Sedative-Anxiolytic Effects on Simulated Driving Performance

Psychomotor Impairment Clinical Trial

Official title:

Alprazolam and Simulated Driving Performance: Next Day Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297944
• Other study ID #: 16-0260-F6A
• Secondary ID: R36DA043714-01A1
• Status: Completed
• Phase: Phase 4
• Start date: September 15, 2017
• Est. completion date: October 25, 2018

Study information

• Verified date: January 2020
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• valid driver's license

• english-speaking and literate

Exclusion Criteria:

• using daily medication for chronic condition

• acute narrow angle glaucoma

• previous adverse experience with study drugs

• experiences motion sickness in response to driving simulator

• BMI > 30

• women who are pregnant, lactating, or planning on becoming pregnant

• regular use of tobacco products

• current substance use disorder

• clinically significant ECG

• current ongoing psychiatric disorder

Related Conditions & MeSH terms

• Psychomotor Impairment

Intervention

Drug:
• Alprazolam 2mg (2ALP/PLC)
2mg alprazolam administered at night, placebo administered in the morning.
• Alprazolam 1mg (1ALP/PLC)
1mg alprazolam administered at night, placebo administered in the morning.
• Alprazolam 0.5mg (0.5ALP/PLC)
0.5mg alprazolam administered at night, placebo administered in the morning.
• Zolpidem 10mg (ZOL/PLC)
10mg alprazolam administered at night, placebo administered in the morning.
• Placebo (PLC/PLC)
Placebo administered at night, placebo administered in the morning.
• Alprazolam 1mg (PLC/ALC)
Placebo administered at night, 1mg alprazolam administered in the morning.

Locations

Country	Name	City	State
United States	Center on Drug and Alcohol Research	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Marion Coe	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard Deviation of Lane Position (SLDP)	Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.	16 hours