Validation of Driving Simulator to Blood Alcohol Concentration Standards for Impaired Driving (ALCDrive)
|Driving Intoxication Impairment Alcohol Impaired Driving||Drug: placebo Drug: Alcohol||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Validation of Driving Simulator Measures and Calibration to Blood Alcohol Concentration Standards for Impaired Driving|
- Weaving (Standard Deviation of Lateral Deviation) [ Time Frame: 6 h ]
- Reaction Time (RT) to unexpected stimuli, and number of accidents [ Time Frame: 6 h ]
|Study Start Date:||February 2008|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Active Comparator: Alcohol
Dose with Alcohol (Vodka) to make blood alcohol concentration 0.08%
Other Name: Vodka
Placebo Comparator: Placebo
Placebo (orange juice), same volume as alcohol
Other Name: Orange Juice
Subjects will be recruited via discreet flyers distributed around the Rush University Medical Campus. Subjects will be scheduled so that a maximum of 6 participants are evaluated on the same day. Some evaluation days may fall on the weekend. Study duration is estimated at 4-5 hours, and at the completion the subjects will be driven to their respective residences.
Upon arrival subjects will complete questionnaires which contain demographic information and measures to evaluate possible alcohol abuse issues. All subjects will be given a short driving simulator practice and then the baseline simulator trial. Subjects will be randomized into two groups as part of a study, with an 80% probability of selection for group A and a 20% probability of selection for Group P. Group P will only be given placebos so that any learning effects can be estimated. In addition to the baseline, both groups will take the full driving test two additional times each preceded by an alcohol or placebo dosing. Of these two trials only on Trial#2 of Group A is alcohol given. Both groups will receiver placebo on simulator Trial #1.
Alcohol trial (Group A only):
The alcohol dose will consist of a 40% alcohol (vodka) liquor in a beverage containing 2 parts orange juice and 1 part liquor. The exact amount/volume of alcohol will be determined based on factors such as weight and sex so as to reach a peak BAC of 0.08%.
The primary contrast of interest is the comparison between the placebo and the alcohol dosed driving simulation trials. Analyses will take place with general linear models framework, using "Proc Mixed" to model the repeated measures design and produce accurate estimate of the pre-planned comparisons as well as main effects and longitudinal estimates. Various outcome variables that measure driving ability will be used, the three primary measures being: a measure of weaving (Standard Deviation of Lateral Deviation), Reaction Time (RT) to unexpected stimuli, and number of accidents. The placebo, Group P, will be evaluated to estimate the effect of learning and to estimate the effectiveness of the placebo sham.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559819
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|Study Director:||Asokumar Buvanendran, MD||Rush University Medical Center|