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The effect of cannabidiol on simulated car driving performance: A randomised, double‐blind, placebo‐controlled, crossover, dose‐ranging clinical trial protocol
Author(s) -
McCartney Danielle,
Benson Melissa J.,
Suraev Anastasia S.,
Irwin Christopher,
Arkell Thomas R.,
Grunstein Ronald R.,
Hoyos Camilla M.,
McGregor Iain S.
Publication year - 2020
Publication title -
human psychopharmacology: clinical and experimental
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.461
H-Index - 78
eISSN - 1099-1077
pISSN - 0885-6222
DOI - 10.1002/hup.2749
Subject(s) - cannabidiol , placebo , crossover study , medicine , psychomotor learning , cognition , randomized controlled trial , protocol (science) , clinical trial , cannabis , effects of sleep deprivation on cognitive performance , anesthesia , psychiatry , alternative medicine , pathology
Objective Interest in the use of cannabidiol (CBD) is increasing worldwide as its therapeutic effects are established and legal restrictions moderated. Unlike Δ 9 ‐tetrahydrocannabinol (Δ 9 ‐THC), CBD does not appear to cause cognitive or psychomotor impairment. However, further assessment of its effects on cognitively demanding day‐to‐day activities, such as driving, is warranted. Here, we describe a study investigating the effects of CBD on simulated driving and cognitive performance. Methods Thirty healthy individuals will be recruited to participate in this randomised, double‐blind, placebo‐controlled crossover trial. Participants will complete four research sessions each involving two 30‐min simulated driving performance tests completed 45 and 210 min following oral ingestion of placebo or 15, 300, or 1,500 mg CBD. Cognitive function and subjective drug effects will be measured, and blood and oral fluid sampled, at regular intervals. Oral fluid drug testing will be performed using the Securetec DrugWipe® 5S and Dräger DrugTest® 5000 devices to determine whether CBD increases the risk of “false‐positive” roadside tests to Δ 9 ‐THC. Noninferiority analyses will test the hypothesis that CBD is no more impairing than placebo. Conclusion This study will clarify the risks involved in driving following CBD use and assist in ensuring the safe use of CBD by drivers.