NCT00967421

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

2 months

First QC Date

August 26, 2009

Last Update Submit

September 28, 2017

Conditions

Automobile Driving

Keywords

DrivingDUIDriving simulationDrugsEthanol

Outcome Measures

Primary Outcomes (1)

  • Standard deviation of lateral position on road (SDLP)

    Instantly (while the subject is inebriated)

Study Arms (3)

BAC 0.5

EXPERIMENTAL

BAC level 0.5 g/dL (drink + placebo pill)

Drug: ethanol

BAC 1.0

EXPERIMENTAL

BAC level 1.0 g/dL (drink + placebo pill)

Drug: Ethanol

placebo

PLACEBO COMPARATOR

BAC level 0,0 g/dL (placebo drink+ placebo pill)

Other: Placebo drink

Interventions

EthanolDRUG

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.

BAC 0.5
Placebo drinkOTHER

Placebo drink containing no alcohol + placebo pill

placebo

Eligibility Criteria

Age25 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SINTEF Health and Research

Trondheim, 7465, Norway

Location

Related Publications (2)

  • 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.

    PMID: 23357031RESULT

  • 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.

    PMID: 26147898RESULT

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Lars Slørdal, PhD, MD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

  • Gunnar D Jenssen

    SINTEF Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2009

First Posted

August 27, 2009

Study Start

September 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2010

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

NO(1)