Opiates and Benzodiazepines on Driving

Driving Behavior Clinical Trial

Official title: SAFER-SIM: Opiates and Benzodiazepines on Driving

Status Completed

Clinical Trial Summary

The aim of this research is to assess drug effects (Xanax and Norco) on driving performance. Researchers will use the Alertness Memory Profiler (AMP) application to compare results to previous related studies.

This study continues a line of research designed to characterize the effects of common recreationally used prescription and illicit drugs with well known stimulant and sedating effects and their relationship to results from the Alertness Memory Profiler (AMP) that included a set of vigilance and memory tasks.

Clinical Trial Description

This study uses EEG, EKG, computerized assessment, blood sampling, and driving simulation.

Individuals recruited will be normal, healthy individuals not currently taking the study drugs. The study will involve five visits, a screening visit as well as four dosing visits. The dosing visits will have a clean (double placebo) and three drugged visits (Xanax and Norco placebo, Xanax placebo and Norco, Xanax and Norco). The screening visit will last about two hours and will include drug and pregnancy testing as well as screening for physical/psychological health. Each of the dosing visits will last approximately five to six hours and will include sleep and food intake surveys, being dosed with study drugs or placebos, AMP assessments, a simulator drive, and wellness surveys. There will also be 4 mL blood sampling before dosing, before driving, and after driving. ;

Related Conditions & MeSH terms

• Driving Behavior

• NCT number: NCT03447353
• Study type: Interventional
• Source: University of Iowa
• Status: Completed
• Phase: Phase 4
• Start date: June 14, 2016
• Completion date: October 25, 2016