Status:
COMPLETED
Do Adolescents and Adults Differ in Their Acute Response to Cannabis?
Lead Sponsor:
University College, London
Collaborating Sponsors:
Medical Research Council
Invicro
Conditions:
Cannabis
Cannabis Intoxication
Eligibility:
All Genders
16-29 years
Phase:
NA
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 exp...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04851392
Start Date
March 11 2019
End Date
June 16 2021
Last Update
September 29 2021
Active Locations (1)
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1
University College London
London, United Kingdom, WC1E 7HB