<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/NCT01722071</url>
  </required_header>
  <id_info>
    <org_study_id>UL1RR024986</org_study_id>
    <nct_id>NCT01722071</nct_id>
  </id_info>
  <brief_title>Deciphering the Role of Oxytocin in Motivation: an fMRI Study</brief_title>
  <official_title>Deciphering the Role of Oxytocin in Motivation: an fMRI Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tiffany Love</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study will investigate the effects of intranasal oxytocin administration on&#xD;
      neural activity associated with social and non-social motivation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Oxytocin is a well-known social and reproductive hormone demonstrated to have a variety of&#xD;
      prosocial effects in humans including enhancing trust and generosity, improving positive&#xD;
      communication, increasing eye gaze, and reducing anxiety. Oxytocin is hypothesized to&#xD;
      facilitate social behaviors via its modulation of motivational networks. With this study, we&#xD;
      will characterize oxytocin's effects on the neural processing of salient stimuli. We will&#xD;
      utilize a noninvasive brain imaging technique, functional magnetic resonance imaging (fMRI),&#xD;
      to assess brain activity while participants perform tests designed to engage neural circuits&#xD;
      associated with the processing of social and non-social stimuli.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.</measure>
    <time_frame>Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).</time_frame>
    <description>Drug effect will be assessed by ascertaining changes in brain activity between placebo and oxytocin sessions.&#xD;
Imaging data will be analyzed from all subjects in a final analysis. Individual subject analyses will be done on a bimonthly basis.&#xD;
Results represent neural responses to the anticipation of an uncertain reward within the Nucleus Accumbens (Bilateral). These are given as beta values (i.e. parameter estimates).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Focus of Study: Neural Correlates of Oxytocin Administration</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Each participant will be studied using fMRI following self-administration of placebo.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant will be studied using fMRI following self-administration of oxytocin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.</description>
    <arm_group_label>Oxytocin</arm_group_label>
    <other_name>Syntocinon®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  20-35 years of age at the time of screening&#xD;
&#xD;
          -  Right-handedness&#xD;
&#xD;
          -  Non-smoking&#xD;
&#xD;
          -  No current or past history of neurological or psychiatric illness, including substance&#xD;
             abuse or dependence&#xD;
&#xD;
          -  No acute medical illness&#xD;
&#xD;
          -  Written informed consent obtained from subject&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Left-handedness or ambidextrous&#xD;
&#xD;
          -  Presence of a condition or abnormality that in the opinion of the Investigator would&#xD;
             compromise the safety of the patient or the quality of the data&#xD;
&#xD;
          -  Known allergies to oxytocin or to preservatives in the nasal spray&#xD;
&#xD;
          -  Participants who exhibit nasal obstruction or upper-respiratory tract infection at the&#xD;
             time of scanning or report the use of intranasally administered medications for up to&#xD;
             two weeks prior to screening&#xD;
&#xD;
          -  Participants unable to tolerate the scanning procedures or would be unfit for scanning&#xD;
             purposes (e.g. metal implants, claustrophobic, unable to lie still for the duration of&#xD;
             the scan)&#xD;
&#xD;
          -  Any current or past history of medical, neurological, or psychiatric illness or family&#xD;
             history of psychiatric or neurologic disease in first-degree relatives&#xD;
&#xD;
          -  Neurological illness, abnormal MRI (except if due to technical factors)&#xD;
&#xD;
          -  Acute or uncorrected medical illnesses, including history of hepatic or renal&#xD;
             dysfunction.&#xD;
&#xD;
          -  Participants currently taking medications including any treatment, current or past&#xD;
             with antipsychotics, mood stabilizers, isoniazid, glucocorticoids, psychostimulants&#xD;
             and psychostimulant appetite suppressants, or centrally active antihypertensive drugs&#xD;
             (e.g., clonidine, reserpine).&#xD;
&#xD;
          -  Treatment within six months with any of the following: hormone use (testosterone,&#xD;
             DHEA), antidepressants, opioid drugs.&#xD;
&#xD;
          -  Treatment within one month with sedative hypnotic medications (benzodiazepines,&#xD;
             barbiturates), or over the counter sleeping aids&#xD;
&#xD;
          -  Current or past history of substance abuse or dependence&#xD;
&#xD;
          -  Any reported lifetime use of any category of illicit drugs&#xD;
&#xD;
          -  Positive urine drug screen&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tiffany M Love, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <results_first_submitted>April 22, 2015</results_first_submitted>
  <results_first_submitted_qc>June 9, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 29, 2015</results_first_posted>
  <last_update_submitted>December 28, 2015</last_update_submitted>
  <last_update_submitted_qc>December 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Tiffany Love</investigator_full_name>
    <investigator_title>Research Investigator</investigator_title>
  </responsible_party>
  <keyword>Oxytocin</keyword>
  <keyword>Functional Magnetic Resonance Imaging</keyword>
  <keyword>Social</keyword>
  <keyword>Motivation</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Placebo Then Oxytocin</title>
          <description>These participants were first studied using fMRI following self-administration of placebo (followed by another scanning session with oxytocin).&#xD;
Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.</description>
        </group>
        <group group_id="P2">
          <title>Oxytocin Then Placebo</title>
          <description>These participants were first studied using fMRI following self-administration of oxytocin (followed by another scanning session with placebo).&#xD;
Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Subjects who completed Baseline Assessments prior to scanning.</population>
      <group_list>
        <group group_id="B1">
          <title>Participants</title>
          <description>Each participant will complete baseline assessments prior to being studied using fMRI</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.</title>
        <description>Drug effect will be assessed by ascertaining changes in brain activity between placebo and oxytocin sessions.&#xD;
