search
Back to results

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

Primary Purpose

Cannabis, Cannabis Intoxication, Cannabis Use

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)
Cannabis with THC without CBD
Placebo cannabis
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cannabis focused on measuring Cannabis, Marijuana, THC, CBD, Adolescence, fMRI, Cognition, Subjective effects, Psychotomimetic effects

Eligibility Criteria

16 Years - 29 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University College London

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

THC condition

THC+CBD condition

PLA condition

Arm Description

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.

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.

PLA condition: Placebo cannabis with no THC or CBD. Route of administration: vaporised and inhaled. Frequency: once. Duration: inhaled in < 18 minutes.

Outcomes

Primary Outcome Measures

Psychotomimetic effect
Measured by total Psychotomimetic States Inventory (PSI) score
Verbal episodic memory
Measured by delayed prose recall performance
Strength of subjective drug effect
Measured by self-reported 'feel drug effect', rated from 0 (not at all) to 10 (extremely)

Secondary Outcome Measures

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)
Functional magnetic resonance imaging (fMRI) measured neural correlates
Reward anticipation and reward feedback, response inhibition, spatial working memory, and resting-state
Magnetic resonance spectroscopy
Measuring glutamate levels in the dorsal striatum
Positive and negative syndrome scale
Kay et al. (1987). Higher scores reflect stronger positive and negative symptoms.
Effort-related decision-making (i.e. amotivation)
Measured by the physical effort task ('apple-gathering' task) as described in Husain & Roiser (2018)
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)
Visual attentional bias to cannabis and food stimuli
Measured by the visual dot-probe task, as described in Morgan et al. (2010)
Heart rate
Measuring heart rate
Blood pressure
Measuring systolic and diastolic blood pressure.
Exogenous and endogenous cannabinoid levels in plasma
Measuring THC and CBD and metabolites; and endocannabinoids
Dissociative states scale
Bremner et al. (1998). Higher scores reflect greater dissociation.

Full Information

First Posted
April 5, 2021
Last Updated
September 28, 2021
Sponsor
University College, London
Collaborators
Medical Research Council, Invicro
search

1. Study Identification

Unique Protocol Identification Number
NCT04851392
Brief Title
Do Adolescents and Adults Differ in Their Acute Response to Cannabis?
Acronym
CannTeenA
Official Title
Do Adolescents and Adults Differ in Their Acute Subjective, Behavioural and Neural Responses to Cannabis, With and Without Cannabidiol?
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
June 16, 2021 (Actual)
Study Completion Date
June 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
Medical Research Council, Invicro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis, Cannabis Intoxication, Cannabis Use, Cannabis Dependence, Marijuana, THC, CBD, Adolescent Development
Keywords
Cannabis, Marijuana, THC, CBD, Adolescence, fMRI, Cognition, Subjective effects, Psychotomimetic effects

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantInvestigator
Masking Description
Double-blind
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
THC condition
Arm Type
Experimental
Arm Description
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.
Arm Title
THC+CBD condition
Arm Type
Experimental
Arm Description
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.
Arm Title
PLA condition
Arm Type
Placebo Comparator
Arm Description
PLA condition: Placebo cannabis with no THC or CBD. Route of administration: vaporised and inhaled. Frequency: once. Duration: inhaled in < 18 minutes.
Intervention Type
Drug
Intervention Name(s)
Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)
Intervention Description
Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) - inhaled and vaporised cannabis flower
Intervention Type
Drug
Intervention Name(s)
Cannabis with THC without CBD
Intervention Description
Cannabis with THC without CBD - inhaled and vaporised cannabis flower
Intervention Type
Drug
Intervention Name(s)
Placebo cannabis
Intervention Description
Placebo cannabis, without THC and without CBD - inhaled and vaporised
Primary Outcome Measure Information:
Title
Psychotomimetic effect
Description
Measured by total Psychotomimetic States Inventory (PSI) score
Time Frame
Measured once, 2 hours after the start of drug administration, on each drug condition
Title
Verbal episodic memory
Description
Measured by delayed prose recall performance
Time Frame
Measured once, 2 hours after the start of drug administration, on each drug condition
Title
Strength of subjective drug effect
Description
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
Secondary Outcome Measure Information:
Title
Self-reported subjective effects
Description
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
Title
Functional magnetic resonance imaging (fMRI) measured neural correlates
Description
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
Title
Magnetic resonance spectroscopy
Description
Measuring glutamate levels in the dorsal striatum
Time Frame
Measured 1 hour & 30 minutes after the start of drug administration, on each drug condition
Title
Positive and negative syndrome scale
Description
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
Title
Effort-related decision-making (i.e. amotivation)
Description
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
Title
Pleasure processing
Description
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
Title
Visual attentional bias to cannabis and food stimuli
Description
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
Title
Heart rate
Description
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
Title
Blood pressure
Description
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
Title
Exogenous and endogenous cannabinoid levels in plasma
Description
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
Title
Dissociative states scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
University College London
City
London
ZIP/Postal Code
WC1E 7HB
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs