<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/NCT03019822</url>
  </required_header>
  <id_info>
    <org_study_id>BASEC 2016-01827</org_study_id>
    <nct_id>NCT03019822</nct_id>
  </id_info>
  <brief_title>Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing</brief_title>
  <acronym>LAM</acronym>
  <official_title>Role of Dopamine, Serotonin and 5-HT2A Receptors in Emotion Processing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will test the effect of dopamine, serotonin, and direct 5-HT2A receptor stimulation&#xD;
      on empathy, mood perception, and amygdala activity to fearful stimuli. In addition, we&#xD;
      predict associations between subjective effects/alterations in emotion processing tests and&#xD;
      functional imaging (fMRI) activity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2017</start_date>
  <completion_date type="Actual">September 4, 2018</completion_date>
  <primary_completion_date type="Actual">August 11, 2018</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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Emotional enhancement as determined by fMRI</measure>
    <time_frame>12 hours</time_frame>
    <description>Emotional enhancement (empathy, oxytocin, mood perception, fMRI amygdala blood oxygen level-dependent (BOLD) signal reactivity to fearful stimuli)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fMRI brain activity</measure>
    <time_frame>1 hour</time_frame>
    <description>Associations between subjective effects/alterations in emotion processing with fMRI amygdala BOLD activity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resting State fMRI</measure>
    <time_frame>1 hour</time_frame>
    <description>Association between emotional enhancement and resting state fMRI neuronal activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect Modulation by personality traits (assessed with questionnaires),</measure>
    <time_frame>12 hours</time_frame>
    <description>Effect modulation by personality traits (assessed with questionnaires), baseline amygdala reactivity to fear in the fMRI, and genetic polymorphisms determined by genotyping of each subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect Modulation by amygdala reactivity to fear (assessed in the fMRI)</measure>
    <time_frame>12 hours</time_frame>
    <description>Effect modulation by personality traits (assessed with questionnaires), baseline amygdala reactivity to fear in the fMRI, and genetic polymorphisms determined by genotyping of each subject</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect Modulation by genetic polymorphisms (determined by genotyping of each subject)</measure>
    <time_frame>12 hours</time_frame>
    <description>Effect modulation by personality traits (assessed with questionnaires), baseline amygdala reactivity to fear in the fMRI, and genetic polymorphisms determined by genotyping of each subject</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Placebo, LSD, d-Amphetamine, MDMA</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, lysergic acid diethylamide (LSD), d-Amphetamine or methylenedioxymethamphetamine (MDMA) and followed by all other drugs each separated by a wash-out phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LSD, d-Amphetamine, MDMA, Placebo</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>d-Amphetamine, MDMA, LSD, Placebo</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MDMA, LSD, Placebo, d-Amphetamine,,</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LSD</intervention_name>
    <description>100ug per os, single dose</description>
    <arm_group_label>LSD, d-Amphetamine, MDMA, Placebo</arm_group_label>
    <arm_group_label>MDMA, LSD, Placebo, d-Amphetamine,,</arm_group_label>
    <arm_group_label>Placebo, LSD, d-Amphetamine, MDMA</arm_group_label>
    <arm_group_label>d-Amphetamine, MDMA, LSD, Placebo</arm_group_label>
    <other_name>Lysergic Acid Diethylamide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MDMA</intervention_name>
    <description>125mg per os, single dose</description>
    <arm_group_label>LSD, d-Amphetamine, MDMA, Placebo</arm_group_label>
    <arm_group_label>MDMA, LSD, Placebo, d-Amphetamine,,</arm_group_label>
    <arm_group_label>Placebo, LSD, d-Amphetamine, MDMA</arm_group_label>
