The levels of performance decrement for the three blood alcohol concentrations will serve as a historical control for comparing the effects that will be observed with psychoactive drugs in future trials. This will make the results of these future…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
alcoholgebruik
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
weaving of the car and number of errors/collisions
Secondary outcome
driving quality questionnaires
Background summary
Driving is an example of complex behavior in which several skills and abilities
are required simultaneously. In this study, driving performance will be tested
utilizing a STISIM Drive simulator (Systems Technology, Hawthorne, CA).
Study objective
The levels of performance decrement for the three blood alcohol concentrations
will serve as a historical control for comparing the effects that will be
observed with psychoactive drugs in future trials. This will make the results
of these future studies more easily to interpret and will provide health care
providers and policy makers who read our scientific work with an
easy-to-understand and clinically relevant comparison, since most people are
more familiar with the effects of alcohol on human performance when compared to
psychotropic drugs.
Study design
single blind, cross-over
Intervention
alcohol (0.05%, 0.08%, and 0.11%) and placebo
Study burden and risks
there is no benefit for participants. There is also no risk: alcohol levels are
relatively low and performance is tested in a simulator.
PoBox 80082
3508 TB Utrecht
Nederland
PoBox 80082
3508 TB Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- 21-50 years old
- Written informed consent (see appendix B)
- Normal static binocular acuity, corrected or uncorrected
- Normal hearing
- Social Drinker (average of 7 to 21 alcoholic drinks per week and experience with drinking 4-6 drinks per occasion)
- Possession of a driver*s license for at least 3 years
- Be considered as reliable and mentally capable of adhering to the protocol.
Exclusion criteria
- Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates)
- Positive urine pregnancy screen in women
- Present or past use of psychoactive medication
- Positive alcohol breath test
- Prior enrolment in the same study
- Physical or mental illness
- Excessive alcohol use (>21 alcoholic drinks per week)
- Excessive smoking (more than 10 cigarettes per day)
- Intake of caffeine-containing beverages over 5 glasses per day
- Simulator sickness, as determined during the training session
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 | NL21124.041.07 |