Opiates and Benzodiazepines on Driving

SAFER-SIM: Opiates and Benzodiazepines on Driving

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.

Study Overview

• Status: Completed
• Conditions: Driving Behavior
• Intervention / Treatment: Drug: Placebo Oral Tablet; Drug: Xanax 1Mg Tablet; Drug: Norco 10Mg-325Mg Tablet

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • National Advanced Driving Simulator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "Sober" or Double Placebo; Subject receives two tablets, both containing placebo	Drug: Placebo Oral Tablet; Single dose on two of the four study visits, double dose on one of the four study visits
Experimental: Active Xanax, Active Norco; Subject receives two tablets, one containing Xanax and one containing Norco	Drug: Xanax 1Mg Tablet; Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco; Other Names: Alprazolam; Drug: Norco 10Mg-325Mg Tablet; Single dose on two of the four study visits, one in conjunction with 1mg alprazolam; Other Names: hydrocodone/acetaminophen
Experimental: Active Xanax, Placebo Norco; Subject receives two tablets, one containing Xanax and one containing placebo	Drug: Placebo Oral Tablet; Single dose on two of the four study visits, double dose on one of the four study visits; Drug: Xanax 1Mg Tablet; Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco; Other Names: Alprazolam
Experimental: Placebo Xanax, Active Norco; Subject receives two tablets, one containing Norco and one containing placebo	Drug: Placebo Oral Tablet; Single dose on two of the four study visits, double dose on one of the four study visits; Drug: Norco 10Mg-325Mg Tablet; Single dose on two of the four study visits, one in conjunction with 1mg alprazolam; Other Names: hydrocodone/acetaminophen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	over course of each simulator drive, approximately 35 minutes per visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	over course of each simulator drive, approximately 35 minutes per visit

Collaborators and Investigators

• Sponsor: Timothy L. Brown
• Investigators: Principal Investigator: Timothy L Brown, Ph.D., National Advanced Driving Simulator at the University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2016
• Primary Completion (Actual): October 25, 2016
• Study Completion (Actual): October 25, 2016

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (Actual): February 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: simulation; driving; Xanax; Norco
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antipyretics; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Respiratory System Agents; Antitussive Agents; Acetaminophen; Alprazolam; Hydrocodone; Acetaminophen, hydrocodone drug combination
• Other Study ID Numbers: 201604731

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No