Imaging data will be analyzed from all subjects in a final analysis. Individual subject analyses will be done on a bimonthly basis.&#xD;
Results represent neural responses to the anticipation of an uncertain reward within the Nucleus Accumbens (Bilateral). These are given as beta values (i.e. parameter estimates).</description>
        <time_frame>Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).</time_frame>
        <population>Only 8 participants' BOLD data were included in the final group analysis in the Placebo then Oxytocin arm -- 1 participant was excluded from the study prior to scanning, 1 participant was scanned but due to technical issues the BOLD data was not used.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo Then Oxytocin</title>
            <description>Each participant will be studied using fMRI following self-administration of placebo.&#xD;
Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.</description>
          </group>
          <group group_id="O2">
            <title>Oxytocin Then Placebo</title>
            <description>Each participant will be studied using fMRI following self-administration of oxytocin.&#xD;
Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.</description>
          </group>
        </group_list>
        <measure>
          <title>Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.</title>
          <description>Drug effect will be assessed by ascertaining changes in brain activity between placebo and oxytocin sessions.&#xD;
Imaging data will be analyzed from all subjects in a final analysis. Individual subject analyses will be done on a bimonthly basis.&#xD;
Results represent neural responses to the anticipation of an uncertain reward within the Nucleus Accumbens (Bilateral). These are given as beta values (i.e. parameter estimates).</description>
          <population>Only 8 participants' BOLD data were included in the final group analysis in the Placebo then Oxytocin arm -- 1 participant was excluded from the study prior to scanning, 1 participant was scanned but due to technical issues the BOLD data was not used.</population>
          <units>BOLD signal change (beta values)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Placebo</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7944" spread="0.3252"/>
                    <measurement group_id="O2" value="0.5790" spread="0.2515"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Oxytocin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6119" spread="0.2040"/>
                    <measurement group_id="O2" value="0.6688" spread="0.3642"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens [Bilateral]). For the group of 18 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.890</p_value>
            <p_value_desc>The a priori threshold for statistical significance was p&lt;0.05.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens [Bilateral]). For the group of 8 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.422</p_value>
            <p_value_desc>The a priori threshold for statistical significance was p&lt;0.05.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A two-sided paired t-test was performed to determine whether oxytocin administration was associated with reward-related BOLD signal changes (within the Nucleus Accumbens [Bilateral]). For the group of 10 participants, BOLD signal activity was compared between oxytocin and placebo scanning days.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.814</p_value>
            <p_value_desc>The a priori threshold for statistical significance was p&lt;0.05.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected on each scanning day and 24 hours later (i.e. assessed at 4 different time points for each participant).</time_frame>
      <desc>Serious adverse events were collected/assessed, but none were observed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo Then Oxytocin</title>
          <description>Each participant will be studied using fMRI following self-administration of placebo.&#xD;
Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.</description>
        </group>
        <group group_id="E2">
          <title>Oxytocin Then Placebo</title>
          <description>Each participant will be studied using fMRI following self-administration of oxytocin.&#xD;
Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Tiffany Love, PhD</name_or_title>
      <organization>University of Michigan</organization>
      <phone>734-219-3674</phone>
      <email>tiflove@umich.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01722071
org study id: UL1RR024986
nct id: NCT01722071
lead sponsor: 
collaborator: 
has dmc: No
The proposed study will investigate the effects of intranasal oxytocin administration on
      neural activity associated with social and non-social motivation.
Oxytocin is a well-known social and reproductive hormone demonstrated to have a variety of
      prosocial effects in humans including enhancing trust and generosity, improving positive
      communication, increasing eye gaze, and reducing anxiety. Oxytocin is hypothesized to
      facilitate social behaviors via its modulation of motivational networks. With this study, we
      will characterize oxytocin's effects on the neural processing of salient stimuli. We will
      utilize a noninvasive brain imaging technique, functional magnetic resonance imaging (fMRI),
      to assess brain activity while participants perform tests designed to engage neural circuits
      associated with the processing of social and non-social stimuli.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Functional Magnetic Resonance Imaging (fMRI) Data: Change in BOLD Activity Between Placebo and Oxytocin Treatment.
time frame: Change from Week 1, Day 1 (Scan 1) and Scan 2 (within the first 30 days after scan 1).
description: Drug effect will be assessed by ascertaining changes in brain activity between placebo and oxytocin sessions.
Imaging data will be analyzed from all subjects in a final analysis. Individual subject analyses will be done on a bimonthly basis.
Results represent neural responses to the anticipation of an uncertain reward within the Nucleus Accumbens (Bilateral). These are given as beta values (i.e. parameter estimates).
arm group label: Placebo
arm group type: Placebo Comparator
description: Each participant will be studied using fMRI following self-administration of placebo.
arm group label: Oxytocin
arm group type: Experimental
description: Each participant will be studied using fMRI following self-administration of oxytocin.
intervention type: Drug
intervention name: Placebo
description: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.
arm group label: Placebo
intervention type: Drug
intervention name: Oxytocin
description: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.
arm group label: Oxytocin
other name: Syntocinon®
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tiffany M Love, PhD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Michigan
investigator full name: Tiffany Love
investigator title: Research Investigator
mesh term: Oxytocin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 