neurosciences n.v.t.
Conditions
Interventions
Each subject will be tested at 4 different periods, each period will be
separated by ca. 1 week.
The first time the subjects will not receive medication or a placebo.
During the 2nd and 3rd visit the
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Healthy, right-handed male individuals between 18-25 year -o.
Exclusion criteria
Exclusion criteria: •Female sex. •Previous participation in a study with MRI. •Clinically significant history of drug allergies (benzodiazepines). •Recent history (within previous 6 months) of alcohol or drug abuse. • History of or current significant medical illness including cardiac arrhythmias or other cardiac disease, hematological disease, bronchospastic respiratory disease, dyspnea, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, infection, or any other illness that the investigator considers clinically significant. • History of or current psychiatric or neurological illness. • Smoking cigarettes (or equivalent) or the use of nicotine based products, within 3 months prior to study drug administration • Positive urine screen for drugs of abuse at screening or admission. • Use of any prescription or over-the-counter psychotropic medication (including herbal medications) within 2 weeks of dosing with the study drug. • Visual disorder that cannot be corrected through the use of corrective lenses • Claustrophobia and/or a panic disorder • Those suffering from phobiae of physical restraint, specifically concerning the head and the hand/finger complex • Participants who do not fulfill the criteria for participating in an fMRI assessment (e.g. people who have metal implants (pacemaker, heartvalves, vascular clips, eye-implants or red tattoos, piercing) • Psychological and/or emotional problems, which limit the ability of the subject to comply with the study requirements. • Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A generally diminished subject performance is expected in the presence of the medication. The study design is such that it will be possible to numerically quantify the effects. Specifically: the working memory task should reveal an increased difficulty in successfully complete the n-back test, possibly due to interference in the underlying mechanism of constant update of the target letter; the episodic memory should reveal an increased difficulty in retrieving a reliable information, and that difficulty should be detectable both as a variation in the answers variance and in their accuracy; finally, the divided attention task could shed light on possible interference effects caused by the medication in successful coping with two different activities. The placebo sessions will provide a reference in order to attempt to disentangle the physical and the psychological components of the effects generated by the assumption of benzodiazepine. These informations may concur in paving the way towards a better understanding of the interaction mechanisms between neuronal activity at a network level and medications, specifically concerning the localization of areas specifically affected by the benzodiazepine, thus setting parameters for future studies of the same kind and for development of novel psychoactive substances targeted at specific regions/functions. | — |
Secondary
| Measure | Time frame |
|---|---|
| n.a. | — |
Countries
Netherlands
Outcome results
None listed