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| Name | Class |
|---|---|
| SINTEF Health Research | OTHER |
| Norwegian University of Science and Technology | OTHER |
| Norwegian Institute of Public Health | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zopiclone 5 mg | Experimental | Zopiclone 5 mg pill + placebo pill + placebo drink |
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| Zopiclone 10 mg | Experimental | 2 x zopiclone 5 mg pills + placebo drink |
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| Ethanol 0.8 g/L | Active Comparator | 2 x placebo pills + ethanol 50 g/70 kg |
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| Placebo | Placebo Comparator | 2 x placebo pills + placebo drink |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zopiclone | Drug | Zopiclone pill 5 or 10 mg, given orally as a single dose. |
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| Measure | Description | Time Frame |
|---|---|---|
| Standard deviation of lateral position (SDLP) on road | 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. | 1 h after intake of study medication (during a 30 min driving simulator test session) |
| Standard deviation of lateral position (SDLP) on road | 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 | 3,5 hrs after intake of study medication (during a 30 min driving simulator test session) |
| Standard deviation of lateral position (SDLP) on road | 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 | 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) |
| Measure | Description | Time Frame |
|---|---|---|
| Average speed | 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) | |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
(*)Modified Apfel-criteria for prediction of postoperative nausea/vomiting:
A score of two or more points excludes participation.
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| Name | Affiliation | Role |
|---|---|---|
| Lars J Slørdal, MD, PhD | Norwegian University of Science and Technology | Principal Investigator |
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| ID | Term |
|---|---|
| C515050 | zopiclone |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Ethanol | Drug | 50 mg per 70 kg body weight, given orally as a single dose |
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| Placebo pill | Drug | Placebo pill identical to zopiclone pill, given orally as a single dose |
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| Placebo drink | Drug | Placebo drink, given orally as a single dose |
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| 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) |
| 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) |
| 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) | 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". | 1,5 hrs, 4 hrs and 7 hrs after intake of study medication (after driving simulator test sessions) |