CompletedNCT03447353Updated Sep 27, 2018Results posted

Opiates and Benzodiazepines on Driving

A Phase 4 interventional study of Xanax 1Mg Tablet and Norco 10Mg-325Mg Tablet in Driving Behavior, sponsored by Timothy L. Brown. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-27.

Sponsored by Timothy L. Brown · Phase 4, Interventional, and Basic science

Phase: Phase 4
Study type: Interventional
Enrollment: 18
Allocation: Randomized
Ages: 18 Years to 40 Years
Sex: All

Study 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.

Read the 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 studied

Driving Behavior

Keywords

driving
Xanax
Norco
simulation

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 18 participants (actual)

Study arms

Experimental
"Sober" or Double Placebo
Subject receives two tablets, both containing placebo
Drug: Placebo Oral Tablet
Experimental
Active Xanax, Active Norco
Subject receives two tablets, one containing Xanax and one containing Norco
Drug: Xanax 1Mg Tablet · Drug: Norco 10Mg-325Mg Tablet
Experimental
Active Xanax, Placebo Norco
Subject receives two tablets, one containing Xanax and one containing placebo
Drug: Xanax 1Mg Tablet · Drug: Placebo Oral Tablet
Experimental
Placebo Xanax, Active Norco
Subject receives two tablets, one containing Norco and one containing placebo
Drug: Norco 10Mg-325Mg Tablet · Drug: Placebo Oral Tablet

Interventions

DrugXanax 1Mg Tablet
Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco
Also known as: Alprazolam
DrugNorco 10Mg-325Mg Tablet
Single dose on two of the four study visits, one in conjunction with 1mg alprazolam
Also known as: hydrocodone/acetaminophen
DrugPlacebo Oral Tablet
Single dose on two of the four study visits, double dose on one of the four study visits

What researchers measure

Primary outcomes

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.
Time frame: over course of each simulator drive, approximately 35 minutes per visit

Secondary outcomes

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.
Time frame: over course of each simulator drive, approximately 35 minutes per visit

Results

Posted Sep 27, 2018

Participant flow

Participant flow — Overall Study
Milestone	Overall Study
Started	18
Completed	8
Not completed	10
Withdrew: Failure at screening visit	2
Withdrew: Lost to follow-up	4
Withdrew: Scheduling conflicts	3
Withdrew: Withdrew - nausea study v1, sim drive	1

Outcome measures

PrimarySDLP

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.

Time frame:: over course of each simulator drive, approximately 35 minutes per visit
Reported as:: Mean · centimeters

SDLP
centimeters	"Sober" or Double Placebo	Active Xanax, Active Norco	Active Xanax, Placebo Norco	Placebo Xanax, Active Norco
SDLP	35.2 ± 11.1	49.8 ± 21.0	50.0 ± 25.3	33.5 ± 9.5

SecondaryLane Departures

Total number of lane departures per drive The total number of lane departures across the drive were analyzed using the SAS GLM procedure.

Time frame:: over course of each simulator drive, approximately 35 minutes per visit
Reported as:: Mean · count

Lane Departures
count	"Sober" or Double Placebo	Active Xanax, Active Norco	Active Xanax, Placebo Norco	Placebo Xanax, Active Norco
Lane Departures	23.8 ± 9.0	72.0 ± 38.2	64.4 ± 29.4	22.3 ± 9.5

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
"Sober" or Double Placebo	0/8 (0%)	0/8 (0%)	0/8 (0%)
Active Xanax, Active Norco	0/8 (0%)	0/8 (0%)	0/8 (0%)
Active Xanax, Placebo Norco	0/8 (0%)	0/8 (0%)	0/8 (0%)
Placebo Xanax, Active Norco	0/8 (0%)	0/8 (0%)	0/8 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	All Study Participants
<=18 years	0
Between 18 and 65 years	8
>=65 years	0

Sex: Female, Male
Sex: Female, Male(Participants)	All Study Participants
Female	4
Male	4

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	All Study Participants
Hispanic or Latino	0
Not Hispanic or Latino	8
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	All Study Participants
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	2
White	6
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	All Study Participants
United States	8

Study locations

1 site

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

Registry details

Key details

Study ID: NCT03447353
Lead sponsor: Timothy L. Brown
Responsible party: Timothy L. Brown (Associate Research Scientist/Engineer, University of Iowa) — Sponsor-investigator
First posted: Feb 27, 2018
Start date: Jun 14, 2016
Primary completion: Oct 25, 2016
Completion: Oct 25, 2016
Results posted: Sep 27, 2018
Last update: Sep 27, 2018

Study contacts

Timothy L Brown, Ph.D.

principal investigator · National Advanced Driving Simulator at the University of Iowa

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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