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Do Adolescents and Adults Differ in Their Acute Response to Cannabis?

Not Applicable
Completed
Conditions
Cannabis Use
THC
Marijuana
Adolescent Development
Cannabis Dependence
Cannabis
Cannabis Intoxication
CBD
Interventions
Registration Number
NCT04851392
Lead Sponsor
University College, London
Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
48
Inclusion Criteria
  • Adolescents: Aged 16-17
  • Adults: Aged 26-29 years
  • Self-reported cannabis use between 0.5 and 3 days/week, averaged over the last 3 months
  • Adults: Body mass index (BMI) between 18.5 and 29.9
  • Adolescents: BMI between 2nd percentile and 98th percentile
  • Self-reported ability to consume approximately half a typical joint of cannabis by themselves within 20 minutes
  • Willing to be cannulated and have four blood samples taken at every acute session
  • Right-handed
Exclusion Criteria
  • Females: Pregnant or breast-feeding
  • Adults: Before the age of 18, had a period of 3 or more months when cannabis was used once per week or more frequently.
  • Severe cannabis use disorder (DSM-5)
  • Illicit drug use of any specific drug more than twice per month, averaged over the last 3 months
  • Receiving treatment (pharmacological or psychological) for a mental health problem within the last month
  • Lifetime psychosis
  • Lifetime psychosis of any immediate family member
  • Hypertension (systolic > 160 or diastolic > 100)
  • Dependent on tobacco or vaping nicotine (> 1 on the Heaviness of Smoking Index)
  • Currently taking a psychotropic medication that will likely affect dependent variables or interact with cannabis
  • Any physical or mental health condition, any medication, or any treatment, that the study doctor considers to be an exclusion
  • MRI contraindications
  • Significant asthma or respiratory problems - severity judged clinically
  • Self-reported moderate/severe acute unpleasant effects from cannabis which occur often or always
  • Positive alcohol breathalyser reading at any acute session (rearrange session)
  • Self-reported use of alcohol within 24 hours at any acute session (rearrange session)
  • Self-reported use of illicit drugs (including cannabis) within 72 hours at any acute session (rearrange session)
  • Positive saliva drug screen at any acute session (rearrange session)

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
THC+CBD conditionCannabis with THC without CBDTHC+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.
PLA conditionPlacebo cannabisPLA condition: Placebo cannabis with no THC or CBD. Route of administration: vaporised and inhaled. Frequency: once. Duration: inhaled in \< 18 minutes.
THC conditionCannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)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.
Primary Outcome Measures
NameTimeMethod
Psychotomimetic effectMeasured once, 2 hours after the start of drug administration, on each drug condition

Measured by total Psychotomimetic States Inventory (PSI) score

Strength of subjective drug effectMeasured 20 minutes after the start of drug administration, on each drug condition

Measured by self-reported 'feel drug effect', rated from 0 (not at all) to 10 (extremely)

Verbal episodic memoryMeasured once, 2 hours after the start of drug administration, on each drug condition

Measured by delayed prose recall performance

Secondary Outcome Measures
NameTimeMethod
Heart rateMeasured -30 minutes, 20 minutes, 30 minutes, 2 hours, and 2 hours & 40 minutes after the start of drug administration, on each drug condition

Measuring heart rate

Blood pressureMeasured -30 minutes, 20 minutes, 30 minutes, 2 hours, and 2 hours & 40 minutes after the start of drug administration, on each drug condition

Measuring systolic and diastolic blood pressure.

Magnetic resonance spectroscopyMeasured 1 hour & 30 minutes after the start of drug administration, on each drug condition

Measuring glutamate levels in the dorsal striatum

Self-reported subjective effectsMeasured -30 minutes, 20 minutes, 30 minutes, 2 hours, and 2 hours & 40 minutes after the start of drug administration, on each drug condition

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)

Exogenous and endogenous cannabinoid levels in plasmaMeasured -30 minutes, 20 minutes, 30 minutes, and 2 hours & 40 minutes after the start of drug administration, on each drug condition

Measuring THC and CBD and metabolites; and endocannabinoids

Functional magnetic resonance imaging (fMRI) measured neural correlatesMeasured between 40 minutes and 1 hour & 20 minutes after the start of drug administration, on each drug condition

Reward anticipation and reward feedback, response inhibition, spatial working memory, and resting-state

Positive and negative syndrome scaleMeasured 2 hours & 40 minutes after the start of drug administration, on each drug condition

Kay et al. (1987). Higher scores reflect stronger positive and negative symptoms.

Visual attentional bias to cannabis and food stimuliMeasured 2 hours & 10 minutes after the start of drug administration, on each drug condition

Measured by the visual dot-probe task, as described in Morgan et al. (2010)

Effort-related decision-making (i.e. amotivation)Measured 2 hours & 20 minutes after the start of drug administration, on each drug condition

Measured by the physical effort task ('apple-gathering' task) as described in Husain \& Roiser (2018)

Dissociative states scaleMeasured 2 hours & 40 minutes after the start of drug administration, on each drug condition

Bremner et al. (1998). Higher scores reflect greater dissociation.

Pleasure processingMeasured 2 hours & 30 minutes after the start of drug administration, on each drug condition

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)

Trial Locations

Locations (1)

University College London

🇬🇧

London, United Kingdom

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