Learning and Decision-making

• Sponsor: Maastricht University (Other)
• Overall Status: Completed
• CT.gov ID: NCT06014606
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 3
• Actual Duration (Months): 29.5
• Patients Per Site Per Month: 5.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Motivation	Drug: placebo; Drug: haloperidol 2mg; Drug: propranolol 40mg	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: double-blind (randomised) between-subjects design
• Primary Purpose: Basic Science
• Official Title: How Does the Brain Learn About Positive and Negative Things?
• Actual Study Start Date: Mar 1, 2021
• Actual Primary Completion Date: Apr 30, 2023
• Actual Study Completion Date: Aug 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: HV/Placebo Oral placebo (tablet)	Drug: placebo; oral formulation
Active Comparator: HV/Haloperidol 2mg (oral)	Drug: haloperidol 2mg; oral formulation
Active Comparator: HV/Propranolol 40mg (oral)	Drug: propranolol 40mg; oral formulation

Outcome Measures

Primary Outcome Measures

1. Cost-benefit reinforcement learning performance [~ 2.5 hours post-drug administration]

   2-choice reinforcement learning task (based on Voulgaropoulou et al., 2021 PNEC)

Secondary Outcome Measures

1. Effort-based decision-making [~ 2 hours post-drug administration]

   motivation to acquire rewards (e.g., Reddy et al. 2015)

Other Outcome Measures

1. Physiology I [pre, +30 min., +60 min., +90 min., +120 min., +190 min. post-drug administration]

   Heart rate

2. Physiology II [pre, +30 min., +60 min., +90 min., +120 min., +190 min. post-drug administration]

   blood pressure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maastricht University	Maastricht		Netherlands

Sponsors and Collaborators

• Maastricht University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maastricht University
• ClinicalTrials.gov Identifier: NCT06014606
• Other Study ID Numbers: DANE1
• First Posted: Aug 28, 2023
• Last Update Posted: Aug 28, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Propranolol; Haloperidol; Haloperidol decanoate

Study Results

No Results Posted as of Aug 28, 2023