Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.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

November 29, 2010
December 12, 2013
August 2012
December 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01257165 on ClinicalTrials.gov Archive Site
  • 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".
Same as current
Not Provided
Not Provided
 
Driving Simulator Performance After Intake of Zopiclone Sleeping Pills
Driving Simulator Performance Related to Serum Concentrations of the Benzodiazepine-like Hypnotic Zopiclone

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Automobile Driving
  • Drug: Zopiclone
    Zopiclone pill 5 or 10 mg, given orally as a single dose.
    Other Names:
    • Imovane
    • Zopiklon
    • Zopiclon
  • 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
  • Drug: Placebo drink
    Placebo drink, given orally as a single dose
  • Experimental: Zopiclone 5 mg
    Zopiclone 5 mg pill + placebo pill + placebo drink
    Interventions:
    • Drug: Zopiclone
    • Drug: Placebo pill
    • Drug: Placebo drink
  • Experimental: Zopiclone 10 mg
    2 x zopiclone 5 mg pills + placebo drink
    Interventions:
    • Drug: Zopiclone
    • Drug: Placebo drink
  • Active Comparator: Ethanol 0.8 g/L
    2 x placebo pills + ethanol 50 g/70 kg
    Interventions:
    • Drug: Ethanol
    • Drug: Placebo pill
  • Placebo Comparator: Placebo
    2 x placebo pills + placebo drink
    Interventions:
    • Drug: Placebo pill
    • Drug: Placebo drink
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
December 2012
December 2012   (final data collection date for primary outcome measure)

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.

Male
25 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01257165
60R020.05
No
St. Olavs Hospital
St. Olavs Hospital
  • SINTEF Health Research
  • Norwegian University of Science and Technology
  • Norwegian Institute of Public Health
Principal Investigator: Lars J Slørdal, MD, PhD Norwegian University of Science and Technology
St. Olavs Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP