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| Name | Class |
|---|---|
| SINTEF Health Research | OTHER |
| Norwegian University of Science and Technology | OTHER |
| Norwegian Institute of Public Health | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAC 0.5 | Experimental | BAC level 0.5 g/dL (drink + placebo pill) |
|
| BAC 1.0 | Experimental | BAC level 1.0 g/dL (drink + placebo pill) |
|
| placebo | Placebo Comparator | BAC level 0,0 g/dL (placebo drink+ placebo pill) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ethanol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Standard deviation of lateral position on road (SDLP) | Instantly (while the subject is inebriated) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Slørdal, PhD, MD | Norwegian University of Science and Technology | Principal Investigator |
| Gunnar D Jenssen | SINTEF Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SINTEF Health and Research | Trondheim | 7465 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23357031 | Result | 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. | |
| 26147898 |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Ethanol | Drug | 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 drink | Other | Placebo drink containing no alcohol + placebo pill |
|
| Helland 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. |