<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/NCT03826693</url>
  </required_header>
  <id_info>
    <org_study_id>48077</org_study_id>
    <nct_id>NCT03826693</nct_id>
  </id_info>
  <brief_title>Efficacy of Nitrous Oxide in OCD: Pilot Study</brief_title>
  <official_title>Efficacy of Nitrous Oxide in OCD: Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Brain &amp; Behavior Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates whether the commonly used and well-tolerated inhaled anesthetic&#xD;
      nitrous oxide can rapidly improve symptoms of OCD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obsessive-compulsive disorder (OCD) is a chronic and disabling disorder characterized by&#xD;
      recurrent intrusive thoughts and associated compulsive behaviors that is estimated to affect&#xD;
      more than 3 million individuals in the US each year.&#xD;
&#xD;
      This study seeks to explore whether a single inhalation of nitrous oxide gas may bring about&#xD;
      rapid symptom relief in OCD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 17, 2021</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>placebo-controlled 2:1 randomized clinical trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)</measure>
    <time_frame>1 week</time_frame>
    <description>Improvement in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Experimental: Nitrous Oxide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control: Nitrogen</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitrous Oxide</intervention_name>
    <description>OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.</description>
    <arm_group_label>Experimental: Nitrous Oxide</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nitrogen</intervention_name>
    <description>OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.</description>
    <arm_group_label>Control: Nitrogen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65&#xD;
&#xD;
          -  Primary diagnosis of OCD&#xD;
&#xD;
          -  Sufficient severity of OCD symptoms&#xD;
&#xD;
          -  Ability to tolerate a treatment-free period&#xD;
&#xD;
          -  Capacity to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric or medical conditions that make participation unsafe&#xD;
&#xD;
          -  Pregnant or nursing females&#xD;
&#xD;
          -  Concurrent use of any medications that might increase the risk of participation (e.g.&#xD;
             drug interactions)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter J van Roessel, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford Univeristy</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pavithra Mukunda, MS</last_name>
    <phone>650-723-4095</phone>
    <email>ocdresearch@stanford.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sindu Menon, MBBS</last_name>
    <phone>650-723-4095</phone>
    <email>ocdresearch@stanford.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pavithra Makunda, MS</last_name>
      <phone>650-723-4095</phone>
      <email>ocdresearch@stanford.edu</email>
    </contact>
    <contact_backup>
      <last_name>Sindu Menon, MBBS</last_name>
      <phone>650-723-4095</phone>
      <email>ocdresearch@stanford.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Peter van Roessel, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://med.stanford.edu/profiles/peter-van-roessel</url>
    <description>Stanford Medicine Faculty Page</description>
  </link>
  <link>
    <url>https://rodriguezlab.stanford.edu</url>
    <description>Rodriguez Lab Website</description>
  </link>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>September 23, 2022</last_update_submitted>
  <last_update_submitted_qc>September 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Peter J van Roessel, MD PhD</investigator_full_name>
    <investigator_title>Clinical Associate Professor, Department of Psychiatry and Behavioral Sciences</investigator_title>
  </responsible_party>
  <keyword>OCD</keyword>
  <keyword>nitrous oxide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nitrous Oxide</mesh_term>
  </intervention_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/NCT03826693
org study id: 48077
nct id: NCT03826693
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study investigates whether the commonly used and well-tolerated inhaled anesthetic
      nitrous oxide can rapidly improve symptoms of OCD.
Obsessive-compulsive disorder (OCD) is a chronic and disabling disorder characterized by
      recurrent intrusive thoughts and associated compulsive behaviors that is estimated to affect
      more than 3 million individuals in the US each year.

      This study seeks to explore whether a single inhalation of nitrous oxide gas may bring about
      rapid symptom relief in OCD.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: placebo-controlled 2:1 randomized clinical trial.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
time frame: 1 week
description: Improvement in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS.
arm group label: Experimental: Nitrous Oxide
arm group type: Experimental
description: OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.
arm group label: Control: Nitrogen
arm group type: Placebo Comparator
description: OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.
intervention type: Drug
intervention name: Nitrous Oxide
description: OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.
arm group label: Experimental: Nitrous Oxide
intervention type: Drug
intervention name: Nitrogen
description: OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.
arm group label: Control: Nitrogen
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Peter J van Roessel, MD, PhD
role: Principal Investigator
affiliation: Stanford Univeristy
last name: Pavithra Mukunda, MS
phone: 650-723-4095
email: ocdresearch@stanford.edu
last name: Sindu Menon, MBBS
phone: 650-723-4095
email: ocdresearch@stanford.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
url: https://med.stanford.edu/profiles/peter-van-roessel
description: Stanford Medicine Faculty Page
url: https://rodriguezlab.stanford.edu
description: Rodriguez Lab Website
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Peter J van Roessel, MD PhD
investigator title: Clinical Associate Professor, Department of Psychiatry and Behavioral Sciences
mesh term: Obsessive-Compulsive Disorder
mesh term: Nitrous Oxide