard Counseling</title>
          <description>As part of the main study, participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).&#xD;
SC: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.</description>
        </group>
        <group group_id="B2">
          <title>Behavioral Activation</title>
          <description>As part of the main study, participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).&#xD;
BAS+: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.</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="19"/>
            <count group_id="B2" value="25"/>
            <count group_id="B3" value="44"/>
          </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="42.32" spread="10.49"/>
                    <measurement group_id="B2" value="45.56" spread="12.66"/>
                    <measurement group_id="B3" value="44.16" spread="11.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black/ African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown or not reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Nicotine Dependence</title>
          <description>The Fagerstrom Test for Nicotine Dependence is a 6-item scale with higher scores indicating greater levels of nicotine dependence. Nicotine dependence scores can range from 0 (low) to 8 (high).</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="4.68" spread="1.92"/>
                    <measurement group_id="B2" value="4.12" spread="1.92"/>
                    <measurement group_id="B3" value="4.36" spread="1.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Depression symptoms</title>
          <description>The 20-item Center for Epidemiologic Studies Depression Scale was used to measure depression symptoms. Likert-style response options range from 0 to 3, with a potential score range of 0 to 60. Higher scores indicate greater depression symptoms.</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="13.74" spread="7.96"/>
                    <measurement group_id="B2" value="11.40" spread="9.12"/>
                    <measurement group_id="B3" value="12.41" spread="8.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>HS Grad or Less</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some College</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>College Grad</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Income</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Under 20K</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>20K - 50K</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Over 50K</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                  </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="11.44" spread="3.67"/>
                    <measurement group_id="B2" value="13.33" spread="5.42"/>
                    <measurement group_id="B3" value="12.52" spread="4.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Food Reinforcement</title>
          <description>Participants chose between a low-effort $ reward and either a food or a $ reward of higher value and effort. Each trial presented a choice between a standard reward (27 button clicks for $0.25) or exerting greater effort to earn a higher value food or $ reward. There were 50 trials for each $ and food (participants could work 0-50 trials for either food or $), with a greater number of trials for food indicative of a higher reinforcing value of food.</description>
          <units>number of trials</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.4" spread="19.3"/>
                    <measurement group_id="B2" value="6.19" spread="11.71"/>
                    <measurement group_id="B3" value="9.75" spread="11.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Complementary Reinforcers</title>
          <description>Complementary reinforcers (CRs) were measured by the adapted Pleasant Events Schedule, assessing reinforcers in the natural environment. These are reinforcers associated with smoking. The 78 events were rated once in frequency (0 = none to 2 = often) and once in enjoyability (0 = none to 2 = very), yielding frequency and enjoyability scores. The cross-product of enjoyability x frequency were summed, with higher scores indicating greater CRs. The possible range was 0-312.</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="31.53" spread="31.15"/>
                    <measurement group_id="B2" value="54.20" spread="28.17"/>
                    <measurement group_id="B3" value="44.41" spread="31.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Substitute Reinforcers</title>
          <description>Substitute reinforcers (SRs) were measured by the adapted Pleasant Events Schedule, assessing reinforcers in the natural environment. These are reinforcers that are not associated with smoking. The 78 events were rated once in frequency (0 = none to 2 = often) and once in enjoyability (0 = none to 2 = very), yielding frequency and enjoyability scores. The cross-product of enjoyability x frequency scores were summed, with higher scores indicating greater SRs. The possible range was 0-312.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.53" spread="42.33"/>
                    <measurement group_id="B2" value="39.68" spread="30.82"/>
                    <measurement group_id="B3" value="46.52" spread="36.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight Concerns</title>
          <description>Weight concerns associated with quitting smoking were measured with 6 items with response options ranging from 1=not at all to 10 = very much. Using the average item score, scores could range from 1 to 10.</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="4.70" spread="2.2"/>
                    <measurement group_id="B2" value="4.70" spread="2.07"/>
                    <measurement group_id="B3" value="4.70" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Kilocalories per day (kcals/day)</title>
          <units>kcals/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2506.78" spread="779.87"/>
                    <measurement group_id="B2" value="2596.66" spread="1261.55"/>
                    <measurement group_id="B3" value="2557.85" spread="1070.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disinhibition</title>
          <description>Disinhibition was measured with a subscale (16 items) of the Eating Inventory (self-report questionnaire) that is thought to reflect responsivity to environmental food cues, and internal cues, and linked to food reinforcement and weight change. Responses are scored 0 or 1 and summed with a possible score range of 0 to 16. Higher scores denote higher levels of disinhibited eating.</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="10.79" spread="4.14"/>
                    <measurement group_id="B2" value="8.96" spread="3.45"/>
                    <measurement group_id="B3" value="9.75" spread="3.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date</title>
        <description>Smoking abstinence was assessed and biochemically verified at the 12-week Follow-Up Visit (12 weeks post target quit date). Seven-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) was biochemically verified by a carbon monoxide (CO) reading &lt; 8 parts per million.</description>
