<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/NCT01730781</url>
  </required_header>
  <id_info>
    <org_study_id>1005006735</org_study_id>
    <secondary_id>1R21DA030702-01A1</secondary_id>
    <secondary_id>1R21MH094961-01A1</secondary_id>
    <nct_id>NCT01730781</nct_id>
  </id_info>
  <brief_title>Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning</brief_title>
  <official_title>Characterization of CB1 Receptors Using [11-C]OMAR</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <brief_summary>
    <textblock>
      The aim of the present study is to assess the availability of cannabinoid receptors (CB1R) in&#xD;
      the human brain. CB1R are present in everyone's brain, regardless of whether or not someone&#xD;
      has used cannabis. The investigators will image brain cannabinoid receptors using Positron&#xD;
      Emission Tomography (PET) imaging and the radioligand OMAR, in healthy individuals and&#xD;
      several conditions including 1) cannabis use disorders, 2) psychotic disorders, 3) prodrome&#xD;
      of psychotic illness and 4) individuals with a family history of alcoholism, 5)&#xD;
      Post-Traumatic Stress Disorder 6) Opioid Use Disorder using the PET imaging agent or&#xD;
      radiotracer, [11C]OMAR. This will allow us to characterize the number and distribution of&#xD;
      CB1R in these conditions. It is likely that the list of conditions will be expanded after the&#xD;
      collection of pilot data and as new data on cannabinoids receptor function and psychiatric&#xD;
      disorders becomes available.&#xD;
&#xD;
      Those in the cannabis us disorder arm of the study will have a PET scan on at least three&#xD;
      occasions: once while smoking as usual, once after 48-hours of abstinence from cannabis, and&#xD;
      a final time after 4 weeks of abstinence. Additional scans may be conducted within the 4&#xD;
      weeks and the last scan may be conducted well beyond 4 weeks. Similarly, while most&#xD;
      schizophrenia patients may get scanned just once, a subgroup of patients may get scanned more&#xD;
      than once. For example to tease out the effects of medications, unmedicated patients may get&#xD;
      scanned while unmedicated and again after treatment with antipsychotic medications. Similarly&#xD;
      prodromes may get scanned while in the prodromal stage off medications, on medications and&#xD;
      after conversion to schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>PET Imaging</measure>
    <time_frame>One time within 4 weeks of screening</time_frame>
    <description>This study will utilize the radioligand [11C]OMAR and High Resolution Research Tomography (HRRT) Positron Emission Tomography (PET) to measure brain CB1 receptor availability in all study populations.&#xD;
Those in the cannabis dependent population of the study will have PET scanning on three occasions: once within four weeks of screening while smoking as usual, once 48-hours later after remaining abstinent, and once four weeks later after remaining abstinent. The change in receptor density at each time point will be evaluated.&#xD;
Those in the other populations will have PET scanning done on one occasion within four weeks of screening.</description>
  </primary_outcome>
  <number_of_groups>7</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Cannabis Dependence</condition>
  <condition>Prodromal for Psychotic Illness</condition>
  <condition>Family History of Alcoholism</condition>
  <condition>Healthy Control</condition>
  <condition>Opioid-use Disorder</condition>
  <condition>Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Schizophrenia</arm_group_label>
    <description>Patients diagnosed with schizophrenia both on medication and off medication</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cannabis dependence</arm_group_label>
    <description>Frequent users of cannabis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Family history of alcoholism</arm_group_label>
    <description>Healthy volunteers with a first degree relative with alcoholism</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Prodrome for psychotic illness</arm_group_label>
    <description>Not meeting full criteria for psychotic illness but exhibiting prodromal symptoms</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <description>Healthy volunteers with no current or past major medical or psychiatric history</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PTSD-Post Traumatic Stress Disorder</arm_group_label>
    <description>Patients diagnosed with Post Traumatic Stress Disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Opioid Use Disorder</arm_group_label>
    <description>Patients diagnosed with Opioid Use Disorder</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>[11-C]OMAR</intervention_name>
    <description>The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.</description>
    <arm_group_label>Cannabis dependence</arm_group_label>
    <arm_group_label>Family history of alcoholism</arm_group_label>
    <arm_group_label>Healthy Volunteers</arm_group_label>
    <arm_group_label>Opioid Use Disorder</arm_group_label>
