Learning and Decision-making

Motivation Clinical Trial

Official title:

How Does the Brain Learn About Positive and Negative Things?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06014606
• Other study ID #: DANE1
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 16, 2023

Study information

• Verified date: August 2023
• Source: Maastricht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A fundamental aspect of daily life decision-making involves the evaluation of costs and benefits. Neural systems underlying cost-benefit evaluation have been extensively examined, but the specific role of different neurotransmitters remains unclear. Numerous studies suggest that both dopamine (DA) and norepinephrine (NE) are closely related to reinforcement learning, guided exploration/exploitation, and behavioural energisation, although no studies to date have investigated the distinct role of DA and NE on cost-benefit decision-making and learning in human subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 16, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Willingness to sign an informed consent

• Age between 18 and 35

• Body-Mass Index (BMI) between 17.5-30

• Availability for participation through the duration of the study

Exclusion Criteria:

• Diagnosis of a psychiatric or neurological disorder, including substance abuse or dependence (yes/no self-report - lifetime)

• Use of any psychopharmacological treatment 3 weeks before the test day (yes/no self-report)

• Use of any blood pressure medication (yes/no self-report - lifetime)

• Pregnancy (confirmed via urine pregnancy test) or nursing (yes/no self-report) or have plans to get pregnant in the near future (yes/no self-report) (females only)

• Diagnosis of a cardiac disease (medical questionnaire), obstructive respiratory disease (medical questionnaire), abnormal blood pressure (diastolic< 60mmHg; systolic< 90mmHg) (medical screening)

• Chronic renal failure (medical questionnaire)

• Hypothyroidism (medical questionnaire)

• Diabetes (medical questionnaire)

• Hypersensitivity to phenothiazines (medical questionnaire)

• Diagnosis of a cardiac disease (medical questionnaire)

• Alcohol consumption in the 24 hours before the test session starts (yes/no self-report)

• Food intake less than 3 hours before the test day (yes/no self-report)

Related Conditions & MeSH terms

• Motivation

Intervention

Drug:
• placebo
oral formulation
• haloperidol 2mg
oral formulation
• propranolol 40mg
oral formulation

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Voulgaropoulou SD, Fauzani F, Pfirrmann J, Vingerhoets C, van Amelsvoort T, Hernaus D. Asymmetric effects of acute stress on cost and benefit learning. Psychoneuroendocrinology. 2022 Apr;138:105646. doi: 10.1016/j.psyneuen.2021.105646. Epub 2021 Dec 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physiology I	Heart rate	pre, +30 min., +60 min., +90 min., +120 min., +190 min. post-drug administration
Other	Physiology II	blood pressure	pre, +30 min., +60 min., +90 min., +120 min., +190 min. post-drug administration
Primary	Cost-benefit reinforcement learning performance	2-choice reinforcement learning task (based on Voulgaropoulou et al., 2021 PNEC)	~ 2.5 hours post-drug administration
Secondary	Effort-based decision-making	motivation to acquire rewards (e.g., Reddy et al. 2015)	~ 2 hours post-drug administration