Automobile DrivingVALIDADNCT00967421
Development of a Valid Test Battery for Assessing Driving Ability When Influenced by Drugs.
A study testing ethanol in people with Automobile Driving, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
The purpose of the validation study is to develop a valid test battery for assessing driving ability in a driving simulator when influenced by drugs. Ethanol has known, well-documented and well-characterized effects on driving behaviour and accident risk, and will be used to assess the simulator test scenarios'… Read more about this study
- Who is it for?
- Ages 25 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Automobile Driving
- What is being tested?
- ethanol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2009to Nov 2010
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, caucasian males aged 25-50 years in possession of a valid driver's license for the last 5 years.
- Recreational alcohol drinkers without alcohol dependence or abuse, no traffic-related convictions or alcohol-influenced behavioural disturbances.
- 1 or 0 points on the modified Apfel scale for predicting post-operative nausea/vomiting (non-smoker, previously experienced nausea/vomiting post-operatively, previously experienced motion sickness)
Who cannot join
- Females (risk of teratogenicity)
- Non-caucasian ethnicity (possibility of deviant ethanol metabolism)
- Previous strong reactions such as nausea, fainting etc. during blood sampling
- Previous abnormal reactions to ethanol
- Previous convictions related to drug intoxication
- Previous excessive drug use
- Regular use of prescription drugs
- Two points or more according to the modified Apfel criteria
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the validation study is to develop a valid test battery for assessing driving ability in a driving simulator when influenced by drugs. Ethanol has known, well-documented and well-characterized effects on driving behaviour and accident risk, and will be used to assess the simulator test scenarios' sensitivity to drug effects. Once the test scenarios have been refined and their ability to predict driving accident risk have been validated, we plan to use the simulator to assess driving ability under the influence of different drugs suspected to produce driving impairment.
- Conditions
- Automobile Driving
- Being tested
- ethanol, Placebo drink
- Keywords
- Driving, DUI, Driving simulation, Drugs, Ethanol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethanolDrug
BAC level 0.5 g/dL (drink + placebo pill). Drink with 2,4 grams per kilo body weight, administered orally during 60 min, administration ending 30 min prior to start of testing. Placebo pill.
EthanolDrug
BAC level 1.0 g/dL (drink + placebo pill). Drink with 3,6 grams per kilo body weight, administered orally during 60 min, administration ending 30 min prior to start of testing. Placebo pill.
Placebo drinkOther
Placebo drink containing no alcohol + placebo pill
| Study group | Role | What they receive |
|---|---|---|
| BAC 0.5 | Experimental | BAC level 0.5 g/dL (drink + placebo pill) Receives: Drug: ethanol |
| BAC 1.0 | Experimental | BAC level 1.0 g/dL (drink + placebo pill) Receives: Drug: Ethanol |
| placebo | Placebo comparator | BAC level 0,0 g/dL (placebo drink+ placebo pill) Receives: Other: Placebo drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard deviation of lateral position on road (SDLP)
Measured: Instantly (while the subject is inebriated)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2009
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Automobile DrivingStudies 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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 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 Slørdal, PhD, MD, Principal investigator, Norwegian University of Science and TechnologyGunnar D Jenssen, Principal investigator, SINTEF Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967421
- Sponsor's protocol ID
- ES437291 VALIDAD
- Acronym
- VALIDAD
- Status last verified
- Sep 2017
- First submitted
- 26 Aug 2009
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Helland A, Jenssen GD, Lervag LE, Westin AA, Moen T, Sakshaug K, Lydersen S, Morland J, Slordal L. Comparison of driving simulator performance with real driving after alcohol intake: a randomised, single blind, placebo-controlled, cross-over trial. Accid Anal Prev. 2013 Apr;53:9-16. doi: 10.1016/j.aap.2012.12.042. Epub 2013 Jan 28.
PubMed 23357031Helland A, Jenssen GD, Lervag LE, Moen T, Engen T, Lydersen S, Morland J, Slordal L. Evaluation of measures of impairment in real and simulated driving: Results from a randomized, placebo-controlled study. Traffic Inj Prev. 2016;17(3):245-50. doi: 10.1080/15389588.2015.1065975. Epub 2015 Jul 6.
