Opiates and Benzodiazepines on Driving

NCT03447353 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 201604731
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Driving Behavior

Keywords

driving; Xanax; Norco; simulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lane Departures

  over course of each simulator drive, approximately 35 minutes per visit

Study Arms (4)

"Sober" or Double Placebo

EXPERIMENTAL

Subject receives two tablets, both containing placebo

Drug: Placebo Oral Tablet

Active Xanax, Active Norco

EXPERIMENTAL

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

Drug: Xanax 1Mg Tablet; Drug: Norco 10Mg-325Mg Tablet

Active Xanax, Placebo Norco

EXPERIMENTAL

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

Drug: Xanax 1Mg Tablet; Drug: Placebo Oral Tablet

Placebo Xanax, Active Norco

EXPERIMENTAL

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

Drug: Norco 10Mg-325Mg Tablet; Drug: Placebo Oral Tablet

Interventions

Xanax 1Mg Tablet DRUG

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

Also known as: Alprazolam

Active Xanax, Active Norco; Active Xanax, Placebo Norco

Norco 10Mg-325Mg Tablet DRUG

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

Also known as: hydrocodone/acetaminophen

Active Xanax, Active Norco; Placebo Xanax, Active Norco

Placebo Oral Tablet DRUG

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

"Sober" or Double Placebo; Active Xanax, Placebo Norco; Placebo Xanax, Active Norco

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Timothy L. Brown: lead

Study Sites (1)

National Advanced Driving Simulator

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Interventions

Alprazolam; Tablets; oxycodone-acetaminophen

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Timothy Brown
• Organization: National Advanced Driving Simulator, University of Iowa

timothy-l-brown@uiowa.edu

3193354785

Study Officials

• Timothy L Brown, Ph.D.

  National Advanced Driving Simulator at the University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Research Scientist/Engineer

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 27, 2018
• Study Start: June 14, 2016
• Primary Completion: October 25, 2016
• Study Completion: October 25, 2016
• Last Updated: September 27, 2018
• Results First Posted: September 27, 2018

Record last verified: 2018-04

Locations

US (1)