Opiates and Benzodiazepines on Driving

NCT ID: NCT03447353

Last Updated: 2018-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-14
• Study Completion Date: 2016-10-25

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.

Conditions

Driving Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

"Sober" or Double Placebo

Subject receives two tablets, both containing placebo

Group Type: EXPERIMENTAL

Placebo Oral Tablet

Intervention Type: DRUG

Single dose on two of the four study visits, double dose on one of the four study visits

Active Xanax, Active Norco

Subject receives two tablets, one containing Xanax and one containing Norco

Group Type: EXPERIMENTAL

Xanax 1Mg Tablet

Intervention Type: DRUG

Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco

Norco 10Mg-325Mg Tablet

Intervention Type: DRUG

Single dose on two of the four study visits, one in conjunction with 1mg alprazolam

Active Xanax, Placebo Norco

Subject receives two tablets, one containing Xanax and one containing placebo

Group Type: EXPERIMENTAL

Xanax 1Mg Tablet

Intervention Type: DRUG

Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco

Placebo Oral Tablet

Intervention Type: DRUG

Single dose on two of the four study visits, double dose on one of the four study visits

Placebo Xanax, Active Norco

Subject receives two tablets, one containing Norco and one containing placebo

Group Type: EXPERIMENTAL

Norco 10Mg-325Mg Tablet

Intervention Type: DRUG

Single dose on two of the four study visits, one in conjunction with 1mg alprazolam

Placebo Oral Tablet

Intervention Type: DRUG

Single dose on two of the four study visits, double dose on one of the four study visits

Interventions

Xanax 1Mg Tablet

Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco

Intervention Type: DRUG

Norco 10Mg-325Mg Tablet

Single dose on two of the four study visits, one in conjunction with 1mg alprazolam

Intervention Type: DRUG

Placebo Oral Tablet

Single dose on two of the four study visits, double dose on one of the four study visits

Intervention Type: DRUG

Other Intervention Names

Alprazolam; hydrocodone/acetaminophen

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Timothy L. Brown

OTHER

Sponsor Role: lead

Responsible Party

Timothy L. Brown

Associate Research Scientist/Engineer

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Timothy L Brown, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Advanced Driving Simulator at the University of Iowa

Locations

National Advanced Driving Simulator

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

201604731

Identifier Type: -

Identifier Source: org_study_id