title: 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.
abstract: 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.
authors.affiliation: Kendle Early Stage-Toronto, Toronto, Ontario, Canada. schoedel.kerri@kendle.com
authors.forename: Kerri Alexandra
authors.initials: KA
authors.lastname: Schoedel
authors.forename: Nancy
authors.initials: N
authors.lastname: Chen
authors.forename: Annie
authors.initials: A
authors.lastname: Hilliard
authors.forename: Linda
authors.initials: L
authors.lastname: White
authors.forename: Colin
authors.initials: C
authors.lastname: Stott
authors.forename: Ethan
authors.initials: E
authors.lastname: Russo
authors.forename: Stephen
authors.initials: S
authors.lastname: Wright
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Guy
authors.forename: Myroslava K
authors.initials: MK
authors.lastname: Romach
authors.forename: Edward M
authors.initials: EM
authors.lastname: Sellers
mesh_terms: D000328:Adult; D002185:Cannabidiol; D002186:Cannabinoids / Q000008:administration & dosage* / Q000097:blood; D003071:Cognition / Q000187:drug effects* / Q000502:physiology; D018592:Cross-Over Studies; D004311:Double-Blind Method; D013759:Dronabinol / Q000008:administration & dosage* / Q000097:blood; D004338:Drug Combinations; D004341:Drug Evaluation / Q000379:methods; D005260:Female; D006801:Humans; D013287:Illicit Drugs / Q000097:blood; D008297:Male; D002189:Marijuana Abuse / Q000097:blood / Q000453:epidemiology; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects* / Q000502:physiology; D058993:Oral Sprays; D010936:Plant Extracts / Q000008:administration & dosage* / Q000097:blood; D055815:Young Adult
chemical_list: D002186:Cannabinoids; D004338:Drug Combinations; D013287:Illicit Drugs; D058993:Oral Sprays; D010936:Plant Extracts; D002185:Cannabidiol; D013759:Dronabinol; C587251:nabiximols