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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06014606
Other study ID # DANE1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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