<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/NCT01719471</url>
  </required_header>
  <id_info>
    <org_study_id>0805003898</org_study_id>
    <secondary_id>RL1AA017539</secondary_id>
    <nct_id>NCT01719471</nct_id>
  </id_info>
  <brief_title>fMRI of Stress in Smoking Behavior</brief_title>
  <official_title>fMRI of Stress in Smoking Behavior</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To examine the influence of current daily tobacco smoking on brain activation during stress,&#xD;
      tobacco cue, and neutral relaxing conditions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects will participate in an fMRI session to examine changes in frontal and limbic brain&#xD;
      regions with tobacco cues, stress and neutral/relaxing imagery. During each fMRI session&#xD;
      subjects will participate in six imagery trials: 2 different neutral/relaxing, 2 different&#xD;
      stress and 2 different tobacco cue scripts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No subjects enrolled&#xD;
  </why_stopped>
  <start_date>February 2008</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>No outcome measures for this study, this is an imaging study only</measure>
    <time_frame>Upon study completion</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>Smokers</arm_group_label>
    <description>Nicotine dependent individuals otherwise medically healthy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <description>Medically healthy individuals who do not smoke</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        30 tobacco dependent and 30 matched healthy controls who have never smoked will be&#xD;
        recruited for this study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 18-50 years inclusive;&#xD;
&#xD;
          2. able to read and write English;&#xD;
&#xD;
          3. for women, being in follicular phase of menstrual cycle;&#xD;
&#xD;
        5) Tobacco dependent sample: smokes 10 or more cigarettes daily for the past year;&#xD;
        Non-smokers, no tobacco consumption for more than one year and never having used tobacco&#xD;
        daily.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. any major neurological illness or injury and any current or prior clinically&#xD;
             significant mental health (including PTSD) or substance use disorder (with possible&#xD;
             exception of nicotine dependence) as determined by SCID interview;&#xD;
&#xD;
          2. use of any psychoactive medication within past four weeks;&#xD;
&#xD;
          3. any significant unstable medical condition such as asthma or heart disease for which&#xD;
             increased cardiovascular reactivity during stress challenge might constitute a&#xD;
             significant risk;&#xD;
&#xD;
          4. IQ&lt;70 based on past intelligence testing;&#xD;
&#xD;
          5. any metal in body that would pose a risk with MRI; and&#xD;
&#xD;
          6. claustrophobia that would interfere with MRI;&#xD;
&#xD;
          7. alcohol and drug use in the 72 hours prior to scanning, with the exception of tobacco;&#xD;
&#xD;
          8. pregnancy for women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Potenza, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>December 12, 2014</last_update_submitted>
  <last_update_submitted_qc>December 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01719471
org study id: 0805003898
secondary id: RL1AA017539
nct id: NCT01719471
lead sponsor: 
collaborator: 
has dmc: Yes
To examine the influence of current daily tobacco smoking on brain activation during stress,
      tobacco cue, and neutral relaxing conditions
Subjects will participate in an fMRI session to examine changes in frontal and limbic brain
      regions with tobacco cues, stress and neutral/relaxing imagery. During each fMRI session
      subjects will participate in six imagery trials: 2 different neutral/relaxing, 2 different
      stress and 2 different tobacco cue scripts.
observational model: Case-Control
time perspective: Prospective
measure: No outcome measures for this study, this is an imaging study only
time frame: Upon study completion
arm group label: Smokers
description: Nicotine dependent individuals otherwise medically healthy
arm group label: Healthy
description: Medically healthy individuals who do not smoke
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marc Potenza, MD, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor