NCT03555968

Effects of THC and Alcohol on Driving Performance

Determining the Combined Effects of THC and Alcohol on Driving Performance

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lakehead University · Academic / Other
• Sex: All
• Age: 19 Years – 25 Years
• Healthy volunteers: Accepted

Summary

Low blood concentrations of THC and alcohol appear to have a minimal effect on driving performance.However, there is a gap in the literature about the combined effects of THC and alcohol. There is little empirical evidence to determine whether the combination of THC and alcohol could be additive or multiplicative. This issue is particularly important when dealing with concentrations that are just below legal thresholds - it is important to identify if someone who may have consumed cannabis and alcohol, in quantities that do not exceed legal thresholds, may nonetheless be impaired to drive. Answering this question requires more research on the combined effects of THC and alcohol under tightly controlled experimental conditions. Hence, the purpose of this study is to determine the additive (or multiplicative) effect of standardized low doses of cannabis, in combination with low-doses of alcohol, on a number of outcome measures related to driving. The investigators will focus specifically on the effect of low blood concentrations of THC (0, 125, and 250 µg/kg) alone and in combination with low blood concentrations of alcohol (BAC 0%, .025%, and .049%). They shall determine the combined effect of THC and alcohol on physiological, cognitive, subjective measures of impairment, and simulated driving. This study will focus on younger adults because they have higher impaired driving rates than other age groups. As a secondary aim of the study, the investigators will examine whether previous driving and drug use history are correlated with driving decisions during the simulated drive and subjective measures. This study will contribute to the evidence base informing legislation, policy making, and law enforcement. This study is particularly timely given upcoming changes in legislation about cannabis, and because the combination of THC and alcohol, even below legal thresholds, may lead to impaired driving and crashes.

Conditions

• Cannabis
• Alcohol Drinking
• Accident, Traffic

Interventions

Type	Name	Description
DRUG	THC 0	THC dose = 0mg
DRUG	THC 5	THC dose = 5mg
DRUG	THC 10	THC dose = 10mg
OTHER	BAC 0	Blood alcohol concentration = .000%
OTHER	BAC .025	Blood alcohol concentration = .025%
OTHER	BAC .049	Blood alcohol concentration = .049%

Timeline

• Start date: 2021-07-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2018-06-14
• Last updated: 2022-04-25

Regulatory

• FDA-regulated drug study