    <arm_group_label>PTSD-Post Traumatic Stress Disorder</arm_group_label>
    <arm_group_label>Prodrome for psychotic illness</arm_group_label>
    <arm_group_label>Schizophrenia</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      At the screening visit, genomic DNA will be extracted from whole blood, assigned a code, and&#xD;
      stored for analysis of group differences in the frequency of CB1R alleles and to examine the&#xD;
      relationship between allelic variation at the CB1R locus and [11-C] OMAR binding. In&#xD;
      addition, other genes or markers that may be related to brain function or to behavior may be&#xD;
      studied.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population is composed of schizophrenia, cannabis dependence, prodromal for&#xD;
        psychotic illness, family history of alcoholism, healthy volunteers, Post-Traumatic Stress&#xD;
        Disorder and Opioid Use Disorder.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males ages 18-55&#xD;
&#xD;
          -  For cannabis users:&#xD;
&#xD;
          -  Willing to abstain from cannabis use for four weeks&#xD;
&#xD;
          -  For schizophrenia:&#xD;
&#xD;
          -  Meets DSM-IV-TR criteria for schizophrenia or schizoaffective disorder&#xD;
&#xD;
          -  For prodrome for psychotic illness:&#xD;
&#xD;
          -  Meets SIPS criteria for prodromal syndrome&#xD;
&#xD;
          -  For family history positive:&#xD;
&#xD;
          -  First degree relative with alcoholism&#xD;
&#xD;
          -  For Post-Traumatic Stress Disorder&#xD;
&#xD;
          -  Meets DSM-IV-TR criteria for PTSD&#xD;
&#xD;
          -  For OUD&#xD;
&#xD;
          -  Meets DSM-IV-TR criteria for Opioid Use Disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current neuro-psychiatric illness (including cannabis dependence) or severe systemic&#xD;
             disease. Cannabis use disorder is permitted in the cannabis dependent group.&#xD;
             Schizophrenia and schizoaffective disorder is permitted in the schizophrenia group.&#xD;
             Psychotic symptoms are permitted in the prodromal group. Post-Traumatic Stress&#xD;
             Disorder is permitted in the PTSD group and Opioid Use Disorder is permitted in the&#xD;
             OUD group.&#xD;
&#xD;
          -  Presence of ferromagnetic metal in the body or heart pacemaker&#xD;
&#xD;
          -  Have had exposure to ionizing radiation that in combination with the study tracer&#xD;
             would result in a cumulative exposure that exceeds recommended exposure limits&#xD;
&#xD;
          -  Are claustrophobic&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Deepak C D'Souza, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Alex Selloni, BA</last_name>
    <phone>203-974-7489</phone>
    <email>alexandria.selloni@yale.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Connecticut Mental Health Center, Clinical Neuroscience Research Unit</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06519</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alex Selloni, BA</last_name>
      <phone>203-974-7489</phone>
      <email>alexandria.selloni@yale.edu</email>
    </contact>
    <investigator>
      <last_name>Deepak C D'Souza, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>June 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>February 28, 2023</last_update_submitted>
  <last_update_submitted_qc>February 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale University</investigator_affiliation>
    <investigator_full_name>Deepak C. D'Souza</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Cannabis dependence</keyword>
  <keyword>Brain Imaging</keyword>
  <keyword>Schizophrenia</keyword>
  <keyword>Control</keyword>
  <keyword>PTSD</keyword>
  <keyword>OUD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Marijuana Abuse</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
    <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/NCT01730781
org study id: 1005006735
secondary id: 1R21DA030702-01A1
secondary id: 1R21MH094961-01A1
nct id: NCT01730781
lead sponsor: 
collaborator: 
collaborator: 
The aim of the present study is to assess the availability of cannabinoid receptors (CB1R) in
      the human brain. CB1R are present in everyone's brain, regardless of whether or not someone
      has used cannabis. The investigators will image brain cannabinoid receptors using Positron
      Emission Tomography (PET) imaging and the radioligand OMAR, in healthy individuals and
      several conditions including 1) cannabis use disorders, 2) psychotic disorders, 3) prodrome
      of psychotic illness and 4) individuals with a family history of alcoholism, 5)
      Post-Traumatic Stress Disorder 6) Opioid Use Disorder using the PET imaging agent or
      radiotracer, [11C]OMAR. This will allow us to characterize the number and distribution of
      CB1R in these conditions. It is likely that the list of conditions will be expanded after the
      collection of pilot data and as new data on cannabinoids receptor function and psychiatric
      disorders becomes available.

