<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/NCT01680718</url>
  </required_header>
  <id_info>
    <org_study_id>Behavioral Neuropeptides</org_study_id>
    <nct_id>NCT01680718</nct_id>
  </id_info>
  <brief_title>Neuropeptides and Social Behavior</brief_title>
  <official_title>Neuropeptides and Social Behavior</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has long been established that interpersonal relationships can have a profound impact on&#xD;
      health and well-being. Yet, we are still learning about the complex biological processes that&#xD;
      contribute to positive social interactions and the ability to develop and maintain social&#xD;
      relationships. Recent research has begun to focus on oxytocin and vasopressin, neuropeptides&#xD;
      that are naturally produced in the hypothalamus, because administration of these&#xD;
      neuropeptides has been associated with increased trust, generosity, empathy, cooperation,&#xD;
      memory of social stimuli (e.g., faces), and brain activity in neural regions associated with&#xD;
      social and emotional processes. To date, several aspects of oxytocin and vasopressin's&#xD;
      effects on social behavior have been unexplored. As such, the overarching goal of this&#xD;
      project is to examine the effects of intranasal oxytocin and vasopressin on social working&#xD;
      memory, deception detection, sensitivity to interpersonal distance, empathy, and altruistic&#xD;
      behavior. Understanding how oxytocin and vasopressin influence these aspects of social&#xD;
      functioning will help to inform research that has begun to establish the potential for use of&#xD;
      these neuropeptides in psychiatric disorders such as autism spectrum disorders and&#xD;
      schizophrenia that are characterized by social deficits. For this study, we will recruit 150&#xD;
      healthy adults without a history of medical or psychiatric illness to come to the laboratory.&#xD;
      In the first session, participants will complete several questionnaires. In the second&#xD;
      session, participants will be randomly assigned to receive oxytocin, vasopressin, or placebo.&#xD;
      The study nurses will measure temperature, heart rate, and blood pressure (female&#xD;
      participants will also be asked to undergo a pregnancy test) before drug administration.&#xD;
      Participants will then complete computer tasks. During the second session, we will also&#xD;
      collect a saliva sample for genetic analysis and participants will be asked to complete&#xD;
      several additional questionnaires. At the end of the experimental session, participants will&#xD;
      be fully debriefed.&#xD;
&#xD;
      The investigators hypothesize that compared to placebo, oxytocin and/or vasopressin will&#xD;
      improve social working memory and deception detection, and increase empathy and altruism. It&#xD;
      is also hypothesized that main effects will not be found for oxytocin or vasopressin, but&#xD;
      rather, analyses of relevant moderators will elucidate these findings.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Factorial Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Speed in social working memory task</measure>
    <time_frame>Between 40-90 minutes post administration</time_frame>
    <description>Between group differences in the amount of time it takes to perform tasks involving social working memory</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Accuracy of deception detection based on self-report</measure>
    <time_frame>Between 40-90 minutes post administration</time_frame>
    <description>Between group differences in deception detection accuracy based on self-reported ratings of unfamiliar others</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported perceptions of trust and threat</measure>
    <time_frame>Between 40-90 minutes post administration</time_frame>
    <description>Between group differences in self-reported perceptions of trust and threat towards unfamiliar faces which appear to vary in interpersonal distance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-reported empathy and altruistic behavior</measure>
    <time_frame>Between 40-90 minutes post administration</time_frame>
    <description>Between group differences in self-reported empathy (empathic concern and personal distress), and altruistic behavior.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Social Psychology</condition>
  <arm_group>
    <arm_group_label>Intranasal oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intranasal vasopressin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intranasal placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter (used previously; Bartz et al., 2010). Participants will self-administer 5 puffs per nostril.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intranasal oxytocin</intervention_name>
    <description>Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).</description>
    <arm_group_label>Intranasal oxytocin</arm_group_label>
    <other_name>Syntocinon nasal spray</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intranasal vasopressin</intervention_name>
    <description>Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).</description>
    <arm_group_label>Intranasal vasopressin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intranasal placebo</intervention_name>
    <description>Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter (used previously; Bartz et al., 2010).</description>
    <arm_group_label>Intranasal placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-50 years of age&#xD;
&#xD;
          -  Healthy (see below)&#xD;
&#xD;
          -  Fluent in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who gave birth in the last six months, are currently pregnant, planning to&#xD;
             become pregnant in the next 6 months, or currently breastfeeding women&#xD;
&#xD;
          -  Symptoms of runny nose due to allergies/cold or other reason&#xD;
&#xD;
          -  Current restricted fluid intake for any reason&#xD;
&#xD;
          -  Heart disease&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  History of myocardial infarction&#xD;
&#xD;
          -  History of cardiac arrhythmia&#xD;
&#xD;
          -  Kidney or liver disease&#xD;
&#xD;
          -  Vascular disease&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Migraine&#xD;
&#xD;
          -  Asthma&#xD;
&#xD;
          -  Nephritis&#xD;
&#xD;
          -  Diabetes and other endocrine diseases&#xD;
&#xD;
          -  Frequent or unexplained fainting&#xD;
&#xD;
          -  History of stroke&#xD;
&#xD;
