Trial Outcomes & Findings for Opiates and Benzodiazepines on Driving (NCT NCT03447353)
NCT ID: NCT03447353
Last Updated: 2018-09-27
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
over course of each simulator drive, approximately 35 minutes per visit
Results posted on
2018-09-27
Participant Flow
Participant milestones
| Measure |
Overall Study
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.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Overall Study
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.
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|---|---|
|
Overall Study
Failure at Screening Visit
|
2
|
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Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Scheduling Conflicts
|
3
|
|
Overall Study
Withdrew - Nausea Study V1, Sim Drive
|
1
|
Baseline Characteristics
Opiates and Benzodiazepines on Driving
Baseline characteristics by cohort
| Measure |
All Study Participants
n=8 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: over course of each simulator drive, approximately 35 minutes per visitPopulation: 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.
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.
Outcome measures
| Measure |
"Sober" or Double Placebo
n=8 Participants
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
|
Active Xanax, Active Norco
n=8 Participants
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
|
Active Xanax, Placebo Norco
n=8 Participants
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
|
Placebo Xanax, Active Norco
n=8 Participants
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
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|---|---|---|---|---|
|
SDLP
|
35.2 centimeters
Standard Deviation 11.1
|
49.8 centimeters
Standard Deviation 21.0
|
50.0 centimeters
Standard Deviation 25.3
|
33.5 centimeters
Standard Deviation 9.5
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SECONDARY outcome
Timeframe: over course of each simulator drive, approximately 35 minutes per visitPopulation: 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.
Total number of lane departures per drive The total number of lane departures across the drive were analyzed using the SAS GLM procedure.
Outcome measures
| Measure |
"Sober" or Double Placebo
n=8 Participants
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
|
Active Xanax, Active Norco
n=8 Participants
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
|
Active Xanax, Placebo Norco
n=8 Participants
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
|
Placebo Xanax, Active Norco
n=8 Participants
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
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|---|---|---|---|---|
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Lane Departures
|
23.8 count
Standard Deviation 9.0
|
72.0 count
Standard Deviation 38.2
|
64.4 count
Standard Deviation 29.4
|
22.3 count
Standard Deviation 9.5
|
Adverse Events
"Sober" or Double Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Xanax, Active Norco
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Xanax, Placebo Norco
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Xanax, Active Norco
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Timothy Brown
National Advanced Driving Simulator, University of Iowa
Phone: 3193354785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place