<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/NCT03819231</url>
  </required_header>
  <id_info>
    <org_study_id>HS-17-00972</org_study_id>
    <nct_id>NCT03819231</nct_id>
  </id_info>
  <brief_title>Mindfulness Training Plus Oxytocin</brief_title>
  <acronym>MOXY</acronym>
  <official_title>Mindfulness Training Plus Oxytocin to Reduce Smoking and Craving Among Smokers in Withdrawal</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>MGM Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the effects of mindfulness training and a drug called&#xD;
      oxytocin on smoking. Mindfulness training allows individuals to be present with their own&#xD;
      emotions, thoughts, and bodily sensations without reactive judgment, and will be given in the&#xD;
      form of daily audio recordings. Oxytocin is a naturally occurring hormone in the brain and&#xD;
      throughout the body. It is also an FDA-approved drug to help induce labor in pregnant women.&#xD;
      In this study, the use oxytocin is experimental and is in the form of a nasal spray.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Study recruitment temporarily suspended due to COVID-19 pandemic.&#xD;
  </why_stopped>
  <start_date type="Actual">October 10, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Smoking Lapse Analogue Task (delay score)</measure>
    <time_frame>2 hours after nasal spray administration</time_frame>
    <description>This task measures ability to resist the temptation to initiate smoking under conditions in which it is advantageous to remain abstinent. The &quot;delay score&quot; is the number of minutes before participants begin smoking (0-50 min).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trier Social Stress Test</measure>
    <time_frame>1 hour after nasal spray administration</time_frame>
    <description>This test measures self-reported responses to stress in a lab setting over the course of 30 minutes through salivary cortisol and heart rate variability.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Systolic blood pressure</measure>
    <time_frame>Throughout study completion, an average of two weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diastolic blood pressure</measure>
    <time_frame>Throughout study completion, an average of two weeks.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>Throughout study completion, an average of two weeks.</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Smoking</condition>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Mindfulness and intranasal oxytocin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Given oxytocin through intranasal administration and self-directed mindfulness training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness and placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Given sterile saline through intranasal adminstration and self-directed mindfulness training.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham mindfulness and placebo</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Given sterile saline through intranasal adminstration and sham self-directed mindfulness training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oxytocin</intervention_name>
    <description>A single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) will be self-administered to each participant. Each 40 IU dose will be transferred into four, 1 ml intranasal atomizers and will be administered in four sprays to each nostril over the course of 15 minutes.</description>
    <arm_group_label>Mindfulness and intranasal oxytocin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness</intervention_name>
    <description>Participants will be instructed to listen to and practice a 20-minute guided mediation each day for 7 days prior to the experimental session. The guided mindfulness practices will include body scan and seated stillness meditations.</description>
    <arm_group_label>Mindfulness and intranasal oxytocin</arm_group_label>
    <arm_group_label>Mindfulness and placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline Solution</intervention_name>
    <description>A single 40mL doses of sterile saline (0.9% provided by USC pharmacy) will be transferred into four, 1 ml intranasal atomizers and will be self-administered in four sprays to each nostril over the course of 15 minutes.</description>
    <arm_group_label>Mindfulness and placebo</arm_group_label>
    <arm_group_label>Sham mindfulness and placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sham mindfulness</intervention_name>
    <description>The mindfulness sham group will be required to listen to 20-minutes of Tedtalk podcasts each day that match the attention and time of the mindfulness group. Participants will be instructed to listen to two 10-minutes segments per day in succession between lab visits while in a seated posture.</description>
    <arm_group_label>Sham mindfulness and placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Smoke at least 10 cigarettes per day for the past year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current DSM-5 substance use disorder&#xD;
&#xD;
          -  Any medial condition that would increase risk for study participation&#xD;
&#xD;
          -  Women who are pregnant or nursing&#xD;
&#xD;
          -  Current use of psychiatric medication for anxiety or mood disorders&#xD;
&#xD;
          -  Planning to quit or reduce smoking in the next 30 days&#xD;
&#xD;
          -  Current regular use of other nicotine-containing products&#xD;
&#xD;
          -  Current mindfulness or mediation practice of greater than 5 minutes per day&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>October 28, 2022</last_update_submitted>
  <last_update_submitted_qc>October 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>David Black</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Mindfulness</keyword>
  <keyword>Oxytocin</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oxytocin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03819231
org study id: HS-17-00972
nct id: NCT03819231
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to examine the effects of mindfulness training and a drug called
      oxytocin on smoking. Mindfulness training allows individuals to be present with their own
      emotions, thoughts, and bodily sensations without reactive judgment, and will be given in the
      form of daily audio recordings. Oxytocin is a naturally occurring hormone in the brain and
      throughout the body. It is also an FDA-approved drug to help induce labor in pregnant women.
      In this study, the use oxytocin is experimental and is in the form of a nasal spray.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Smoking Lapse Analogue Task (delay score)
time frame: 2 hours after nasal spray administration
description: This task measures ability to resist the temptation to initiate smoking under conditions in which it is advantageous to remain abstinent. The "delay score" is the number of minutes before participants begin smoking (0-50 min).
measure: Trier Social Stress Test
time frame: 1 hour after nasal spray administration
description: This test measures self-reported responses to stress in a lab setting over the course of 30 minutes through salivary cortisol and heart rate variability.
measure: Systolic blood pressure
time frame: Throughout study completion, an average of two weeks.
measure: Diastolic blood pressure
time frame: Throughout study completion, an average of two weeks.
measure: Heart rate
time frame: Throughout study completion, an average of two weeks.
arm group label: Mindfulness and intranasal oxytocin
arm group type: Experimental
description: Given oxytocin through intranasal administration and self-directed mindfulness training.
arm group label: Mindfulness and placebo
arm group type: Active Comparator
description: Given sterile saline through intranasal adminstration and self-directed mindfulness training.
arm group label: Sham mindfulness and placebo
arm group type: Sham Comparator
description: Given sterile saline through intranasal adminstration and sham self-directed mindfulness training.
intervention type: Drug
intervention name: Oxytocin
description: A single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) will be self-administered to each participant. Each 40 IU dose will be transferred into four, 1 ml intranasal atomizers and will be administered in four sprays to each nostril over the course of 15 minutes.
arm group label: Mindfulness and intranasal oxytocin
intervention type: Behavioral
intervention name: Mindfulness
description: Participants will be instructed to listen to and practice a 20-minute guided mediation each day for 7 days prior to the experimental session. The guided mindfulness practices will include body scan and seated stillness meditations.
arm group label: Mindfulness and intranasal oxytocin
arm group label: Mindfulness and placebo
intervention type: Drug
intervention name: Saline Solution
description: A single 40mL doses of sterile saline (0.9% provided by USC pharmacy) will be transferred into four, 1 ml intranasal atomizers and will be self-administered in four sprays to each nostril over the course of 15 minutes.
arm group label: Mindfulness and placebo
arm group label: Sham mindfulness and placebo
intervention type: Behavioral
intervention name: Sham mindfulness
description: The mindfulness sham group will be required to listen to 20-minutes of Tedtalk podcasts each day that match the attention and time of the mindfulness group. Participants will be instructed to listen to two 10-minutes segments per day in succession between lab visits while in a seated posture.
arm group label: Sham mindfulness and placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: David Black
investigator title: Assistant Professor
mesh term: Oxytocin
sharing ipd: No