    <arm_group_label>d-Amphetamine, MDMA, LSD, Placebo</arm_group_label>
    <other_name>3,4-methylenedioxymethamphetamine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amphetamine</intervention_name>
    <description>40.3mg per os, single dose</description>
    <arm_group_label>LSD, d-Amphetamine, MDMA, Placebo</arm_group_label>
    <arm_group_label>MDMA, LSD, Placebo, d-Amphetamine,,</arm_group_label>
    <arm_group_label>Placebo, LSD, d-Amphetamine, MDMA</arm_group_label>
    <arm_group_label>d-Amphetamine, MDMA, LSD, Placebo</arm_group_label>
    <other_name>d-amphetamine sulfate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Capsules containing mannitol looking identical to the other drugs</description>
    <arm_group_label>LSD, d-Amphetamine, MDMA, Placebo</arm_group_label>
    <arm_group_label>MDMA, LSD, Placebo, d-Amphetamine,,</arm_group_label>
    <arm_group_label>Placebo, LSD, d-Amphetamine, MDMA</arm_group_label>
    <arm_group_label>d-Amphetamine, MDMA, LSD, Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 25 and 50 years.&#xD;
&#xD;
          2. Sufficient understanding of the German language&#xD;
&#xD;
          3. Subjects understand the procedures and the risks associated with the study.&#xD;
&#xD;
          4. Participants must be willing to adhere to the protocol and sign the consent form.&#xD;
&#xD;
          5. Participants must be willing to refrain from taking illicit psychoactive substances&#xD;
             during the study.&#xD;
&#xD;
          6. Participants must be willing to drink only alcohol-free liquids and no coffee, black&#xD;
             or green tea, or energy drink after midnight of the evening before the study session,&#xD;
             as well as during the study day.&#xD;
&#xD;
          7. Participants must be willing not to drive a traffic vehicle or to operate machines&#xD;
             within 48 h after substance administration.&#xD;
&#xD;
          8. Women of childbearing potential must have a negative pregnancy test at the beginning&#xD;
             of the study. Pregnancy tests are repeated before each study session. Women and men&#xD;
             must agree to use an effective form of birth control (double-barrier method).&#xD;
&#xD;
          9. Body mass index 18-29 kg/m2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Chronic or acute medical condition&#xD;
&#xD;
          2. Hypertension (&gt;140/90 mmHg) or Hypotension (SBP&lt;85 mmHg)&#xD;
&#xD;
          3. Current or previous major psychiatric disorder&#xD;
&#xD;
          4. Psychotic disorder in first-degree relatives&#xD;
&#xD;
          5. Illicit substance use (with the exception of cannabis) more than 10 times or any time&#xD;
             within the previous two months.&#xD;
&#xD;
          6. Pregnant or nursing women.&#xD;
&#xD;
          7. Participation in another clinical trial (currently or within the last 30 days)&#xD;
&#xD;
          8. Use of medications that may interfere with the effects of the study medications (any&#xD;
             psychiatric medications).&#xD;
&#xD;
          9. fMRI related criteria including: metal implants (clips from operations, cochlea, large&#xD;
             red/yellow tattoos in the neck area)&#xD;
&#xD;
         10. Tobacco smoking (&gt;10 cigarettes/day)&#xD;
&#xD;
         11. Consumption of alcoholic drinks (&gt;10/week)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias E Liechti, MD, MAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Basel, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <state>Basel Stadt</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>October 12, 2018</last_update_submitted>
  <last_update_submitted_qc>October 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 15, 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>Amphetamine</mesh_term>
    <mesh_term>Dextroamphetamine</mesh_term>
    <mesh_term>N-Methyl-3,4-methylenedioxyamphetamine</mesh_term>
    <mesh_term>Lysergic Acid Diethylamide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03019822
org study id: BASEC 2016-01827
nct id: NCT03019822
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study will test the effect of dopamine, serotonin, and direct 5-HT2A receptor stimulation
      on empathy, mood perception, and amygdala activity to fearful stimuli. In addition, we
      predict associations between subjective effects/alterations in emotion processing tests and
      functional imaging (fMRI) activity.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Emotional enhancement as determined by fMRI
time frame: 12 hours
description: Emotional enhancement (empathy, oxytocin, mood perception, fMRI amygdala blood oxygen level-dependent (BOLD) signal reactivity to fearful stimuli)
measure: fMRI brain activity
time frame: 1 hour
description: Associations between subjective effects/alterations in emotion processing with fMRI amygdala BOLD activity
measure: Resting State fMRI
time frame: 1 hour
description: Association between emotional enhancement and resting state fMRI neuronal activity
measure: Effect Modulation by personality traits (assessed with questionnaires),
time frame: 12 hours
description: Effect modulation by personality traits (assessed with questionnaires), baseline amygdala reactivity to fear in the fMRI, and genetic polymorphisms determined by genotyping of each subject
measure: Effect Modulation by amygdala reactivity to fear (assessed in the fMRI)
time frame: 12 hours
description: Effect modulation by personality traits (assessed with questionnaires), baseline amygdala reactivity to fear in the fMRI, and genetic polymorphisms determined by genotyping of each subject
measure: Effect Modulation by genetic polymorphisms (determined by genotyping of each subject)
time frame: 12 hours
description: Effect modulation by personality traits (assessed with questionnaires), baseline amygdala reactivity to fear in the fMRI, and genetic polymorphisms determined by genotyping of each subject
arm group label: Placebo, LSD, d-Amphetamine, MDMA
arm group type: Other
description: Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, lysergic acid diethylamide (LSD), d-Amphetamine or methylenedioxymethamphetamine (MDMA) and followed by all other drugs each separated by a wash-out phase
arm group label: LSD, d-Amphetamine, MDMA, Placebo
arm group type: Other
description: Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
arm group label: d-Amphetamine, MDMA, LSD, Placebo
arm group type: Other
description: Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
arm group label: MDMA, LSD, Placebo, d-Amphetamine,,
arm group type: Other
description: Cross-over within-subjects design with all treatment conditions, arms starting with either Placebo, LSD, d-Amphetamine or MDMA and followed by all other drugs each separated by a wash-out phase
intervention type: Drug
intervention name: LSD
description: 100ug per os, single dose
arm group label: LSD, d-Amphetamine, MDMA, Placebo
arm group label: MDMA, LSD, Placebo, d-Amphetamine,,
arm group label: Placebo, LSD, d-Amphetamine, MDMA
arm group label: d-Amphetamine, MDMA, LSD, Placebo
other name: Lysergic Acid Diethylamide
intervention type: Drug
intervention name: MDMA
description: 125mg per os, single dose
arm group label: LSD, d-Amphetamine, MDMA, Placebo
arm group label: MDMA, LSD, Placebo, d-Amphetamine,,
arm group label: Placebo, LSD, d-Amphetamine, MDMA
arm group label: d-Amphetamine, MDMA, LSD, Placebo
other name: 3,4-methylenedioxymethamphetamine
intervention type: Drug
intervention name: Amphetamine
description: 40.3mg per os, single dose
arm group label: LSD, d-Amphetamine, MDMA, Placebo
arm group label: MDMA, LSD, Placebo, d-Amphetamine,,
arm group label: Placebo, LSD, d-Amphetamine, MDMA
arm group label: d-Amphetamine, MDMA, LSD, Placebo
other name: d-amphetamine sulfate
intervention type: Drug
intervention name: Placebo
description: Capsules containing mannitol looking identical to the other drugs
arm group label: LSD, d-Amphetamine, MDMA, Placebo
arm group label: MDMA, LSD, Placebo, d-Amphetamine,,
arm group label: Placebo, LSD, d-Amphetamine, MDMA
arm group label: d-Amphetamine, MDMA, LSD, Placebo
criteria: 
gender: All
minimum age: 25 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthias E Liechti, MD, MAS
role: Principal Investigator
affiliation: University Hospital, Basel, Switzerland
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Amphetamine
mesh term: Dextroamphetamine
mesh term: N-Methyl-3,4-methylenedioxyamphetamine
mesh term: Lysergic Acid Diethylamide
sharing ipd: Undecided