<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/NCT01719458</url>
  </required_header>
  <id_info>
    <org_study_id>0705002688</org_study_id>
    <secondary_id>RL1AA017540</secondary_id>
    <nct_id>NCT01719458</nct_id>
  </id_info>
  <brief_title>Norepinephrine Transporter Imaging in Addiction Disorders</brief_title>
  <official_title>Norepinephrine Transporter Imaging in Addiction Disorders</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>
      In this study we propose to study 24 unmedicated abstinent alcohol dependent patients, 24&#xD;
      obese individuals and 24 individually matched healthy control subjects and determine&#xD;
      Norepinephrine Transporter (NET) expression in vivo using (S,S)-[11C]MRB and PET.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study we propose to study 24 unmedicated abstinent alcohol dependent patients, 24&#xD;
      obese individuals and 24 individually matched healthy control subjects and determine NET&#xD;
      expression in vivo using (S,S)-[11C]MRB and PET. This will provide novel insight into&#xD;
      alterations in pre- and post-synaptic homeostasis in alcoholism and obese people with the&#xD;
      goal to explain regulatory processes and their alterations in these disorders. A better&#xD;
      understanding of brain mechanisms and contributory stress would have an enormous impact on&#xD;
      the public's understanding of the vulnerabilities for these disorders, influence medical and&#xD;
      legal response to these problems, could lead to a new understanding of these phenomena, and&#xD;
      stimulate a better means of prevention and treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>July 2007</start_date>
  <completion_date type="Actual">January 4, 2023</completion_date>
  <primary_completion_date type="Actual">July 2012</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>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity</condition>
  <condition>Alcohol Dependence</condition>
  <arm_group>
    <arm_group_label>Alcohol</arm_group_label>
    <description>Subjects diagnosed with alcohol dependence</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Obese</arm_group_label>
    <description>Subjects diagnosed with obesity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <description>Subjects deemed to be medically healthy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>(S,S)-[11C]MRB</intervention_name>
    <description>PET radioligand</description>
    <arm_group_label>Alcohol</arm_group_label>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Obese</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        24 unmedicated abstinent alcohol dependent patients, 24 obese individuals and 24&#xD;
        individually matched healthy control subjects&#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 at the time of the PET scan as&#xD;
             determined by calculating the time since the last menses and assessments of serum&#xD;
             hormone levels;&#xD;
&#xD;
          4. 30 &lt; BMI &lt; 35 for obese subjects (upper limit of 35 selected given our experience with&#xD;
             heavier individuals fitting comfortably in the MRI scanner) and 18.5 &lt; BMI &lt;25 for&#xD;
             normal weight subjects, and no recent weight changes in prior 12 weeks prior to the&#xD;
             study;&#xD;
&#xD;
          5. for alcohol dependent patients meet current DSM-IV criteria for alcohol dependence or&#xD;
             being in partial remission; abstinence on the MRI and PET scan days will be determined&#xD;
             by patient self-report, breath alcohol tests (BACs) conducted during inpatient stay at&#xD;
             the CNRU/GCRC, participants have to be non-obese BMI &lt; 30, and&#xD;
&#xD;
          6. for current daily smokers, having smoked 10 or more cigarettes daily for the past year&#xD;
             and CO level &gt; 10 ppm at intake; for non-smokers, no tobacco consumption for more than&#xD;
             one year and never having used tobacco daily.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. any major neurological illness or injury and any current or prior clinically&#xD;
             significant mental health or substance use disorder (with possible exception of&#xD;
             nicotine dependence and alcohol dependence per the inclusion criteria) as determined&#xD;
             by SCID interview and the judgement of the PI;&#xD;
&#xD;
          2. use of any psychoactive medication within past three weeks;&#xD;
&#xD;
          3. any significant unstable medical condition such as asthma or heart disease which may&#xD;
             limit the interpretation of the imaging results, for example due to changes in tracer&#xD;
             delivery in hypertensive patients;&#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 or PET imaging;&#xD;
&#xD;
          7. presence of alcohol and drug use in the 72 hours prior to scanning, with the exception&#xD;
             of tobacco;&#xD;
&#xD;
          8. pregnancy or nursing for women,&#xD;
&#xD;
          9. peri- and post- menopausal women, and those with ovarectomies will be excluded&#xD;
&#xD;
         10. current eating disorders, including binge eating.&#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 N 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>March 2023</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>March 1, 2023</last_update_submitted>
  <last_update_submitted_qc>March 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale University</investigator_affiliation>
    <investigator_full_name>Marc Potenza</investigator_full_name>
    <investigator_title>Professor of Psychiatry, Child Study, and Neurobiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
  </condition_browse>
  <!-- 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/NCT01719458
org study id: 0705002688
secondary id: RL1AA017540
nct id: NCT01719458
lead sponsor: 
collaborator: 
has dmc: Yes
In this study we propose to study 24 unmedicated abstinent alcohol dependent patients, 24
      obese individuals and 24 individually matched healthy control subjects and determine
      Norepinephrine Transporter (NET) expression in vivo using (S,S)-[11C]MRB and PET.
In this study we propose to study 24 unmedicated abstinent alcohol dependent patients, 24
      obese individuals and 24 individually matched healthy control subjects and determine NET
      expression in vivo using (S,S)-[11C]MRB and PET. This will provide novel insight into
      alterations in pre- and post-synaptic homeostasis in alcoholism and obese people with the
      goal to explain regulatory processes and their alterations in these disorders. A better
      understanding of brain mechanisms and contributory stress would have an enormous impact on
      the public's understanding of the vulnerabilities for these disorders, influence medical and
      legal response to these problems, could lead to a new understanding of these phenomena, and
      stimulate a better means of prevention and treatment.
observational model: Case-Control
time perspective: Prospective
arm group label: Alcohol
description: Subjects diagnosed with alcohol dependence
arm group label: Obese
description: Subjects diagnosed with obesity
arm group label: Healthy
description: Subjects deemed to be medically healthy
intervention type: Drug
intervention name: (S,S)-[11C]MRB
description: PET radioligand
arm group label: Alcohol
arm group label: Healthy
arm group label: Obese
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 N Potenza, MD, PhD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Yale University
investigator full name: Marc Potenza
investigator title: Professor of Psychiatry, Child Study, and Neurobiology
mesh term: Alcoholism