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Completed

NCT Number: NCT04851392

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

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).

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Key information

Conditions

Cannabis Adolescent Development CBD Cannabis Dependence Cannabis Intoxication Cannabis Use Chemically-Induced Disorders Marijuana Marijuana Abuse Mental Disorders Substance-Related Disorders THC

Age range

16 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London

London, WC1E 7HB, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)

Drug

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

Cannabis with THC without CBD

Drug

Cannabis with THC without CBD - inhaled and vaporised cannabis flower

Placebo cannabis

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Invicro
  • Medical Research Council

Registry information

Official study title

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

Acronym: CannTeenA

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2021
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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