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Subjective and physiological effects after controlled Sativex and oral THC administration.

E L Karschner, William D Darwin, Robert P McMahon, F Liu, S Wright, R S Goodwin, Marilyn A. Huestis

Clinical Pharmacology & Therapeutics March 2011 DOI: 10.1038/clpt.2010.318 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Randomized crossover trial Peer reviewed
Sample size 9
Population Cannabis smokers
Interventions Oral synthetic THC Sativex
Dose 5 and 15 mg oral THC; Sativex low (5.4 mg THC, 5.0 mg CBD) and high (16.2 mg THC, 15.0 mg CBD)
Duration 10.5 hours
Topics Cannabis
Key findings Sativex and oral THC produced similar, clinically insignificant increases in heart rate, anxiety, and "good drug effects," with no substantial CBD-induced modulation of THC's effects at therapeutic doses. Oral and oromucosal THC had slower absorption and fewer adverse events than smoked cannabis.

Abstract

Sativex is a cannabis-plant extract delivering nearly 1:1 Δ(9)-tetrahydrocannabinol (THC) and cannabidiol (CBD) by oromucosal spray. It has been suggested that CBD attenuates THC-induced tachycardia, anxiety, and euphoria. In this study, pharmacodynamic effects were compared over 10.5 h in nine cannabis smokers randomly assigned to receive placebo, 5 and 15 mg oral synthetic THC, and low (5.4 mg THC, 5.0 mg CBD) and high (16.2 mg THC, 15.0 mg CBD) doses of Sativex. At therapeutic doses, no substantial CBD-induced modulation of THC's effects was evident. Oral THC and Sativex produced similar, clinically insignificant increases in heart rate, anxiety, and "good drug effects" with no serious adverse events. Oral and oromucosal THC have slower absorption, lower rate of THC delivery to the brain, and fewer associated adverse events as compared with smoked cannabis. These results indicate that Sativex has a pharmacodynamic safety profile comparable to that of oral THC at low, therapeutic doses.

Comparable studies

Other randomized controlled trials on cannabis, most cited first.

Study Year Design Participants
Cannabidiol inhibits THC-elicited paranoid symptoms and hippocampal-dependent memory impairment Healthy participants 2012 Randomized controlled trial n = 48
Distinct Effects of Δ9-Tetrahydrocannabinol and Cannabidiol on Neural Activation During Emotional Processing Healthy, English-native, right-handed men who had used cannabis 15 times or less in... 2009 Double-blind, randomized, placebo-controlled crossover trial n = 15
Acute Effects of a Single, Oral dose of d9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) Administration in Healthy Volunteers Healthy male subjects 2012 Randomized controlled trial n = 16
Modulation of Mediotemporal and Ventrostriatal Function in Humans by Δ9-Tetrahydrocannabinol Healthy, native English-speaking, right-handed men of white race/ethnicity who had used... 2009 Randomized controlled trial n = 15
Cannabidiol (CBD) content in vaporized cannabis does not prevent tetrahydrocannabinol (THC)-induced impairment of driving and cognition Healthy volunteers with a history of light cannabis use 2019 Randomized, double-blind, within-subjects crossover n = 14

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