<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/NCT02237703</url>
  </required_header>
  <id_info>
    <org_study_id>S12-01521</org_study_id>
    <nct_id>NCT02237703</nct_id>
  </id_info>
  <brief_title>Kappa Opioid Receptor Imaging in Post-traumatic Stress Disorder (PTSD)</brief_title>
  <official_title>Kappa Opioid Receptor Imaging in Post-traumatic Stress Disorder (PTSD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study uses positron emission tomography (PET) imaging to measure kappa opioid receptors&#xD;
      (KOR) in the brains of individuals with and without post-traumatic stress disorder (PTSD).&#xD;
      The investigators propose to recruit 45 drug-naïve individuals, N=15 patients with PTSD, N=15&#xD;
      trauma-exposed, but asymptomatic healthy control subjects (TC) and N=15 non-trauma exposed&#xD;
      healthy control subjects (HC) to participate in one magnetic resonance imaging (MRI) and one&#xD;
      PET study. The investigators will also carefully document trauma history, and collect&#xD;
      behavioral and neuroendocrine measures to provide a more integrative view on the neurobiology&#xD;
      of PTSD and its phenotype. The investigators predict PTSD will show greater carbon - 11&#xD;
      (11C)[11C]LY2795050 volume of distribution (VT) (i.e. KOR binding) values than control&#xD;
      populations in an a priori defined PTSD circuit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.&#xD;
  </why_stopped>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Volume of distribution (VT) of cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand [11C]LY2795050 and PET</measure>
    <time_frame>Two months</time_frame>
    <description>To examine group differences in cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand [11C]LY2795050 and PET.&#xD;
Hypothesis: PTSD will show greater [11C]LY2795050 VT (i.e. KOR binding) values than control populations in an a priori defined PTSD circuit.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">17</enrollment>
  <condition>Post-traumatic Stress Disorder (PTSD)</condition>
  <condition>Trauma</condition>
  <arm_group>
    <arm_group_label>Post-traumatic stress disorder (PTSD)</arm_group_label>
    <description>Post-traumatic stress disorder (PTSD)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trauma Control (TC)</arm_group_label>
    <description>Trauma Control (TC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control (HC)</arm_group_label>
    <description>Healthy Control (HC)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Positron emission tomography (PET) imaging</intervention_name>
    <description>Positron emission tomography (PET) imaging</description>
    <arm_group_label>Healthy Control (HC)</arm_group_label>
    <arm_group_label>Post-traumatic stress disorder (PTSD)</arm_group_label>
    <arm_group_label>Trauma Control (TC)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects are between the age range of 18 to 55, are medically healthy and currently not&#xD;
        taking any medications to treat any medical illness, have a history of post-traumatic&#xD;
        stress disorder, or are a healthy control who has or has not been exposed to trauma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria for patients with PTSD:&#xD;
&#xD;
          1. age 18-55 years old&#xD;
&#xD;
          2. currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale&#xD;
             (CAPS) score &gt; 50.&#xD;
&#xD;
        Exclusion criteria for patients with PTSD:&#xD;
&#xD;
          1. any primary Axis I disorder other than PTSD (e.g. psychosis)&#xD;
&#xD;
          2. medical or neurological illnesses likely to affect physiology or anatomy, i.e.&#xD;
             uncontrolled hypertension, cardiovascular disorders&#xD;
&#xD;
          3. a history of drug (including benzodiazepines (BZD)) dependence (Diagnostic and&#xD;
             Statistical Manual of Mental Disorders (DSM IV) criteria) within 1 year of the study&#xD;
             and lasting longer than 2 years, except for alcohol dependence&#xD;
&#xD;
          4. current pregnancy (as documented by pregnancy testing at screening or on the day of&#xD;
             PET imaging study)&#xD;
&#xD;
          5. current breast feeding&#xD;
&#xD;
          6. use of tobacco- or nicotine-containing products in excess of the equivalent of 5&#xD;
             cigarettes per day, or cannot abstain from smoking during the prescribed tests&#xD;
&#xD;
          7. acute suicidal ideation or behavior, as defined by suicidal ideation and behavior&#xD;
             during the 3-month period prior to enrollment in the study and while being enrolled in&#xD;
             the study&#xD;
&#xD;
          8. general MRI exclusion criteria, i.e. pacemakers, metals in the body&#xD;
&#xD;
          9. Human immunodeficiency virus (HIV) (due to possible neuropsychiatric effects);&#xD;
&#xD;
