Back to resultsSedative-Anxiolytic Effects on Simulated Driving Performance
Primary Purpose
Psychomotor Impairment
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Alprazolam 2mg (2ALP/PLC)
Alprazolam 1mg (1ALP/PLC)
Alprazolam 0.5mg (0.5ALP/PLC)
Zolpidem 10mg (ZOL/PLC)
Placebo (PLC/PLC)
Alprazolam 1mg (PLC/ALC)
Sponsored by
About this trial
This is an interventional other trial for Psychomotor Impairment
Eligibility Criteria
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
Sites / Locations
- Center on Drug and Alcohol Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All Participants
Arm Description
All participants received each intervention with alprazolam, zolpidem and placebo.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03297944
First Posted
September 26, 2017
Last Updated
January 17, 2020
Sponsor
Marion Coe
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03297944
Brief Title
Sedative-Anxiolytic Effects on Simulated Driving Performance
Official Title
Alprazolam and Simulated Driving Performance: Next Day Effects
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
October 25, 2018 (Actual)
Study Completion Date
October 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marion Coe
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychomotor Impairment
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Participants and outcomes assessors were masked with respect to each individual intervention.
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All Participants
Arm Type
Experimental
Arm Description
All participants received each intervention with alprazolam, zolpidem and placebo.
Intervention Type
Drug
Intervention Name(s)
Alprazolam 2mg (2ALP/PLC)
Intervention Description
2mg alprazolam administered at night, placebo administered in the morning.
Intervention Type
Drug
Intervention Name(s)
Alprazolam 1mg (1ALP/PLC)
Intervention Description
1mg alprazolam administered at night, placebo administered in the morning.
Intervention Type
Drug
Intervention Name(s)
Alprazolam 0.5mg (0.5ALP/PLC)
Intervention Description
0.5mg alprazolam administered at night, placebo administered in the morning.
Intervention Type
Drug
Intervention Name(s)
Zolpidem 10mg (ZOL/PLC)
Intervention Description
10mg alprazolam administered at night, placebo administered in the morning.
Intervention Type
Drug
Intervention Name(s)
Placebo (PLC/PLC)
Intervention Description
Placebo administered at night, placebo administered in the morning.
Intervention Type
Drug
Intervention Name(s)
Alprazolam 1mg (PLC/ALC)
Intervention Description
Placebo administered at night, 1mg alprazolam administered in the morning.
Primary Outcome Measure Information:
Title
Standard Deviation of Lane Position (SLDP)
Description
Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.
Time Frame
16 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marion Coe
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center on Drug and Alcohol Research
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sedative-Anxiolytic Effects on Simulated Driving Performance
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