NCT01257165

Driving Simulator Performance After Intake of Zopiclone Sleeping Pills

Driving Simulator Performance Related to Serum Concentrations of the Benzodiazepine-like Hypnotic Zopiclone

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: St. Olavs Hospital · Academic / Other
• Sex: Male
• Age: 25 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Automobile Driving

Interventions

Type	Name	Description
DRUG	Zopiclone	Zopiclone pill 5 or 10 mg, given orally as a single dose.
DRUG	Ethanol	50 mg per 70 kg body weight, given orally as a single dose
DRUG	Placebo pill	Placebo pill identical to zopiclone pill, given orally as a single dose
DRUG	Placebo drink	Placebo drink, given orally as a single dose

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-12-09
• Last updated: 2013-12-13