          -  Aneurysm or brain hemorrhage&#xD;
&#xD;
          -  Active psychiatric diagnosis&#xD;
&#xD;
          -  Current psychopharmacologic treatment&#xD;
&#xD;
          -  Drug or alcohol abuse&#xD;
&#xD;
          -  Medical or neurological illness&#xD;
&#xD;
          -  Regular use of medication (e.g., vasoconstrictive medications)&#xD;
&#xD;
          -  Medication intake less than 2 weeks prior to study (5 weeks for fluoxetine) including&#xD;
             daily non-steroidal anti-inflammatory drugs&#xD;
&#xD;
          -  Smoking more than 15 cigarettes a day&#xD;
&#xD;
          -  Consumption of any alcoholic beverages in the past 24 hours will be excluded&#xD;
&#xD;
          -  Elevated blood pressure (&gt;130/90)&#xD;
&#xD;
          -  Low blood pressure (&lt;90/60)&#xD;
&#xD;
          -  Body temperature &gt;100.1 F&#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>Naomi I Eisenberger, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA Department of Psychology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095-1563</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>May 27, 2015</last_update_submitted>
  <last_update_submitted_qc>May 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Naomi Eisenberger</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>oxytocin</keyword>
  <keyword>vasopressin</keyword>
  <keyword>intranasal administration</keyword>
  <keyword>healthy sample</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vasopressins</mesh_term>
    <mesh_term>Arginine Vasopressin</mesh_term>
    <mesh_term>Oxytocin</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/NCT01680718
org study id: Behavioral Neuropeptides
nct id: NCT01680718
lead sponsor: 
has dmc: No
It has long been established that interpersonal relationships can have a profound impact on
      health and well-being. Yet, we are still learning about the complex biological processes that
      contribute to positive social interactions and the ability to develop and maintain social
      relationships. Recent research has begun to focus on oxytocin and vasopressin, neuropeptides
      that are naturally produced in the hypothalamus, because administration of these
      neuropeptides has been associated with increased trust, generosity, empathy, cooperation,
      memory of social stimuli (e.g., faces), and brain activity in neural regions associated with
      social and emotional processes. To date, several aspects of oxytocin and vasopressin's
      effects on social behavior have been unexplored. As such, the overarching goal of this
      project is to examine the effects of intranasal oxytocin and vasopressin on social working
      memory, deception detection, sensitivity to interpersonal distance, empathy, and altruistic
      behavior. Understanding how oxytocin and vasopressin influence these aspects of social
      functioning will help to inform research that has begun to establish the potential for use of
      these neuropeptides in psychiatric disorders such as autism spectrum disorders and
      schizophrenia that are characterized by social deficits. For this study, we will recruit 150
      healthy adults without a history of medical or psychiatric illness to come to the laboratory.
      In the first session, participants will complete several questionnaires. In the second
      session, participants will be randomly assigned to receive oxytocin, vasopressin, or placebo.
      The study nurses will measure temperature, heart rate, and blood pressure (female
      participants will also be asked to undergo a pregnancy test) before drug administration.
      Participants will then complete computer tasks. During the second session, we will also
      collect a saliva sample for genetic analysis and participants will be asked to complete
      several additional questionnaires. At the end of the experimental session, participants will
      be fully debriefed.

      The investigators hypothesize that compared to placebo, oxytocin and/or vasopressin will
      improve social working memory and deception detection, and increase empathy and altruism. It
      is also hypothesized that main effects will not be found for oxytocin or vasopressin, but
      rather, analyses of relevant moderators will elucidate these findings.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Speed in social working memory task
time frame: Between 40-90 minutes post administration
description: Between group differences in the amount of time it takes to perform tasks involving social working memory
measure: Accuracy of deception detection based on self-report
time frame: Between 40-90 minutes post administration
description: Between group differences in deception detection accuracy based on self-reported ratings of unfamiliar others
measure: Self-reported perceptions of trust and threat
time frame: Between 40-90 minutes post administration
description: Between group differences in self-reported perceptions of trust and threat towards unfamiliar faces which appear to vary in interpersonal distance
measure: Self-reported empathy and altruistic behavior
time frame: Between 40-90 minutes post administration
description: Between group differences in self-reported empathy (empathic concern and personal distress), and altruistic behavior.
arm group label: Intranasal oxytocin
arm group type: Experimental
description: Participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).
arm group label: Intranasal vasopressin
arm group type: Experimental
description: Participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).
arm group label: Intranasal placebo
arm group type: Placebo Comparator
description: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter (used previously; Bartz et al., 2010). Participants will self-administer 5 puffs per nostril.
intervention type: Drug
intervention name: Intranasal oxytocin
description: Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).
arm group label: Intranasal oxytocin
other name: Syntocinon nasal spray
intervention type: Drug
intervention name: Intranasal vasopressin
description: Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).
arm group label: Intranasal vasopressin
intervention type: Drug
intervention name: Intranasal placebo
description: Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter (used previously; Bartz et al., 2010).
arm group label: Intranasal placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Naomi I Eisenberger, PhD
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Naomi Eisenberger
investigator title: Assistant Professor
mesh term: Vasopressins
mesh term: Arginine Vasopressin
mesh term: Oxytocin