Phase 4
N=15
Sedative-Anxiolytic Effects on Simulated Driving Performance
Psychomotor Impairment
Bottom Line
View on ClinicalTrials.gov: NCT03297944 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Standard Deviation of Lane Position (SLDP) — 40.08; 37.28; 36.06; 37.61 distance (cm)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Alprazolam 2mg (2ALP/PLC) (Drug); Alprazolam 1mg (1ALP/PLC) (Drug); Alprazolam 0.5mg (0.5ALP/PLC) (Drug); Zolpidem 10mg (ZOL/PLC) (Drug); Placebo (PLC/PLC) (Drug); Alprazolam 1mg (PLC/ALC) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Marion Coe
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Standard Deviation of Lane Position (SLDP) |
40.08; 37.28; 36.06; 37.61; 36.30; 40.72 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03297944). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.