A Phase 4 interventional study of Alprazolam 2mg (2ALP/PLC) and Alprazolam 1mg (1ALP/PLC) in Psychomotor Impairment, sponsored by Marion Coe. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by Marion Coe · Phase 4, Interventional, and Other
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.
Exclusion Criteria:
All participants received each intervention with alprazolam, zolpidem and placebo.
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)
2mg alprazolam administered at night, placebo administered in the morning.
1mg alprazolam administered at night, placebo administered in the morning.
0.5mg alprazolam administered at night, placebo administered in the morning.
10mg alprazolam administered at night, placebo administered in the morning.
Placebo administered at night, placebo administered in the morning.
Placebo administered at night, 1mg alprazolam administered in the morning.
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.
Time frame: 16 hours
| Milestone | All Participants |
|---|---|
| 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 |
Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane.
| distance (cm) | All Participants |
|---|---|
| 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) |
Collected over 16 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 2ALP/PLC | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| 1ALP/PLC | 0/15 (0%) | 0/15 (0%) | 1/15 (6.7%) |
| 0.5ALP/PLC | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| ZOL/PLC | 0/15 (0%) | 0/15 (0%) | 2/15 (13.3%) |
| PLC/PLC | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| PLC/ALP | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Event | 2ALP/PLC | 1ALP/PLC | 0.5ALP/PLC | ZOL/PLC | PLC/PLC | PLC/ALP |
|---|---|---|---|---|---|---|
| HeadacheGeneral disorders | 0/15 | 1/15 | 0/15 | 1/15 | 0/15 | 0/15 |
| Stomach AcheGastrointestinal disorders | 0/15 | 0/15 | 0/15 | 1/15 | 0/15 | 0/15 |
| Age, Continuous(years) | All Participants |
|---|---|
| Mean | 30.53 ± 8.18 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 9 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 15 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 14 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | All Participants |
|---|---|
| United States | 15 |
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