NCT01620177

Effects of Inhaled Cannabis on Driving Performance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Gary R Gaffney · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to expand understanding of the effects of cannabis on driving performance with and without the presence of low levels of alcohol. This project will involve the development a of a protocol and driving environment that is sensitive to the effects of cannabis on driving performance by building on prior driving situations used previously for testing the effects of alcohol on driving.

Detailed description

Individuals will be recruited who are currently users of cannabis and alcohol to participate in this study. They will undergo a physical exam at screening. 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. After dosing, participants will have provide saliva samples and blood drawn periodically to check cannabis levels and will complete a driving simulation. After completing the drive, additional saliva samples and blood draws will occur and participants will be monitored until it is safe to transport home.

Conditions

• Alcohol Drinking
• Cannabis

Interventions

Type	Name	Description
DRUG	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
DRUG	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

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-06-15
• Last updated: 2018-05-02
• Results posted: 2017-06-01

Locations

1 site across 1 country: United States