<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/NCT02237677</url>
  </required_header>
  <id_info>
    <org_study_id>12-02787</org_study_id>
    <nct_id>NCT02237677</nct_id>
  </id_info>
  <brief_title>CB1 Receptor PET Imaging Reveals Gender Differences in PTSD</brief_title>
  <official_title>Cannabinoid-1 (CB1) Receptor Positron Emission Tomography (PET) Imaging Reveals Gender Differences in Posttraumatic 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>
      The objective of the proposed translational study is to test a model, based upon basic&#xD;
      science studies, exploring multisystem impairments in PTSD including endocannabinoid (eCB)&#xD;
      and glucocorticoids in the modulation of fear memories by examining the cannabinoid type 1&#xD;
      (CB1) receptor in a PTSD fear circuit as well as glucocorticoid function. The investigators&#xD;
      propose that impaired eCB signaling in PTSD resulting in the maladaptive neurobehavioral&#xD;
      response to the stressor is associated with an upregulation of the CB1 receptors and&#xD;
      insufficient glucocorticoid signaling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The eCB - anandamide and 2-arachidonoylglycerol (2-AG) - and their attending cannabinoid (CB)&#xD;
      receptors which are found in high densities in a fear circuitry involving the amygdala,&#xD;
      hippocampus, the anterior cingulate cortex and prefrontal cortex serve important functions in&#xD;
      the regulation of stress-coping behaviors. Besides eCB regulation there is strong evidence&#xD;
      from ongoing research of the investigators group and others suggesting an important role for&#xD;
      glucocorticoid signaling as an endpoint of the biochemical sequelae initiated by stressful or&#xD;
      aversive stimuli. One of the long-term research goals of our lab is to understand such&#xD;
      functions and determine their relevance to the pathogenesis of PTSD and to provide a more&#xD;
      integrative view on neurobiological mechanisms that are involved in the regulation of the&#xD;
      neuroadaptive response to stress. The objective of the proposed translational study is to&#xD;
      test a model, based upon basic science studies, exploring multisystem impairments in PTSD&#xD;
      including eCB and glucocorticoids in the modulation of fear memories by examining the CB1&#xD;
      receptor in a PTSD fear circuit as well as glucocorticoid function. The investigators propose&#xD;
      that impaired eCB signaling in PTSD resulting in the maladaptive neurobehavioral response to&#xD;
      the stressor is associated with an upregulation of the CB1 receptors and insufficient&#xD;
      glucocorticoid signaling.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The original PI, Alexander Neumeister, left NYULMC. No data was analyzed.&#xD;
  </why_stopped>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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 CB1 receptor expression in PTSD and controls within a fear circuit of brain regions that regulate stress-related behaviors using the CB1 radioligand carbon - 11 (11C) [11C]OMAR and PET.</measure>
    <time_frame>Two months</time_frame>
    <description>To examine group differences in cerebral CB1 receptor expression in PTSD and controls within a fear circuit of cortical and subcortical brain regions that regulate stress-related behaviors using the CB1 radioligand [11C]OMAR and PET.&#xD;
Hypothesis: PTSD patients will show greater [11C]OMAR VT (i.e. CB1 binding) values than both control groups, trauma-exposed and non-trauma exposed control subjects who will not be different.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">36</enrollment>
  <condition>Post-traumatic Stress Disorder (PTSD)</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>Healthy Controls (HC)</arm_group_label>
    <description>Healthy Controls (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 Controls (HC)</arm_group_label>
    <arm_group_label>Post-traumatic stress disorder (PTSD)</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, history of post-traumatic stress&#xD;
        disorder (PTSD) or healthy control.&#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;
        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 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 (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. nicotine dependence&#xD;
&#xD;
          7. suicidal ideation or behavior&#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 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;
&#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. nicotine dependence&#xD;
&#xD;
          7. suicidal ideation or behavior&#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>August 2016</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>August 15, 2016</last_update_submitted>
  <last_update_submitted_qc>August 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Post-traumatic stress disorder (PTSD)</keyword>
  <keyword>Trauma</keyword>
  <keyword>Neuroimaging</keyword>
  <keyword>Positron emission tomography (PET)</keyword>
  <keyword>[11C]OMAR</keyword>
  <keyword>Endocannabinoid</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/NCT02237677
org study id: 12-02787
nct id: NCT02237677
lead sponsor: 
collaborator: 
has dmc: Yes
The objective of the proposed translational study is to test a model, based upon basic
      science studies, exploring multisystem impairments in PTSD including endocannabinoid (eCB)
      and glucocorticoids in the modulation of fear memories by examining the cannabinoid type 1
      (CB1) receptor in a PTSD fear circuit as well as glucocorticoid function. The investigators
      propose that impaired eCB signaling in PTSD resulting in the maladaptive neurobehavioral
      response to the stressor is associated with an upregulation of the CB1 receptors and
      insufficient glucocorticoid signaling.
The eCB - anandamide and 2-arachidonoylglycerol (2-AG) - and their attending cannabinoid (CB)
      receptors which are found in high densities in a fear circuitry involving the amygdala,
      hippocampus, the anterior cingulate cortex and prefrontal cortex serve important functions in
      the regulation of stress-coping behaviors. Besides eCB regulation there is strong evidence
      from ongoing research of the investigators group and others suggesting an important role for
      glucocorticoid signaling as an endpoint of the biochemical sequelae initiated by stressful or
      aversive stimuli. One of the long-term research goals of our lab is to understand such
      functions and determine their relevance to the pathogenesis of PTSD and to provide a more
      integrative view on neurobiological mechanisms that are involved in the regulation of the
      neuroadaptive response to stress. The objective of the proposed translational study is to
      test a model, based upon basic science studies, exploring multisystem impairments in PTSD
      including eCB and glucocorticoids in the modulation of fear memories by examining the CB1
      receptor in a PTSD fear circuit as well as glucocorticoid function. The investigators propose
      that impaired eCB signaling in PTSD resulting in the maladaptive neurobehavioral response to
      the stressor is associated with an upregulation of the CB1 receptors and insufficient
      glucocorticoid signaling.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Volume of distribution (VT) of cerebral CB1 receptor expression in PTSD and controls within a fear circuit of brain regions that regulate stress-related behaviors using the CB1 radioligand carbon - 11 (11C) [11C]OMAR and PET.
time frame: Two months
description: To examine group differences in cerebral CB1 receptor expression in PTSD and controls within a fear circuit of cortical and subcortical brain regions that regulate stress-related behaviors using the CB1 radioligand [11C]OMAR and PET.
Hypothesis: PTSD patients will show greater [11C]OMAR VT (i.e. CB1 binding) values than both control groups, trauma-exposed and non-trauma exposed control subjects who will not be different.
arm group label: Post-traumatic stress disorder (PTSD)
description: Post-traumatic stress disorder (PTSD)
arm group label: Healthy Controls (HC)
description: Healthy Controls (HC)
intervention type: Other
intervention name: Positron emission tomography (PET) imaging
description: Positron emission tomography (PET) imaging
arm group label: Healthy Controls (HC)
arm group label: Post-traumatic stress disorder (PTSD)
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