A randomized, double-blind, placebo-controlled, crossover study to evaluate the subjective abuse potential and cognitive effects of nabiximols oromucosal spray in subjects with a history of recreational cannabis use

Author(s): Schoedel KA, Chen N, Hilliard A, White L, Stott C, et al.


Objective:This study aimed to evaluate the abuse potential and cognitive effects of nabiximols (Sativex, GW Pharma Ltd. Salisbury, UK), an oromucosal spray primarily containing delta‐9‐tetrahydrocannabinol (THC) and cannabidiol (CBD).

Methods:This was a single‐dose, randomized, double‐blind, crossover study comparing nabiximols (4, 8, and 16 consecutive sprays: 10.8, 21.6, and 43.2 mg THC, respectively) with dronabinol 20 and 40 mg (synthetic THC: Marinol, Solvay Pharmaceuticals, Brussels, Belgium) and matching placebos in 23 recreational cannabis users. Subjective and cognitive/psychomotor measures were administered over 24 h post‐dose.

Results:Dronabinol was significantly different from placebo on abuse potential measures, thereby confirming study validity. Nabiximols 10.8 mg was not significantly different from placebo on primary measures but was different on some secondary measures. Nabiximols 21.6 mg was significantly greater than placebo on some primary/secondary measures, whereas nabiximols 43.2 mg showed significant effects on most measures. Nabiximols 10.8 mg was significantly lower than dronabinol doses on most measures ( p < 0.05). Dronabinol 20 mg effects were numerically higher than nabiximols 21.6 mg but were statistically significant only for some measures. Dronabinol 40 mg and nabiximols 43.2 mg were generally not statistically different.

Conclusions:Both dronabinol and nabiximols had significant abuse potential compared with placebo at higher doses. Nabiximols showed similar or slightly less abuse potential compared with dronabinol. Therefore, the abuse potential of nabiximols should be no higher than that of dronabinol.

Similar Articles

Prevalence and treatment of spasticity reported by multiple sclerosis patients

Author(s): Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer TL

Anti-spasticity agents for multiple sclerosis

Author(s): Shakespeare DT, Boggild M, Young C

Randomized controlled trial of cannabis-based medicine in spasticity caused by multiple sclerosis

Author(s): Collin C, Davies P, Mutiboko IK, Ratcliffe S; Sativex Spasticity in MS Study Group

The endocannabinoid system and the brain

Author(s): Mechoulam R, Parker LA

Exploring the association between cannabis use and depression

Author(s): Degenhardt L, Hall W, Lynskey M

Impulsivity, attention, memory, and decision-making among adolescent marijuana users

Author(s): Dougherty DM, Mathias CW, Dawes MA, Furr RM, Charles N, et al.

Modeling of cognitive impairment by disease duration in multiple sclerosis: a cross-sectional study

Author(s): Achiron A, Chapman J, Magalashvili D, Dolev M, Lavie M, et al.