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

NCT00559819 | Completed Phase 3

• 1 other identifier: MMoric111207
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Driving; Intoxication; Impairment; Alcohol Impaired Driving

Keywords

Alcohol; Driving; Impairment

Outcome Measures

Primary Outcomes (1)

• Weaving (Standard Deviation of Lateral Deviation)

  6 h

Secondary Outcomes (1)

• Reaction Time (RT) to unexpected stimuli, and number of accidents

  6 h

Study Arms (2)

Alcohol

ACTIVE COMPARATOR

Alcohol

Drug: Alcohol

Placebo

PLACEBO COMPARATOR

Orange juice

Drug: placebo

Interventions

placebo DRUG

Placebo (orange juice), same volume as alcohol

Also known as: Orange Juice

Placebo

Alcohol DRUG

Dose with Alcohol (Vodka) to make blood alcohol concentration 0.08%

Also known as: Vodka

Alcohol

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Legal drinking age (=\> 21).
• Moderate alcohol consumption
• Defined as: at least 1 unit per week but less than 20 units per week. (unit = 12 oz. beer or equivalent).
• Current driver's license.
• Subjects can understand and communicate in English.

You may not qualify if:

• Known alcoholic or drug abuser.
• Alcohol naïve.
• Use of medications that may be aggravated (or contraindicated) by alcohol.
• Pregnant or breast feeding.
• Younger than 21 years or older than 80 years.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Asokumar Buvanendran, MD

  Rush University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 16, 2007
• Study Start: February 1, 2008
• Primary Completion: March 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

US (1)