<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/NCT01728909</url>
  </required_header>
  <id_info>
    <org_study_id>11-07691</org_study_id>
    <nct_id>NCT01728909</nct_id>
  </id_info>
  <brief_title>Methadone Oxytocin Option</brief_title>
  <acronym>MOO</acronym>
  <official_title>The Effects of Intranasal Oxytocin on Social Cognition and Social Approach Behaviors in Opioid-dependent Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>San Francisco Veterans Affairs Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to examine the effects of intranasal oxytocin administration on&#xD;
      social cognition in patients receiving methadone maintenance treatment (MMT), examine the&#xD;
      effects of intranasal oxytocin administration on opioid craving and on the subjective effects&#xD;
      of methadone, and examine the effects of intranasal oxytocin administration on implicit&#xD;
      preferences for drug-related and social stimuli in patients receiving MMT.&#xD;
&#xD;
      Hypothesis 1: Patients will perform better on measures of social cognition (including affect&#xD;
      recognition and recognition of sarcasm) after administration of oxytocin compared with&#xD;
      placebo.&#xD;
&#xD;
      Hypothesis 2: Patients will demonstrate lower craving for opioids and greater subjective&#xD;
      effects of methadone after administration of oxytocin compared with placebo.&#xD;
&#xD;
      Hypothesis 3: Patients will demonstrate increased implicit preferences for social stimuli and&#xD;
      decreased implicit preferences for drug related stimuli after administration of oxytocin&#xD;
      compared with placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Computerized Social Cognition Tasks</measure>
    <time_frame>Participants will complete 2 days of the study. These 2 days will be at least a week apart.</time_frame>
    <description>Participants will undergo computer tasks that measure social cognition, which include the TASIT, RMET, and the IAT. The TASIT measures the awareness of social inference, the RMET measures the ability to guess the emotions of others, and the IAT measures implicit associations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Craving Questionnaires</measure>
    <time_frame>Participants will complete 2 days of the study. These 2 days will be at least a week apart.</time_frame>
    <description>Participants are asked to rate their current symptoms and current craving levels and for different substances.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Substance Abuse</condition>
  <condition>Opioid Dependence</condition>
  <condition>Methadone Treatment</condition>
  <arm_group>
    <arm_group_label>Oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>40 IU Oxytocin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline Nasal Spray</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Comparator</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.</description>
    <arm_group_label>Oxytocin</arm_group_label>
    <other_name>Syntocinon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Nasal Spray</intervention_name>
    <description>40 IU of the saline nasal spray will be administered once at the beginning of the visit.</description>
    <arm_group_label>Saline Nasal Spray</arm_group_label>
    <other_name>Placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for patients:&#xD;
&#xD;
          -  Primary diagnosis of opioid dependence according to DSM-IV TR&#xD;
&#xD;
          -  Opioid of choice be either heroin or oral opioid analgesics&#xD;
&#xD;
          -  Currently be on stable dose of methadone with no dose change in the last 14 days&#xD;
&#xD;
        Inclusion Criteria for healthy volunteers&#xD;
&#xD;
        -No diagnosis of mental disorder according to DSM-IV TR&#xD;
&#xD;
        Exclusion Criteria for patients and healthy volunteers:&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Current illicit drug use (within the past one month)&#xD;
&#xD;
          -  Current sever depression with suicidal thoughts and/or actions&#xD;
&#xD;
          -  Addiction to alcohol or drugs other than opiates, caffeine, or nicotine&#xD;
&#xD;
          -  Psychotic illness&#xD;
&#xD;
          -  Bipolar disorder&#xD;
&#xD;
          -  Brain trauma&#xD;
&#xD;
          -  Severe Neuropsychological disorder&#xD;
&#xD;
          -  Kidney Disease (i.e., kidney stones, recurrent bladder infections, or known kidney&#xD;
             failure)&#xD;
&#xD;
          -  Sensitivity to preservatives (in particular E216, E218, and chlorobutanol hemihydrate)&#xD;
&#xD;
          -  Nasal obstruction, discharge, or bleeding&#xD;
&#xD;
          -  Cardiovascular problems (e.g., heart disease, history of heart attacks), high blood&#xD;
             pressure (hypertension)&#xD;
&#xD;
          -  Habitually drink large volumes of water&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joshua Woolley, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California San Francisco, San Francisco Veterans Affairs Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>San Francisco VA Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>May 17, 2019</last_update_submitted>
  <last_update_submitted_qc>May 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Francisco</investigator_affiliation>
    <investigator_full_name>Joshua Woolley</investigator_full_name>
    <investigator_title>Assistant Professor in Residence</investigator_title>
  </responsible_party>
  <keyword>Oxytocin</keyword>
  <keyword>Syntocinon</keyword>
  <keyword>Social Cognition</keyword>
  <keyword>Social Approach Behaviors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <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/NCT01728909
org study id: 11-07691
nct id: NCT01728909
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of the study is to examine the effects of intranasal oxytocin administration on
      social cognition in patients receiving methadone maintenance treatment (MMT), examine the
      effects of intranasal oxytocin administration on opioid craving and on the subjective effects
      of methadone, and examine the effects of intranasal oxytocin administration on implicit
      preferences for drug-related and social stimuli in patients receiving MMT.

      Hypothesis 1: Patients will perform better on measures of social cognition (including affect
      recognition and recognition of sarcasm) after administration of oxytocin compared with
      placebo.

      Hypothesis 2: Patients will demonstrate lower craving for opioids and greater subjective
      effects of methadone after administration of oxytocin compared with placebo.

      Hypothesis 3: Patients will demonstrate increased implicit preferences for social stimuli and
      decreased implicit preferences for drug related stimuli after administration of oxytocin
      compared with placebo.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Computerized Social Cognition Tasks
time frame: Participants will complete 2 days of the study. These 2 days will be at least a week apart.
description: Participants will undergo computer tasks that measure social cognition, which include the TASIT, RMET, and the IAT. The TASIT measures the awareness of social inference, the RMET measures the ability to guess the emotions of others, and the IAT measures implicit associations.
measure: Craving Questionnaires
time frame: Participants will complete 2 days of the study. These 2 days will be at least a week apart.
description: Participants are asked to rate their current symptoms and current craving levels and for different substances.
arm group label: Oxytocin
arm group type: Experimental
description: 40 IU Oxytocin
arm group label: Saline Nasal Spray
arm group type: Placebo Comparator
description: Placebo Comparator
intervention type: Drug
intervention name: Oxytocin
description: 40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
arm group label: Oxytocin
other name: Syntocinon
intervention type: Drug
intervention name: Saline Nasal Spray
description: 40 IU of the saline nasal spray will be administered once at the beginning of the visit.
arm group label: Saline Nasal Spray
other name: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joshua Woolley, MD, PhD
role: Principal Investigator
affiliation: University of California San Francisco, San Francisco Veterans Affairs Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Francisco
investigator full name: Joshua Woolley
investigator title: Assistant Professor in Residence
mesh term: Substance-Related Disorders
mesh term: Opioid-Related Disorders
mesh term: Oxytocin