Opiates and Benzodiazepines on Driving

• Sponsor: Timothy L. Brown (Other)
• Overall Status: Completed
• CT.gov ID: NCT03447353
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 4
• Actual Duration (Months): 4.4
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Driving Behavior	Drug: Xanax 1Mg Tablet; Drug: Norco 10Mg-325Mg Tablet; Drug: Placebo Oral Tablet	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: SAFER-SIM: Opiates and Benzodiazepines on Driving
• Actual Study Start Date: Jun 14, 2016
• Actual Primary Completion Date: Oct 25, 2016
• Actual Study Completion Date: Oct 25, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. SDLP [over course of each simulator drive, approximately 35 minutes per visit]

   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.

Secondary Outcome Measures

1. Lane Departures [over course of each simulator drive, approximately 35 minutes per visit]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Advanced Driving Simulator	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• Timothy L. Brown

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Timothy L. Brown, Associate Research Scientist/Engineer, University of Iowa
• ClinicalTrials.gov Identifier: NCT03447353
• Other Study ID Numbers: 201604731
• First Posted: Feb 27, 2018
• Last Update Posted: Sep 27, 2018
• Last Verified: Apr 1, 2018

• 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
• Keywords provided by Timothy L. Brown, Associate Research Scientist/Engineer, University of Iowa: driving; Xanax; Norco; simulation
• Additional relevant MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Alprazolam

Study Results

Participant Flow

Arm/Group Title	Overall Study
Arm/Group Description	Individuals who completed the study completed all four arms of the study and the data is aggregated. Subjects who did not complete the study may have completed one arm and their data is not included in the analysis. There was a screening visit and four study visits where the subject arrived at the National Advanced Driving Simulator. At each study visit, subjects received one of the following four dosing regimens: double placebo or "Sober"; active Xanax with active Norco, active Xanax and placebo Norco, and placebo Xanax and active Norco.
Period Title: Overall Study
STARTED	18
COMPLETED	8
NOT COMPLETED	10

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	All participants were randomized to receive all interventions. "Sober" or Double Placebo: Participant receives two tablets, both containing placebo. Active Xanax, Active Norco: Participant receives two tablets, one containing Xanax and one containing Norco Active Xanax, Placebo Norco: Participant receives two tablets, one containing Xanax and one containing placebo Placebo Xanax, Active Norco: Participant receives two tablets, one containing Norco and one containing placebo Placebo Oral Tablet: Single dose on two of the four study visits, double dose on one of the four study visits Xanax 1Mg Tablet: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco Norco 10Mg-325Mg Tablet: Single dose on two of the four study visits, one in conjunction with 1mg alprazolam
Overall Participants	8
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	8 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	4 50%
Male	4 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	8 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 25%
White	6 75%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	8 100%

Outcome Measures

1. Primary Outcome

Title	SDLP
Description	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

Outcome Measure Data

Analysis Population Description

For the purposes of analysis, the individual interventions are broken down to observe differences. Each of the 8 participants experienced the 4 interventions, in varying order, so each intervention will have 8 overall participants analyzed.

Arm/Group Title	"Sober" or Double Placebo	Active Xanax, Active Norco	Active Xanax, Placebo Norco	Placebo Xanax, Active Norco
Arm/Group Description	Subject receives two tablets, both containing placebo Placebo Oral Tablet: Single dose on two of the four study visits, double dose on one of the four study visits	Subject receives two tablets, one containing Xanax and one containing Norco Xanax 1Mg Tablet: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco Norco 10Mg-325Mg Tablet: Single dose on two of the four study visits, one in conjunction with 1mg alprazolam	Subject receives two tablets, one containing Xanax and one containing placebo Xanax 1Mg Tablet: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco Placebo Oral Tablet: Single dose on two of the four study visits, double dose on one of the four study visits	Subject receives two tablets, one containing Norco and one containing placebo Norco 10Mg-325Mg Tablet: Single dose on two of the four study visits, one in conjunction with 1mg alprazolam Placebo Oral Tablet: Single dose on two of the four study visits, double dose on one of the four study visits
Measure Participants	8	8	8	8
Mean (Standard Deviation) [centimeters]	35.2 (11.1)	49.8 (21.0)	50.0 (25.3)	33.5 (9.5)

2. Secondary Outcome

Title	Lane Departures
Description	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

Outcome Measure Data

Analysis Population Description

For the purposes of analysis, the individual interventions are broken down to observe differences. Each of the 8 participants experienced the 4 interventions, in varying order, so each intervention will have 8 overall participants analyzed.

Arm/Group Title	"Sober" or Double Placebo	Active Xanax, Active Norco	Active Xanax, Placebo Norco	Placebo Xanax, Active Norco
Arm/Group Description	Subject receives two tablets, both containing placebo Placebo Oral Tablet: Single dose on two of the four study visits, double dose on one of the four study visits	Subject receives two tablets, one containing Xanax and one containing Norco Xanax 1Mg Tablet: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco Norco 10Mg-325Mg Tablet: Single dose on two of the four study visits, one in conjunction with 1mg alprazolam	Subject receives two tablets, one containing Xanax and one containing placebo Xanax 1Mg Tablet: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco Placebo Oral Tablet: Single dose on two of the four study visits, double dose on one of the four study visits	Subject receives two tablets, one containing Norco and one containing placebo Norco 10Mg-325Mg Tablet: Single dose on two of the four study visits, one in conjunction with 1mg alprazolam Placebo Oral Tablet: Single dose on two of the four study visits, double dose on one of the four study visits
Measure Participants	8	8	8	8
Mean (Standard Deviation) [count]	23.8 (9.0)	72.0 (38.2)	64.4 (29.4)	22.3 (9.5)

Adverse Events

Arm/Group Title	"Sober" or Double Placebo		Active Xanax, Active Norco		Active Xanax, Placebo Norco		Placebo Xanax, Active Norco
Arm/Group Description	Participant receives two tablets, both containing placebo.		Participant receives two tablets, one containing Xanax and one containing Norco Xanax 1Mg Tablet: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco Norco 10Mg-325Mg Tablet: Single dose on two of the four study visits, one in conjunction with 1mg alprazolam		Participant receives two tablets, one containing Xanax and one containing placebo Xanax 1Mg Tablet: Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco		Participant receives two tablets, one containing Norco and one containing placebo Norco 10Mg-325Mg Tablet: Single dose on two of the four study visits, one in conjunction with 1mg alprazolam
All Cause Mortality
	"Sober" or Double Placebo		Active Xanax, Active Norco		Active Xanax, Placebo Norco		Placebo Xanax, Active Norco
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/8 (0%)
Serious Adverse Events
	"Sober" or Double Placebo		Active Xanax, Active Norco		Active Xanax, Placebo Norco		Placebo Xanax, Active Norco
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	"Sober" or Double Placebo		Active Xanax, Active Norco		Active Xanax, Placebo Norco		Placebo Xanax, Active Norco
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/8 (0%)		0/8 (0%)		0/8 (0%)		0/8 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.