        <time_frame>12-Week Follow-Up Visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Counseling</title>
            <description>As part of the main study, participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).&#xD;
SC: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.</description>
          </group>
          <group group_id="O2">
            <title>Behavioral Activation</title>
            <description>As part of the main study, participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).&#xD;
BAS+: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.</description>
          </group>
        </group_list>
        <measure>
          <title>Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date</title>
          <description>Smoking abstinence was assessed and biochemically verified at the 12-week Follow-Up Visit (12 weeks post target quit date). Seven-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) was biochemically verified by a carbon monoxide (CO) reading &lt; 8 parts per million.</description>
          <units>ppm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.47" spread="0.51"/>
                    <measurement group_id="O2" value="0.40" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline Food Intake (Kcals/Day) at 12 Weeks Post Target Quit Date</title>
        <description>Food intake was assessed via 3 telephone-administered, 24-hour dietary recalls during the week after (or near) the Baseline Visit, Mid-Treatment 3 Visit (week 4), End of Treatment Visit (week 8) and the 12-week Follow-Up Visit. A trained member of the research staff used a multi-pass method with an interactive computerized software program, the ASA24® (Automated Self-Administered 24-hour Recall), to determine total kcal/day (outcome variable).</description>
        <time_frame>Baseline,12-Week Follow-Up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Counseling</title>
            <description>As part of the main study, participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).&#xD;
SC: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.</description>
          </group>
          <group group_id="O2">
            <title>Behavioral Activation</title>
            <description>As part of the main study, participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).&#xD;
BAS+: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline Food Intake (Kcals/Day) at 12 Weeks Post Target Quit Date</title>
          <description>Food intake was assessed via 3 telephone-administered, 24-hour dietary recalls during the week after (or near) the Baseline Visit, Mid-Treatment 3 Visit (week 4), End of Treatment Visit (week 8) and the 12-week Follow-Up Visit. A trained member of the research staff used a multi-pass method with an interactive computerized software program, the ASA24® (Automated Self-Administered 24-hour Recall), to determine total kcal/day (outcome variable).</description>
          <units>kcal/day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-201.85" spread="553.74"/>
                    <measurement group_id="O2" value="121.78" spread="1322.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Pre-treatment fMRI BOLD Signal at End of Treatment</title>
        <description>T2*-weighted Blood Oxygen-Level-Dependent (BOLD) images will be acquired using a wholebrain, single-shot gradient-echo (GE) echo-planar imaging (EPI) sequence. BOLD images were captured (and subsequently analyzed) while participants complete a Food Cue-Induced Craving, Relative Reinforcing Value of Food, and Working Memory task inside the MRI Scanner.</description>
        <time_frame>Pre-Treatment fMRI Scan (~week -2), End of Treatment fMRI Scan (~week 8)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Counseling</title>
            <description>As part of the main study, participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).&#xD;
SC: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.</description>
          </group>
          <group group_id="O2">
            <title>Behavioral Activation</title>
            <description>As part of the main study, participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).&#xD;
BAS+: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Pre-treatment fMRI BOLD Signal at End of Treatment</title>
          <description>T2*-weighted Blood Oxygen-Level-Dependent (BOLD) images will be acquired using a wholebrain, single-shot gradient-echo (GE) echo-planar imaging (EPI) sequence. BOLD images were captured (and subsequently analyzed) while participants complete a Food Cue-Induced Craving, Relative Reinforcing Value of Food, and Working Memory task inside the MRI Scanner.</description>
          <units>Percent Signal Change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="25"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3318" spread="0.22944"/>
                    <measurement group_id="O2" value="-0.0003" spread="0.2230"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <desc>Serious Adverse Events were defined as any severe or serious medical event definitely related to participating in an fMRI scan.&#xD;
Other Adverse Events were defined as any unexpected medical event definitely related to participating in an fMRI scan.&#xD;
Only events related to participating in the fMRI scans were monitored/assessed in this sub-study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Standard Counseling (SC)</title>
          <description>As part of the main study, participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).&#xD;
SC: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.</description>
        </group>
        <group group_id="E2">
          <title>Behavioral Activation (BAS+)</title>
          <description>As part of the main study, participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).&#xD;
BAS+: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.</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="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="31"/>
              </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>Janet Audrain-McGovern, Ph.D. Director, Addictions, Department of Psychiatry</name_or_title>
      <organization>Perelman School of Medicine, University of Pennsylvania</organization>
      <phone>(215) 746-7145</phone>
      <email>audrain@pennmedicine.upenn.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/NCT03254433
org study id: 825425-Supplement
secondary id: 3R01CA206058-02S1
nct id: NCT03254433
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research study is a sub-study within the Behavioral Activation for Smoking Cessation and
      the Prevention of Post-Cessation Weight Gain main study (NCT02906787). Participants who are
      eligible for the main study and meet certain MRI (Magnetic Resonance Imaging) related study
      criteria (i.e. conditions) may also elect to complete a series of computer tasks inside a
      standard, closed MRI scanner to examine changes in brain activity associated with the smoking
      cessation counseling that participants will receive in the main study. In total, participants
      will be asked to complete 2, one-hour fMRI scans: 1 before completing their first counseling
      session and 1 during the final 7 days of the scheduled 8-week nicotine patch treatment
      period.
This neuroimaging sub-study will examine a sub-set of the main study's (Smoking Cessation and
      the Prevention of Post-Cessation Weight Gain) randomized clinical trial participants
      (balanced sample between BAS+ and SC). Participants who meet MRI eligibility and elect to
      participate in the sub-study will complete two, 1-hour functional magnetic resonance imaging
      (fMRI) scans while completing computer tasks inside an MRI scanner. fMRI can identify
      mechanisms underlying behavior change beyond self-report and behavioral measures. The
      investigators will examine neural responses in three parallel pathways including: cognitive
      control, food cue reactivity, and food reinforcement. The project's three aims address: 1)
      identifying putative brain mechanisms underlying BAS+ (vs. SC) treatment for smoking
      cessation and PCWG; 2) evaluating the relative contribution of treatment-induced changes in
      task related brain signal (Food Cue Response, Food Reinforcement/Choice) in prediction of
      post treatment food intake; and 3) testing whether BAS+ (vs. SC) induced change in neural
      responses to food cues and food reinforcement is a stronger predictor of food intake among
      smokers with greater cognitive control. The findings will address why BAS+ may be effective
      in managing PCWG and provide insight into which patients are best supported by this
      treatment. The investigators will also test whether cognitive control processes moderate the
      influence of BAS+ treatment on food intake.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are randomized to one of two counseling conditions (BAS+ or SC) as part of the main (parent) study.
primary purpose: Other
masking: Single (Participant)
measure: Seven-day Point Prevalence Abstinence (Carbon Monoxide) at 12 Weeks Post Target Quit Date
time frame: 12-Week Follow-Up Visit
description: Smoking abstinence was assessed and biochemically verified at the 12-week Follow-Up Visit (12 weeks post target quit date). Seven-day point prevalence abstinence (no smoking, not even a puff, for at least 7 days prior to the assessment) was biochemically verified by a carbon monoxide (CO) reading < 8 parts per million.
measure: Change From Baseline Food Intake (Kcals/Day) at 12 Weeks Post Target Quit Date
time frame: Baseline,12-Week Follow-Up
description: Food intake was assessed via 3 telephone-administered, 24-hour dietary recalls during the week after (or near) the Baseline Visit, Mid-Treatment 3 Visit (week 4), End of Treatment Visit (week 8) and the 12-week Follow-Up Visit. A trained member of the research staff used a multi-pass method with an interactive computerized software program, the ASA24® (Automated Self-Administered 24-hour Recall), to determine total kcal/day (outcome variable).
measure: Change From Pre-treatment fMRI BOLD Signal at End of Treatment
time frame: Pre-Treatment fMRI Scan (~week -2), End of Treatment fMRI Scan (~week 8)
description: T2*-weighted Blood Oxygen-Level-Dependent (BOLD) images will be acquired using a wholebrain, single-shot gradient-echo (GE) echo-planar imaging (EPI) sequence. BOLD images were captured (and subsequently analyzed) while participants complete a Food Cue-Induced Craving, Relative Reinforcing Value of Food, and Working Memory task inside the MRI Scanner.
arm group label: BAS+
arm group type: Experimental
description: As part of the main study, participants will attend 8 counseling sessions and receive a behavioral activation intervention to smoking cessation and to post-cessation weight gain (BAS+).
arm group label: SC
arm group type: Placebo Comparator
description: As part of the main study, participants will attend 8 counseling sessions and receive standard smoking cessation counseling (SC).
intervention type: Behavioral
intervention name: BAS+
description: The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.
arm group label: BAS+
intervention type: Behavioral
intervention name: SC
description: Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.
arm group label: SC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Janet Audrain-McGovern, Ph.D.
role: Principal Investigator
affiliation: Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pennsylvania
investigator full name: Janet Audrain-McGovern
investigator title: Associate Professor
mesh term: Body Weight
mesh term: Weight Loss
mesh term: Weight Gain
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 