CNS Drug Effect Profiling in Children: an Educational Class Experiment using Caffeine as a Model.

Completed

Conditions: psychostimulantia zonder beoogd effect op aandoening bij adolescenten
N/A (see C21)

Registration Number: NL-OMON32655

Lead Sponsor: Centre for Human Drug Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 16

Inclusion Criteria

Written informed consent from parents having parental responsibility or from legal guardian.
Written informed consent from child.
Aged 15-18 (extremes including).
Able to communicate with the investigator in Dutch.
Non-smoker.

Exclusion Criteria

Any significant medical condition that in the opinion of the medical investigator would be a contraindication for the use of caffeine and/or would interfere with the study objectives.
Cannabis use 7 days before the study days (by medical history).
Alcohol use of more than 14 units per week (by medical history).
Daily use of more than 5 units of xanthine-containing food products or drinks (including but not limited to coffee, tea, Red Bull, chocolate).
Distaste of coffee.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacodynamics:<br /><br>- Results of neurocognitive and psychomotor test (including adaptive tracking,<br /><br>smooth eye pursuit, saccadic eye movement, finger tapping, choice reaction<br /><br>task, critical flicker fusion task, attention switching task, body sway, and<br /><br>visual verbal learning test)<br /><br>- Autonomic nervous system parameters (including heart rate, blood pressure,<br /><br>and pupil size)<br /><br><br /><br>Pharmacokinetics: caffeine concentrations in saliva</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Results of a short questionnaire which will be taken after completion of the<br /><br>neurocognitive tasks on how volunteers experienced participation.</p><br>