<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/NCT03228901</url>
  </required_header>
  <id_info>
    <org_study_id>IG15-B052</org_study_id>
    <nct_id>NCT03228901</nct_id>
  </id_info>
  <brief_title>Oxytocin and Non-verbal Communication</brief_title>
  <official_title>Exploring the Effects of Oxytocin on Non-verbal Communication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale-NUS College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale-NUS College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this protocol registration, the investigators plan a secondary data analysis of a dataset&#xD;
      to explore the effects of intra-nasal oxytocin on the non-verbal expression of affiliation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using Liu et al.'s (2012) dataset, the investigators seek to observe whether the&#xD;
      administration of oxytocin modifies non-verbal communication with a stranger.&#xD;
&#xD;
      This dataset involves a conversation between two strangers that took place 45 minutes after&#xD;
      drug administration. While Liu et al. coded the video for markers of interpersonal distance&#xD;
      (physical distance, eye contact, conversational intimacy), the investigators seek to analyse&#xD;
      oxytocin's effects on non-verbal communication of affiliative and sexual cues (e.g., smiles,&#xD;
      lip puckers). Based on findings that oxytocin's effects depend on context, the investigators&#xD;
      will explore these relationships as a function of the conversational context (where&#xD;
      participants converse with each other using low-, medium-, and high-intimacy topics, or in an&#xD;
      unstructured conversation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2007</start_date>
  <completion_date type="Actual">July 2009</completion_date>
  <primary_completion_date type="Actual">July 2009</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>Factorial Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Non-verbal communication</measure>
    <time_frame>Measured in the interaction which commenced 45mins after drug administration</time_frame>
    <description>Based on coding the video-recorded interaction between two strangers, using a coding scheme by Gonzaga et al. (for affiliative and sexual cues)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ratings of the person participants interacted with</measure>
    <time_frame>Measured following the interaction (which commenced 45 mins after drug administration)</time_frame>
    <description>Positivity or sexual attraction towards the other participant in the conversation (as measured using visual analogue scales based on person perception studies)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Social Interaction</condition>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24IU Syntocinon, delivered in a single nose via a nasal spray</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matched nasal spray</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Administration of the hormone oxytocin</description>
    <arm_group_label>Oxytocin</arm_group_label>
    <other_name>Syntocinon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant;&#xD;
&#xD;
          -  history of epilepsy, severe depression, severe anxiety, or psychosis;&#xD;
&#xD;
          -  smoking more than 15 cigarettes a day;&#xD;
&#xD;
          -  addicted to illegal substances.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of New South Wales</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yale-NUS College</investigator_affiliation>
    <investigator_full_name>Jean Liu</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Oxytocin</keyword>
  <keyword>Affiliation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03228901
org study id: IG15-B052
nct id: NCT03228901
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this protocol registration, the investigators plan a secondary data analysis of a dataset
      to explore the effects of intra-nasal oxytocin on the non-verbal expression of affiliation.
Using Liu et al.'s (2012) dataset, the investigators seek to observe whether the
      administration of oxytocin modifies non-verbal communication with a stranger.

      This dataset involves a conversation between two strangers that took place 45 minutes after
      drug administration. While Liu et al. coded the video for markers of interpersonal distance
      (physical distance, eye contact, conversational intimacy), the investigators seek to analyse
      oxytocin's effects on non-verbal communication of affiliative and sexual cues (e.g., smiles,
      lip puckers). Based on findings that oxytocin's effects depend on context, the investigators
      will explore these relationships as a function of the conversational context (where
      participants converse with each other using low-, medium-, and high-intimacy topics, or in an
      unstructured conversation).
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Non-verbal communication
time frame: Measured in the interaction which commenced 45mins after drug administration
description: Based on coding the video-recorded interaction between two strangers, using a coding scheme by Gonzaga et al. (for affiliative and sexual cues)
measure: Ratings of the person participants interacted with
time frame: Measured following the interaction (which commenced 45 mins after drug administration)
description: Positivity or sexual attraction towards the other participant in the conversation (as measured using visual analogue scales based on person perception studies)
arm group label: Oxytocin
arm group type: Experimental
description: 24IU Syntocinon, delivered in a single nose via a nasal spray
arm group label: Placebo
arm group type: Placebo Comparator
description: Matched nasal spray
intervention type: Drug
intervention name: Oxytocin
description: Administration of the hormone oxytocin
arm group label: Oxytocin
other name: Syntocinon
intervention type: Drug
intervention name: Placebos
arm group label: Placebo
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: Yale-NUS College
investigator full name: Jean Liu
investigator title: Assistant Professor
mesh term: Oxytocin
sharing ipd: No