The effect of cannabidiol on simulated car driving performance: A randomised, double‐blind, placebo‐controlled, crossover, dose‐ranging clinical trial protocol
| Autor: | Ronald R. Grunstein, Camilla M. Hoyos, Christopher Irwin, Anastasia S. Suraev, Danielle McCartney, Iain S. McGregor, Melissa J. Benson, Thomas R. Arkell |
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| Rok vydání: | 2020 |
| Předmět: |
Automobile Driving
medicine.medical_specialty Time Factors Placebo digestive system 03 medical and health sciences Cognition 0302 clinical medicine Double-Blind Method medicine Cannabidiol Humans Pharmacology (medical) Effects of sleep deprivation on cognitive performance Tetrahydrocannabinol Psychomotor learning Cross-Over Studies Dose-Response Relationship Drug business.industry Therapeutic effect Crossover study digestive system diseases 030227 psychiatry Clinical trial Psychiatry and Mental health surgical procedures operative Neurology Physical therapy Neurology (clinical) business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Human Psychopharmacology: Clinical and Experimental. 35 |
| ISSN: | 1099-1077 0885-6222 |
| Popis: | Objective Interest in the use of cannabidiol (CBD) is increasing worldwide as its therapeutic effects are established and legal restrictions moderated. Unlike Δ9 -tetrahydrocannabinol (Δ9 -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 Drager DrugTest® 5000 devices to determine whether CBD increases the risk of "false-positive" roadside tests to Δ9 -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. |
| Databáze: | OpenAIRE |
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