An interventional study of Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and Cannabis with THC without CBD in Cannabis, Cannabis Intoxication and Cannabis Use, sponsored by University College, London. Completed at 1 site in United Kingdom. Open to participants aged 16 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-29.
Sponsored by University College, London · Not applicable, Interventional, and Basic science
The acute effects of cannabis may differ between adolescents and adults. Furthermore, these effects may be tempered by the presence of cannabidiol. This double-blind, placebo-controlled, crossover experiment investigates the acute effects of cannabis (with and without cannabidiol) on subjective effects, behavioural responses and neural functioning in 16-17 year-olds and 26-29 year-olds who regularly use cannabis (0.5-3 days per week).
517 studies on the registry are indexed under Marijuana Abuse; 114 are open to participants now.
This study's enrollment of 48 is below the median of 60 across 421 interventional studies indexed under Marijuana Abuse.
Browse Marijuana Abuse studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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Exclusion Criteria:
THC condition: Cannabis with delta-9-tetrahydrocannabinol (THC) and no cannabidiol (CBD). 0.107mg/kg of THC. A 75kg person receives 8mg of THC. Route of administration: vaporised and inhaled. Frequency: once. Duration: inhaled in \< 18 minutes.
Drug: Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)
THC+CBD condition: Cannabis with THC and CBD (i.e. THC+CBD condition). 0.107mg/kg of THC and 0.320mg/kg of CBD. A 75kg person receives 8mg of THC and 24mg of CBD. Route of administration: vaporised and inhaled. Frequency: once. Duration: inhaled in \< 18 minutes.
Drug: Cannabis with THC without CBD
PLA condition: Placebo cannabis with no THC or CBD. Route of administration: vaporised and inhaled. Frequency: once. Duration: inhaled in \< 18 minutes.
Drug: Placebo cannabis
Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) - inhaled and vaporised cannabis flower
Cannabis with THC without CBD - inhaled and vaporised cannabis flower
Placebo cannabis, without THC and without CBD - inhaled and vaporised
Psychotomimetic effect
Measured by total Psychotomimetic States Inventory (PSI) score
Time frame: Measured once, 2 hours after the start of drug administration, on each drug condition
Verbal episodic memory
Measured by delayed prose recall performance
Time frame: Measured once, 2 hours after the start of drug administration, on each drug condition
Strength of subjective drug effect
Measured by self-reported 'feel drug effect', rated from 0 (not at all) to 10 (extremely)
Time frame: Measured 20 minutes after the start of drug administration, on each drug condition
Self-reported subjective effects
Feel drug effect, like drug effect, dislike drug effect, alert, want to have cannabis, happy, relaxed, anxious, paranoid, mentally impaired, stoned, dry mouth, unmotivated, intensified sensory perception, want to listen to music, want food, want to see friends, rated from 0 (not at all) to 10 (extremely)
Time frame: Measured -30 minutes, 20 minutes, 30 minutes, 2 hours, and 2 hours & 40 minutes after the start of drug administration, on each drug condition
Functional magnetic resonance imaging (fMRI) measured neural correlates
Reward anticipation and reward feedback, response inhibition, spatial working memory, and resting-state
Time frame: Measured between 40 minutes and 1 hour & 20 minutes after the start of drug administration, on each drug condition
Magnetic resonance spectroscopy
Measuring glutamate levels in the dorsal striatum
Time frame: Measured 1 hour & 30 minutes after the start of drug administration, on each drug condition
Positive and negative syndrome scale
Kay et al. (1987). Higher scores reflect stronger positive and negative symptoms.
Time frame: Measured 2 hours & 40 minutes after the start of drug administration, on each drug condition
Effort-related decision-making (i.e. amotivation)
Measured by the physical effort task ('apple-gathering' task) as described in Husain \& Roiser (2018)
Time frame: Measured 2 hours & 20 minutes after the start of drug administration, on each drug condition
Pleasure processing
Measured by subjective liking in response to chocolate, music and cartoons, rated from 0 (not at all) to 10 (extremely), similar to Lawn et al. (2015)
Time frame: Measured 2 hours & 30 minutes after the start of drug administration, on each drug condition
Visual attentional bias to cannabis and food stimuli
Measured by the visual dot-probe task, as described in Morgan et al. (2010)
Time frame: Measured 2 hours & 10 minutes after the start of drug administration, on each drug condition
Heart rate
Measuring heart rate
Time frame: Measured -30 minutes, 20 minutes, 30 minutes, 2 hours, and 2 hours & 40 minutes after the start of drug administration, on each drug condition
Blood pressure
Measuring systolic and diastolic blood pressure.
Time frame: Measured -30 minutes, 20 minutes, 30 minutes, 2 hours, and 2 hours & 40 minutes after the start of drug administration, on each drug condition
Exogenous and endogenous cannabinoid levels in plasma
Measuring THC and CBD and metabolites; and endocannabinoids
Time frame: Measured -30 minutes, 20 minutes, 30 minutes, and 2 hours & 40 minutes after the start of drug administration, on each drug condition
Dissociative states scale
Bremner et al. (1998). Higher scores reflect greater dissociation.
Time frame: Measured 2 hours & 40 minutes after the start of drug administration, on each drug condition
Plan to share: No
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University College, London