Sedative-Anxiolytic Effects on Simulated Driving Performance

January 17, 2020 updated by: Marion Coe

Alprazolam and Simulated Driving Performance: Next Day Effects

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40508
        • Center on Drug and Alcohol Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All Participants
All participants received each intervention with alprazolam, zolpidem and placebo.
Drug: Alprazolam 2mg (2ALP/PLC)
2mg alprazolam administered at night, placebo administered in the morning.
Drug: Alprazolam 1mg (1ALP/PLC)
1mg alprazolam administered at night, placebo administered in the morning.
Drug: Alprazolam 0.5mg (0.5ALP/PLC)
0.5mg alprazolam administered at night, placebo administered in the morning.
Drug: Zolpidem 10mg (ZOL/PLC)
10mg alprazolam administered at night, placebo administered in the morning.
Drug: Placebo (PLC/PLC)
Placebo administered at night, placebo administered in the morning.
Drug: Alprazolam 1mg (PLC/ALC)
Placebo administered at night, 1mg alprazolam administered in the morning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
16 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marion Coe

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Marion Coe, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2017

Primary Completion (Actual)

October 25, 2018

Study Completion (Actual)

October 25, 2018

Study Registration Dates

First Submitted

September 26, 2017

First Submitted That Met QC Criteria

September 26, 2017

First Posted (Actual)

September 29, 2017

Study Record Updates

Last Update Posted (Actual)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-0260-F6A
  • R36DA043714-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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