Clinical trial NCT01257165: Driving Simulator Performance After Intake of Zopiclone Sleeping Pills
Official title: Driving Simulator Performance Related to Serum Concentrations of the Benzodiazepine-like Hypnotic Zopiclone
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Automobile Driving
Keywords: Automobile driving
Zopiclone
Drug safety
Traffic accidents
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: SINTEF Health Research
name: Norwegian University of Science and Technology
name: Norwegian Institute of Public Health
First posted: 2010-12-09
Enrollment: 0
Sex: MALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Standard deviation of lateral position (SDLP) on road
timeFrame: 1 h after intake of study medication (during a 30 min driving simulator test session)
measure: Standard deviation of lateral position (SDLP) on road
timeFrame: 3,5 hrs after intake of study medication (during a 30 min driving simulator test session)
measure: Standard deviation of lateral position (SDLP) on road
timeFrame: 6,5 hrs after intake of study medication (during a 30 min driving simulator test session)
Secondary outcomes:
measure: Average speed
timeFrame: 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session)
measure: Standard deviation of speed
timeFrame: 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session)
measure: Frequency of brake pedal pressures
timeFrame: 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session)
measure: Frequency of accelerator pedal pressures
timeFrame: 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session)
measure: Steering wheel movement speed and reversal frequency
timeFrame: 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session)
measure: Driving behavior at incidents
timeFrame: 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session)
measure: Clinical test for impairment (CTI)
timeFrame: 1,5 hrs, 4 hrs and 7 hrs after intake of study medication (after driving simulator test sessions)
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology
name: Lars J Slørdal, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: