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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Sober" or Double Placebo | Experimental | Subject receives two tablets, both containing placebo |
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| Active Xanax, Active Norco | Experimental | Subject receives two tablets, one containing Xanax and one containing Norco |
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| Active Xanax, Placebo Norco | Experimental | Subject receives two tablets, one containing Xanax and one containing placebo |
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| Placebo Xanax, Active Norco | Experimental | Subject receives two tablets, one containing Norco and one containing placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xanax 1Mg Tablet | Drug | Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | over course of each simulator drive, approximately 35 minutes per visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | over course of each simulator drive, approximately 35 minutes per visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy L Brown, Ph.D. | National Advanced Driving Simulator at the University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Advanced Driving Simulator | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | centimeters | over course of each simulator drive, approximately 35 minutes per visit |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | "Sober" or Double Placebo | Participant receives two tablets, both containing placebo. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Timothy Brown | National Advanced Driving Simulator, University of Iowa | 3193354785 | timothy-l-brown@uiowa.edu |
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| ID | Term |
|---|---|
| D000525 | Alprazolam |
| D013607 | Tablets |
| C514822 | oxycodone-acetaminophen |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Norco 10Mg-325Mg Tablet | Drug | Single dose on two of the four study visits, one in conjunction with 1mg alprazolam |
|
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| Placebo Oral Tablet | Drug | Single dose on two of the four study visits, double dose on one of the four study visits |
|
| Withdrew - Nausea Study V1, Sim Drive |
|
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 |
| Active Xanax, Active Norco |
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 |
| OG002 | Active Xanax, Placebo Norco | 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 |
| OG003 | Placebo Xanax, Active Norco | 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 |
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | count | over course of each simulator drive, approximately 35 minutes per visit |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Active Xanax, Active Norco | 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 | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Active Xanax, Placebo Norco | 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 | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | Placebo Xanax, Active 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 | 0 | 8 | 0 | 8 | 0 | 8 |
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| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |