Driving Simulator Performance After Intake of Zopiclone Sleeping Pills

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
SINTEF Health Research
Norwegian University of Science and Technology
Norwegian Institute of Public Health
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01257165
First received: November 29, 2010
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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 Intervention
Automobile Driving
Drug: Zopiclone
Drug: Ethanol
Drug: Placebo pill
Drug: Placebo drink

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Driving Simulator Performance Related to Serum Concentrations of the Benzodiazepine-like Hypnotic Zopiclone

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3,5 hrs after intake of study medication (during a 30 min driving simulator test session) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 h, 3,5 hrs and 6,5 hrs after intake of study medication (during a 30 min driving simulator test session) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
    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".


Enrollment: 0
Study Start Date: August 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 35 Years
Genders 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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01257165     History of Changes
Other Study ID Numbers: 60R020.05
Study First Received: November 29, 2010
Last Updated: December 12, 2013
Health Authority: Norway: Regional Ethics Commitee

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

Additional relevant MeSH terms:
Ethanol
Zopiclone
Contraceptives, Oral
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on August 21, 2014