<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/NCT04404712</url>
  </required_header>
  <id_info>
    <org_study_id>2000027585</org_study_id>
    <nct_id>NCT04404712</nct_id>
  </id_info>
  <brief_title>FAAH Availability in Psychiatric Disorders: A PET Study</brief_title>
  <official_title>FAAH Availability in Psychiatric Disorders: A PET Study</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>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to examine Fatty Acid Amide Hydrolase (FAAH) availability in&#xD;
      humans, including healthy individuals and across a spectrum of psychiatric disorders in which&#xD;
      alterations in the endocannabinoid system are observed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study involves in vivo examination of FAAH availability, implicated both in the&#xD;
      pathophysiology and therapeutics of disorders including PTSD, substance use disorders (e.g.,&#xD;
      alcohol use disorder, cannabis/cannabinoid use disorder, nicotine use disorder), psychotic&#xD;
      disorders including schizophrenia, and mood disorders. The endocannabinoid system is a&#xD;
      neuromodulatory system that has been implicated across a wide range of psychiatric disorders&#xD;
      and may be implicated in the regulation of mood, appetitive behaviors, sleep, and cognition.&#xD;
      Thus, alterations in the ECS have wide ranging implications. Finally, the ECS is being&#xD;
      explored as a novel therapeutic target for several psychiatric disorders. Additionally, the&#xD;
      test/retest reliability of the radiotracer, [11C]MK-3168, will be studied in up to 10 healthy&#xD;
      control individuals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Ligand was not effective.&#xD;
  </why_stopped>
  <start_date type="Actual">September 23, 2020</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total distribution of [11C]MK-3168 in the brain</measure>
    <time_frame>PET scan day</time_frame>
    <description>FAAH availability will be approximated using the FAAH positron emission tomography (PET) tracer [11C]MK-3168 total distribution</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Post Traumatic Stress Disorder</condition>
  <condition>Alcohol Use Disorder</condition>
  <condition>Psychosis</condition>
  <arm_group>
    <arm_group_label>[11C]MK-3168 PET Scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[11C]MK-3168</intervention_name>
    <description>One PET scan involving administration of PET ligand [11C]MK-3168</description>
    <arm_group_label>[11C]MK-3168 PET Scan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 18 and 65 years, inclusive&#xD;
&#xD;
          -  Good physical health as determined by history, physical and laboratory examinations,&#xD;
             ECG, and vital signs&#xD;
&#xD;
        PTSD Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Post-Traumatic Stress Disorder&#xD;
&#xD;
        AUD Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Alcohol Use Disorder&#xD;
&#xD;
        Psychosis Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of psychotic disorder such as Schizophrenia, Schizoaffective disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of ferromagnetic metal in the body or heart pacemaker&#xD;
&#xD;
          -  Women with a positive pregnancy test or women who are lactating&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohini Ranganathan, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Neuroscience Research Training Program (NRTP); Office of Cooperative Research; Psychiatry; Schizophrenia Research Clinic; Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Connecticut Mental Health Center</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>February 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale University</investigator_affiliation>
    <investigator_full_name>Mohini Ranganathan</investigator_full_name>
    <investigator_title>Associate Professor of Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    <mesh_term>Problem Behavior</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/NCT04404712
org study id: 2000027585
nct id: NCT04404712
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The aim of the present study is to examine Fatty Acid Amide Hydrolase (FAAH) availability in
      humans, including healthy individuals and across a spectrum of psychiatric disorders in which
      alterations in the endocannabinoid system are observed.
This study involves in vivo examination of FAAH availability, implicated both in the
      pathophysiology and therapeutics of disorders including PTSD, substance use disorders (e.g.,
      alcohol use disorder, cannabis/cannabinoid use disorder, nicotine use disorder), psychotic
      disorders including schizophrenia, and mood disorders. The endocannabinoid system is a
      neuromodulatory system that has been implicated across a wide range of psychiatric disorders
      and may be implicated in the regulation of mood, appetitive behaviors, sleep, and cognition.
      Thus, alterations in the ECS have wide ranging implications. Finally, the ECS is being
      explored as a novel therapeutic target for several psychiatric disorders. Additionally, the
      test/retest reliability of the radiotracer, [11C]MK-3168, will be studied in up to 10 healthy
      control individuals.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Total distribution of [11C]MK-3168 in the brain
time frame: PET scan day
description: FAAH availability will be approximated using the FAAH positron emission tomography (PET) tracer [11C]MK-3168 total distribution
arm group label: [11C]MK-3168 PET Scan
arm group type: Experimental
intervention type: Drug
intervention name: [11C]MK-3168
description: One PET scan involving administration of PET ligand [11C]MK-3168
arm group label: [11C]MK-3168 PET Scan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohini Ranganathan, MBBS
role: Principal Investigator
affiliation: Neuroscience Research Training Program (NRTP); Office of Cooperative Research; Psychiatry; Schizophrenia Research Clinic; Yale University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Yale University
investigator full name: Mohini Ranganathan
investigator title: Associate Professor of Psychiatry
mesh term: Alcoholism
mesh term: Stress Disorders, Traumatic
mesh term: Mental Disorders
mesh term: Stress Disorders, Post-Traumatic
mesh term: Problem Behavior