Driving Simulator Performance After Intake of Zopiclone Sleeping Pills

Not Applicable

Withdrawn

• Conditions: Automobile Driving
• Interventions: Drug: Zopiclone; Drug: Ethanol; Drug: Placebo pill; Drug: Placebo drink

• Registration Number: NCT01257165
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-29
• Study First Submitted QC: 2010-12-08
• Study First Posted: 2010-12-09
• Study Start: 2012-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-12
• Last Update Posted: 2013-12-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Zopiclone 5 mg	Zopiclone	Zopiclone 5 mg pill + placebo pill + placebo drink
Zopiclone 5 mg	Placebo pill	Zopiclone 5 mg pill + placebo pill + placebo drink
Zopiclone 5 mg	Placebo drink	Zopiclone 5 mg pill + placebo pill + placebo drink
Zopiclone 10 mg	Zopiclone	2 x zopiclone 5 mg pills + placebo drink
Zopiclone 10 mg	Placebo drink	2 x zopiclone 5 mg pills + placebo drink
Ethanol 0.8 g/L	Ethanol	2 x placebo pills + ethanol 50 g/70 kg
Ethanol 0.8 g/L	Placebo pill	2 x placebo pills + ethanol 50 g/70 kg
Placebo	Placebo pill	2 x placebo pills + placebo drink
Placebo	Placebo drink	2 x placebo pills + placebo drink

Primary Outcome Measures

Name	Time	Method
Standard deviation of lateral position (SDLP) on road	6,5 hrs after intake of study medication (during a 30 min driving simulator test session)	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

Secondary Outcome Measures

Name	Time	Method
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)
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 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)	1,5 hrs, 4 hrs and 7 hrs after intake of study medication (after driving simulator test sessions)	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".