<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/NCT01665573</url>
  </required_header>
  <id_info>
    <org_study_id>120303009906</org_study_id>
    <nct_id>NCT01665573</nct_id>
  </id_info>
  <brief_title>Cannabinoid Augmentation of Fear Response in Humans</brief_title>
  <official_title>Cannabinoid Augmentation of Fear Response in Humans</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this double blind, randomized, controlled, proof-of-concept study is to test&#xD;
      the effects of cannabinoid receptor augmentation on the facilitation of fear conditioning. On&#xD;
      three days over not more than two weeks, subjects will be trained to associate cues with two&#xD;
      different stimuli, then this association will be extinguished. Cannabinoid receptor&#xD;
      stimulation will be accomplished indirectly by harnessing the brain's capacity to&#xD;
      endocannabinoids through the administration of an enzyme (FAAH inhibitor) that prevents&#xD;
      degradation of anandamide. Subjects will receive placebo or the FAAH-inhibitor PF-04457845.&#xD;
      Some details of this study have not been disclosed to preserve the study design.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 17, 2012</start_date>
  <completion_date type="Actual">October 16, 2015</completion_date>
  <primary_completion_date type="Actual">October 16, 2015</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Galvanic skin response</measure>
    <time_frame>Test days #1, #2, and #3, on average a week</time_frame>
    <description>Measure of sympathetic autonomic activation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cortisol levels measured in blood</measure>
    <time_frame>Test days #1, #2, and #3, on average a week</time_frame>
    <description>Salivary b-amylase and serum cortisol levels will be assessed as neurochemical measures of stress response.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">31</enrollment>
  <condition>Fear Conditioning</condition>
  <arm_group>
    <arm_group_label>PF-04457845</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Acquisition of conditioning Administration of drug Extinction of conditioning</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-04457845</intervention_name>
    <description>Acquisition of conditioning Administration of drug Extinction of conditioning</description>
    <arm_group_label>PF-04457845</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Acquisition of conditioning Administration of placebo Extinction of conditioning</description>
    <arm_group_label>PF-04457845</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 18 and 65&#xD;
&#xD;
          -  Male and female&#xD;
&#xD;
          -  No major medical problems&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hearing problems&#xD;
&#xD;
          -  Psychiatric or mental problems&#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, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Connecticut Healthcare System</name>
      <address>
        <city>West Haven</city>
        <state>Connecticut</state>
        <zip>06516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 11, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <last_update_submitted>February 24, 2022</last_update_submitted>
  <last_update_submitted_qc>February 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2022</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>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Fear Conditioning</keyword>
  <keyword>Cannabinoids</keyword>
  <keyword>Fear Response</keyword>
  <!-- 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/NCT01665573
org study id: 120303009906
nct id: NCT01665573
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this double blind, randomized, controlled, proof-of-concept study is to test
      the effects of cannabinoid receptor augmentation on the facilitation of fear conditioning. On
      three days over not more than two weeks, subjects will be trained to associate cues with two
      different stimuli, then this association will be extinguished. Cannabinoid receptor
      stimulation will be accomplished indirectly by harnessing the brain's capacity to
      endocannabinoids through the administration of an enzyme (FAAH inhibitor) that prevents
      degradation of anandamide. Subjects will receive placebo or the FAAH-inhibitor PF-04457845.
      Some details of this study have not been disclosed to preserve the study design.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Galvanic skin response
time frame: Test days #1, #2, and #3, on average a week
description: Measure of sympathetic autonomic activation
measure: Cortisol levels measured in blood
time frame: Test days #1, #2, and #3, on average a week
description: Salivary b-amylase and serum cortisol levels will be assessed as neurochemical measures of stress response.
arm group label: PF-04457845
arm group type: Active Comparator
description: Acquisition of conditioning Administration of drug Extinction of conditioning
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Drug
intervention name: PF-04457845
description: Acquisition of conditioning Administration of drug Extinction of conditioning
arm group label: PF-04457845
arm group label: Placebo
intervention type: Drug
intervention name: Placebo
description: Acquisition of conditioning Administration of placebo Extinction of conditioning
arm group label: PF-04457845
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mohini Ranganathan, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Yale University
investigator full name: Mohini Ranganathan
investigator title: Assistant Professor