NCT03297944|CompletedPhase 4ResultsFDA Drug
Sedative-Anxiolytic Effects on Simulated Driving Performance
Alprazolam and Simulated Driving Performance: Next Day Effects
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Sponsor study identifier
Secondary identifiers
interventional
15
1 country
1
Study Start
September 15, 2017
Actual (reported)Primary Completion
October 25, 2018
Actual (reported)Study Completion
October 25, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 25, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 15, 2017
Actual (reported)September 26, 2017
Actual (reported)September 29, 2017
Actual (reported)October 25, 2018
Actual (reported)October 25, 2018
Actual (reported)January 29, 2020
Actual (reported)Standard Deviation of Lane Position (SLDP)
Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.
16 hours
All participants received each intervention with alprazolam, zolpidem and placebo.
2mg alprazolam administered at night, placebo administered in the morning.
1mg alprazolam administered at night, placebo administered in the morning.
Center on Drug and Alcohol Research
Lexington, Kentucky, 40508, United States
Roszkowski SC, Babalonis S, Coe MA, Nuzzo PA, Lofwall MR, Fanucchi LC, Walsh SL. Residual next-day effects of alprazolam on psychomotor performance and simulated driving in healthy normal adults. Exp Clin Psychopharmacol. 2025 Apr;33(2):178-188. doi: 10.1037/pha0000746. Epub 2024 Nov 14.
Marion Coe
University of Kentucky
15 participants (actual enrollment reported by the registry).
First Submitted
September 26, 2017
First Posted
September 29, 2017
Study Start
September 15, 2017
Actual (reported)High Confusion: Cannabis & Driving
0.5mg alprazolam administered at night, placebo administered in the morning.
10mg alprazolam administered at night, placebo administered in the morning.
Placebo administered at night, placebo administered in the morning.
Placebo administered at night, 1mg alprazolam administered in the morning.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
October 25, 2018
Actual (reported)Study Completion
October 25, 2018
Actual (reported)Last Updated
January 29, 2020
Results First Posted
January 29, 2020
Record last verified: 2020-01
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Source: ClinicalTrials.gov.
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