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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
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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Psychomotor Impairment
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)
Enrollment 15
Recruitment Details  
Pre-assignment Details All 15 participants received every intervention.
Arm/Group Title All Participants
Hide Arm/Group Description All participants received all six interventions; combinations of placebo (PLC), alprazolam (ALP) or zolpidem (ZOL).
Period Title: Overall Study
Started 15
2ALP/PLC 15
1ALP/PLC 15
0.5ALP/PLC 15
ZOL/PLC 15
PLC/PLC 15
PLC/ALP 15
Completed 15
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description All 15 participants received each intervention.
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants
30.53  (8.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
9
  60.0%
Male
6
  40.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
15
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   6.7%
White
14
  93.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
 100.0%
1.Primary Outcome
Title Standard Deviation of Lane Position (SLDP)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All 15 participants received each intervention.
Arm/Group Title All Participants
Hide Arm/Group Description:
All participants received all 6 interventions.
Overall Number of Participants Analyzed 15
Mean (Full Range)
Unit of Measure: distance (cm)
2ALP/PLC
40.08
(28.1 to 68.1)
1ALP/PLC
37.28
(28.0 to 54.9)
0.5ALP/PLC
36.06
(27.6 to 53.7)
ZOL/PLC
37.61
(28.3 to 65.6)
PLC/PLC
36.30
(29.7 to 58.9)
PLC/ALP
40.72
(28.5 to 68.7)
Time Frame 16 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2ALP/PLC 1ALP/PLC 0.5ALP/PLC ZOL/PLC PLC/PLC PLC/ALP
Hide Arm/Group Description

2mg Alprazolam administered at night, placebo administered in the morning

Alprazolam: 0.5 to 2mg administered at night or in the morning

1mg Alprazolam administered at night, placebo administered in the morning

Alprazolam: 0.5 to 2mg administered at night or in the morning

0.5mg Alprazolam administered at night, placebo administered in the morning

Alprazolam: 0.5 to 2mg administered at night or in the morning

10mg Zolpidem administered at night, placebo administered in the morning

Zolpidem: 10mg administered at night or in the morning

Placebo administered at night, placebo administered in the morning

Placebo: placebo administered at night and/or in the morning

Placebo administered at night, 1mg alprazolam administered in the morning

Alprazolam: 0.5 to 2mg administered at night or in the morning

All-Cause Mortality
2ALP/PLC 1ALP/PLC 0.5ALP/PLC ZOL/PLC PLC/PLC PLC/ALP
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)    
Hide Serious Adverse Events
2ALP/PLC 1ALP/PLC 0.5ALP/PLC ZOL/PLC PLC/PLC PLC/ALP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
2ALP/PLC 1ALP/PLC 0.5ALP/PLC ZOL/PLC PLC/PLC PLC/ALP
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      1/15 (6.67%)      0/15 (0.00%)      2/15 (13.33%)      0/15 (0.00%)      0/15 (0.00%)    
Gastrointestinal disorders             
Stomach Ache *  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
General disorders             
Headache *  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marion Coe
Organization: University of Kentucky
Phone: 859-257-6488
EMail: mcoe07@gmail.com
Layout table for additonal information
Responsible Party: Marion Coe, University of Kentucky
ClinicalTrials.gov Identifier: NCT03297944    
Other Study ID Numbers: 16-0260-F6A
R36DA043714-01A1 ( U.S. NIH Grant/Contract )
First Submitted: September 26, 2017
First Posted: September 29, 2017
Results First Submitted: October 31, 2019
Results First Posted: January 29, 2020
Last Update Posted: January 29, 2020