Simulated Driving PerformanceNCT00720551
Calibration and Validation of the STISIM Driving Simulator
A study testing alcohol in people with Simulated Driving Performance, run by Utrecht Institute for Pharmaceutical Sciences at 1 site in Netherlands.
Trial summary
The aim of this study is to calibrate the STISIM driving simulator under influence of three different dosages of ethanol (0.05%, 0.08% and 0.11% BAC). The levels of performance decrement for the three blood alcohol concentrations will serve as a standard for comparing the effects that will be observed with… Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Simulated Driving Performance
- What is being tested?
- alcohol
- How many people
- 27 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2008to Feb 2009
- 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 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-50 years old
- Written informed consent
- Normal static binocular acuity, corrected or uncorrected
- Normal hearing
- Social Drinker (average of 7 to 21 alcoholic drinks per week and experience with drinking 4-6 drinks per occasion)
- No current or past drug use
- Possession of a driver's license for at least 3 years
- Be considered as reliable and mentally capable of adhering to the protocol
Who cannot join
- Current and past drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates)
- Positive urine pregnancy screen in women
- Present use of psychoactive medication
- Positive alcohol breath test
- Prior enrollment in the same study
- Physical or mental illness
Show all 10Show fewer
- Excessive alcohol use ( > 21 alcoholic drinks per week)
- Excessive smoking (more than 10 cigarettes per day)
- Intake of caffeine-containing beverages over 5 glasses per day
- Simulator sickness, as determined during the training session
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Utrecht University, Section Psychopharmacology
Utrecht, 3508 TB
About this study
Official title: Calibration and Validation of the STISIM Driving Simulator: Simulated Driving Performance Under the Influence of Alcohol (0.05%, 0.08% AND 0.11%), and Placebo
The aim of this study is to calibrate the STISIM driving simulator under influence of three different dosages of ethanol (0.05%, 0.08% and 0.11% BAC). The levels of performance decrement for the three blood alcohol concentrations will serve as a standard for comparing the effects that will be observed with psychoactive drugs in future trials. This will make the results of these future studies more easily to interpret and will provide health care providers and policy makers who read our scientific work with an easy-to-understand and clinically relevant comparison.
- Conditions
- Simulated Driving Performance
- Being tested
- alcohol
- Keywords
- STISIM, Alcohol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alcoholOther
alcohol 0.05%, 0.08% or 0.11% or placebo
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard Deviation of the Lateral Position (SDLP)
Measured: one day
Secondary outcomes (1)
Number of collisions and traffic violations
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Simulated Driving PerformanceStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Utrecht Institute for Pharmaceutical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Joris C Verster, PhD, Principal investigator, Utrecht UniversityLieke M de Senerpont Domis, MSc, Study director, Utrecht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720551
- Sponsor's protocol ID
- 07-374
- Status last verified
- Feb 2009
- First submitted
- 18 Jul 2008
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Mets MA, Kuipers E, de Senerpont Domis LM, Leenders M, Olivier B, Verster JC. Effects of alcohol on highway driving in the STISIM driving simulator. Hum Psychopharmacol. 2011 Aug;26(6):434-9. doi: 10.1002/hup.1226. Epub 2011 Aug 5.
PubMed 21823173
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibration and Validation of the STISIM Driving Simulator: Simulated Driving Performance Under the Influence of Alcohol (0.05%, 0.08% AND 0.11%), and Placebo
- ClinicalTrials.gov ID
- NCT00720551
- Acronym / sponsor ID
- 07-374
- Conditions
- Simulated Driving Performance
- Keywords
- STISIM, Alcohol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Utrecht Institute for Pharmaceutical SciencesUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 22 Jul 2008 (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.
The aim of this study is to calibrate the STISIM driving simulator under influence of three different dosages of ethanol (0.05%, 0.08% and 0.11% BAC). The levels of performance decrement for the three blood alcohol concentrations will serve as a standard for comparing the effects that will be observed with psychoactive drugs in future trials. This will make the results of these future studies more easily to interpret and will provide health care providers and policy makers who read our scientific work with an easy-to-understand and clinically relevant comparison.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 21-50 years old
- Written informed consent
- Normal static binocular acuity, corrected or uncorrected
- Normal hearing
- Social Drinker (average of 7 to 21 alcoholic drinks per week and experience with drinking 4-6 drinks per occasion)
Key exclusion criteria (10 listed)
- Current and past drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates)
- Positive urine pregnancy screen in women
- Present use of psychoactive medication
- Positive alcohol breath test
- Prior enrollment in the same study
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 |
|---|---|---|
| alcoholalcohol 0.05%, 0.08% or 0.11% or placebo | Other | – |
Primary outcome
Standard Deviation of the Lateral Position (SDLP)
Time frame: one day
1 secondary outcome
Number of collisions and traffic violations
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2009.
- Derived from this study: PubMed 21823173Mets MA, Kuipers E, de Senerpont Domis LM, Leenders M, Olivier B, Verster JC. Effects of alcohol on highway driving in the STISIM driving simulator. Hum Psychopharmacol. 2011 Aug;26(6):434-9. doi: 10.1002/hup.1226. Epub 2011 Aug 5.
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.
Joris C Verster, PhD principal investigator
Utrecht University
Lieke M de Senerpont Domis, MSc study director
Utrecht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alcohol in people with Simulated Driving Performance, run by Utrecht Institute for Pharmaceutical Sciences at 1 site in Netherlands.
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 8 inclusion and 10 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: finished, as of the sponsor's last update on 13 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the Lateral Position (SDLP) (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00720551, which also lists 1 linked publication.
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 Feb 2009.