Trial Outcomes & Findings for Sedative-Anxiolytic Effects on Simulated Driving Performance (NCT NCT03297944)
NCT ID: NCT03297944
Last Updated: 2020-01-29
Results Overview
Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
15 participants
Primary outcome timeframe
16 hours
Results posted on
2020-01-29
Participant Flow
All 15 participants received every intervention.
Participant milestones
| Measure |
All Participants
All participants received all six interventions; combinations of placebo (PLC), alprazolam (ALP) or zolpidem (ZOL).
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
2ALP/PLC
|
15
|
|
Overall Study
1ALP/PLC
|
15
|
|
Overall Study
0.5ALP/PLC
|
15
|
|
Overall Study
ZOL/PLC
|
15
|
|
Overall Study
PLC/PLC
|
15
|
|
Overall Study
PLC/ALP
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sedative-Anxiolytic Effects on Simulated Driving Performance
Baseline characteristics by cohort
| Measure |
All Participants
n=15 Participants
All 15 participants received each intervention.
|
|---|---|
|
Age, Continuous
|
30.53 years
STANDARD_DEVIATION 8.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 hoursPopulation: All 15 participants received each intervention.
Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.
Outcome measures
| Measure |
All Participants
n=15 Participants
All participants received all 6 interventions.
|
|---|---|
|
Standard Deviation of Lane Position (SLDP)
2ALP/PLC
|
40.08 distance (cm)
Interval 28.1 to 68.1
|
|
Standard Deviation of Lane Position (SLDP)
1ALP/PLC
|
37.28 distance (cm)
Interval 28.0 to 54.9
|
|
Standard Deviation of Lane Position (SLDP)
0.5ALP/PLC
|
36.06 distance (cm)
Interval 27.6 to 53.7
|
|
Standard Deviation of Lane Position (SLDP)
ZOL/PLC
|
37.61 distance (cm)
Interval 28.3 to 65.6
|
|
Standard Deviation of Lane Position (SLDP)
PLC/PLC
|
36.30 distance (cm)
Interval 29.7 to 58.9
|
|
Standard Deviation of Lane Position (SLDP)
PLC/ALP
|
40.72 distance (cm)
Interval 28.5 to 68.7
|
Adverse Events
2ALP/PLC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1ALP/PLC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
0.5ALP/PLC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ZOL/PLC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
PLC/PLC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PLC/ALP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
2ALP/PLC
n=15 participants at risk
2mg Alprazolam administered at night, placebo administered in the morning
Alprazolam: 0.5 to 2mg administered at night or in the morning
|
1ALP/PLC
n=15 participants at risk
1mg Alprazolam administered at night, placebo administered in the morning
Alprazolam: 0.5 to 2mg administered at night or in the morning
|
0.5ALP/PLC
n=15 participants at risk
0.5mg Alprazolam administered at night, placebo administered in the morning
Alprazolam: 0.5 to 2mg administered at night or in the morning
|
ZOL/PLC
n=15 participants at risk
10mg Zolpidem administered at night, placebo administered in the morning
Zolpidem: 10mg administered at night or in the morning
|
PLC/PLC
n=15 participants at risk
Placebo administered at night, placebo administered in the morning
Placebo: placebo administered at night and/or in the morning
|
PLC/ALP
n=15 participants at risk
Placebo administered at night, 1mg alprazolam administered in the morning
Alprazolam: 0.5 to 2mg administered at night or in the morning
|
|---|---|---|---|---|---|---|
|
General disorders
Headache
|
0.00%
0/15 • 16 hours
|
6.7%
1/15 • Number of events 1 • 16 hours
|
0.00%
0/15 • 16 hours
|
6.7%
1/15 • Number of events 1 • 16 hours
|
0.00%
0/15 • 16 hours
|
0.00%
0/15 • 16 hours
|
|
Gastrointestinal disorders
Stomach Ache
|
0.00%
0/15 • 16 hours
|
0.00%
0/15 • 16 hours
|
0.00%
0/15 • 16 hours
|
6.7%
1/15 • Number of events 1 • 16 hours
|
0.00%
0/15 • 16 hours
|
0.00%
0/15 • 16 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place