A Phase 4 interventional study of Xanax 1Mg Tablet and Norco 10Mg-325Mg Tablet in Driving Behavior, sponsored by Timothy L. Brown. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-27.
Sponsored by Timothy L. Brown · Phase 4, Interventional, and Basic science
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.
1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.
This study's enrollment of 18 is below the median of 120 across 1,197 interventional studies indexed under Behavior.
Browse Behavior studies →Timothy L. Brown is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subject receives two tablets, both containing placebo
Drug: Placebo Oral Tablet
Subject receives two tablets, one containing Xanax and one containing Norco
Drug: Xanax 1Mg Tablet · Drug: Norco 10Mg-325Mg Tablet
Subject receives two tablets, one containing Xanax and one containing placebo
Drug: Xanax 1Mg Tablet · Drug: Placebo Oral Tablet
Subject receives two tablets, one containing Norco and one containing placebo
Drug: Norco 10Mg-325Mg Tablet · Drug: Placebo Oral Tablet
Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco
Also known as: Alprazolam
Single dose on two of the four study visits, one in conjunction with 1mg alprazolam
Also known as: hydrocodone/acetaminophen
Single dose on two of the four study visits, double dose on one of the four study visits
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.
Time frame: over course of each simulator drive, approximately 35 minutes per visit
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.
Time frame: over course of each simulator drive, approximately 35 minutes per visit
| Milestone | Overall Study |
|---|---|
| Started | 18 |
| Completed | 8 |
| Not completed | 10 |
| Withdrew: Failure at screening visit | 2 |
| Withdrew: Lost to follow-up | 4 |
| Withdrew: Scheduling conflicts | 3 |
| Withdrew: Withdrew - nausea study v1, sim drive | 1 |
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.
| centimeters | "Sober" or Double Placebo | Active Xanax, Active Norco | Active Xanax, Placebo Norco | Placebo Xanax, Active Norco |
|---|---|---|---|---|
| SDLP | 35.2 ± 11.1 | 49.8 ± 21.0 | 50.0 ± 25.3 | 33.5 ± 9.5 |
Total number of lane departures per drive The total number of lane departures across the drive were analyzed using the SAS GLM procedure.
| count | "Sober" or Double Placebo | Active Xanax, Active Norco | Active Xanax, Placebo Norco | Placebo Xanax, Active Norco |
|---|---|---|---|---|
| Lane Departures | 23.8 ± 9.0 | 72.0 ± 38.2 | 64.4 ± 29.4 | 22.3 ± 9.5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| "Sober" or Double Placebo | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Active Xanax, Active Norco | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Active Xanax, Placebo Norco | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Placebo Xanax, Active Norco | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Categorical(Participants) | All Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 8 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 4 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 8 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 6 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| United States | 8 |
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Alprazolam
Timothy L. Brown