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

NCT00559819 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-12-14

No results posted yet for this study

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

Interventions

DRUG

placebo

Placebo (orange juice), same volume as alcohol

DRUG

Alcohol

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

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Asokumar Buvanendran, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2022-03-31
Completion
2022-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00559819 on ClinicalTrials.gov