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Clinical Trials/NCT03297944
NCT03297944CompletedPhase 4

Alprazolam and Simulated Driving Performance: Next Day Effects

Marion Coe1 site in 1 country15 target enrollmentStarted: September 15, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
15
Locations
1
Primary Endpoint
Standard Deviation of Lane Position (SLDP)

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Masking Description

Participants and outcomes assessors were masked with respect to each individual intervention.

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

All Participants

Experimental

All participants received each intervention with alprazolam, zolpidem and placebo.

Intervention: Alprazolam 2mg (2ALP/PLC) (Drug)

All Participants

Experimental

All participants received each intervention with alprazolam, zolpidem and placebo.

Intervention: Alprazolam 1mg (1ALP/PLC) (Drug)

All Participants

Experimental

All participants received each intervention with alprazolam, zolpidem and placebo.

Intervention: Alprazolam 0.5mg (0.5ALP/PLC) (Drug)

All Participants

Experimental

All participants received each intervention with alprazolam, zolpidem and placebo.

Intervention: Zolpidem 10mg (ZOL/PLC) (Drug)

All Participants

Experimental

All participants received each intervention with alprazolam, zolpidem and placebo.

Intervention: Placebo (PLC/PLC) (Drug)

All Participants

Experimental

All participants received each intervention with alprazolam, zolpidem and placebo.

Intervention: Alprazolam 1mg (PLC/ALC) (Drug)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Marion Coe
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Marion Coe

Doctoral Candidate

University of Kentucky

Study Sites (1)

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