Validation of Driving Simulator to Blood Alcohol Concentration Standards for Impaired Driving

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: Ethanol

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.