Clinical trial NCT04851392: Do Adolescents and Adults Differ in Their Acute Response to Cannabis?
Official title: Do Adolescents and Adults Differ in Their Acute Subjective, Behavioural and Neural Responses to Cannabis, With and Without Cannabidiol?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis
Cannabis Intoxication
Cannabis Use
Cannabis Dependence
Marijuana
THC
CBD
Adolescent Development
Keywords: Cannabis
Marijuana
THC
CBD
Adolescence
fMRI
Cognition
Subjective effects
Psychotomimetic effects
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: Invicro
First posted: 2021-04-20
Enrollment: 48
Sex: ALL
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, placebo-controlled, crossover experiment with drug condition block randomised and stratified by age-group and gender, such that drug order is counterbalanced.

There are two groups: adolescents (16-17 years old) and adults (26-29 years old). These groups are matched on current cannabis use frequency.

There are three drug conditions: (1) cannabis with delta-9-tetrahydrocannabinol (THC) and without cannabidiol (CBD), (2) cannabis with THC but without CBD, and (3) placebo cannabis without THC and without CBD.
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Psychotomimetic effect
timeFrame: Measured once, 2 hours after the start of drug administration, on each drug condition
measure: Verbal episodic memory
timeFrame: Measured once, 2 hours after the start of drug administration, on each drug condition
measure: Strength of subjective drug effect
timeFrame: Measured 20 minutes after the start of drug administration, on each drug condition
Secondary outcomes:
measure: Self-reported subjective effects
timeFrame: Measured -30 minutes, 20 minutes, 30 minutes, 2 hours, and 2 hours & 40 minutes after the start of drug administration, on each drug condition
measure: Functional magnetic resonance imaging (fMRI) measured neural correlates
timeFrame: Measured between 40 minutes and 1 hour & 20 minutes after the start of drug administration, on each drug condition
measure: Magnetic resonance spectroscopy
timeFrame: Measured 1 hour & 30 minutes after the start of drug administration, on each drug condition
measure: Positive and negative syndrome scale
timeFrame: Measured 2 hours & 40 minutes after the start of drug administration, on each drug condition
measure: Effort-related decision-making (i.e. amotivation)
timeFrame: Measured 2 hours & 20 minutes after the start of drug administration, on each drug condition
measure: Pleasure processing
timeFrame: Measured 2 hours & 30 minutes after the start of drug administration, on each drug condition
measure: Visual attentional bias to cannabis and food stimuli
timeFrame: Measured 2 hours & 10 minutes after the start of drug administration, on each drug condition
measure: Heart rate
timeFrame: Measured -30 minutes, 20 minutes, 30 minutes, 2 hours, and 2 hours & 40 minutes after the start of drug administration, on each drug condition
measure: Blood pressure
timeFrame: Measured -30 minutes, 20 minutes, 30 minutes, 2 hours, and 2 hours & 40 minutes after the start of drug administration, on each drug condition
measure: Exogenous and endogenous cannabinoid levels in plasma
timeFrame: Measured -30 minutes, 20 minutes, 30 minutes, and 2 hours & 40 minutes after the start of drug administration, on each drug condition
measure: Dissociative states scale
timeFrame: Measured 2 hours & 40 minutes after the start of drug administration, on each drug condition
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
References: