Opiates and Benzodiazepines on Driving

Phase 4

Completed

Interventions: Drug: Norco 10Mg-325Mg Tablet
Drug: Placebo Oral Tablet
Drug: Xanax 1Mg Tablet

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo Xanax, Active Norco	Norco 10Mg-325Mg Tablet	Subject receives two tablets, one containing Norco and one containing placebo
Active Xanax, Active Norco	Norco 10Mg-325Mg Tablet	Subject receives two tablets, one containing Xanax and one containing Norco
"Sober" or Double Placebo	Placebo Oral Tablet	Subject receives two tablets, both containing placebo
Active Xanax, Active Norco	Xanax 1Mg Tablet	Subject receives two tablets, one containing Xanax and one containing Norco
Active Xanax, Placebo Norco	Xanax 1Mg Tablet	Subject receives two tablets, one containing Xanax and one containing placebo
Active Xanax, Placebo Norco	Placebo Oral Tablet	Subject receives two tablets, one containing Xanax and one containing placebo
Placebo Xanax, Active Norco	Placebo Oral Tablet	Subject receives two tablets, one containing Norco and one containing placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.