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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00967421

Acronym

VALIDAD

Enrollment

Registered

2009-08-27

Start date

2009-09-30

Completion date

2010-11-30

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Automobile Driving

Keywords

Driving, DUI, Driving simulation, Drugs, Ethanol

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.

Interventions

DRUGethanol

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.

DRUGEthanol

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.

OTHERPlacebo drink

Placebo drink containing no alcohol + placebo pill

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

MALE

Age

25 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Standard deviation of lateral position on road (SDLP)	Instantly (while the subject is inebriated)

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026