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OpenTrials
Completed

NCT Number: NCT03297944

Sedative-Anxiolytic Effects on Simulated Driving Performance

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.

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Key information

Conditions

Psychomotor Impairment Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Psychomotor Disorders Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Center on Drug and Alcohol Research

Lexington, Kentucky, 40508, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alprazolam 2mg (2ALP/PLC)

Drug

2mg alprazolam administered at night, placebo administered in the morning.

Alprazolam 1mg (1ALP/PLC)

Drug

1mg alprazolam administered at night, placebo administered in the morning.

Alprazolam 0.5mg (0.5ALP/PLC)

Drug

0.5mg alprazolam administered at night, placebo administered in the morning.

Zolpidem 10mg (ZOL/PLC)

Drug

10mg alprazolam administered at night, placebo administered in the morning.

Placebo (PLC/PLC)

Drug

Placebo administered at night, placebo administered in the morning.

Alprazolam 1mg (PLC/ALC)

Drug

Placebo administered at night, 1mg alprazolam administered in the morning.

Primary outcomes

  1. Standard Deviation of Lane Position (SLDP)

    Time frame: 16 hours

    Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.

Sponsors and collaborators

Lead sponsor

Marion Coe

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Alprazolam and Simulated Driving Performance: Next Day Effects

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 29, 2017
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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