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

Cannabis Use Clinical Trial

— CannTeenA  

Official title:

Do Adolescents and Adults Differ in Their Acute Subjective, Behavioural and Neural Responses to Cannabis, With and Without Cannabidiol?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04851392
• Other study ID #: 5929/005
• Status: Completed
• Phase: N/A
• Start date: March 11, 2019
• Est. completion date: June 16, 2021

Study information

• Verified date: September 2021
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 16, 2021
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 29 Years

Eligibility

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)

Related Conditions & MeSH terms

• Adolescent Development
• Cannabis
• Cannabis Dependence
• Cannabis Intoxication
• Cannabis Use
• CBD
• Marijuana
• Marijuana Abuse
• THC

Intervention

Drug:
• Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)
Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) - inhaled and vaporised cannabis flower
• Cannabis with THC without CBD
Cannabis with THC without CBD - inhaled and vaporised cannabis flower
• Placebo cannabis
Placebo cannabis, without THC and without CBD - inhaled and vaporised

Locations

Country	Name	City	State
United Kingdom	University College London	London

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	Invicro, Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychotomimetic effect	Measured by total Psychotomimetic States Inventory (PSI) score	Measured once, 2 hours after the start of drug administration, on each drug condition
Primary	Verbal episodic memory	Measured by delayed prose recall performance	Measured once, 2 hours after the start of drug administration, on each drug condition
Primary	Strength of subjective drug effect	Measured by self-reported 'feel drug effect', rated from 0 (not at all) to 10 (extremely)	Measured 20 minutes after the start of drug administration, on each drug condition
Secondary	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)	Measured -30 minutes, 20 minutes, 30 minutes, 2 hours, and 2 hours & 40 minutes after the start of drug administration, on each drug condition
Secondary	Functional magnetic resonance imaging (fMRI) measured neural correlates	Reward anticipation and reward feedback, response inhibition, spatial working memory, and resting-state	Measured between 40 minutes and 1 hour & 20 minutes after the start of drug administration, on each drug condition
Secondary	Magnetic resonance spectroscopy	Measuring glutamate levels in the dorsal striatum	Measured 1 hour & 30 minutes after the start of drug administration, on each drug condition
Secondary	Positive and negative syndrome scale	Kay et al. (1987). Higher scores reflect stronger positive and negative symptoms.	Measured 2 hours & 40 minutes after the start of drug administration, on each drug condition
Secondary	Effort-related decision-making (i.e. amotivation)	Measured by the physical effort task ('apple-gathering' task) as described in Husain & Roiser (2018)	Measured 2 hours & 20 minutes after the start of drug administration, on each drug condition
Secondary	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)	Measured 2 hours & 30 minutes after the start of drug administration, on each drug condition
Secondary	Visual attentional bias to cannabis and food stimuli	Measured by the visual dot-probe task, as described in Morgan et al. (2010)	Measured 2 hours & 10 minutes after the start of drug administration, on each drug condition
Secondary	Heart rate	Measuring heart rate	Measured -30 minutes, 20 minutes, 30 minutes, 2 hours, and 2 hours & 40 minutes after the start of drug administration, on each drug condition
Secondary	Blood pressure	Measuring systolic and diastolic blood pressure.	Measured -30 minutes, 20 minutes, 30 minutes, 2 hours, and 2 hours & 40 minutes after the start of drug administration, on each drug condition
Secondary	Exogenous and endogenous cannabinoid levels in plasma	Measuring THC and CBD and metabolites; and endocannabinoids	Measured -30 minutes, 20 minutes, 30 minutes, and 2 hours & 40 minutes after the start of drug administration, on each drug condition
Secondary	Dissociative states scale	Bremner et al. (1998). Higher scores reflect greater dissociation.	Measured 2 hours & 40 minutes after the start of drug administration, on each drug condition