xml: <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/NCT06034158</url>
    </required_header>
    <id_info>
      <org_study_id>20230496</org_study_id>
      <nct_id>NCT06034158</nct_id>
    </id_info>
    <brief_title>Molecular Basis of Loss Aversion</brief_title>
    <official_title>Molecular Basis of Loss Aversion</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sir Run Run Shaw Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sir Run Run Shaw Hospital</source>
    <oversight_info>
      <has_dmc>No</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 goal of this clinical trial is to test the roles of dopamine and norepinephrine in&#xD;
        decision making related to loss aversion in the healthy population. The main question it aims&#xD;
        to answer is whether temporarily boosting dopamine activity or temporarily suppressing&#xD;
        norepinephrine activity has an impact on processing of potential gains and losses in&#xD;
        financial decision making, social decision making, transaction decision making and moral&#xD;
        decision making. Accordingly, participants will complete four decision-making tasks, namely&#xD;
        investment task, driving task, trading task, and die task, after taking madopar, propranolol&#xD;
        or placebo. Participants' psychological traits and psychiatric symptoms will be assessed once&#xD;
        they are enrolled before the first-session day.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 5, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <phase>N/A</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Choices to invest or not in the investment task</measure>
      <time_frame>between 1-2 hours after taking the drugs or the placebo</time_frame>
      <description>Participants decide whether or not to accept investment options that entail a 50/50 chance of winning some amount of money and losing some amount of money.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response times to invest or not in the investment task</measure>
      <time_frame>between 1-2 hours after taking the drugs or the placebo</time_frame>
      <description>Participants decide whether or not to accept investment options that entail a 50/50 chance of winning some amount of money and losing some amount of money.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Choices to turn or not in the driving task</measure>
      <time_frame>between 1-2 hours after taking the drugs or the placebo</time_frame>
      <description>Participants decide whether or not to make turns during driving in order to sacrifice some number of person(s) to save some number of person(s) .</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response times to turn or not in the driving task</measure>
      <time_frame>between 1-2 hours after taking the drugs or the placebo</time_frame>
      <description>Participants decide whether or not to make turns during driving in order to sacrifice some number of person(s) to save some number of person(s) .</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Choices to buy or sell in the trading task</measure>
      <time_frame>between 1-2 hours after taking the drugs or the placebo</time_frame>
      <description>Participants decide whether or not to buy or sell a product at certain prices.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Response times to buy or sell in the trading task</measure>
      <time_frame>between 1-2 hours after taking the drugs or the placebo</time_frame>
      <description>Participants decide whether or not to buy or sell a product at certain prices.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Reported outcomes in die task</measure>
      <time_frame>between 1-2 hours after taking the drugs or the placebo</time_frame>
      <description>Participants report the outcome for each throw of the die.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Affects</measure>
      <time_frame>before and 1 hour after taking the drugs or the placebo</time_frame>
      <description>Participants' affects will be assessed using the Positive and Negative Affective Scale (PANAS).Scores can range from 10 to 50 for both the Positive and Negative Affect, with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.</description>
    </secondary_outcome>
    <number_of_arms>6</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>madopar-propranolol-placebo</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In a within-subjects design, participants will take madopar, propranolol, and placebo each once in three separate sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>madopar-placebo-propranolol</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In a within-subjects design, participants will take madopar, placebo, and propranolol each once in three separate sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>propranolol-madopar-placebo</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In a within-subjects design, participants will take propranolol, madopar, and placebo each once in three separate sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>propranolol-placebo-madopar</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In a within-subjects design, participants will take propranolol, placebo, and madopar each once in three separate sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo-propranolol-madopar</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In a within-subjects design, participants will take placebo, propranolol, and madopar each once in three separate sessions.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo-madopar-propranolol</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>In a within-subjects design, participants will take placebo, madopar, and propranolol each once in three separate sessions.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>single-dose madopar, single-dose propranolol, and single-dose placebo by order</intervention_name>
      <description>Participants will take madopar, propranolol, and placebo (orange juice) each once in three separate sessions. The interval between every two sessions will be at least 3 days.</description>
