Driving Simulator Performance After Intake of Zopiclone Sleeping Pills

December 12, 2013 updated by: St. Olavs Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: Placebo pill
Placebo pill identical to zopiclone pill, given orally as a single dose
Drug: Ethanol
50 mg per 70 kg body weight, given orally as a single dose
Other Names:
  • Alcohol
  • Ethyl alcohol
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 h after intake of study medication (during a 30 min driving simulator test session)
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
3,5 hrs after intake of study medication (during a 30 min driving simulator test session)
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
6,5 hrs after intake of study medication (during a 30 min driving simulator test session)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
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)
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)
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)
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)
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".
1,5 hrs, 4 hrs and 7 hrs after intake of study medication (after driving simulator test sessions)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Olavs Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Norwegian Institute of Public Health
Norwegian University of Science and Technology
SINTEF Health Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lars J Slørdal, MD, PhD, Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 60R020.05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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