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

University College London (UCL)

Status: Completed

Conditions: Adolescent Development; Cannabis Dependence; THC; Cannabis; Cannabis Use; Cannabis Intoxication; CBD; Marijuana

Treatments: Drug: Cannabis with THC without CBD; Drug: Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD); Drug: Placebo cannabis

Study type: Interventional

Funder types: Other

Identifiers

NCT04851392

5929/005

Details and patient eligibility

About

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).

Enrollment: 48 patients

Sex: All

Ages: 16 to 29 years old

Volunteers: Accepts 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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 3 patient groups, including a placebo group

THC condition

Experimental group

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.

Treatment:

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

THC+CBD condition

Experimental group

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.

Treatment:

Drug: Cannabis with THC without CBD

PLA condition

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo cannabis