<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/NCT01665560</url>
  </required_header>
  <id_info>
    <org_study_id>0505027690</org_study_id>
    <nct_id>NCT01665560</nct_id>
  </id_info>
  <brief_title>Neural, Behavioral and Physiological Correlates of Feeding in Humans</brief_title>
  <official_title>Neural, Behavioral and Physiological Correlates of Feeding in Humans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overarching goal of this project is to understand how nicotine addiction interacts with&#xD;
      feeding behaviors and brain representation of food reward. The current proposal is part of a&#xD;
      larger effort to begin a program of research to elucidate similarities and differences in&#xD;
      perception of, and behavioral and neural response to, food and cigarette aromas as a function&#xD;
      of 1) smoking status (smokers, ex-smokers who do gain weight, ex-smokers who do not gain&#xD;
      weight, non-smokers), 2) internal state (hungry, full), and 3) cigarette deprivation (acute,&#xD;
      chronic). A general hypothesis is that there are overlapping neural mechanisms governing food&#xD;
      reward and cigarette reward in smokers and that this overlap includes incentive salience&#xD;
      encoding.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Weight gain frequently follows smoking cessation. Fear of weight gain is cited as a key&#xD;
      reason not to quit and actual weight gain is a primary reason for relapse, especially among&#xD;
      women. Although the causes of weight gain following smoking cessation are complex, increased&#xD;
      caloric intake is recognized as one of the primary sources. One explanation for increased&#xD;
      caloric intake is that, there are common neural mechanisms for food and cigarette reward and&#xD;
      hence food reward can substitute for cigarette reward and vice versa. An alternative&#xD;
      explanation for weight gain following smoking cessation is that there is an overall decrease&#xD;
      in brain reward function during nicotine withdrawal, which leads to a decrease in the reward&#xD;
      value of food and consequent increase in intake to maintain the total amount of reward&#xD;
      obtained by food. The success of the proposed studies relies upon our ability to deliver&#xD;
      odorants in the fMRI scanner and to measure neural activation in regions such as the&#xD;
      amygdala, which are susceptible to inhomogeneity artifacts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2005</start_date>
  <completion_date type="Actual">July 2009</completion_date>
  <primary_completion_date type="Actual">July 2009</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>fMRI w/ taste and smell stimuli</measure>
    <time_frame>1-2 hours</time_frame>
    <description>Subjects will be scanned on a 3T Trio magnet while tasting and smelling various food and non-food substances. Our primary outcome measure will be differential brain responses to taste and smell stimuli as a function of group (smokers vs. nonsmokers).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">27</enrollment>
  <condition>Magnetic Resonance Imaging, Functional</condition>
  <arm_group>
    <arm_group_label>Smokers--Currently Smoking</arm_group_label>
    <description>Individuals that are right handed, and not claustrophobic were recruited. This same group was used for the smoking-group and refrain from smoking was evaluated by CO2 evaluation. To be classified as smokers, they had to report smoking 3-10 cigarettes daily for at least the last year and have a carbon monoxide reading of CO &gt;10 ppm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Smoker</arm_group_label>
    <description>Healthy individuals meeting the inclusion criteria who claim to not smoke. This is confirmed w/ CO testing.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      saliva samples were obtained and are stored using a coded ID in a secure part of our facility&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy adults in the New Haven, CT area.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  between the ages of 18-45&#xD;
&#xD;
          -  fMRI safe&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  outside of the above age range&#xD;
&#xD;
          -  not able to have an fMRI (non-removable metal, pacemaker, etc)&#xD;
&#xD;
          -  medical diagnosis related to neurological problems, anxiety, psychiatric conditions&#xD;
&#xD;
          -  Did not refrain from smoking for the described time in the smoking group, or showed a&#xD;
             CO2 level consistent with a smoker in the non-smoking group&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dana M Small, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale &amp; John B Pierce Laboratory</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>John B Pierce Laboratory</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>August 9, 2012</last_update_submitted>
  <last_update_submitted_qc>August 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>smoking</keyword>
  <keyword>fMRI</keyword>
  <keyword>odors</keyword>
  <keyword>taste</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01665560
org study id: 0505027690
nct id: NCT01665560
lead sponsor: 
has dmc: Yes
The overarching goal of this project is to understand how nicotine addiction interacts with
      feeding behaviors and brain representation of food reward. The current proposal is part of a
      larger effort to begin a program of research to elucidate similarities and differences in
      perception of, and behavioral and neural response to, food and cigarette aromas as a function
      of 1) smoking status (smokers, ex-smokers who do gain weight, ex-smokers who do not gain
      weight, non-smokers), 2) internal state (hungry, full), and 3) cigarette deprivation (acute,
      chronic). A general hypothesis is that there are overlapping neural mechanisms governing food
      reward and cigarette reward in smokers and that this overlap includes incentive salience
      encoding.
Weight gain frequently follows smoking cessation. Fear of weight gain is cited as a key
      reason not to quit and actual weight gain is a primary reason for relapse, especially among
      women. Although the causes of weight gain following smoking cessation are complex, increased
      caloric intake is recognized as one of the primary sources. One explanation for increased
      caloric intake is that, there are common neural mechanisms for food and cigarette reward and
      hence food reward can substitute for cigarette reward and vice versa. An alternative
      explanation for weight gain following smoking cessation is that there is an overall decrease
      in brain reward function during nicotine withdrawal, which leads to a decrease in the reward
      value of food and consequent increase in intake to maintain the total amount of reward
      obtained by food. The success of the proposed studies relies upon our ability to deliver
      odorants in the fMRI scanner and to measure neural activation in regions such as the
      amygdala, which are susceptible to inhomogeneity artifacts.
observational model: Cohort
time perspective: Prospective
measure: fMRI w/ taste and smell stimuli
time frame: 1-2 hours
description: Subjects will be scanned on a 3T Trio magnet while tasting and smelling various food and non-food substances. Our primary outcome measure will be differential brain responses to taste and smell stimuli as a function of group (smokers vs. nonsmokers).
arm group label: Smokers--Currently Smoking
description: Individuals that are right handed, and not claustrophobic were recruited. This same group was used for the smoking-group and refrain from smoking was evaluated by CO2 evaluation. To be classified as smokers, they had to report smoking 3-10 cigarettes daily for at least the last year and have a carbon monoxide reading of CO >10 ppm.
arm group label: Non-Smoker
description: Healthy individuals meeting the inclusion criteria who claim to not smoke. This is confirmed w/ CO testing.
saliva samples were obtained and are stored using a coded ID in a secure part of our facility
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dana M Small, PhD
role: Principal Investigator
affiliation: Yale & John B Pierce Laboratory
facility: 
country: United States
responsible party type: Sponsor