CNS drug effect profiling in adolescents: an educational class experiment using alcohol as a model.

Completed

Conditions: N/A
use of substances

Registration Number: NL-OMON34604

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 legal guardian (if subject < 18 years);
Written informed consent from subject;
Aged 16-18 (extremes included);
Attending high school on VWO level;
Able to communicate with investigator in Dutch;
Acquainted with effects of alcohol (e.g., use of at least 4 units during the month preceding study participation)

Exclusion Criteria

Any significant medical condition that in the opinion of the medical investigator would be a contraindication for the use of alcohol and/or would interfere with the study objectives;
Regular alcohol use exceeding an average of more than one unit daily (by medical history);
Inability to abstain from alcohol for more than 3 consecutive days prior to study days;
Previously experienced serious adverse event after drinking maximum of 2 drinks per occasion (by medical history);
Daily use of more than 5 cigarettes (or other nicotine(-containing) equivalent);
Regular use of illicit drugs (including cannabis); cannabis use exceeding more than 1 intake weekly is considered an exclusion criterion (by medical history);
Daily use of more than 5 units of xanthine-containing food products or drinks (including but not limited to coffee, tea, energy drinks, chocolate);
Distaste of orange juice.

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 momevent, choice reaction task, body sway, and<br /><br>visual verbal learning test)<br /><br>* Results of visual analogue scales (Bond & Lader, alcohol effect)<br /><br>* Autonomic nervous system parameters (including heart rate and blood pressure)<br /><br>Pharmacokinetics:<br /><br> Alcohol concentrations in breath</p><br>

Secondary Outcome Measures