Molecular Basis of Loss Aversion

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: Recruiting
• Conditions: Healthy
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 360000
      • Recruiting
      • Sir Run Run Shaw Hospital
      • Contact: Jinsong Tang; Phone Number: 13627311963; Email: tangliaoyanhui@163.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Reported outcomes in die task	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	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Affects	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

• Sponsor: Sir Run Run Shaw Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: September 5, 2023
• First Submitted That Met QC Criteria: September 5, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Dopamine Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Propranolol; Levodopa; Benserazide; Benserazide, levodopa drug combination
• Other Study ID 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