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Completed

NCT Number: NCT00967421

Development of a Valid Test Battery for Assessing Driving Ability When Influenced by Drugs.

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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Key information

Conditions

Automobile Driving

Age range

25 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

SINTEF Health and Research

Trondheim, 7465, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Placebo drink

Other

Placebo drink containing no alcohol + placebo pill

Primary outcomes

  1. Standard deviation of lateral position on road (SDLP)

    Time frame: Instantly (while the subject is inebriated)

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Norwegian Institute of Public Health
  • Norwegian University of Science and Technology
  • SINTEF Health Research

Registry information

Acronym: VALIDAD

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Aug 27, 2009
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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