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.
Kerri Alexandra Schoedel, Nancy Chen, Annie Hilliard, Linda White, Colin Stott, Ethan B. Russo, Stephen Wright, Geoffrey W Guy, Myroslava K. Romach, Edward M. Sellers
Human psychopharmacology April 2011 DOI: 10.1002/hup.1196 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized, double-blind, crossover study Placebo-controlled Peer reviewed |
|---|---|
| Sample size | 23 |
| Population | Recreational cannabis users |
| Interventions | Nabiximols Dronabinol |
| Dose | Nabiximols 10.8, 21.6, and 43.2 mg THC (4, 8, and 16 sprays); dronabinol 20 and 40 mg |
| Duration | 24 h post-dose |
| Topics | Cannabis |
| Key points | Both dronabinol and nabiximols showed significant abuse potential compared with placebo at higher doses, with nabiximols showing similar or slightly less abuse potential than dronabinol. The authors conclude that the abuse potential of nabiximols should be no higher than that of dronabinol. |
Abstract
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). 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. 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. 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.
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 |
Citations in the library
Cited by 11
- Cannabidiol Increases Psychotropic Effects and Plasma Concentrations of Δ9-Tetrahydrocannabinol Without Improving Its Analgesic Properties. Clinical Pharmacology & Therapeutics November 1, 2024
- The effect of tetrahydrocannabinol:cannabidiol oromucosal spray on cognition: a systematic review. European Journal of Clinical Pharmacology March 2023
- Cannabis exposure during adolescence: A uniquely sensitive period for neurobiological effects. International review of neurobiology 2022
- How does cannabidiol (CBD) influence the acute effects of delta-9-tetrahydrocannabinol (THC) in humans? A systematic review. Neuroscience & Biobehavioral Reviews September 30, 2019
- A regulatory perspective on the evaluation of hallucinogen drugs for human use. Neuropharmacology November 2018
and 6 more in the library
Cites 9
- Neurophysiological and subjective profile of marijuana with varying concentrations of cannabinoids Behavioural Pharmacology September 1, 2005
- Neurocognitive performance during acute THC intoxication in heavy and occasional cannabis users. Journal of Psychopharmacology May 2009
- Psychopathological and cognitive effects of therapeutic cannabinoids in multiple sclerosis: a double-blind, placebo controlled, crossover study. Clinical Neuropharmacology 2009
- Blunted psychotomimetic and amnestic effects of delta-9-tetrahydrocannabinol in frequent users of cannabis. Neuropsychopharmacology September 2008
- Divergent effects of cannabidiol on the discriminative stimulus and place conditioning effects of Delta(9)-tetrahydrocannabinol. Drug and Alcohol Dependence April 1, 2008
and 4 more in the library