Alcohol calibration study to establish limits for fitness to drive.

The Dutch assessment of driving ability with the use of potentially dangerous
drugs when driving refers to the classification of thet International Council
on Alcohol, Drugs and traffic Safety (ICADTS). Medications are categorized in
class I (safe to drive), class II (be carefull when driving) and class III (do
not drive).
This classification is mainly based on double-blind research in healthy
subjects using the medication only once, or just briefly. There is, however,
insufficient knowledge of everyday effects in chronic users of these drugs. The
Netherlands has a large number of chronic users of ICADTS class III drugs. It
is very likely that the majority of these ambulatory patients also drives the
car.
Being able to determine when a patient is fit to drive despite the use of class
III drugs has major social and economic benefits. Both for the user who then is
fully mobile, but also for society because there is possibly a group of users
that is wrongly declared unfit to drive. If it turns out that they still can
participate in traffic they are better employable in the labor market and less
dependent on others to meet their mobility needs.
Currently, the limit values for the driving ability of the aforementioned Cat.
III drug users are being established (Protocol number NL47435.068.13, EudraCT
number 2013-004936-31).
The research proposed in this protocol to the legal limit of alcohol (e.g. BAC
0.5 mg / ml) on drive ability serves as a reference for the above-mentioned
study on the limits for the fitness to drive of the aforementioned Cat. III
drug users.
Conducting neuropsychological tests, letting people drive in a simulator and on
the public highway, after administration of a dose of alcohol that results in a
BAC of up to 0.5 mg / ml and comparing the results on these tests with the
performance when they are not under the influence of alcohol (eg after
placebo), will create a basic standard. It will be possible to compare the test
results against the performance on the same tests by users of Cat. III drugs in
another study.

The aim is to establish substantiated limit values based on the results of this
study for tests used to determine driving ability in another study conducted
with Cat. III drug users.

In addition to a training day, there will be a double-blind randomized trial of
two test days, in which alcohol (BAC 0.5 mg / ml) or placebo-alcohol is
administered.

Alcohol (amount related to sex, age, size and weight, in order to achieve a BAC
of 0.5 mg/ml) and placebo-alcohol.

There are for participants no benefits to expect from participation. Except
that they will be compensated for their participation with an amount of 120
euros plus travel expenses.
The disadvantages to the subject are:
1. The time they spend with participation in the research and medical
examinations. Each volunteer comes to the test center three times. A time for a
training and twice for a test day. Each day takes about 5 hours.
2. In addition, some participants can get simulator sickness while driving in
the simulator (similar to motion sickness). This is told in advance and they
will be closely monitored while driving. It is made clear that they can stop
the investigation at any time.
There are no anticipated risks to participants in this study. For the following
reasons
1. Only healthy volunteers will be enrolled.
2. The administered dose of alcohol is relatively low and participants are
accustomed to drink this amount of alcohol in everyday life. We therefore
expect no serious adverse events during their participation.