The main objective is to test whether an improved cognitive performance, achieved by administering modafinil, is associated with improved economic decision making, in particular regarding preferences over time, risk and losses, as well as social…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are behavioral data from economic decision-making
paradigms. In particular, elicited parameters describing preferences over risk,
time, and losses.
Secondary outcome
Social preferences, trust, and reciprocity are secondary parameters, as well as
cognitive performance on our control tasks.
Background summary
Cognition is a broad concept and entails many brain functions. This includes
attention or memory but also more complex decision making. Recently, a relation
between a good performance in neuropsychological tasks (measuring attention and
memory) and complex decision making processes (for example gambling tasks in
which probabilities of outcomes differ, economic decisions) has attracted a lot
of interest. It is generally assumed that better cognition is associated with
better decision making, although the exact causal link has not been shown yet.
In this study, we would like to investigate the relation between these two
cognitive dimensions. In order to modulate cognitive performance, and to test
whether this is associated with better decision making, we will use modafinil
treatment. While modafinil is widely known to improve cognitive performance, it
is yet unknown how it affects decision making. Thus, this allows investigating
the relation between cognition and decision making.
Study objective
The main objective is to test whether an improved cognitive performance,
achieved by administering modafinil, is associated with improved economic
decision making, in particular regarding preferences over time, risk and
losses, as well as social preferences and trust.
Study design
The experiment will be randomized, double-blind and placebo-controlled. All
effects are measured between subjects.
Intervention
Given the between-subjects design, subjects will either receive placebo or 200
mg modafinil. The medication will be administered orally. The participants will
be asked to perform various tests related to cognitive performance and decision
making.
Study burden and risks
The time investment for the participants will be around 270 min, which is
comprised of 1) filling in medical questionnaire, 30 min and 2) one test
session of around 210 min. The day before their test day, the participants are
not allowed to drink any alcohol. On the test day, participants are not allowed
to smoke or drink caffeinated drinks. Furthermore, they are asked to refrain
from using drugs throughout the study. The treatments are a single dose of
either modafinil 200 mg or placebo.
Universiteitssingel 40
Maastricht 6229ER
NL
Universiteitssingel 40
Maastricht 6229ER
NL
Listed location countries
Age
Inclusion criteria
• In the opinion of the investigator, the participant is capable of
understanding and complying with protocol requirements.
• The participant is male or female.
• The participant has a body mass index of 18.5-30 kg/m2, inclusive, as stated
in the medical screening form.
• The participant is aged 18 to 40 years, inclusive, at the time of informed
consent.
• The volunteer is healthy, i.e., the absence of all exclusion criteria and had
normal or corrected to normal static binocular acuity with or without
correction.
• The participant signs and dates a written informed consent form before the
start of the experiment.
Exclusion criteria
• The subject has an uncontrolled, clinically significant neurologic,
cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or
endocrine disease or other abnormality which may impact the ability of the
subject to participate or potentially confound the study results.
• The volunteer has uncontrolled existing major psychiatric symptoms.
• The participant has known hypersensitivity to any component of the
formulation or Modafinil or related compounds.
• The subject has a history of drug abuse (defined as any illicit drug use) or
a history of alcohol abuse within 1 year prior to the first visit or is
unwilling to agree to abstain from alcohol from 24 hours prior to each test day
and/or drugs throughout the study.
• The participant has any sensory or motor deficits which could reasonably be
expected to affect test performance.
• Other exclusion criteria are smoking, excessive drinking (>20 glasses of
alcohol-containing beverages a week), use of medication.
• For females, exclusion criteria are taking the birth control pill and being
pregnant.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66481.068.18 |