Trial Outcomes & Findings for Effects of Inhaled Cannabis on Driving Performance (NCT NCT01620177)
NCT ID: NCT01620177
Last Updated: 2018-05-02
Results Overview
Measured by standard deviation of lane position. Metrics of driving performance were modeled using the SAS GLM Select function to identify changes in driver performance. Numbers represents coefficients on the regression equation such that this increase would be expected for every unit increase. A unit for THC is 1 ng/ml and a unit for BAC is 0.01% BAC. In understanding the regression coefficients, for THC the units for the coefficient would be expressed as cm per (ng/ml of THC), and for BrAC the units for the coefficient would be expressed as cm per (0.01% BrAC). The overall regression equation would be represented as SDLP = Intercept + Cthc x THC + Cbrac x BrAC. The coefficients indicate the strength of the effect on driving performance with higher coefficients indicating larger effects relative to the concentrations. Coefficients of zero indicate no effect or interactive effect.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
98 participants
Primary outcome timeframe
Through entire drive, 0.5-1.3 hr post cannabis administration.
Results posted on
2018-05-02
Participant Flow
Participant milestones
| Measure |
Overall Study
Individuals who completed the study completed all six arms of the study and the data is aggregated. Non-completers may have completed some arms and not others and their data is aggregated. There will be six study visits where the subject will arrive at the Clinical Research Unit(University of Iowa Hospitals \& Clinics) the night before dosing. At each visit subjects will be receive one of the following six dosing regimens: placebo alcohol with placebo cannabis; placebo alcohol with low-dose cannabis, placebo alcohol with higher-dose of cannabis, low dose alcohol with placebo cannabis; low dose alcohol with low dose cannabis, low dose alcohol with higher-dose of cannabis.
|
|---|---|
|
Overall Study
STARTED
|
98
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
79
|
Reasons for withdrawal
| Measure |
Overall Study
Individuals who completed the study completed all six arms of the study and the data is aggregated. Non-completers may have completed some arms and not others and their data is aggregated. There will be six study visits where the subject will arrive at the Clinical Research Unit(University of Iowa Hospitals \& Clinics) the night before dosing. At each visit subjects will be receive one of the following six dosing regimens: placebo alcohol with placebo cannabis; placebo alcohol with low-dose cannabis, placebo alcohol with higher-dose of cannabis, low dose alcohol with placebo cannabis; low dose alcohol with low dose cannabis, low dose alcohol with higher-dose of cannabis.
|
|---|---|
|
Overall Study
Failure at Screening Visit
|
43
|
|
Overall Study
Withdrawal by Subject
|
26
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Randomized, Not Active due to Scheduling
|
1
|
Baseline Characteristics
Effects of Inhaled Cannabis on Driving Performance
Baseline characteristics by cohort
| Measure |
Overall Study
n=98 Participants
Individuals who completed the study completed all six arms of the study and the data is aggregated. Non-completers may have completed some arms and not others and their data is aggregated.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
98 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through entire drive, 0.5-1.3 hr post cannabis administration.Population: One subject who was an extreme outlier across driving performance measures was excluded. Due to the variability in THC and BrAC levels across subjects and conditions, a regression model was used which combined all of the data.
Measured by standard deviation of lane position. Metrics of driving performance were modeled using the SAS GLM Select function to identify changes in driver performance. Numbers represents coefficients on the regression equation such that this increase would be expected for every unit increase. A unit for THC is 1 ng/ml and a unit for BAC is 0.01% BAC. In understanding the regression coefficients, for THC the units for the coefficient would be expressed as cm per (ng/ml of THC), and for BrAC the units for the coefficient would be expressed as cm per (0.01% BrAC). The overall regression equation would be represented as SDLP = Intercept + Cthc x THC + Cbrac x BrAC. The coefficients indicate the strength of the effect on driving performance with higher coefficients indicating larger effects relative to the concentrations. Coefficients of zero indicate no effect or interactive effect.
Outcome measures
| Measure |
Cannabis - THC
n=18 Participants
Data from all dosing conditions combined to estimate the effect of THC concentrations using a regression equation.
|
Alcohol - BrAC (Breath Alcohol Concentration)
n=18 Participants
Data from all dosing conditions combined to estimate the effect of BrACconcentrations using a regression equation.
|
THC x BrAC
n=18 Participants
Data from all dosing conditions combined to estimate the interactive effect of THC and BrAC concentrations using a regression equation.
|
2.5-3.5% THC With 0 g/dL BAC
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
6.0-7.5% THC With 0 g/dL BAC
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
0% THC With 0 g/dL BAC
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
|---|---|---|---|---|---|---|
|
Driving Performance
|
0.26 cm
|
0.42 cm
|
0 cm
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: -0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabis administrationPopulation: We performed noncompartmental analyses with Phoenix WinNonLin® 6.3 for Windows (Pharsight) for maximum concentration (Cmax) of 11-OH-THC (LOQ 1 μg/L).
Measurement of THC concentration levels in plasma over the course of each visit compared to that of the other visits.
