NCT03447353

Opiates and Benzodiazepines on Driving

SAFER-SIM: Opiates and Benzodiazepines on Driving

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Timothy L. Brown · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Driving Behavior

Interventions

Type	Name	Description
DRUG	Xanax 1Mg Tablet	Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco
DRUG	Norco 10Mg-325Mg Tablet	Single dose on two of the four study visits, one in conjunction with 1mg alprazolam
DRUG	Placebo Oral Tablet	Single dose on two of the four study visits, double dose on one of the four study visits

Timeline

• Start date: 2016-06-14
• Primary completion: 2016-10-25
• Completion: 2016-10-25
• First posted: 2018-02-27
• Last updated: 2018-09-27
• Results posted: 2018-09-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study