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

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ClinicalTrials.gov Identifier: NCT04851392
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Collaborators:
Medical Research Council
Invicro
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Cannabis Cannabis Intoxication Cannabis Use Cannabis Dependence Marijuana THC CBD Adolescent Development Drug: Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) Drug: Cannabis with THC without CBD Drug: Placebo cannabis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.

Masking: Double (Participant, Investigator)
Masking Description: Double-blind
Primary Purpose: Basic Science
Official Title: Do Adolescents and Adults Differ in Their Acute Subjective, Behavioural and Neural Responses to Cannabis, With and Without Cannabidiol?
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: THC condition

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)
Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) - inhaled and vaporised cannabis flower

Experimental: THC+CBD condition

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
Cannabis with THC without CBD - inhaled and vaporised cannabis flower

Placebo Comparator: PLA condition

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
Placebo cannabis, without THC and without CBD - inhaled and vaporised




Primary Outcome Measures :
  1. Psychotomimetic effect [ Time Frame: Measured once, 2 hours after the start of drug administration, on each drug condition ]
    Measured by total Psychotomimetic States Inventory (PSI) score

  2. Verbal episodic memory [ Time Frame: Measured once, 2 hours after the start of drug administration, on each drug condition ]
    Measured by delayed prose recall performance

  3. Strength of subjective drug effect [ Time Frame: Measured 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)


Secondary Outcome Measures :
  1. Self-reported subjective effects [ 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 ]
    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)

  2. Functional magnetic resonance imaging (fMRI) measured neural correlates [ Time Frame: Measured 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

  3. Magnetic resonance spectroscopy [ Time Frame: Measured 1 hour & 30 minutes after the start of drug administration, on each drug condition ]
    Measuring glutamate levels in the dorsal striatum

  4. Positive and negative syndrome scale [ Time Frame: Measured 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.

  5. Effort-related decision-making (i.e. amotivation) [ Time Frame: 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)

  6. Pleasure processing [ Time Frame: Measured 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)

  7. Visual attentional bias to cannabis and food stimuli [ Time Frame: Measured 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)

  8. 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 ]
    Measuring heart rate

  9. 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 ]
    Measuring systolic and diastolic blood pressure.

  10. Exogenous and endogenous cannabinoid levels in plasma [ Time Frame: Measured -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

  11. Dissociative states scale [ Time Frame: Measured 2 hours & 40 minutes after the start of drug administration, on each drug condition ]
    Bremner et al. (1998). Higher scores reflect greater dissociation.



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Ages Eligible for Study:   16 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851392


Contacts
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Contact: Will Lawn, PhD 02031083319 will.lawn@ucl.ac.uk
Contact: H Valerie Curran, PhD, DClinPsy v.curran@ucl.ac.uk

Locations
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United Kingdom
University College London Recruiting
London, United Kingdom, WC1E 7HB
Contact: Will Lawn, PhD    02031083319    will.lawn@ucl.ac.uk   
Principal Investigator: H Valerie Curran, PhD, DClinPsy         
Sub-Investigator: Tom P Freeman, PhD         
Sponsors and Collaborators
University College, London
Medical Research Council
Invicro
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04851392    
Other Study ID Numbers: 5929/005
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University College, London:
Cannabis
Marijuana
THC
CBD
Adolescence
fMRI
Cognition
Subjective effects
Psychotomimetic effects
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Epidiolex
Anticonvulsants
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists