use of substances N/A
Conditions
Interventions
Alcohol challenge will be done with a two oral doses of approx. 10 grams
alcohol each (e.g., two standard glasses of 200 mL containing Malibu mixed with
orange juice)
(2) placebo (same total volume orange juice without alcohol but
with coconut milk).
Sponsors
Centre for Human Drug Research
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: Written informed consent from parents having parental responsibility or legal guardian (if subject
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamics: * Results of neurocognitive and psychomotor test (including adaptive tracking, smooth eye pursuit, saccadic eye momevent, choice reaction task, body sway, and visual verbal learning test) * Results of visual analogue scales (Bond & Lader, alcohol effect) * Autonomic nervous system parameters (including heart rate and blood pressure) *Pharmacokinetics: * Alcohol concentrations in breath | — |
Secondary
| Measure | Time frame |
|---|---|
| Results of a short questionnaire on subject*s view on alcohol * Results of a short questionnaire on study participation | — |
Countries
Netherlands
Outcome results
None listed