Molecular Basis of Loss Aversion

September 22, 2023 updated by: Jinsong Tang, Sir Run Run Shaw Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 360000
        • Recruiting
        • Sir Run Run Shaw Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
Other: 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.
Other: 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.
Other: 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.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
between 1-2 hours after taking the drugs or the placebo
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.
between 1-2 hours after taking the drugs or the placebo
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.
between 1-2 hours after taking the drugs or the placebo
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) .
between 1-2 hours after taking the drugs or the placebo
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) .
between 1-2 hours after taking the drugs or the placebo
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.
between 1-2 hours after taking the drugs or the placebo
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.
between 1-2 hours after taking the drugs or the placebo

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
before and 1 hour after taking the drugs or the placebo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sir Run Run Shaw Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230496

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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