Driving Simulator Performance After Intake of Zopiclone Sleeping Pills

Sponsor

St. Olavs Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01257165

Collaborator

SINTEF Health Research (Other), Norwegian University of Science and Technology (Other), Norwegian Institute of Public Health (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Automobile Driving	Drug: Zopiclone Drug: Ethanol Drug: Placebo pill Drug: Placebo drink	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Official Title:

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

Study Start Date :

Aug 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

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: Ethanol 50 mg per 70 kg body weight, given orally as a single dose Other Names: Alcohol Ethyl alcohol Drug: Placebo pill Placebo pill identical to zopiclone pill, given orally as a single dose
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

Outcome Measures

Primary Outcome Measures

Standard deviation of lateral position (SDLP) on road [1 h 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.
Standard deviation of lateral position (SDLP) on road [3,5 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
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

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) [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".

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 35 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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:

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.