Driving Simulator Performance After Intake of Zopiclone Sleeping Pills

Automobile Driving Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01257165
• Other study ID #: 60R020.05
• Status: Withdrawn
• Phase: N/A
• First received: November 29, 2010
• Last updated: December 12, 2013
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Automobile Driving

Intervention

Drug:
• Zopiclone
Zopiclone pill 5 or 10 mg, given orally as a single dose.
• Ethanol
50 mg per 70 kg body weight, given orally as a single dose
• Placebo pill
Placebo pill identical to zopiclone pill, given orally as a single dose
• Placebo drink
Placebo drink, given orally as a single dose

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian Institute of Public Health, Norwegian University of Science and Technology, SINTEF Health Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Primary	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)	Yes
Primary	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)	Yes
Secondary	Average speed		1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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)	Yes