NCT06014606

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

2.2 years

First QC Date

September 5, 2022

Last Update Submit

August 23, 2023

Conditions

Motivation

Outcome Measures

Primary Outcomes (1)

  • Cost-benefit reinforcement learning performance

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

    ~ 2.5 hours post-drug administration

Secondary Outcomes (1)

  • Effort-based decision-making

    ~ 2 hours post-drug administration

Other Outcomes (2)

  • Physiology I

    pre, +30 min., +60 min., +90 min., +120 min., +190 min. post-drug administration

  • Physiology II

    pre, +30 min., +60 min., +90 min., +120 min., +190 min. post-drug administration

Study Arms (3)

HV/Placebo

PLACEBO COMPARATOR

Oral placebo (tablet)

Drug: placebo

HV/Haloperidol

ACTIVE COMPARATOR

2mg (oral)

Drug: haloperidol 2mg

HV/Propranolol

ACTIVE COMPARATOR

40mg (oral)

Drug: propranolol 40mg

Interventions

placeboDRUG

oral formulation

HV/Placebo
haloperidol 2mgDRUG

oral formulation

HV/Haloperidol
propranolol 40mgDRUG

oral formulation

HV/Propranolol

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Netherlands

Location

Related 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.

    PMID: 35065334RESULT

MeSH Terms

Interventions

HaloperidolPropranolol

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic ChemicalsPhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double-blind (randomised) between-subjects design
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2022

First Posted

August 28, 2023

Study Start

March 1, 2021

Primary Completion

April 30, 2023

Study Completion

August 16, 2023

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations

NL(1)