Automobile Driving
Conditions
Keywords
Automobile driving, Zopiclone, Drug safety, Traffic accidents
Brief summary
Zopiclone, a widely used hypnotic drug, is frequently found in blood samples taken from drivers suspected of driving under the influence. In this study, the investigators aim to correlate zopiclone serum concentrations with degrees of driving impairment in healthy volunteers by use of a validated driving simulator. The investigators also aim to compare their results with the results from a previous study that investigated zopiclone impairment of cognitive and psychometric tests.
Interventions
DRUGZopiclone
Zopiclone pill 5 or 10 mg, given orally as a single dose.
DRUGEthanol
50 mg per 70 kg body weight, given orally as a single dose
DRUGPlacebo pill
Placebo pill identical to zopiclone pill, given orally as a single dose
DRUGPlacebo drink
Placebo drink, given orally as a single dose
Sponsors
St. Olavs Hospital
SINTEF Health Research
Norwegian University of Science and Technology
Norwegian Institute of Public Health
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
25 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Male * Caucasian ethnicity * Age 25-35 years * Possession of a driver's licence for at least five years
Exclusion criteria
* Score ≥ 2 on the modified Apfel-scale to assess risk for motion sickness(\*) * History of driving under the influence of alcohol and/or illicit substances * History or presence of alcohol or illicit drug abuse * Former abnormal reaction to any hypnotic drug * History of strong averse reactions to blood sampling procedures * Regular (daily) intake of any prescribed drug, or intake of grapefruit juice or herbal remedies that can influence the metabolism of zopiclone (e.g. St John's wort) * History of severe allergic reactions, or significant mental, cardiovascular, renal or hepatic disorder, or other significant disease as judged by the investigators * Detection of any drugs of abuse on pre-session urine drug screening (\*)Modified Apfel-criteria for prediction of postoperative nausea/vomiting: 1. Smoker? yes 0, no 1 2. History of nausea and/or vomiting following surgery, dental treatment, injections or similar procedures? yes 0, no 1 3. History of car sickness after 10 years of age? yes 0, no 1 A score of two or more points excludes participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard deviation of lateral position (SDLP) on road | 1 h after intake of study medication (during a 30 min driving simulator test session) | SDLP is a measure that quantifies the extent of car weaving while driving. It has been shown to correlate well with blood alcohol concentrations, and traffic accident risk. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standard deviation of speed | 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) | — |
| Frequency of brake pedal pressures | 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) | — |
| Frequency of accelerator pedal pressures | 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) | — |
| Average speed | 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) | — |
| Driving behavior at incidents | 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) | — |
| Clinical test for impairment (CTI) | 1,5 hrs, 4 hrs and 7 hrs after intake of study medication (after driving simulator test sessions) | The Norwegian CTI is a 25-item clinical test that is administered by physicians on subjects suspected of driving under the influence of drugs. The test conclusion is either impaired or not impaired. |
| Steering wheel movement speed and reversal frequency | 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) | — |
Outcome results
None listed