<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/NCT04505904</url>
  </required_header>
  <id_info>
    <org_study_id>CGOT1620</org_study_id>
    <nct_id>NCT04505904</nct_id>
  </id_info>
  <brief_title>Oxytocin and Approach-avoid in Grief</brief_title>
  <official_title>A Pull to be Close: the Differentiating Effects of Oxytocin and Grief Stimulus Type on Approach Behavior in Complicated Grief</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Arizona</source>
  <brief_summary>
    <textblock>
      This is a completed project which was initiated prior to January 18,2017&#xD;
&#xD;
      Background: Theoretical models of complicated grief (CG) suggest that maladaptive approach&#xD;
      (e.g., perseverative proximity-seeking of the deceased) or avoidance (e.g., excessive&#xD;
      avoidance of reminders) behaviors interfere with a person's ability to integrate the loss and&#xD;
      recover from their loved one's death. Due in part to conflicting evidence, little mechanistic&#xD;
      understanding of how these behaviors develop in grief exists. We sought to (1) identify&#xD;
      behavioral differences between CG and non-CG groups based on implicit bias for grief-,&#xD;
      deceased-, and social-related stimuli, and (2) test the role of the neuropeptide oxytocin in&#xD;
      shaping approach/avoidance bias.&#xD;
&#xD;
      Methods: Widowed older adults with (n = 17) and without (n = 22) CG completed an&#xD;
      approach/avoidance task measuring implicit bias for personalized, non-specific,&#xD;
      grief-related, and other stimuli. In a double-blinded, randomized, counterbalanced design,&#xD;
      each participant attended both an intranasal oxytocin session and a placebo session. Aims&#xD;
      were to (1) identify differential effects of CG and stimulus type on implicit&#xD;
      approach/avoidance bias [placebo session], and (2) investigate interactive effects of CG,&#xD;
      stimulus type, and oxytocin vs. placebo on approach/avoidance bias [both sessions].&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 20, 2015</start_date>
  <completion_date type="Actual">May 12, 2017</completion_date>
  <primary_completion_date type="Actual">May 12, 2017</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>
    <primary_purpose>Basic Science</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Reaction Time</measure>
    <time_frame>120 minutes</time_frame>
    <description>Participant reaction time to visual stimuli in a behavioral task</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Prolonged Grief Disorder</condition>
  <condition>Bereavement</condition>
  <arm_group>
    <arm_group_label>Syntocinon First</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates those who received syntocinon at visit one and placebo at visit two. Syntocinon is 24 IU dose administered intranasally in spray form.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo First</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates those who received placebo at visit one, and syntocinon at visit two.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Syntocinon</intervention_name>
    <description>Synthetic oxytocin spray, 24 IU per spray.</description>
    <arm_group_label>Placebo First</arm_group_label>
    <arm_group_label>Syntocinon First</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo spray with no active ingredient.</description>
    <arm_group_label>Placebo First</arm_group_label>
    <arm_group_label>Syntocinon First</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Adult individual experiencing death of a spouse or partner between 6 and 36 months prior&#xD;
        to enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to comprehend English;&#xD;
&#xD;
          -  medical contraindications for other components of the study,&#xD;
&#xD;
          -  active suicidality&#xD;
&#xD;
          -  active homicidality&#xD;
&#xD;
          -  active psychotic symptoms&#xD;
&#xD;
          -  ongoing major health conditions such as cancer; uncontrolled hypertension; and&#xD;
             medications likely to impact the oxytocin system (e.g., systemic corticosteroids).&#xD;
&#xD;
          -  pregnant status or suspected pregnant status&#xD;
&#xD;
          -  premenopausal status&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Arizona</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85721</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oxytocin</keyword>
  <keyword>Approach/Avoid</keyword>
  <keyword>Older adults</keyword>
  <keyword>Complicated Grief</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 27, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT04505904/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>July 9, 2021</submitted>
    <returned>July 30, 2021</returned>
    <submitted>October 25, 2021</submitted>
    <returned>November 16, 2021</returned>
  </pending_results>
  <!-- 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/NCT04505904
org study id: CGOT1620
nct id: NCT04505904
lead sponsor: 
This is a completed project which was initiated prior to January 18,2017

      Background: Theoretical models of complicated grief (CG) suggest that maladaptive approach
      (e.g., perseverative proximity-seeking of the deceased) or avoidance (e.g., excessive
      avoidance of reminders) behaviors interfere with a person's ability to integrate the loss and
      recover from their loved one's death. Due in part to conflicting evidence, little mechanistic
      understanding of how these behaviors develop in grief exists. We sought to (1) identify
      behavioral differences between CG and non-CG groups based on implicit bias for grief-,
      deceased-, and social-related stimuli, and (2) test the role of the neuropeptide oxytocin in
      shaping approach/avoidance bias.

      Methods: Widowed older adults with (n = 17) and without (n = 22) CG completed an
      approach/avoidance task measuring implicit bias for personalized, non-specific,
      grief-related, and other stimuli. In a double-blinded, randomized, counterbalanced design,
      each participant attended both an intranasal oxytocin session and a placebo session. Aims
      were to (1) identify differential effects of CG and stimulus type on implicit
      approach/avoidance bias [placebo session], and (2) investigate interactive effects of CG,
      stimulus type, and oxytocin vs. placebo on approach/avoidance bias [both sessions].
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
measure: Reaction Time
time frame: 120 minutes
description: Participant reaction time to visual stimuli in a behavioral task
arm group label: Syntocinon First
arm group type: Experimental
description: Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates those who received syntocinon at visit one and placebo at visit two. Syntocinon is 24 IU dose administered intranasally in spray form.
arm group label: Placebo First
arm group type: Placebo Comparator
description: Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates those who received placebo at visit one, and syntocinon at visit two.
intervention type: Drug
intervention name: Syntocinon
description: Synthetic oxytocin spray, 24 IU per spray.
arm group label: Placebo First
arm group label: Syntocinon First
intervention type: Drug
intervention name: Placebo
description: Placebo spray with no active ingredient.
arm group label: Placebo First
arm group label: Syntocinon First
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Oxytocin
provided document: 
submitted: July 9, 2021
returned: July 30, 2021
submitted: October 25, 2021
returned: November 16, 2021