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

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ClinicalTrials.gov Identifier: NCT00967421
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : October 2, 2017
Sponsor:
Collaborators:
SINTEF Health Research
Norwegian University of Science and Technology
Norwegian Institute of Public Health
Information provided by (Responsible Party):
St. Olavs Hospital

Brief 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' 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.

Condition or disease Intervention/treatment Phase
Automobile Driving Drug: ethanol Drug: Ethanol Other: Placebo drink Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Development of a Valid Test Battery for Assessing Driving Ability When Influenced by Drugs.
Actual Study Start Date : September 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2010

Arm Intervention/treatment
Experimental: BAC 0.5
BAC level 0.5 g/dL (drink + placebo pill)
Drug: ethanol
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.
Experimental: BAC 1.0
BAC level 1.0 g/dL (drink + placebo pill)
Drug: Ethanol
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 Comparator: placebo
BAC level 0,0 g/dL (placebo drink+ placebo pill)
Other: Placebo drink
Placebo drink containing no alcohol + placebo pill



Primary Outcome Measures :
  1. Standard deviation of lateral position on road (SDLP) [ Time Frame: Instantly (while the subject is inebriated) ]


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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967421


Locations
Norway
SINTEF Health and Research
Trondheim, Norway, 7465
Sponsors and Collaborators
St. Olavs Hospital
SINTEF Health Research
Norwegian University of Science and Technology
Norwegian Institute of Public Health
Investigators
Principal Investigator: Lars Slørdal, PhD, MD Norwegian University of Science and Technology
Principal Investigator: Gunnar D Jenssen SINTEF Health Research

Publications of Results:
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00967421     History of Changes
Other Study ID Numbers: ES437291 VALIDAD
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: October 2, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Olavs Hospital:
Driving
DUI
Driving simulation
Drugs
Ethanol

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs