Alcohol calibration study to establish limits for fitness to drive.

Completed

• Conditions: het betreft gezonde vrijwilligers die alcohol toegediend krijgen; n.a.

• Registration Number: NL-OMON42508
• Lead Sponsor: Ministerie van Infrastructuur en Milieu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 99

Inclusion Criteria

- A BMI between 19 and 29 m2/kg (BMI Classification. Global Database on Body Mass Index. World Health Organization. 2006)
- Minimum 5 years in possession of a valid driving license
- Minimal driving experience of on average 3,000 km/year
- Sufficient visual acuity (defined as a score of at least 0.5 on the SnellenCard).
- Age from 23 to 75 years. The lower age limit is set at 23 years, so there no participants with an initial drivers license are included. The legal alcohollimit is actually lower for the initial license (0.2 instead of 0.5 per mille per mille). The upper limit is set at 75 years, since over 75 years the risk of neurological disorders greatly increases.
- Alcohol consumption of 3 or more glasses of alcohol/week.

Exclusion Criteria

- Presence of a neurological and psychiatric disorder (for example, Alzheimer's Disease, Parkinson's Disease, sleep disorders, etc.)
- Medication use (with the exception of the contraceptive pill and paracetamol)
- Drug use
- Excessive alcohol consumption (defined as> 21 units of alcohol/week)
- Smoking on average > 10 cigarettes / day
- Female participants may not be pregnant (this is checked by means of a pregnancy test) or bebreastfeeding.
- In possession of an initial drivers license.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure in this study is the Standard Deviation of Lateral<br /><br>Position (SDLP, in cm) of the Highway Driving test conducted on public roads.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcome measures will be the results on the following cognitive<br /><br>tests:<br /><br>- Trailmaking A en B<br /><br>- Digit Symbol Substitution Test<br /><br>- Adaptive Tachistoscopic Traffic Perception Test (ATTPT)<br /><br>- Reaction Test<br /><br>- Determination Test<br /><br>- Vienna Risk-Taking Test Traffic<br /><br>- Psychomotor Vigilance Taak<br /><br>- Driving simulator tests (Swingdrive (fixed en free speed), Intersections,<br /><br>Merging, Vigilantie-SDLP)</p><br>