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Sedative-Anxiolytic Effects on Simulated Driving Performance

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ClinicalTrials.gov Identifier: NCT03297944
Recruitment Status : Completed
First Posted : September 29, 2017
Last Update Posted : May 15, 2019
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
Last Update Posted Date May 15, 2019
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: September 26, 2017)
standard deviation of lane position [ Time Frame: 16 hours ]
measure of swerving on the driving simulator
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03297944 on ClinicalTrials.gov Archive Site
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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Psychomotor Impairment
Intervention  ICMJE
  • Drug: Alprazolam
    0.5 to 2mg administered at night or in the morning
  • Drug: Zolpidem
    10mg administered at night or in the morning
  • Drug: Placebo
    placebo administered at night and/or in the morning
Study Arms  ICMJE
  • Experimental: 2ALP/PLC
    2mg Alprazolam administered at night, placebo administered in the morning
    Intervention: Drug: Alprazolam
  • Experimental: 1ALP/PLC
    1mg Alprazolam administered at night, placebo administered in the morning
    Intervention: Drug: Alprazolam
  • Experimental: 0.5ALP/PLC
    0.5mg Alprazolam administered at night, placebo administered in the morning
    Intervention: Drug: Alprazolam
  • Active Comparator: ZOL/PLC
    10mg Zolpidem administered at night, placebo administered in the morning
    Intervention: Drug: Zolpidem
  • Placebo Comparator: PLC/PLC
    Placebo administered at night, placebo administered in the morning
    Intervention: Drug: Placebo
  • Active Comparator: PLC/ALP
    Placebo administered at night, 1mg alprazolam administered in the morning
    Intervention: Drug: Alprazolam
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: May 14, 2019)
14
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 May 2019

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