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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.
Hum Psychopharmacol. 2011 Apr; 26(3):224-36.HP

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+Show Affiliations

Kendle Early Stage-Toronto, Toronto, Ontario, Canada. schoedel.kerri@kendle.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21671456

Citation

Schoedel, Kerri Alexandra, et al. "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." Human Psychopharmacology, vol. 26, no. 3, 2011, pp. 224-36.
Schoedel KA, Chen N, Hilliard A, et al. 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. Hum Psychopharmacol. 2011;26(3):224-36.
Schoedel, K. A., Chen, N., Hilliard, A., White, L., Stott, C., Russo, E., Wright, S., Guy, G., Romach, M. K., & Sellers, E. M. (2011). 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. Human Psychopharmacology, 26(3), 224-36. https://doi.org/10.1002/hup.1196
Schoedel KA, et al. 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. Hum Psychopharmacol. 2011;26(3):224-36. PubMed PMID: 21671456.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Schoedel,Kerri Alexandra, AU - Chen,Nancy, AU - Hilliard,Annie, AU - White,Linda, AU - Stott,Colin, AU - Russo,Ethan, AU - Wright,Stephen, AU - Guy,Geoffrey, AU - Romach,Myroslava K, AU - Sellers,Edward M, PY - 2011/6/15/entrez PY - 2011/6/15/pubmed PY - 2012/12/14/medline SP - 224 EP - 36 JF - Human psychopharmacology JO - Hum Psychopharmacol VL - 26 IS - 3 N2 - 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. SN - 1099-1077 UR - https://www.unboundmedicine.com/medline/citation/21671456/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_ L2 - https://doi.org/10.1002/hup.1196 DB - PRIME DP - Unbound Medicine ER -