Status:
WITHDRAWN
Driving Simulator Performance After Intake of Zopiclone Sleeping Pills
Lead Sponsor:
St. Olavs Hospital
Collaborating Sponsors:
SINTEF Health Research
Norwegian University of Science and Technology
Conditions:
Automobile Driving
Eligibility:
MALE
25-35 years
Phase:
NA
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 se...
Eligibility Criteria
Inclusion
- Male
- Caucasian ethnicity
- Age 25-35 years
- Possession of a driver's licence for at least five years
Exclusion
- 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:
- Smoker? yes 0, no 1
- History of nausea and/or vomiting following surgery, dental treatment, injections or similar procedures? yes 0, no 1
- History of car sickness after 10 years of age? yes 0, no 1
- A score of two or more points excludes participation.
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01257165
Start Date
August 1 2012
End Date
December 1 2012
Last Update
December 13 2013
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