<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/NCT03278860</url>
  </required_header>
  <id_info>
    <org_study_id>UESTC-neuSCAN-39</org_study_id>
    <nct_id>NCT03278860</nct_id>
  </id_info>
  <brief_title>The Effects of Oxytocin on Social Touch</brief_title>
  <official_title>The Effects of Intranasal Oxytocin on Social Touch: an fMRI-based Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Electronic Science and Technology of China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Electronic Science and Technology of China</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>
      The main aim of the study is to investigate whether intranasal oxytocin (24IU) can enhance&#xD;
      hedonic experience and associated brain-reward reward responses to social touch.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A double-blind, within-subject, placebo controlled design is employed in this study. In total&#xD;
      50 healthy male subjects will be recruited and they will come twice, once with the&#xD;
      administration of oxytocin nasal spray and the other placebo (interval time is more than 2&#xD;
      weeks). 45 minutes after treatment subjects will be applied two different types of pleasant&#xD;
      touch: social touch from a masseur (professional therapist) and non-social touch from a&#xD;
      massage device. After each condition the subjects will be asked to rate pleasantness,&#xD;
      likability, and arousal. Simultaneously functional brain activity will be acquired via fMRI.&#xD;
      Blood samples will be taken before and after the intervention to assess oxytocin levels. All&#xD;
      subjects were asked to complete a range of questionnaires measuring trait personality and&#xD;
      mood: Beck Depression Inventory (BDI), Cheek and Buss Shyness Scale (CBSS),Autism Spectrum&#xD;
      Quotient (ASQ), Empathy Quotient (EQ), NEO Five Factor Inventory (NEO-FFI), Liebowitz Social&#xD;
      Anxiety Scale (LSAS),Behavioral Inhibition System and Behavioral Activation System Scale&#xD;
      (BISBAS),Sensitivity to Punishment and Sensitivity to Reward Questionnaire&#xD;
      (SPSRQ),State-Trait Anxiety Inventory (STAI), Social Touch Questionnaire (STQ), Sensory over&#xD;
      Responsivity Scale (SOR) and Under Responsivity Scale (URS) one day before the first&#xD;
      scanning. On the first and second scanning day, the subjects were asked to complete Positive&#xD;
      and Negative Affect Schedule (PANAS) before and after treatment administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 28, 2017</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized placebo-controlled double-blind within-subject design</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neural indices: fMRI-based measures of interoceptive and reward processing</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>fMRI-based measures of social and non-social touch-related brain activity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Behavioral index: pleasantness experience</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>Ratings for pleasantness during the application of social and non-social touch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral index: likability experience</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>Ratings for likability during the application of social and non-social touch</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavioral index: arousal experience</measure>
    <time_frame>45-90 minutes after treatment administration</time_frame>
    <description>Ratings for arousal during the application of social and non-social touch</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Oxytocin then placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants first received oxytocin (24 IU). After a washout period of 2 weeks, they then received placebo (24 IU).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo then oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants first received placebo (24 IU). After a washout period of 2 weeks, they then received oxytocin (24 IU).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intranasal oxytocin</intervention_name>
    <description>24 IU of oxytocin nasal spray will be applied to each subject.</description>
    <arm_group_label>Oxytocin then placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intranasal placebo</intervention_name>
    <description>an identical amount of placebo nasal spray will be applied to each subject.</description>
    <arm_group_label>Oxytocin then placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intranasal oxytocin</intervention_name>
    <description>24 IU of oxytocin nasal spray will be applied to each subject.</description>
    <arm_group_label>Placebo then oxytocin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intranasal placebo</intervention_name>
    <description>an identical amount of placebo nasal spray will be applied to each subject.</description>
    <arm_group_label>Placebo then oxytocin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects without any past or present psychiatric or neurological disorders&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of brain injury&#xD;
&#xD;
          -  Medical or mental illness&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qin Li, MA</last_name>
    <role>Study Chair</role>
    <affiliation>University of Electronic Science and Technology of China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Keith M Kendrick, Dr.</last_name>
    <phone>86-28-61830811</phone>
    <email>k.kendrick.uestc@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Benjamin Becker, Dr.</last_name>
    <phone>86-28-61830988</phone>
    <email>ben_becker@gmx.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Electronic Science and Technology of China(UESTC)</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>611731</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qin Li, MA</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>October 26, 2018</last_update_submitted>
  <last_update_submitted_qc>October 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Electronic Science and Technology of China</investigator_affiliation>
    <investigator_full_name>Keith Kendrick</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Oxytocin</keyword>
  <keyword>social touch</keyword>
  <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>


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/NCT03278860
org study id: UESTC-neuSCAN-39
nct id: NCT03278860
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main aim of the study is to investigate whether intranasal oxytocin (24IU) can enhance
      hedonic experience and associated brain-reward reward responses to social touch.