Outcome measures
| Measure |
Cannabis - THC
n=19 Participants
Data from all dosing conditions combined to estimate the effect of THC concentrations using a regression equation.
|
Alcohol - BrAC (Breath Alcohol Concentration)
n=19 Participants
Data from all dosing conditions combined to estimate the effect of BrACconcentrations using a regression equation.
|
THC x BrAC
n=19 Participants
Data from all dosing conditions combined to estimate the interactive effect of THC and BrAC concentrations using a regression equation.
|
2.5-3.5% THC With 0 g/dL BAC
n=19 Participants
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
6.0-7.5% THC With 0 g/dL BAC
n=19 Participants
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
0% THC With 0 g/dL BAC
n=19 Participants
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
|---|---|---|---|---|---|---|
|
THC Concentration in Plasma Sample
|
0 ng/ml
Interval 0.0 to 3.2
|
4.8 ng/ml
Interval 1.3 to 8.0
|
7.5 ng/ml
Interval 0.0 to 27.3
|
4.1 ng/ml
Interval 0.0 to 13.7
|
7 ng/ml
Interval 1.0 to 20.3
|
0 ng/ml
Interval 0.0 to 4.3
|
SECONDARY outcome
Timeframe: -0.7 hr, 0.25hr, 1.1 hr, 2 hr, 3 hr, 4.5 hr, 6 hr, 8 hr post cannabisMeasurement of THC concentration levels in whole blood over the course of each visit compared to that of the other visits.
Outcome measures
| Measure |
Cannabis - THC
n=19 Participants
Data from all dosing conditions combined to estimate the effect of THC concentrations using a regression equation.
|
Alcohol - BrAC (Breath Alcohol Concentration)
n=19 Participants
Data from all dosing conditions combined to estimate the effect of BrACconcentrations using a regression equation.
|
THC x BrAC
n=19 Participants
Data from all dosing conditions combined to estimate the interactive effect of THC and BrAC concentrations using a regression equation.
|
2.5-3.5% THC With 0 g/dL BAC
n=19 Participants
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
6.0-7.5% THC With 0 g/dL BAC
n=19 Participants
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
0% THC With 0 g/dL BAC
n=19 Participants
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
|---|---|---|---|---|---|---|
|
THC Concentration Levels in Whole Blood
|
0 ng/ml
Interval 0.0 to 2.4
|
3.7 ng/ml
Interval 1.4 to 6.0
|
6.0 ng/ml
Interval 0.0 to 24.8
|
2.8 ng/ml
Interval 0.0 to 9.1
|
5.0 ng/ml
Interval 0.0 to 14.2
|
0 ng/ml
Interval 0.0 to 2.5
|
Adverse Events
0% THC With 0.065 g/dL BAC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
2.5-3.5% THC With 0.065 g/dL BAC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
6.0-7.5% THC and 0.065 g/dL BAC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
2.5-3.5% THC With 0 g/dL BAC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
6.0-7.5% THC With 0 g/dL BAC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
0% THC With 0 g/dL BAC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0% THC With 0.065 g/dL BAC
n=29 participants at risk
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
2.5-3.5% THC With 0.065 g/dL BAC
n=27 participants at risk
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
6.0-7.5% THC and 0.065 g/dL BAC
n=24 participants at risk
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
2.5-3.5% THC With 0 g/dL BAC
n=26 participants at risk
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
6.0-7.5% THC With 0 g/dL BAC
n=31 participants at risk
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
0% THC With 0 g/dL BAC
n=27 participants at risk
Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
10.3%
3/29 • Number of events 3
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
16.7%
4/24 • Number of events 4
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/26
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
3.2%
1/31 • Number of events 1
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
3.7%
1/27 • Number of events 1
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
12.5%
3/24 • Number of events 3
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/26
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/31
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
|
Gastrointestinal disorders
Tooth Ache
|
3.4%
1/29 • Number of events 1
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/24
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/26
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/31
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/29
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
3.7%
1/27 • Number of events 1
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/24
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/26
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/31
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
|
Nervous system disorders
Loss of Consciousness with IV Insertion
|
0.00%
0/29
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/24
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/26
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
3.2%
1/31 • Number of events 1
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
|
Nervous system disorders
Disorientation
|
0.00%
0/29
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/24
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/26
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
3.2%
1/31 • Number of events 1
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
7.4%
2/27 • Number of events 2
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
8.3%
2/24 • Number of events 2
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/26
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
3.2%
1/31 • Number of events 1
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
|
Nervous system disorders
Light-Headed
|
0.00%
0/29
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
7.4%
2/27 • Number of events 2
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/24
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/26
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/31
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
|
Nervous system disorders
Anxiety
|
0.00%
0/29
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
3.7%
1/27 • Number of events 1
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
16.7%
4/24 • Number of events 4
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/26
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/31
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
|
Nervous system disorders
Headache
|
0.00%
0/29
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/24
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/26
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/31
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
|
Nervous system disorders
Change in Status Perception
|
0.00%
0/29
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
3.7%
1/27 • Number of events 1
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
4.2%
1/24 • Number of events 1
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/26
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/31
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
|
Nervous system disorders
Diaphoresis
|
0.00%
0/29
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
3.7%
1/27 • Number of events 1
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/24
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/26
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/31
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/29
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
3.7%
1/27 • Number of events 1
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/24
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/26
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/31
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
0.00%
0/27
Adverse events were reported for all subjects who completed at least one dosing visit. The number of subjects varies across conditions based on the number of dosing visits by subjects who did not complete the study and which randomization arm they were assigned.
|
Additional Information
Dr. Timothy L. Brown, Co-PI
National Advanced Driving Simulator
Phone: 319-335-4785
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60