Driving Behavior
Conditions
Keywords
driving, Xanax, Norco, simulation
Brief summary
The aim of this research is to assess drug effects (Xanax and Norco) on driving performance. Researchers will use the Alertness Memory Profiler (AMP) application to compare results to previous related studies. This study continues a line of research designed to characterize the effects of common recreationally used prescription and illicit drugs with well known stimulant and sedating effects and their relationship to results from the Alertness Memory Profiler (AMP) that included a set of vigilance and memory tasks.
Detailed description
This study uses EEG, EKG, computerized assessment, blood sampling, and driving simulation. Individuals recruited will be normal, healthy individuals not currently taking the study drugs. The study will involve five visits, a screening visit as well as four dosing visits. The dosing visits will have a clean (double placebo) and three drugged visits (Xanax and Norco placebo, Xanax placebo and Norco, Xanax and Norco). The screening visit will last about two hours and will include drug and pregnancy testing as well as screening for physical/psychological health. Each of the dosing visits will last approximately five to six hours and will include sleep and food intake surveys, being dosed with study drugs or placebos, AMP assessments, a simulator drive, and wellness surveys. There will also be 4 mL blood sampling before dosing, before driving, and after driving.
Interventions
DRUGXanax 1Mg Tablet
Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco
DRUGNorco 10Mg-325Mg Tablet
Single dose on two of the four study visits, one in conjunction with 1mg alprazolam
DRUGPlacebo Oral Tablet
Single dose on two of the four study visits, double dose on one of the four study visits
Sponsors
Timothy L. Brown
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy adult men and women, based on medical and psychological evaluation * Currently valid unrestricted (except for vision correction) US driver's license * Licensed driver for at least the past two years * Drove at least 5000 miles in the past year, by self-report * Live within a 60 mile radius of NADS * Available for five study sessions, with one being approximately 2 hours and four being approximately 5-6 hours * Peripheral veins suitable for repeated venipuncture * Systolic blood pressure within a clinically normal range (120 ± 30 mmHg) and diastolic blood pressure of 80 ± 20 mmHg * Good command of written and spoken English * Female subjects with reproductive potential must agree to use (and/or have their partner use) one (1) acceptable method of birth control beginning at the screening visit throughout the study (including intervals between treatment periods/panels) and until 2 weeks after the last dose of study drug in the last treatment period. Acceptable methods of birth control include the following: intrauterine device (IUD-with or without local hormone release), diaphragm, spermicides, cervical cap, contraceptive sponge, oral contraceptives or condoms. Abstinence is an alternative lifestyle and subjects practicing abstinence may be included in the study.
Exclusion criteria
* Requires any special equipment to help drive, such as pedal extensions, hand brake or throttle, spinner wheel knobs, or other non-standard equipment * Presence of any clinically significant illness, as detected by history, physical examination, and/or laboratory tests, that might influence driving performance (e.g., seizures, sleep apnea, narcolepsy, vertigo, chronic fatigue syndrome) or put the subject at increased risk of adverse events (e.g., cardiac arrhythmia, hypertension) * If female, pregnant or nursing * Currently taking drugs that are contraindicated for use with study drugs * Significant history of motion sickness or demonstrates significant simulator sickness during practice drives at screening (SSQ). Subjects must have scores below the following values on the SSQ: Nausea \< 21, Oculomotor \<32, Disorientation \< 15, and Total Score \< 32. * History of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject from study participation * Prior participation in a driver impairment or distraction-related research study conducted at NADS that uses the same base drive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SDLP | over course of each simulator drive, approximately 35 minutes per visit | Standard Deviation of Lane Position Standard deviation of lane position was analyzed using the SAS GLM function to identify changes in driver performance. Values represents means across the driving environments studied. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lane Departures | over course of each simulator drive, approximately 35 minutes per visit | Total number of lane departures per drive The total number of lane departures across the drive were analyzed using the SAS GLM procedure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All participants were randomized to receive all interventions.
Sober or Double Placebo: Participant receives two tablets, both containing placebo.
Active Xanax, Active Norco: Participant receives two tablets, one containing Xanax and one containing Norco Active Xanax, Placebo Norco: Participant receives two tablets, one containing Xanax and one containing placebo Placebo Xanax, Active Norco: Participant receives two tablets, one containing Norco and one containing placebo
Placebo Oral Tablet: Single dose on two of the four study visits, double dose on one of the four study visits Xanax 1Mg Tablet: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco Norco 10Mg-325Mg Tablet: Single dose on two of the four study visits, one in conjunction with 1mg alprazolam | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Failure at Screening Visit | 2 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Scheduling Conflicts | 3 |
| Overall Study | Withdrew - Nausea Study V1, Sim Drive | 1 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 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 | 2 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 | 6 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
Outcome results
Primary
SDLP
Standard Deviation of Lane Position Standard deviation of lane position was analyzed using the SAS GLM function to identify changes in driver performance. Values represents means across the driving environments studied.
Time frame: over course of each simulator drive, approximately 35 minutes per visit
Population: For the purposes of analysis, the individual interventions are broken down to observe differences. Each of the 8 participants experienced the 4 interventions, in varying order, so each intervention will have 8 overall participants analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sober or Double Placebo | SDLP | 35.2 centimeters | Standard Deviation 11.1 |
| Active Xanax, Active Norco | SDLP | 49.8 centimeters | Standard Deviation 21 |
| Active Xanax, Placebo Norco | SDLP | 50.0 centimeters | Standard Deviation 25.3 |
| Placebo Xanax, Active Norco | SDLP | 33.5 centimeters | Standard Deviation 9.5 |
Secondary
Lane Departures
Total number of lane departures per drive The total number of lane departures across the drive were analyzed using the SAS GLM procedure.
Time frame: over course of each simulator drive, approximately 35 minutes per visit
Population: For the purposes of analysis, the individual interventions are broken down to observe differences. Each of the 8 participants experienced the 4 interventions, in varying order, so each intervention will have 8 overall participants analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sober or Double Placebo | Lane Departures | 23.8 count | Standard Deviation 9 |
| Active Xanax, Active Norco | Lane Departures | 72.0 count | Standard Deviation 38.2 |
| Active Xanax, Placebo Norco | Lane Departures | 64.4 count | Standard Deviation 29.4 |
| Placebo Xanax, Active Norco | Lane Departures | 22.3 count | Standard Deviation 9.5 |