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Validation of Driving Simulator to Blood Alcohol Concentration Standards for Impaired Driving (ALCDrive)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mario Moric, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT00559819
First received: November 14, 2007
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  Purpose

The proposed study will validate and determine sensitivity of our new driving simulator, created to evaluate driving ability in a related study to show similar driving performance between patients on chronic opioid treatment and a control group. Although the commercial version of the simulator has been validated for certain populations and certain measures, these require re-calibration for our own clinical study. The investigators propose a prospective randomized clinical trial to evaluate driving skills under alcohol consumption using a driving simulator. Two groups of study subjects will be utilized, with the majority (80%) receiving alcohol and placebo at different times. A smaller set of study subjects (20%) will be given placebo on both trials to evaluate learning effects and placebo blinding effectiveness. Each group will take the driving test at three time points: once as a baseline at the beginning of the study, once after the 1st dosing of the placebo and again after dosing two of the alcohol or placebo beverage. This information will allow us to evaluate driving ability under other potentially impairing conditions such as opioid usage.


Condition Intervention Phase
Driving
Intoxication
Impairment
Alcohol Impaired Driving
 Drug: placebo
Drug: Alcohol
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Validation of Driving Simulator Measures and Calibration to Blood Alcohol Concentration Standards for Impaired Driving

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • Weaving (Standard Deviation of Lateral Deviation) [ Time Frame: 6 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reaction Time (RT) to unexpected stimuli, and number of accidents [ Time Frame: 6 h ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: February 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Alcohol
Alcohol
 Drug: Alcohol
Dose with Alcohol (Vodka) to make blood alcohol concentration 0.08%
Other Names:
  • Alcohol
  • Vodka
Placebo Comparator: Placebo
Orange juice
 Drug: placebo
Placebo (orange juice), same volume as alcohol
Other Names:
  • Placebo
  • Orange Juice

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Legal drinking age (=> 21).

  2. Moderate alcohol consumption

    • Defined as: at least 1 unit per week but less than 20 units per week. (unit = 12 oz. beer or equivalent).
  3. Current driver's license.
  4. Subjects can understand and communicate in English.

Exclusion Criteria:

  1. Known alcoholic or drug abuser.
  2. Alcohol naïve.
  3. Use of medications that may be aggravated (or contraindicated) by alcohol.
  4. Pregnant or breast feeding.
  5. Younger than 21 years or older than 80 years.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559819

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Study Director: Asokumar Buvanendran, MD Rush University Medical Center
  More Information

No publications provided

Responsible Party: Mario Moric, Research Coordinator, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT00559819     History of Changes
Other Study ID Numbers: MMoric111207
Study First Received: November 14, 2007
Last Updated: October 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Alcohol
Driving
Impairment

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 May 22, 2013