Psychomotor Impairment
Conditions
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.
Interventions
DRUGAlprazolam 2mg (2ALP/PLC)
2mg alprazolam administered at night, placebo administered in the morning.
DRUGAlprazolam 1mg (1ALP/PLC)
1mg alprazolam administered at night, placebo administered in the morning.
DRUGAlprazolam 0.5mg (0.5ALP/PLC)
0.5mg alprazolam administered at night, placebo administered in the morning.
DRUGZolpidem 10mg (ZOL/PLC)
10mg alprazolam administered at night, placebo administered in the morning.
DRUGPlacebo (PLC/PLC)
Placebo administered at night, placebo administered in the morning.
DRUGAlprazolam 1mg (PLC/ALC)
Placebo administered at night, 1mg alprazolam administered in the morning.
Sponsors
National Institute on Drug Abuse (NIDA)
Marion Coe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
Participants and outcomes assessors were masked with respect to each individual intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standard Deviation of Lane Position (SLDP) | 16 hours | Lane deviation (swerving) on a driving simulator. This is measured as the distance (cm) the driver deviates from the lane. |
Countries
United States
Participant flow
Pre-assignment details
All 15 participants received every intervention.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All 15 participants received each intervention. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 30.53 years STANDARD_DEVIATION 8.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 1 / 15 | 0 / 15 | 2 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
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
Population: All 15 participants received each intervention.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants | Standard Deviation of Lane Position (SLDP) | 2ALP/PLC | 40.08 distance (cm) |
| All Participants | Standard Deviation of Lane Position (SLDP) | 1ALP/PLC | 37.28 distance (cm) |
| All Participants | Standard Deviation of Lane Position (SLDP) | 0.5ALP/PLC | 36.06 distance (cm) |
| All Participants | Standard Deviation of Lane Position (SLDP) | ZOL/PLC | 37.61 distance (cm) |
| All Participants | Standard Deviation of Lane Position (SLDP) | PLC/PLC | 36.30 distance (cm) |
| All Participants | Standard Deviation of Lane Position (SLDP) | PLC/ALP | 40.72 distance (cm) |