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Molecular Basis of Loss Aversion

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ClinicalTrials.gov Identifier: NCT06034158
Recruitment Status : Recruiting
First Posted : September 13, 2023
Last Update Posted : September 26, 2023
Sponsor:
Information provided by (Responsible Party):
Jinsong Tang, Sir Run Run Shaw Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: single-dose madopar, single-dose propranolol, and single-dose placebo by order Drug: single-dose madopar, single-dose placebo, and single-dose propranolol by order Drug: single-dose propranolol, single-dose madopar, and single-dose placebo by order Drug: single-dose propranolol, single-dose placebo, and single-dose madopar by order Drug: single-dose placebo, single-dose propranolol, and single-dose madopar by order Drug: single-dose placebo, single-dose madopar, and single-dose propranolol by order Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Molecular Basis of Loss Aversion
Actual Study Start Date : September 18, 2023
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : September 1, 2024
Arms and Interventions
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Arm Intervention/treatment
madopar-propranolol-placebo
In a within-subjects design, participants will take madopar, propranolol, and placebo each once in three separate sessions.
 Drug: single-dose madopar, single-dose propranolol, and single-dose placebo by order
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.
madopar-placebo-propranolol
In a within-subjects design, participants will take madopar, placebo, and propranolol each once in three separate sessions.
 Drug: single-dose madopar, single-dose placebo, and single-dose propranolol by order
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.
propranolol-madopar-placebo
In a within-subjects design, participants will take propranolol, madopar, and placebo each once in three separate sessions.
 Drug: single-dose propranolol, single-dose madopar, and single-dose placebo by order
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.
propranolol-placebo-madopar
In a within-subjects design, participants will take propranolol, placebo, and madopar each once in three separate sessions.
 Drug: single-dose propranolol, single-dose placebo, and single-dose madopar by order
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.
placebo-propranolol-madopar
In a within-subjects design, participants will take placebo, propranolol, and madopar each once in three separate sessions.
 Drug: single-dose placebo, single-dose propranolol, and single-dose madopar by order
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.
placebo-madopar-propranolol
In a within-subjects design, participants will take placebo, madopar, and propranolol each once in three separate sessions.
 Drug: single-dose placebo, single-dose madopar, and single-dose propranolol by order
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.


Outcome Measures
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Primary Outcome Measures :
  1. Choices to invest or not in the investment task [ Time Frame: between 1-2 hours after taking the drugs or the placebo ]
    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.

  2. Response times to invest or not in the investment task [ Time Frame: between 1-2 hours after taking the drugs or the placebo ]
    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.

  3. Choices to turn or not in the driving task [ Time Frame: between 1-2 hours after taking the drugs or the placebo ]
    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) .

  4. Response times to turn or not in the driving task [ Time Frame: between 1-2 hours after taking the drugs or the placebo ]
    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) .

  5. Choices to buy or sell in the trading task [ Time Frame: between 1-2 hours after taking the drugs or the placebo ]
    Participants decide whether or not to buy or sell a product at certain prices.

  6. Response times to buy or sell in the trading task [ Time Frame: between 1-2 hours after taking the drugs or the placebo ]
    Participants decide whether or not to buy or sell a product at certain prices.

  7. Reported outcomes in die task [ Time Frame: between 1-2 hours after taking the drugs or the placebo ]
    Participants report the outcome for each throw of the die.


Secondary Outcome Measures :
  1. Affects [ Time Frame: before and 1 hour after taking the drugs or the placebo ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 25-40 years old (including boundary value).
  2. Elementary school education or above, able to understand the research content.
  3. Body temperature, blood pressure, heart rate, respiratory rate, and electrocardiogram are all normal. Among them, the blood pressure range is 100-139/70-89 mmHg, and the heart rate range is 60-85 beats/min.

Exclusion Criteria:

  1. Vulnerable groups, including people with mental illness, cognitive impairment, critically ill subjects, minors, pregnant women, illiterates, etc.
  2. Family history of genetic diseases.
  3. Major physical diseases, including cardiovascular, respiratory, digestive, renal, endocrine, blood and other systemic diseases.
  4. History of alcohol/drug dependence.
  5. Lactating women.
  6. The cardiopulmonary function test results are poor.
  7. Have ever taken madopar or propranolol for medical use.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06034158


Locations
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China, Zhejiang
Sir Run Run Shaw Hospital Recruiting
Hangzhou, Zhejiang, China, 360000
Contact: Jinsong Tang    13627311963    tangliaoyanhui@163.com   
Sponsors and Collaborators
Sir Run Run Shaw Hospital
More Information
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Publications:

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Responsible Party: Jinsong Tang, Deputy Chief Physician, Sir Run Run Shaw Hospital
ClinicalTrials.gov Identifier: NCT06034158    
Other Study ID Numbers: 20230496
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Propranolol
Benserazide
Levodopa
Benserazide, levodopa drug combination
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Enzyme Inhibitors
Dopamine Agents
Antiparkinson Agents
Anti-Dyskinesia Agents