A double-blind, within-subject, placebo controlled design is employed in this study. In total
      50 healthy male subjects will be recruited and they will come twice, once with the
      administration of oxytocin nasal spray and the other placebo (interval time is more than 2
      weeks). 45 minutes after treatment subjects will be applied two different types of pleasant
      touch: social touch from a masseur (professional therapist) and non-social touch from a
      massage device. After each condition the subjects will be asked to rate pleasantness,
      likability, and arousal. Simultaneously functional brain activity will be acquired via fMRI.
      Blood samples will be taken before and after the intervention to assess oxytocin levels. All
      subjects were asked to complete a range of questionnaires measuring trait personality and
      mood: Beck Depression Inventory (BDI), Cheek and Buss Shyness Scale (CBSS),Autism Spectrum
      Quotient (ASQ), Empathy Quotient (EQ), NEO Five Factor Inventory (NEO-FFI), Liebowitz Social
      Anxiety Scale (LSAS),Behavioral Inhibition System and Behavioral Activation System Scale
      (BISBAS),Sensitivity to Punishment and Sensitivity to Reward Questionnaire
      (SPSRQ),State-Trait Anxiety Inventory (STAI), Social Touch Questionnaire (STQ), Sensory over
      Responsivity Scale (SOR) and Under Responsivity Scale (URS) one day before the first
      scanning. On the first and second scanning day, the subjects were asked to complete Positive
      and Negative Affect Schedule (PANAS) before and after treatment administration.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized placebo-controlled double-blind within-subject design
primary purpose: Basic Science
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Neural indices: fMRI-based measures of interoceptive and reward processing
time frame: 45-90 minutes after treatment administration
description: fMRI-based measures of social and non-social touch-related brain activity
measure: Behavioral index: pleasantness experience
time frame: 45-90 minutes after treatment administration
description: Ratings for pleasantness during the application of social and non-social touch
measure: Behavioral index: likability experience
time frame: 45-90 minutes after treatment administration
description: Ratings for likability during the application of social and non-social touch
measure: Behavioral index: arousal experience
time frame: 45-90 minutes after treatment administration
description: Ratings for arousal during the application of social and non-social touch
arm group label: Oxytocin then placebo
arm group type: Experimental
description: Participants first received oxytocin (24 IU). After a washout period of 2 weeks, they then received placebo (24 IU).
arm group label: Placebo then oxytocin
arm group type: Experimental
description: Participants first received placebo (24 IU). After a washout period of 2 weeks, they then received oxytocin (24 IU).
intervention type: Drug
intervention name: intranasal oxytocin
description: 24 IU of oxytocin nasal spray will be applied to each subject.
arm group label: Oxytocin then placebo
intervention type: Drug
intervention name: intranasal placebo
description: an identical amount of placebo nasal spray will be applied to each subject.
arm group label: Oxytocin then placebo
intervention type: Drug
intervention name: intranasal oxytocin
description: 24 IU of oxytocin nasal spray will be applied to each subject.
arm group label: Placebo then oxytocin
intervention type: Drug
intervention name: intranasal placebo
description: an identical amount of placebo nasal spray will be applied to each subject.
arm group label: Placebo then oxytocin
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Qin Li, MA
role: Study Chair
affiliation: University of Electronic Science and Technology of China
last name: Keith M Kendrick, Dr.
phone: 86-28-61830811
email: k.kendrick.uestc@gmail.com
last name: Benjamin Becker, Dr.
phone: 86-28-61830988
email: ben_becker@gmx.de
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: University of Electronic Science and Technology of China
investigator full name: Keith Kendrick
investigator title: Professor
mesh term: Oxytocin