         10. use of opioid medications within 2 weeks of the PET study&#xD;
&#xD;
         11. having an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of&#xD;
             the investigator, increases the risks associated with participation in the study&#xD;
&#xD;
         12. seriously claustrophobic&#xD;
&#xD;
         13. blood donation within 8 weeks prior to the study.&#xD;
&#xD;
        Inclusion criteria for Healthy Subjects:&#xD;
&#xD;
          1. age 18-55 years old&#xD;
&#xD;
          2. no personal or first-degree family history of any Axis I diagnosis.&#xD;
&#xD;
        Exclusion criteria for Healthy Subjects:&#xD;
&#xD;
          1. any history or current primary Axis I disorder&#xD;
&#xD;
          2. medical or neurological illnesses likely to affect physiology or anatomy, i.e.&#xD;
             uncontrolled hypertension, cardiovascular disorders&#xD;
&#xD;
          3. a history of drug (including benzodiazepines [BZD]) dependence (DSM IV criteria)&#xD;
             within 1 year of the study and lasting longer than 2 years, except for alcohol&#xD;
             dependence&#xD;
&#xD;
          4. current pregnancy (as documented by pregnancy testing at screening or on the day of&#xD;
             PET imaging study)&#xD;
&#xD;
          5. current breast feeding&#xD;
&#xD;
          6. use of tobacco- or nicotine-containing products in excess of the equivalent of 5&#xD;
             cigarettes per day, or cannot abstain from smoking during the prescribed tests&#xD;
&#xD;
          7. acute suicidal ideation or behavior, as defined by suicidal ideation and behavior&#xD;
             during the 3-month period prior to enrollment in the study and while being enrolled in&#xD;
             the study&#xD;
&#xD;
          8. general MRI exclusion criteria, i.e. pacemakers, metals in the body&#xD;
&#xD;
          9. HIV (due to possible neuropsychiatric effects)&#xD;
&#xD;
         10. use of opioid medications within 2 weeks of the PET study&#xD;
&#xD;
         11. having an abnormality in the 12-lead ECG that, in the opinion of the investigator,&#xD;
             increases the risks associated with participation in the study&#xD;
&#xD;
         12. seriously claustrophobic&#xD;
&#xD;
         13. blood donation within 8 weeks prior to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Charles Marmar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NYU School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Post-traumatic Stress Disorder (PTSD)</keyword>
  <keyword>Positron emission tomography (PET)</keyword>
  <keyword>Neuroimaging</keyword>
  <keyword>Kappa opioid receptor (KOR)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT02237703
org study id: S12-01521
nct id: NCT02237703
lead sponsor: 
collaborator: 
has dmc: Yes
This study uses positron emission tomography (PET) imaging to measure kappa opioid receptors
      (KOR) in the brains of individuals with and without post-traumatic stress disorder (PTSD).
      The investigators propose to recruit 45 drug-naïve individuals, N=15 patients with PTSD, N=15
      trauma-exposed, but asymptomatic healthy control subjects (TC) and N=15 non-trauma exposed
      healthy control subjects (HC) to participate in one magnetic resonance imaging (MRI) and one
      PET study. The investigators will also carefully document trauma history, and collect
      behavioral and neuroendocrine measures to provide a more integrative view on the neurobiology
      of PTSD and its phenotype. The investigators predict PTSD will show greater carbon - 11
      (11C)[11C]LY2795050 volume of distribution (VT) (i.e. KOR binding) values than control
      populations in an a priori defined PTSD circuit.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Volume of distribution (VT) of cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand [11C]LY2795050 and PET
time frame: Two months
description: To examine group differences in cerebral KOR expression in PTSD and healthy control subjects with and without trauma history using the KOR radioligand [11C]LY2795050 and PET.
Hypothesis: PTSD will show greater [11C]LY2795050 VT (i.e. KOR binding) values than control populations in an a priori defined PTSD circuit.
arm group label: Post-traumatic stress disorder (PTSD)
description: Post-traumatic stress disorder (PTSD)
arm group label: Trauma Control (TC)
description: Trauma Control (TC)
arm group label: Healthy Control (HC)
description: Healthy Control (HC)
intervention type: Other
intervention name: Positron emission tomography (PET) imaging
description: Positron emission tomography (PET) imaging
arm group label: Healthy Control (HC)
arm group label: Post-traumatic stress disorder (PTSD)
arm group label: Trauma Control (TC)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Charles Marmar, MD
role: Principal Investigator
affiliation: NYU School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic