Effect of vaporizing cannabis rich in cannabidiol on cannabinoid levels in blood and on driving ability - a randomized clinical trial.

"Declarations Ethical approvalThe study was approved on 29.05.2019 by the ethics committee northwest/central Switzerland (BASEC-ID 2019–00639) and conducted in accordance with the Declaration of Helsinki ethical standards between September 2019 and August 2020 at the Institute of Forensic Medicine, University of Basel. Research involving human participantsThis trial was registered with the German Clinical Trials Register (DRKS00018836) on 25.10.2019 and with the Coordination Office for Human Research (kofam) which is operated by the Federal Office of Public Health (FOPH) (SNCTP000003294). Informed consentWritten informed consent was obtained from all individual participants included in the study. Competing interestsThe authors have no competing interests to declare that are relevant to the content of this article. Competing interests The authors have no competing interests to declare that are relevant to the content of this article."

"Funding Open access funding provided by University of Basel. This work received funding from the Federal Office of Public Health (FOPH), department of consumer protection, Switzerland."

"The study was approved on 29.05.2019 by the ethics committee northwest/central Switzerland (BASEC-ID 2019–00639) and conducted in accordance with the Declaration of Helsinki ethical standards between September 2019 and August 2020 at the Institute of Forensic Medicine, University of Basel. This trial was registered with the German Clinical Trials Register (DRKS00018836) on 25.10.2019 and with the Coordination Office for Human Research (kofam) which is operated by the Federal Office of Public Health (FOPH) (SNCTP000003294). The aim of this prospective, placebo-controlled, double-blind, randomized, cross-over study was to determine cannabinoid levels in blood and driving-related ability after single (S1) and repetitive (S2) vaporization of cannabis rich in cannabidiol (CBD) containing < 1% Δ9-etrahydrocannabinol (THC). Healthy adult volunteers (Nsingle = 27, Nrepetitive = 20) with experience in smoking vapor-inhaled two low-THC/CBD-rich cannabis products both with < 1% THC (product 1: 38 mg CBD, 1.8 mg THC; product 2: 39 mg CBD, 0.6 mg THC) and placebo. Main outcomes were THC- and CBD-levels in whole blood and overall assessment of driving-related ability by computerized tests. Among 74 participants included, 27 (mean age ± SD, 28.9 ± 12.5 years) completed S1, and 20 (25.2 ± 4.0) completed S2. Peak concentrations and duration of detectability depended on the THC-content of the product. After single consumption THC dropped below 1.5 µg/L after 1.5 h, but was detected in some participants up to 5 h. Pairwise comparison of driving-related ability revealed no significant differences between low-THC/CBD-rich products (P1, P2) and placebo. Detection of THC after consumption of low-THC/CBD-rich cannabis might have legal consequences for drivers. Regarding overall driving-related ability, no significant differences were observed between the interventional products. This trial was registered with the German Clinical Trials Register (DRKS00018836) on 25.10.2019 and with the Coordination Office for Human Research (kofam) which is operated by the Federal Office of Public Health (FOPH) (SNCTP000003294). Declarations: Ethical approvalThe study was approved on 29.05.2019 by the ethics committee northwest/central Switzerland (BASEC-ID 2019–00639) and conducted in accordance with the Declaration of Helsinki ethical standards between September 2019 and August 2020 at the Institute of Forensic Medicine, University of Basel.: Research involving human participantsThis trial was registered with the German Clinical Trials Register (DRKS00018836) on 25.10.2019 and with the Coordination Office for Human Research (kofam) which is operated by the Federal Office of Public Health (FOPH) (SNCTP000003294).: Informed consentWritten informed consent was obtained from all individual participants included in the study.: Competing interestsThe authors have no competing interests to declare that are relevant to the content of this article. Research involving human participants: This trial was registered with the German Clinical Trials Register (DRKS00018836) on 25.10.2019 and with the Coordination Office for Human Research (kofam) which is operated by the Federal Office of Public Health (FOPH) (SNCTP000003294)."