Opiates and Benzodiazepines on Driving
Condition: Driving Behavior
Intervention: Xanax 1Mg Tablet; Norco 10Mg-325Mg Tablet; Placebo Oral Tablet
Intervention description: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco; Single dose on two of the four study visits, one in conjunction with 1mg alprazolam; Single dose on two of the four study visits, double dose on one of the four study visits
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Alprazolam
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: driving; Xanax; Norco; simulation

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.
    

Eligibility criteria:

        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