<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/NCT01719497</url>
  </required_header>
  <id_info>
    <org_study_id>0906005296</org_study_id>
    <nct_id>NCT01719497</nct_id>
  </id_info>
  <brief_title>Imaging of Cannabinoid 1 Receptors Using [11C]OMAR and PET</brief_title>
  <official_title>Imaging of Cannabinoid 1 Receptors Using [11C]OMAR and PET</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to conduct a human trial of [C-11]OMAR, a new PET imaging&#xD;
      agent for the brain cannabinoid type 1 receptors (CB1), to determine its pharmacokinetics and&#xD;
      binding characteristics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a pilot, 2-part study to assess the kinetics of radioactivity in medically healthy&#xD;
      subjects, subjects with alcohol dependency (AD), and obese subjects following the intravenous&#xD;
      administration of the imaging agent [C-11]OMAR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2009</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>
  <primary_outcome>
    <measure>No outcome measures for this study, this is an imaging study only</measure>
    <time_frame>Upon study completion</time_frame>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">74</enrollment>
  <condition>Obesity</condition>
  <condition>Alcohol Dependence</condition>
  <condition>High Stress</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>High Stress</arm_group_label>
    <description>Subjects diagnosed with high stress</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <description>Subjects deemed medically healthy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[C-11]OMAR</intervention_name>
    <description>PET radioligand</description>
    <arm_group_label>Alcohol</arm_group_label>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>High Stress</arm_group_label>
    <arm_group_label>Obese</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        N = 30 Medically Healthy control subjects N = 30 Subjects with high stress exposure N = 30&#xD;
        Subjects with Alcohol Dependence (AD) N = 30 Obese subjects&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Are overtly healthy males or females (other than AD or obesity), as determined by&#xD;
             medical history and physical examination. Males and females with stable medical&#xD;
             problems that, in the investigator's opinion, will not significantly alter the&#xD;
             disposition of the drug, will not place the subject at increased risk by participating&#xD;
             in the study, and will not interfere with interpretation of the data.&#xD;
&#xD;
          2. Are between the ages of 18 and 65 years, inclusive.&#xD;
&#xD;
          3. Have clinical laboratory test results within normal reference range for the population&#xD;
             or investigator site, or results with acceptable deviations that are judged to be not&#xD;
             clinically significant by the investigator. (Note: specific laboratory tests are&#xD;
             listed in section 3.4)&#xD;
&#xD;
          4. Have arterial access sufficient to allow blood sampling as per the protocol.&#xD;
&#xD;
          5. Are reliable and willing to make themselves available for the duration of the study&#xD;
             and are willing to follow study procedures.&#xD;
&#xD;
          6. Have given written informed consent approved by the ethical review board governing the&#xD;
             site.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Are currently enrolled in, or discontinued within the last [30 days] from, a clinical&#xD;
             trial involving an off-label use of an investigational drug or device, or are&#xD;
             concurrently enrolled in any other type of medical research judged not to be&#xD;
             scientifically or medically compatible with this study.&#xD;
&#xD;
          2. Current substance abuse (other than AD) including marijuana use, or severe systemic&#xD;
             disease based on history and physical exam.&#xD;
&#xD;
          3. Laboratory tests with clinically significant abnormalities or positive urine&#xD;
             toxicology screen. (Note: specific laboratory tests are listed in section 3.4)&#xD;
&#xD;
          4. Prior participation in other research protocols in the last year such that radiation&#xD;
             exposure would exceed the annual limits.&#xD;
&#xD;
          5. Presence of ferromagnetic metal in the body or heart pacemaker.&#xD;
&#xD;
          6. Are persons who have previously completed or withdrawn from this study or any other&#xD;
             study investigating [C-11]OMAR.&#xD;
&#xD;
          7. Regularly use known drugs of abuse (other than alcohol) within 30 days of the study&#xD;
             and/or show positive findings on urinary drug screening.&#xD;
&#xD;
          8. Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV&#xD;
             antibodies.&#xD;
&#xD;
          9. Are women with a positive pregnancy test or women who are lactating.&#xD;
&#xD;
         10. Have a history of head trauma with prolonged loss of consciousness (&gt;10 minutes), or&#xD;
             any neurological condition including stroke or seizure (excluding a single childhood&#xD;
             febrile seizure) or a history of migraine headaches&#xD;
&#xD;
         11. History of adverse drug reactions or intolerance to more than three types of&#xD;
             systemically administered medications&#xD;
&#xD;
         12. Have used any prescription medication (except for oral contraceptives or hormone&#xD;
             replacement therapy) or over-the-counter medication (including herbal remedies or diet&#xD;
             aids) within 14 days of the imaging session. Multiple vitamins are specifically&#xD;
             permitted&#xD;
&#xD;
         13. Have implanted or embedded metal objects or fragments in the head or body that would&#xD;
             present a risk during the MRI scanning procedure, or have worked with ferrous metals&#xD;
             either as a vocation or hobby (for example, as a sheet metal worker, welder, or&#xD;
             machinist) in such a way that might have led to unknown, indwelling metal fragments&#xD;
             that could cause injury if they moved in response to placement in the magnetic field&#xD;
&#xD;
         14. 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;
      </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>July 2022</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>July 11, 2022</last_update_submitted>
  <last_update_submitted_qc>July 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT01719497
org study id: 0906005296
nct id: NCT01719497
lead sponsor: 
has dmc: Yes
The aim of the present study is to conduct a human trial of [C-11]OMAR, a new PET imaging
      agent for the brain cannabinoid type 1 receptors (CB1), to determine its pharmacokinetics and
      binding characteristics.
This is a pilot, 2-part study to assess the kinetics of radioactivity in medically healthy
      subjects, subjects with alcohol dependency (AD), and obese subjects following the intravenous
      administration of the imaging agent [C-11]OMAR.
observational model: Case-Control
time perspective: Prospective
measure: No outcome measures for this study, this is an imaging study only
time frame: Upon study completion
arm group label: Alcohol
description: Subjects diagnosed with alcohol dependence
arm group label: Obese
description: Subjects diagnosed with obesity
arm group label: High Stress
description: Subjects diagnosed with high stress
arm group label: Healthy
description: Subjects deemed medically healthy
intervention type: Drug
intervention name: [C-11]OMAR
description: PET radioligand
arm group label: Alcohol
arm group label: Healthy
arm group label: High Stress
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: Sponsor
mesh term: Alcoholism