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NCT03297944 · ClinicalTrials.gov registry record · Phase 4

Sedative-Anxiolytic Effects on Simulated Driving Performance

A Phase 4 study of Psychomotor Impairment, sponsored by Marion Coe.

Completed
Registry status
Phase 4
Development phase
15
Enrollment target
1
Study location

NCT03297944: Completed Phase 4 study of Psychomotor Impairment, sponsored by Marion Coe.

NCT03297944 is a Phase 4 study of Psychomotor Impairment that has completed, run by Marion Coe. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03297944, a Phase 4 study of Psychomotor Impairment, has completed, sponsored by Marion Coe.

COMPLETED
Registry status
Phase 4
Development phase
15 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.

Conditions Studied

Interventions

  • DRUG 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)

Study Locations (1)

Kentucky

  • Center on Drug and Alcohol Research - Lexington

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2017-09-15
Est. Completion 2018-10-25
Phase Phase 4
Marion Coe

1 total trials

What the finished NCT03297944 record still lists

NCT03297944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 1 condition, with Psychomotor Impairment appearing as the primary indexed condition, and to 5 interventions - of which Alprazolam 2mg (2ALP/PLC) is the first listed.

NCT03297944 reports a single indexed study location in Kentucky.

Frequently Asked Questions

What is clinical trial NCT03297944 about?

NCT03297944 is a clinical study titled "Sedative-Anxiolytic Effects on Simulated Driving Performance". 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.

What is the current status of trial NCT03297944?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2017-09-15. Estimated completion is 2018-10-25.

What conditions does trial NCT03297944 study?

This clinical trial studies the following conditions: Psychomotor Impairment.

What interventions are being tested in trial NCT03297944?

The interventions under investigation include: 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).

Who is sponsoring clinical trial NCT03297944?

This trial is sponsored by Marion Coe, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03297944 being conducted?

This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03297944's enrollment target sits among peer trials

15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03297944, the US trial registry maintained by the National Library of Medicine. NCT03297944 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.