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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON32655
Enrollment
16
Registered
2009-12-22
Start date
2009-12-21
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Caffeine (approximately 135 mg caffeine in Nespresso coffee) or placebo (

Sponsors

Centre for Human Drug Research
Lead Sponsor

Eligibility

Age
12 Years to 17 Years

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Results of a short questionnaire which will be taken after completion of the neurocognitive tasks on how volunteers experienced participation.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)