      <arm_group_label>madopar-propranolol-placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>single-dose madopar, single-dose placebo, and single-dose propranolol by order</intervention_name>
      <description>Participants will take madopar, placebo(orange juice), and propranolol each once in three separate sessions. The interval between every two sessions will be at least 3 days.</description>
      <arm_group_label>madopar-placebo-propranolol</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>single-dose propranolol, single-dose madopar, and single-dose placebo by order</intervention_name>
      <description>Participants will take propranolol, madopar, and placebo(orange juice) each once in three separate sessions. The interval between every two sessions will be at least 3 days.</description>
      <arm_group_label>propranolol-madopar-placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>single-dose propranolol, single-dose placebo, and single-dose madopar by order</intervention_name>
      <description>Participants will take propranolol, placebo(orange juice), and madopar each once in three separate sessions. The interval between every two sessions will be at least 3 days.</description>
      <arm_group_label>propranolol-placebo-madopar</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>single-dose placebo, single-dose propranolol, and single-dose madopar by order</intervention_name>
      <description>Participants will take placebo(orange juice), propranolol, and madopar each once in three separate sessions. The interval between every two sessions will be at least 3 days.</description>
      <arm_group_label>placebo-propranolol-madopar</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>single-dose placebo, single-dose madopar, and single-dose propranolol by order</intervention_name>
      <description>Participants will take placebo(orange juice), madopar, and propranolol each once in three separate sessions. The interval between every two sessions will be at least 3 days.</description>
      <arm_group_label>placebo-madopar-propranolol</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 25-40 years old (including boundary value).&#xD;
  &#xD;
            2. Elementary school education or above, able to understand the research content.&#xD;
  &#xD;
            3. Body temperature, blood pressure, heart rate, respiratory rate, and electrocardiogram&#xD;
               are all normal. Among them, the blood pressure range is 100-139/70-89 mmHg, and the&#xD;
               heart rate range is 60-85 beats/min.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Vulnerable groups, including people with mental illness, cognitive impairment,&#xD;
               critically ill subjects, minors, pregnant women, illiterates, etc.&#xD;
  &#xD;
            2. Family history of genetic diseases.&#xD;
  &#xD;
            3. Major physical diseases, including cardiovascular, respiratory, digestive, renal,&#xD;
               endocrine, blood and other systemic diseases.&#xD;
  &#xD;
            4. History of alcohol/drug dependence.&#xD;
  &#xD;
            5. Lactating women.&#xD;
  &#xD;
            6. The cardiopulmonary function test results are poor.&#xD;
  &#xD;
            7. Have ever taken madopar or propranolol for medical use.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <reference>
      <citation>Sheng F, Ramakrishnan A, Seok D, Zhao WJ, Thelaus S, Cen P, Platt ML. Decomposing loss aversion from gaze allocation and pupil dilation. Proc Natl Acad Sci U S A. 2020 May 26;117(21):11356-11363. doi: 10.1073/pnas.1919670117. Epub 2020 May 8.</citation>
      <PMID>32385152</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sir Run Run Shaw Hospital</investigator_affiliation>
      <investigator_full_name>Jinsong Tang</investigator_full_name>
      <investigator_title>Deputy Chief Physician</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Propranolol</mesh_term>
      <mesh_term>Benserazide</mesh_term>
      <mesh_term>Levodopa</mesh_term>
      <mesh_term>Benserazide, levodopa drug combination</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06034158
  org study id: 20230496
  nct id: NCT06034158
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test the roles of dopamine and norepinephrine in
        decision making related to loss aversion in the healthy population. The main question it aims
        to answer is whether temporarily boosting dopamine activity or temporarily suppressing
        norepinephrine activity has an impact on processing of potential gains and losses in
        financial decision making, social decision making, transaction decision making and moral
        decision making. Accordingly, participants will complete four decision-making tasks, namely
        investment task, driving task, trading task, and die task, after taking madopar, propranolol
        or placebo. Participants' psychological traits and psychiatric symptoms will be assessed once
        they are enrolled before the first-session day.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Basic Science
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Choices to invest or not in the investment task
  time frame: between 1-2 hours after taking the drugs or the placebo
  description: Participants decide whether or not to accept investment options that entail a 50/50 chance of winning some amount of money and losing some amount of money.
  measure: Response times to invest or not in the investment task
  time frame: between 1-2 hours after taking the drugs or the placebo
  description: Participants decide whether or not to accept investment options that entail a 50/50 chance of winning some amount of money and losing some amount of money.
  measure: Choices to turn or not in the driving task
  time frame: between 1-2 hours after taking the drugs or the placebo
  description: Participants decide whether or not to make turns during driving in order to sacrifice some number of person(s) to save some number of person(s) .
