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

This study has been completed.
Sponsor:
Collaborators:
SINTEF Health Research
Norwegian University of Science and Technology
Norwegian Institute of Public Health
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00967421
First received: August 26, 2009
Last updated: January 30, 2013
Last verified: November 2011
  Purpose

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 Intervention
Automobile Driving
Drug: ethanol
Drug: Ethanol
Other: Placebo drink

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: Development of a Valid Test Battery for Assessing Driving Ability When Influenced by Drugs.

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Standard deviation of lateral position on road (SDLP) [ Time Frame: Instantly (while the subject is inebriated) ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2009
Study Completion Date: November 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 50 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00967421     History of Changes
Other Study ID Numbers: ES437291 VALIDAD
Study First Received: August 26, 2009
Last Updated: January 30, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on August 27, 2014