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Sedative-Anxiolytic Effects on Simulated Driving Performance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03297944
Recruitment Status : Completed
First Posted : September 29, 2017
Results First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Marion Coe, University of Kentucky

Tracking Information
First Submitted Date  ICMJE September 26, 2017
First Posted Date  ICMJE September 29, 2017
Results First Submitted Date  ICMJE October 31, 2019
Results First Posted Date  ICMJE January 29, 2020
Last Update Posted Date January 29, 2020
Actual Study Start Date  ICMJE September 15, 2017
Actual Primary Completion Date October 25, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 26, 2017)
standard deviation of lane position [ Time Frame: 16 hours ]
measure of swerving on the driving simulator
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sedative-Anxiolytic Effects on Simulated Driving Performance
Official Title  ICMJE Alprazolam and Simulated Driving Performance: Next Day Effects
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Participants and outcomes assessors were masked with respect to each individual intervention.
Primary Purpose: Other
Condition  ICMJE Psychomotor Impairment
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Experimental: All Participants
All participants received each intervention with alprazolam, zolpidem and placebo.
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)
  • Drug: Alprazolam 1mg (PLC/ALC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2020)
15
Original Estimated Enrollment  ICMJE
 (submitted: September 26, 2017)
30
Actual Study Completion Date  ICMJE October 25, 2018
Actual Primary Completion Date October 25, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03297944
Other Study ID Numbers  ICMJE 16-0260-F6A
R36DA043714-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marion Coe, University of Kentucky
Study Sponsor  ICMJE Marion Coe
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Marion Coe University of Kentucky
PRS Account University of Kentucky
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP