Primary objective of this study is to assess the acute dose dependent effects of single doses of oxazepam (10 mg and 30 mg) on driving performance and compare it with a single dose of diazepam 10 mg and placebo.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cognitief functioneren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the Standard Deviation of Lateral Position (SDLP in
cm) in the highway driving test.
Secondary outcome
Secondary parameters will be accuracy and/or speed in the following tests:
* Psychomotor Vigilance Test (PVT)
* Critical tracking test (CTT)
* Divided Attention Test (DAT)
* Useful Field of View (UFOV)
* Digit Symbol Substition Test (DSST)
* Postural Balance test (PBT)
* Vienna Test System Determination Test (DT)
* Attention Network Test (ANT)
Background summary
Benzodiazepines, taken as anxiolytics, remain an important pharmacotherapeutic
option to relieve anxiety symptoms. They are generally well-tolerated, but
side-effects such as sedation and impaired psychomotor performance can occur.
Epidemiological data has found significant increases of accident risk with
benzodiazepines, especially within one or two weeks after prescription and with
an increase of dose. Therefore, prescribers and users should be informed about
the potential acute impairing effects of anxiolytics on functioning, such as
driving performance.
In the Netherlands, oxazepam is regarded as the first choice of treatment for
initial relieve of anxiety symptoms. Epidemiological data indicates no increase
of crash risk with oxazepam. However, the acute effects of single doses of
oxazepam on driving performance have not yet been investigated and not much is
known about the impairing effects on cognitive functioning. It is unknown
whether there is a difference between the acute effects of a single low dose of
oxazepam (10 mg) and a single high dose of oxazepam (30 mg) on driving
performance and cognitive functioning.
The acute effects of oxazepam 10 mg and 30 mg will be compared with diazepam 10
mg, which has known impairing effects on driving performance and cognitive
functioning.
Study objective
Primary objective of this study is to assess the acute dose dependent effects
of single doses of oxazepam (10 mg and 30 mg) on driving performance and
compare it with a single dose of diazepam 10 mg and placebo.
Study design
a four-way, double-blind, randomized placebo-controlled, cross-over design to
compare the acute effects of two single doses of oxazepam (10 mg and 30 mg)
with diazepam (10 mg) and placebo on actual driving performance and a range of
cognitive tests.
Intervention
Participants will receive one dose of oxazepam 10 mg, oxazepam 30 mg, diazepam
10 mg, or placebo. Balancing of treatments will be accomplished by randomly
assigning participants to one of the four treatment sequences.
Study burden and risks
Volunteers* health will be assessed before treatment during a screening visit
(1 hour, including an ECG test and assessment of a medical history
questionnaire). Eligible subjects will visit the research unit on six more
occasions. The first two sessions include familiarization and practice of the
performance tests (approximately 3 hours). Subsequently, they will visit four
times for intervention and testing (approximately 7 hours for each condition).
The treatments are oxazepam 10 mg, oxazepam 30 mg, diazepam 10 mg, and
placebo. At the end of testing on intervention days participants will be
transported home by taxi. Total time spent by the participants will be
approximately 32 hours.
Universiteitssingel 40
Maastricht 6229 ER
NL
Universiteitssingel 40
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
- healthy males or females, in the opinion of the medical supervisor, based on a pre-study physical examination, medical history, vital signs, electrocardiogram, and the results of blood chemistry, haematology, and urinalysis
- aged between 23 and 50 years (inclusive)
- BMI between 19 and 29 m2/kg (inclusive)
- possession of a valid driving license for 4 years or more
- driving experience of at least 3000 km per year on average
- good sleepers
- subjects should sign an Informed Consent Form
Exclusion criteria
- history of mental illness
- sleep disorders such as insomnia and narcolepsy
- history of or current drug or alcohol abuse
- current use of psycho-active medication, and inability to stay abstinent during the study
- excessive alcohol use, defined as drinking more than 21 glasses of alcohol per week
- excessive caffeine use, defined as drinking 5 or more cups of coffee per day
- smoking more than 10 cigarettes per day
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-001801-42-NL |
| CCMO | NL49512.068.14 |
| Other | nog niet beschikbaar |