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Driving Simulator Performance After Intake of Zopiclone Sleeping Pills

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ClinicalTrials.gov Identifier: NCT01257165
Recruitment Status : Withdrawn
First Posted : December 9, 2010
Last Update Posted : December 13, 2013
Sponsor:
Collaborators:
SINTEF Health Research
Norwegian University of Science and Technology
Norwegian Institute of Public Health
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Automobile Driving Drug: Zopiclone Drug: Ethanol Drug: Placebo pill Drug: Placebo drink Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : August 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

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




Primary Outcome Measures :
  1. Standard deviation of lateral position (SDLP) on road [ Time Frame: 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.

  2. Standard deviation of lateral position (SDLP) on road [ Time Frame: 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

  3. Standard deviation of lateral position (SDLP) on road [ Time Frame: 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 :
  1. Average speed [ Time Frame: 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) ]
  2. Standard deviation of speed [ Time Frame: 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) ]
  3. Frequency of brake pedal pressures [ Time Frame: 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) ]
  4. Frequency of accelerator pedal pressures [ Time Frame: 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) ]
  5. Steering wheel movement speed and reversal frequency [ Time Frame: 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) ]
  6. Driving behavior at incidents [ Time Frame: 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) ]
  7. Clinical test for impairment (CTI) [ Time Frame: 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".



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Ages Eligible for Study:   25 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257165


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

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01257165     History of Changes
Other Study ID Numbers: 60R020.05
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: December 2013

Keywords provided by St. Olavs Hospital:
Automobile driving
Zopiclone
Drug safety
Traffic accidents

Additional relevant MeSH terms:
Ethanol
Zopiclone
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives