NCT03297944

Sedative-Anxiolytic Effects on Simulated Driving Performance

Alprazolam and Simulated Driving Performance: Next Day Effects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Marion Coe · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the effect of anxiety drugs taken at night on the ability to drive a car the next day. Participants will receive alprazolam, placebo, or zolpidem at night before bed or in the morning before using a driving simulator to assess impairment.

Conditions

• Psychomotor Impairment

Interventions

Type	Name	Description
DRUG	Alprazolam 2mg (2ALP/PLC)	2mg alprazolam administered at night, placebo administered in the morning.
DRUG	Alprazolam 1mg (1ALP/PLC)	1mg alprazolam administered at night, placebo administered in the morning.
DRUG	Alprazolam 0.5mg (0.5ALP/PLC)	0.5mg alprazolam administered at night, placebo administered in the morning.
DRUG	Zolpidem 10mg (ZOL/PLC)	10mg alprazolam administered at night, placebo administered in the morning.
DRUG	Placebo (PLC/PLC)	Placebo administered at night, placebo administered in the morning.
DRUG	Alprazolam 1mg (PLC/ALC)	Placebo administered at night, 1mg alprazolam administered in the morning.

Timeline

• Start date: 2017-09-15
• Primary completion: 2018-10-25
• Completion: 2018-10-25
• First posted: 2017-09-29
• Last updated: 2020-01-29
• Results posted: 2020-01-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study