<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/NCT03790618</url>
  </required_header>
  <id_info>
    <org_study_id>IRB15-780</org_study_id>
    <nct_id>NCT03790618</nct_id>
  </id_info>
  <brief_title>Effect of Stimulant Drugs on Social Perception</brief_title>
  <acronym>ESP</acronym>
  <official_title>Effect of Stimulant Drugs on Social Perception</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chicago</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 study will improve our understanding of the &quot;prosocial&quot; effects of ±&#xD;
      3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant,&#xD;
      methamphetamine (MA). The investigators seek to characterize the &quot;uniquely social&quot; effects of&#xD;
      MDMA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2016</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</primary_completion_date>
  <phase>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>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Responses to affective touch</measure>
    <time_frame>End of study (time 0 and approximately six weeks later)</time_frame>
    <description>Participants will complete an affective touch task during which time they will rate pleasantness of touch</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Effects of MDMA on Healthy Human Volunteers</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects will attend one session during which they will receive a placebo capsule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose MDMA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will attend one session during which they will receive 0.75mg/kg MDMA.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dose MDMA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will attend one session during which they will receive 1.5mg/kg MDMA.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Methamphetamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will attend one session during which they will receive 20mg methamphetamine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3,4-Methylenedioxymethamphetamine</intervention_name>
    <description>Participants will be given 0.75mg/kg of 1.5mg/kg MDMA</description>
    <arm_group_label>High dose MDMA</arm_group_label>
    <arm_group_label>Low dose MDMA</arm_group_label>
    <arm_group_label>Methamphetamine</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>methamphetamine</intervention_name>
    <description>Please see above.</description>
    <arm_group_label>High dose MDMA</arm_group_label>
    <arm_group_label>Low dose MDMA</arm_group_label>
    <arm_group_label>Methamphetamine</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  High school degree&#xD;
&#xD;
          -  English fluency&#xD;
&#xD;
          -  Healthy&#xD;
&#xD;
          -  Has used MDMA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or trying to become pregnant&#xD;
&#xD;
          -  Any medical or psychiatry condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Matthew Bona</last_name>
    <email>mbona@yoda.bsd.uchicago.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anya Bershad</last_name>
    <email>abershad@uchicago.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Bona</last_name>
    </contact>
    <contact_backup>
      <last_name>Anya Bershad</last_name>
      <email>mbona@yoda.bsd.uchicago.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>December 28, 2018</last_update_submitted>
  <last_update_submitted_qc>December 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methamphetamine</mesh_term>
    <mesh_term>N-Methyl-3,4-methylenedioxyamphetamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>June 14, 2022</submitted>
    <returned>March 29, 2023</returned>
    <submitted>March 29, 2023</submitted>
  </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/NCT03790618
org study id: IRB15-780
nct id: NCT03790618
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The study will improve our understanding of the "prosocial" effects of ±
      3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant,
      methamphetamine (MA). The investigators seek to characterize the "uniquely social" effects of
      MDMA.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Outcomes Assessor)
measure: Responses to affective touch
time frame: End of study (time 0 and approximately six weeks later)
description: Participants will complete an affective touch task during which time they will rate pleasantness of touch
arm group label: Placebo
arm group type: Placebo Comparator
description: Subjects will attend one session during which they will receive a placebo capsule.
arm group label: Low dose MDMA
arm group type: Experimental
description: Subjects will attend one session during which they will receive 0.75mg/kg MDMA.
arm group label: High dose MDMA
arm group type: Experimental
description: Subjects will attend one session during which they will receive 1.5mg/kg MDMA.
arm group label: Methamphetamine
arm group type: Experimental
description: Subjects will attend one session during which they will receive 20mg methamphetamine.
intervention type: Drug
intervention name: 3,4-Methylenedioxymethamphetamine
description: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA
arm group label: High dose MDMA
arm group label: Low dose MDMA
arm group label: Methamphetamine
arm group label: Placebo
intervention type: Drug
intervention name: methamphetamine
description: Please see above.
arm group label: High dose MDMA
arm group label: Low dose MDMA
arm group label: Methamphetamine
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew Bona
email: mbona@yoda.bsd.uchicago.edu
last name: Anya Bershad
email: abershad@uchicago.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Methamphetamine
mesh term: N-Methyl-3,4-methylenedioxyamphetamine
sharing ipd: Undecided
submitted: June 14, 2022
returned: March 29, 2023
submitted: March 29, 2023