      Those in the cannabis us disorder arm of the study will have a PET scan on at least three
      occasions: once while smoking as usual, once after 48-hours of abstinence from cannabis, and
      a final time after 4 weeks of abstinence. Additional scans may be conducted within the 4
      weeks and the last scan may be conducted well beyond 4 weeks. Similarly, while most
      schizophrenia patients may get scanned just once, a subgroup of patients may get scanned more
      than once. For example to tease out the effects of medications, unmedicated patients may get
      scanned while unmedicated and again after treatment with antipsychotic medications. Similarly
      prodromes may get scanned while in the prodromal stage off medications, on medications and
      after conversion to schizophrenia.
observational model: Other
time perspective: Other
measure: PET Imaging
time frame: One time within 4 weeks of screening
description: This study will utilize the radioligand [11C]OMAR and High Resolution Research Tomography (HRRT) Positron Emission Tomography (PET) to measure brain CB1 receptor availability in all study populations.
Those in the cannabis dependent population of the study will have PET scanning on three occasions: once within four weeks of screening while smoking as usual, once 48-hours later after remaining abstinent, and once four weeks later after remaining abstinent. The change in receptor density at each time point will be evaluated.
Those in the other populations will have PET scanning done on one occasion within four weeks of screening.
arm group label: Schizophrenia
description: Patients diagnosed with schizophrenia both on medication and off medication
arm group label: Cannabis dependence
description: Frequent users of cannabis
arm group label: Family history of alcoholism
description: Healthy volunteers with a first degree relative with alcoholism
arm group label: Prodrome for psychotic illness
description: Not meeting full criteria for psychotic illness but exhibiting prodromal symptoms
arm group label: Healthy Volunteers
description: Healthy volunteers with no current or past major medical or psychiatric history
arm group label: PTSD-Post Traumatic Stress Disorder
description: Patients diagnosed with Post Traumatic Stress Disorder
arm group label: Opioid Use Disorder
description: Patients diagnosed with Opioid Use Disorder
intervention type: Radiation
intervention name: [11-C]OMAR
description: The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.
arm group label: Cannabis dependence
arm group label: Family history of alcoholism
arm group label: Healthy Volunteers
arm group label: Opioid Use Disorder
arm group label: PTSD-Post Traumatic Stress Disorder
arm group label: Prodrome for psychotic illness
arm group label: Schizophrenia
At the screening visit, genomic DNA will be extracted from whole blood, assigned a code, and
      stored for analysis of group differences in the frequency of CB1R alleles and to examine the
      relationship between allelic variation at the CB1R locus and [11-C] OMAR binding. In
      addition, other genes or markers that may be related to brain function or to behavior may be
      studied.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Deepak C D'Souza, MD
role: Principal Investigator
affiliation: Yale University
last name: Alex Selloni, BA
phone: 203-974-7489
email: alexandria.selloni@yale.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Yale University
investigator full name: Deepak C. D'Souza
investigator title: Associate Professor
mesh term: Marijuana Abuse
mesh term: Opioid-Related Disorders
mesh term: Alcoholism
mesh term: Schizophrenia
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic