Alprazolam and Simulated Driving Performance: Next Day Effects
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
All participants received each intervention with alprazolam, zolpidem and placebo.
Intervention: Alprazolam 2mg (2ALP/PLC) (Drug)
All Participants
All participants received each intervention with alprazolam, zolpidem and placebo.
Intervention: Alprazolam 1mg (1ALP/PLC) (Drug)
All Participants
All participants received each intervention with alprazolam, zolpidem and placebo.
Intervention: Alprazolam 0.5mg (0.5ALP/PLC) (Drug)
All Participants
All participants received each intervention with alprazolam, zolpidem and placebo.
Intervention: Zolpidem 10mg (ZOL/PLC) (Drug)
All Participants
All participants received each intervention with alprazolam, zolpidem and placebo.
Intervention: Placebo (PLC/PLC) (Drug)
All Participants
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
Marion Coe
Doctoral Candidate
University of Kentucky