- To educate adolescents on clinical drug studies by involving them as project team members and participants in an intervention trial of negligible risk and minimal burden; - To investigate the CNS effects of caffeine on neurocognitive and…
Source
Brief title
Condition
- Other condition
Synonym
Health condition
psychostimulantia zonder beoogd effect op aandoening bij adolescenten
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
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 outcome
Results of a short questionnaire which will be taken after completion of the
neurocognitive tasks on how volunteers experienced participation.
Background summary
Children and adolescents are increasingly involved in clinical drug trials
because of the recent intensification of pediatric drug research following the
adoption and implementation of the new EU pediatric regulation. Therefore,
there is a need to educate them about the need for and procedures involving
clinical drug trials in children. Ultimately, children and adolescents learn
most about these issues by being involved themselves at several levels/phases
of this type of research, from being participants to being project team
members.
This study will therefore be conducted as an educational class experiment (as
part of the Pre University College Research Program) on the effects of
caffeine. Caffeine is a compound familiar to most adolescents. This class
experiment provides them with the opportunity to learn more about the
biological effects of psychostimulants, like caffeine, in humans. There is an
increase in use of other compounds with effects of central stimulation (like
methylphenidate) among adolescents. Information about effect profiles of these
compounds is limited, however, and there is a general lack of quantitative
measurements that allow the evaluation of individual responses and CNS side
effects that may affect learning or brain development.
For this educational class experiment, caffeine (1,3,7-trimethylxanthine) is a
good candidate as a model compound to investigate the effects of a stimulants
in adolescents, as it is safe (even in very large doses) and the world*s most
commonly consumed stimulant (Barone and Roberts 1996). There has been extensive
research on the behavioral effects of caffeine (Lieberman 1992; Smith 2002,
2005a).
The aims of this study are twofold: (1) Educating children by involving them in
clinical drug studies; (2) Identification and validation of predictive efficacy
and safety biomarkers that can be used for classes of CNS-stimulant drugs. PK
sampling for caffeine will be done non-invasively in saliva. CNS-profiling will
be done using a validated non-invasive neuropsychological test battery
(Neurocart). If possible, PK/PD relationships will be described and factors
attributing to heterogeneity of the effects will be investigated.
Study objective
- To educate adolescents on clinical drug studies by involving them as project
team members and participants in an intervention trial of negligible risk and
minimal burden;
- To investigate the CNS effects of caffeine on neurocognitive and psychomotor
functioning;
- To investigate the effects of caffeine on the autonomic nervous system;
- To describe the drug concentrations of caffeine in saliva;
- To describe the PK/PD relationship using the obtained saliva samples;
- To evaluate how adolescents have experienced trial participation.
Study design
Randomized, placebo-controlled, double-blind cross-over study with treatment
arms (1) caffeine (caffeinated Nespresso beverage); (2) placebo (decaffeinated
Nespresso beverage). There will be a wash-out period of at least 3 days between
occasions.
Intervention
Caffeine (approximately 135 mg caffeine in Nespresso coffee) or placebo (<10 mg
caffeine in decaffeinated Nespresso coffee).
Study burden and risks
Children participating in this trial will be asked to come to CHDR for two
measurement days each lasting approximately 8 hours. To prevent unnecessary
school absence, these measurement days will be planned on weekend days, during
holiday periods or on days that are considered to be suitable by the parents,
school and the adolescent.
At each measurement day the participants will be requested to complete 9
measurement sessions of approximately 20 min. The time between the sessions can
be spent with the other volunteers and/or parents in a room, where
entertainment like game consoles, DVD player and computers with internet access
is available. Staff experienced in working with adolescents will be present to
supervise and entertain the volunteers. Food and beverages will be provided.
The duration of study days is comparable to the duration of a day in school.
Additionally, all measurements are non-invasive. This study therefore is below
the threshold of minimal burden.
When a volunteer displays resistance against any study related activity, the
*Gedragscode verzet minderjarigen* (Code of conduct in case of resistance in
minors) will be followed.
Caffeine has few unwanted side effects and is safe even in very large doses.
All measurements will be without imposing risk on the volunteer. Therefore, the
risk related to participating in this study is considered to be minimal.
Zernikedreef 10
2333 CL Leiden
Nederland
Zernikedreef 10
2333 CL Leiden
Nederland
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL30680.000.09 |