Driving Simulator Performance After Intake of Zopiclone Sleeping Pills

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Automobile Driving
• Intervention / Treatment: Drug: Zopiclone; Drug: Placebo pill; Drug: Placebo drink; Drug: Ethanol

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zopiclone 5 mg; Zopiclone 5 mg pill + placebo pill + placebo drink	Drug: Zopiclone; Zopiclone pill 5 or 10 mg, given orally as a single dose.; Other Names: Imovane; Zopiklon; Zopiclon; 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
Experimental: Zopiclone 10 mg; 2 x zopiclone 5 mg pills + placebo drink	Drug: Zopiclone; Zopiclone pill 5 or 10 mg, given orally as a single dose.; Other Names: Imovane; Zopiklon; Zopiclon; Drug: Placebo drink; Placebo drink, given orally as a single dose
Active Comparator: Ethanol 0.8 g/L; 2 x placebo pills + ethanol 50 g/70 kg	Drug: Placebo pill; Placebo pill identical to zopiclone pill, given orally as a single dose; Drug: Ethanol; 50 mg per 70 kg body weight, given orally as a single dose; Other Names: Alcohol; Ethyl alcohol
Placebo Comparator: Placebo; 2 x placebo pills + placebo drink	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: St. Olavs Hospital
• Collaborators: Norwegian Institute of Public Health; Norwegian University of Science and Technology; SINTEF Health Research
• Investigators: Principal Investigator: Lars J Slørdal, MD, PhD, Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: November 29, 2010
• First Submitted That Met QC Criteria: December 8, 2010
• First Posted (Estimate): December 9, 2010

Study Record Updates

• Last Update Posted (Estimate): December 13, 2013
• Last Update Submitted That Met QC Criteria: December 12, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Automobile driving; Zopiclone; Drug safety; Traffic accidents
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Central Nervous System Depressants; Hypnotics and Sedatives; Ethanol; Zopiclone
• Other Study ID Numbers: 60R020.05