Sedative-Anxiolytic Effects on Simulated Driving Performance
Phase 4
Completed
- Conditions
- Psychomotor Impairment
- Interventions
- Registration Number
- NCT03297944
- Lead Sponsor
- Marion Coe
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All Participants Alprazolam 1mg (1ALP/PLC) All participants received each intervention with alprazolam, zolpidem and placebo. All Participants Alprazolam 0.5mg (0.5ALP/PLC) All participants received each intervention with alprazolam, zolpidem and placebo. All Participants Alprazolam 2mg (2ALP/PLC) All participants received each intervention with alprazolam, zolpidem and placebo. All Participants Placebo (PLC/PLC) All participants received each intervention with alprazolam, zolpidem and placebo. All Participants Zolpidem 10mg (ZOL/PLC) All participants received each intervention with alprazolam, zolpidem and placebo. All Participants Alprazolam 1mg (PLC/ALC) All participants received each intervention with alprazolam, zolpidem and placebo.
- Primary Outcome Measures
Name Time Method Standard Deviation of Lane Position (SLDP) 16 hours Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which alprazolam and zolpidem induce psychomotor impairment in simulated driving tasks?
How does the next-day driving performance of alprazolam compare to standard-of-care anxiolytic medications like lorazepam or clonazepam?
Are there specific biomarkers that correlate with residual sedation effects from GABAergic drugs in driving simulations?
What adverse events are commonly reported with alprazolam use in sleep-disordered populations and how do they impact psychomotor function?
How do alprazolam and zolpidem's pharmacokinetic profiles influence their next-day driving impairment potential compared to non-benzodiazepine hypnotics?
Trial Locations
- Locations (1)
Center on Drug and Alcohol Research
🇺🇸Lexington, Kentucky, United States
Center on Drug and Alcohol Research🇺🇸Lexington, Kentucky, United States