xml: <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/NCT05968651</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00013670</org_study_id>
      <nct_id>NCT05968651</nct_id>
    </id_info>
    <brief_title>Social Safety Learning in the Brain Oxytocin System</brief_title>
    <official_title>Social Safety Learning in the Brain Oxytocin System</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Washington</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Washington</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 investigators are conducting this research study to examine whether oxytocin enhances&#xD;
        social safety learning (learning safety through the experience of another individual) in&#xD;
        people with social anxiety disorder (SAD) compared to healthy volunteers. Oxytocin is a&#xD;
        hormone that can also act as a chemical messenger in the brain. Oxytocin plays a role in a&#xD;
        number of functions, including responding to fear and social interactions. In this study, the&#xD;
        investigators would like to compare the effects of oxytocin and placebo nasal sprays in&#xD;
        adults with SAD and healthy adults. This research study will compare an oxytocin nasal spray&#xD;
        to a placebo nasal spray. About 120 people will take part in this research study, all at the&#xD;
        University of Washington (UW).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of the current study is to examine the potential role of oxytocin in enhancing&#xD;
        social learning in SAD. The investigators' primary hypothesis is that vicarious extinction&#xD;
        learning will contribute to safety learning and that oxytocin will potentiate vicarious&#xD;
        extinction learning in patients with SAD, compared to healthy controls (HC). The&#xD;
        investigators will directly test the effect of intranasal oxytocin and matching placebo on&#xD;
        the brain mechanisms underlying vicarious extinction learning using a novel task. 60 adults&#xD;
        with SAD and 60 healthy control participants will perform a task that involves three phases:&#xD;
        (i) a standard social fear acquisition procedure while in a mock scanner, followed by (ii) a&#xD;
        vicarious extinction and (iii) fear reinstatement test procedure, while being scanned during&#xD;
        functional magnetic resonance imaging (fMRI). Participants will receive oxytocin or placebo&#xD;
        prior to the extinction phase. The investigators will also measure skin conductance responses&#xD;
        as an index of learning in each phase.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 26, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>neural responses (e.g., regional brain activation in the ventromedial prefrontal cortex (vmPFC) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement</measure>
      <time_frame>immediately after the intervention</time_frame>
      <description>vmPFC blood oxygen level dependent (BOLD) responses for non-reinforced conditioned stimulus (CS-) versus reinforced conditioned stimulus (CS+)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>skin conductance responses (SCR) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement</measure>
      <time_frame>immediately after the intervention</time_frame>
      <description>mean SCR for CS- versus CS+</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Social Phobia</condition>
    <arm_group>
      <arm_group_label>Clinical</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive either an oxytocin or placebo administration (blind randomization).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Controls</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive either an oxytocin or placebo administration (blind randomization).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oxytocin nasal spray</intervention_name>
      <description>Single acute administration of 24 international units (IU) oxytocin</description>
      <arm_group_label>Clinical</arm_group_label>
      <arm_group_label>Controls</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          For Clinical Sample&#xD;
  &#xD;
            -  Men and women age 18-45&#xD;
  &#xD;
            -  Women must be having regular menstrual cycles and not be taking oral contraception&#xD;
  &#xD;
            -  Primary diagnosis of social anxiety disorder&#xD;
  &#xD;
          For Healthy Sample&#xD;
  &#xD;
            -  Men and women age 18-45&#xD;
  &#xD;
            -  Women must be having regular menstrual cycles and not be taking oral contraception&#xD;
  &#xD;
            -  No current or lifetime history of psychiatric, neurological, or medical disorders&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          For All Groups&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Positive urine drug screening test result&#xD;
  &#xD;
            -  History of nasal pathology&#xD;
  &#xD;
            -  Current use of any psychotropic medication or steroids&#xD;
  &#xD;
            -  Active substance use disorder within the past 6 months&#xD;
  &#xD;
            -  History of serious medical illnesses or untreated endocrine diseases&#xD;
  &#xD;
            -  History of head injury, neurological disorder, or neurosurgical procedure&#xD;
  &#xD;
            -  Positive magnetic resonance (MR) screen&#xD;
  &#xD;
          For Clinical Sample&#xD;
  &#xD;
            -  Lifetime diagnoses of mania or psychotic disorder based on the Diagnostic and&#xD;
               Statistical Manual (DSM- 5th ed)&#xD;
  &#xD;
            -  Acute suicidal ideation&#xD;
  &#xD;
          For Healthy Sample&#xD;
  &#xD;
            -  Lifetime DSM-5 diagnosis of any medical, neurological, or psychiatric illness&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Angela Fang, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Washington</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jessica Crane</last_name>
      <phone>206-221-1278</phone>
      <email>jcrane2@uw.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Washington</name>
        <address>
          <city>Seattle</city>
          <state>Washington</state>
          <zip>98195</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Margaret Sarkisova, B.S.</last_name>
        <phone>206-221-1278</phone>
        <email>msark@uw.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Washington</investigator_affiliation>
      <investigator_full_name>Angela Fang</investigator_full_name>
      <investigator_title>Assistant Professor, Department of Psychology</investigator_title>
    </responsible_party>
    <keyword>Social Phobia</keyword>
    <keyword>Social Anxiety Disorder</keyword>
    <keyword>Social Safety Learning</keyword>
    <keyword>Intranasal Oxytocin</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Phobia, Social</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Oxytocin</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968651
  org study id: STUDY00013670
  nct id: NCT05968651
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The investigators are conducting this research study to examine whether oxytocin enhances
        social safety learning (learning safety through the experience of another individual) in
        people with social anxiety disorder (SAD) compared to healthy volunteers. Oxytocin is a
        hormone that can also act as a chemical messenger in the brain. Oxytocin plays a role in a
        number of functions, including responding to fear and social interactions. In this study, the
        investigators would like to compare the effects of oxytocin and placebo nasal sprays in
        adults with SAD and healthy adults. This research study will compare an oxytocin nasal spray
        to a placebo nasal spray. About 120 people will take part in this research study, all at the
        University of Washington (UW).
  The goal of the current study is to examine the potential role of oxytocin in enhancing
        social learning in SAD. The investigators' primary hypothesis is that vicarious extinction
        learning will contribute to safety learning and that oxytocin will potentiate vicarious
        extinction learning in patients with SAD, compared to healthy controls (HC). The
        investigators will directly test the effect of intranasal oxytocin and matching placebo on
        the brain mechanisms underlying vicarious extinction learning using a novel task. 60 adults
        with SAD and 60 healthy control participants will perform a task that involves three phases:
        (i) a standard social fear acquisition procedure while in a mock scanner, followed by (ii) a
        vicarious extinction and (iii) fear reinstatement test procedure, while being scanned during
        functional magnetic resonance imaging (fMRI). Participants will receive oxytocin or placebo
        prior to the extinction phase. The investigators will also measure skin conductance responses
        as an index of learning in each phase.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: neural responses (e.g., regional brain activation in the ventromedial prefrontal cortex (vmPFC) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement
  time frame: immediately after the intervention
  description: vmPFC blood oxygen level dependent (BOLD) responses for non-reinforced conditioned stimulus (CS-) versus reinforced conditioned stimulus (CS+)
  measure: skin conductance responses (SCR) to vicariously extinguished cue versus vicariously reinforced cue during reinstatement
  time frame: immediately after the intervention
  description: mean SCR for CS- versus CS+
  arm group label: Clinical
  arm group type: Experimental
  description: This group consists of individuals with at least moderate symptoms of social anxiety disorder. This group will receive either an oxytocin or placebo administration (blind randomization).
  arm group label: Controls
  arm group type: Placebo Comparator
  description: This group consists of a healthy sample of individuals (no lifetime diagnoses of mania or psychotic disorders). This group will receive either an oxytocin or placebo administration (blind randomization).
  intervention type: Drug
  intervention name: Oxytocin nasal spray
  description: Single acute administration of 24 international units (IU) oxytocin
  arm group label: Clinical
  arm group label: Controls
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Angela Fang, PhD
  role: Principal Investigator
  affiliation: University of Washington
  last name: Jessica Crane
  phone: 206-221-1278
  email: jcrane2@uw.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Washington
  investigator full name: Angela Fang
  investigator title: Assistant Professor, Department of Psychology
  mesh term: Phobia, Social
  mesh term: Oxytocin