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Opiates and Benzodiazepines on Driving

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ClinicalTrials.gov Identifier: NCT03447353
Recruitment Status : Completed
First Posted : February 27, 2018
Results First Posted : September 27, 2018
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Timothy L. Brown, University of Iowa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Driving Behavior
Interventions Drug: Xanax 1Mg Tablet
Drug: Norco 10Mg-325Mg Tablet
Drug: Placebo Oral Tablet
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Overall Study
Hide 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
Reason Not Completed
Failure at Screening Visit             2
Lost to Follow-up             4
Scheduling Conflicts             3
Withdrew - Nausea Study V1, Sim Drive             1
Arm/Group Title All Study Participants
Hide 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 Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
4
  50.0%
Male
4
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
8
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  25.0%
White
6
  75.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title SDLP
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: centimeters
35.2  (11.1) 49.8  (21.0) 50.0  (25.3) 33.5  (9.5)
2.Secondary Outcome
Title Lane Departures
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: count
23.8  (9.0) 72.0  (38.2) 64.4  (29.4) 22.3  (9.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title "Sober" or Double Placebo Active Xanax, Active Norco Active Xanax, Placebo Norco Placebo Xanax, Active Norco
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
"Sober" or Double Placebo Active Xanax, Active Norco Active Xanax, Placebo Norco Placebo Xanax, Active Norco
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
"Sober" or Double Placebo Active Xanax, Active Norco Active Xanax, Placebo Norco Placebo Xanax, Active Norco
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Timothy Brown
Organization: National Advanced Driving Simulator, University of Iowa
Phone: 3193354785
EMail: timothy-l-brown@uiowa.edu
Layout table for additonal information
Responsible Party: Timothy L. Brown, University of Iowa
ClinicalTrials.gov Identifier: NCT03447353     History of Changes
Other Study ID Numbers: 201604731
First Submitted: February 7, 2018
First Posted: February 27, 2018
Results First Submitted: March 27, 2018
Results First Posted: September 27, 2018
Last Update Posted: September 27, 2018