Driving Simulator Performance After Intake of Zopiclone Sleeping Pills

Overview

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.

Full Title of Study: “Driving Simulator Performance Related to Serum Concentrations of the Benzodiazepine-like Hypnotic Zopiclone”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2012

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Zopiclone 5 mg
    • Zopiclone 5 mg pill + placebo pill + placebo drink
  • Experimental: Zopiclone 10 mg
    • 2 x zopiclone 5 mg pills + placebo drink
  • Active Comparator: Ethanol 0.8 g/L
    • 2 x placebo pills + ethanol 50 g/70 kg
  • Placebo Comparator: Placebo
    • 2 x placebo pills + placebo drink

Clinical Trial Outcome Measures

Primary 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)
    • 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)
    • 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)
    • 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 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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)
  • 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”.

Participating in This Clinical Trial

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.

Gender Eligibility: Male

Minimum Age: 25 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • St. Olavs Hospital
  • Collaborator
    • SINTEF Health Research
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lars J Slørdal, MD, PhD, Principal Investigator, Norwegian University of Science and Technology

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