  measure: Response times to turn or not in the driving task
  time frame: between 1-2 hours after taking the drugs or the placebo
  description: Participants decide whether or not to make turns during driving in order to sacrifice some number of person(s) to save some number of person(s) .
  measure: Choices to buy or sell in the trading task
  time frame: between 1-2 hours after taking the drugs or the placebo
  description: Participants decide whether or not to buy or sell a product at certain prices.
  measure: Response times to buy or sell in the trading task
  time frame: between 1-2 hours after taking the drugs or the placebo
  description: Participants decide whether or not to buy or sell a product at certain prices.
  measure: Reported outcomes in die task
  time frame: between 1-2 hours after taking the drugs or the placebo
  description: Participants report the outcome for each throw of the die.
  measure: Affects
  time frame: before and 1 hour after taking the drugs or the placebo
  description: Participants' affects will be assessed using the Positive and Negative Affective Scale (PANAS).Scores can range from 10 to 50 for both the Positive and Negative Affect, with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.
  arm group label: madopar-propranolol-placebo
  arm group type: Other
  description: In a within-subjects design, participants will take madopar, propranolol, and placebo each once in three separate sessions.
  arm group label: madopar-placebo-propranolol
  arm group type: Other
  description: In a within-subjects design, participants will take madopar, placebo, and propranolol each once in three separate sessions.
  arm group label: propranolol-madopar-placebo
  arm group type: Other
  description: In a within-subjects design, participants will take propranolol, madopar, and placebo each once in three separate sessions.
  arm group label: propranolol-placebo-madopar
  arm group type: Other
  description: In a within-subjects design, participants will take propranolol, placebo, and madopar each once in three separate sessions.
  arm group label: placebo-propranolol-madopar
  arm group type: Other
  description: In a within-subjects design, participants will take placebo, propranolol, and madopar each once in three separate sessions.
  arm group label: placebo-madopar-propranolol
  arm group type: Other
  description: In a within-subjects design, participants will take placebo, madopar, and propranolol each once in three separate sessions.
  intervention type: Drug
  intervention name: single-dose madopar, single-dose propranolol, and single-dose placebo by order
  description: Participants will take madopar, propranolol, and placebo (orange juice) each once in three separate sessions. The interval between every two sessions will be at least 3 days.
  arm group label: madopar-propranolol-placebo
  intervention type: Drug
  intervention name: single-dose madopar, single-dose placebo, and single-dose propranolol by order
  description: Participants will take madopar, placebo(orange juice), and propranolol each once in three separate sessions. The interval between every two sessions will be at least 3 days.
  arm group label: madopar-placebo-propranolol
  intervention type: Drug
  intervention name: single-dose propranolol, single-dose madopar, and single-dose placebo by order
  description: Participants will take propranolol, madopar, and placebo(orange juice) each once in three separate sessions. The interval between every two sessions will be at least 3 days.
  arm group label: propranolol-madopar-placebo
  intervention type: Drug
  intervention name: single-dose propranolol, single-dose placebo, and single-dose madopar by order
  description: Participants will take propranolol, placebo(orange juice), and madopar each once in three separate sessions. The interval between every two sessions will be at least 3 days.
  arm group label: propranolol-placebo-madopar
  intervention type: Drug
  intervention name: single-dose placebo, single-dose propranolol, and single-dose madopar by order
  description: Participants will take placebo(orange juice), propranolol, and madopar each once in three separate sessions. The interval between every two sessions will be at least 3 days.
  arm group label: placebo-propranolol-madopar
  intervention type: Drug
  intervention name: single-dose placebo, single-dose madopar, and single-dose propranolol by order
  description: Participants will take placebo(orange juice), madopar, and propranolol each once in three separate sessions. The interval between every two sessions will be at least 3 days.
  arm group label: placebo-madopar-propranolol
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  citation: Sheng F, Ramakrishnan A, Seok D, Zhao WJ, Thelaus S, Cen P, Platt ML. Decomposing loss aversion from gaze allocation and pupil dilation. Proc Natl Acad Sci U S A. 2020 May 26;117(21):11356-11363. doi: 10.1073/pnas.1919670117. Epub 2020 May 8.
  PMID: 32385152
  responsible party type: Principal Investigator
  investigator affiliation: Sir Run Run Shaw Hospital
  investigator full name: Jinsong Tang
  investigator title: Deputy Chief Physician
  mesh term: Propranolol
  mesh term: Benserazide
  mesh term: Levodopa
  mesh term: Benserazide, levodopa drug combination
  sharing ipd: No