PubMed 26147898
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Valid Test Battery for Assessing Driving Ability When Influenced by Drugs.
- ClinicalTrials.gov ID
- NCT00967421
- Acronym / sponsor ID
- VALIDAD / ES437291 VALIDAD
- Conditions
- Automobile Driving
- Keywords
- Driving, DUI, Driving simulation, Drugs, Ethanol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 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
- Sep 2009 (actual)
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 27 Aug 2009 (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 purpose of the validation study is to develop a valid test battery for assessing driving ability in a driving simulator when influenced by drugs. Ethanol has known, well-documented and well-characterized effects on driving behaviour and accident risk, and will be used to assess the simulator test scenarios' sensitivity to drug effects. Once the test scenarios have been refined and their ability to predict driving accident risk have been validated, we plan to use the simulator to assess driving ability under the influence of different drugs suspected to produce driving impairment.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BAC 0.5 | Experimental | Drug: ethanolBAC level 0.5 g/dL (drink + placebo pill) |
| BAC 1.0 | Experimental | Drug: EthanolBAC level 1.0 g/dL (drink + placebo pill) |
| placebo | Placebo comparator | Other: Placebo drinkBAC level 0,0 g/dL (placebo drink+ placebo pill) |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, caucasian males aged 25-50 years in possession of a valid driver's license for the last 5 years.
- Recreational alcohol drinkers without alcohol dependence or abuse, no traffic-related convictions or alcohol-influenced behavioural disturbances.
- 1 or 0 points on the modified Apfel scale for predicting post-operative nausea/vomiting (non-smoker, previously experienced nausea/vomiting post-operatively, previously experienced motion sickness)
Key exclusion criteria (8 listed)
- Females (risk of teratogenicity)
- Non-caucasian ethnicity (possibility of deviant ethanol metabolism)
- Previous strong reactions such as nausea, fainting etc. during blood sampling
- Previous abnormal reactions to ethanol
- Previous convictions related to drug intoxication
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 |
|---|---|---|
| ethanolBAC level 0.5 g/dL (drink + placebo pill). Drink with 2,4 grams per kilo body weight, administered orally during 60 min, administration ending 30 min prior to start of testing. Placebo pill. | Drug | BAC 0.5 |
| EthanolBAC level 1.0 g/dL (drink + placebo pill). Drink with 3,6 grams per kilo body weight, administered orally during 60 min, administration ending 30 min prior to start of testing. Placebo pill. | Drug | BAC 1.0 |
| Placebo drinkPlacebo drink containing no alcohol + placebo pill | Other | placebo |
Primary outcome
Standard deviation of lateral position on road (SDLP)
Time frame: Instantly (while the subject is inebriated)
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 2 Oct 2017.
- Results publication: PubMed 23357031Helland A, Jenssen GD, Lervag LE, Westin AA, Moen T, Sakshaug K, Lydersen S, Morland J, Slordal L. Comparison of driving simulator performance with real driving after alcohol intake: a randomised, single blind, placebo-controlled, cross-over trial. Accid Anal Prev. 2013 Apr;53:9-16. doi: 10.1016/j.aap.2012.12.042. Epub 2013 Jan 28.
- Results publication: PubMed 26147898Helland A, Jenssen GD, Lervag LE, Moen T, Engen T, Lydersen S, Morland J, Slordal L. Evaluation of measures of impairment in real and simulated driving: Results from a randomized, placebo-controlled study. Traffic Inj Prev. 2016;17(3):245-50. doi: 10.1080/15389588.2015.1065975. Epub 2015 Jul 6.
Related trials for Automobile Driving
Recruiting
Randomized Trial on Mobile Technology and Young Drivers' Cellphone Use
Cell Phone Use, Automobile Driving
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 Slørdal, PhD, MD principal investigator
Norwegian University of Science and Technology
Gunnar D Jenssen principal investigator
SINTEF Health Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ethanol in people with Automobile Driving, run by St. Olavs Hospital at 1 site in Norway.
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 3 inclusion and 8 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 2 Oct 2017. 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 Norway. 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. 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 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 lateral position on road (SDLP) (time frame: Instantly (while the subject is inebriated)). 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 NCT00967421, which also lists 2 linked publications.
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 2 Oct 2017.