Automobile DrivingNCT01257165
Driving Simulator Performance After Intake of Zopiclone Sleeping Pills
A study testing Zopiclone and Ethanol in people with Automobile Driving, run by St. Olavs Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Automobile Driving
- What is being tested?
- Zopiclone and Ethanol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Caucasian ethnicity
- Age 25-35 years
- Possession of a driver's licence for at least five years
Who cannot join
- 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)
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- 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:
- Smoker? yes 0, no 1
- History of nausea and/or vomiting following surgery, dental treatment, injections or similar procedures? yes 0, no 1
- History of car sickness after 10 years of age? yes 0, no 1
- A score of two or more points excludes participation.
About this study
Official title: 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.
- Conditions
- Automobile Driving
- Being tested
- Zopiclone, Ethanol, Placebo pill, Placebo drink
- Keywords
- Automobile driving, Zopiclone, Drug safety, Traffic accidents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZopicloneDrug
Also called Imovane, Zopiklon, Zopiclon
Zopiclone pill 5 or 10 mg, given orally as a single dose.
EthanolDrug
Also called Alcohol, Ethyl alcohol
50 mg per 70 kg body weight, given orally as a single dose
Placebo pillDrug
Placebo pill identical to zopiclone pill, given orally as a single dose
Placebo drinkDrug
Placebo drink, given orally as a single dose
| Study group | Role | What they receive |
|---|---|---|
| Zopiclone 5 mg | Experimental | Zopiclone 5 mg pill + placebo pill + placebo drink Receives: Drug: Zopiclone; Drug: Placebo pill; Drug: Placebo drink |
| Zopiclone 10 mg | Experimental | 2 x zopiclone 5 mg pills + placebo drink Receives: Drug: Zopiclone; Drug: Placebo drink |
| Ethanol 0.8 g/L | Active comparator | 2 x placebo pills + ethanol 50 g/70 kg Receives: Drug: Ethanol; Drug: Placebo pill |
| Placebo | Placebo comparator | 2 x placebo pills + placebo drink Receives: Drug: Placebo pill; Drug: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard deviation of lateral position (SDLP) on road
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.
Measured: 1 h after intake of study medication (during a 30 min driving simulator test session)
Standard deviation of lateral position (SDLP) on road
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
Measured: 3,5 hrs after intake of study medication (during a 30 min driving simulator test session)
Standard deviation of lateral position (SDLP) on road
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
Measured: 6,5 hrs after intake of study medication (during a 30 min driving simulator test session)
Secondary outcomes (7)
Average speed
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
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".
Measured: 1,5 hrs, 4 hrs and 7 hrs after intake of study medication (after driving simulator test sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startAug 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Automobile DrivingStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SINTEF Health Research, Norwegian University of Science and Technology, Norwegian Institute of Public Health
- Responsible party
- Sponsor
- Investigators
- Lars J Slørdal, MD, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257165
- Sponsor's protocol ID
- 60R020.05
- Status last verified
- Dec 2013
- First submitted
- 29 Nov 2010
- Last updated
- 13 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Simulator Performance Related to Serum Concentrations of the Benzodiazepine-like Hypnotic Zopiclone
- ClinicalTrials.gov ID
- NCT01257165
- Acronym / sponsor ID
- 60R020.05
- Conditions
- Automobile Driving
- Keywords
- Automobile driving, Zopiclone, Drug safety, Traffic accidents
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- SINTEF Health Research, Norwegian University of Science and Technology, Norwegian Institute of Public Health
- Study start
- Aug 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Zopiclone 5 mg | Experimental | Drug: Zopiclone, Drug: Placebo pill, Drug: Placebo drinkZopiclone 5 mg pill + placebo pill + placebo drink |
| Zopiclone 10 mg | Experimental | Drug: Zopiclone, Drug: Placebo drink2 x zopiclone 5 mg pills + placebo drink |
| Ethanol 0.8 g/L | Active comparator | Drug: Ethanol, Drug: Placebo pill2 x placebo pills + ethanol 50 g/70 kg |
| Placebo | Placebo comparator | Drug: Placebo pill, Drug: Placebo drink2 x placebo pills + placebo drink |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Caucasian ethnicity
- Age 25-35 years
- Possession of a driver's licence for at least five years
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZopicloneAlso: Imovane, Zopiklon, ZopiclonZopiclone pill 5 or 10 mg, given orally as a single dose. | Drug | Zopiclone 10 mg, Zopiclone 5 mg |
| EthanolAlso: Alcohol, Ethyl alcohol50 mg per 70 kg body weight, given orally as a single dose | Drug | Ethanol 0.8 g/L |
| Placebo pillPlacebo pill identical to zopiclone pill, given orally as a single dose | Drug | Ethanol 0.8 g/L, Placebo, Zopiclone 5 mg |
| Placebo drinkPlacebo drink, given orally as a single dose | Drug | Placebo, Zopiclone 10 mg, Zopiclone 5 mg |
Primary outcome
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
7 secondary outcomes
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)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars J Slørdal, MD, PhD principal investigator
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Zopiclone and Ethanol in people with Automobile Driving, run by St. Olavs Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2013.