Do Adolescents and Adults Differ in Their Acute Response to Cannabis?
NCT ID: NCT04851392
Last Updated: 2021-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2019-03-11
2021-06-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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.
BASIC_SCIENCE
DOUBLE
Study Groups
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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.
Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)
Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) - inhaled and vaporised cannabis flower
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.
Cannabis with THC without CBD
Cannabis with THC without CBD - inhaled and vaporised cannabis flower
PLA condition
PLA condition: Placebo cannabis with no THC or CBD.
Route of administration: vaporised and inhaled.
Frequency: once.
Duration: inhaled in \< 18 minutes.
Placebo cannabis
Placebo cannabis, without THC and without CBD - inhaled and vaporised
Interventions
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Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)
Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) - inhaled and vaporised cannabis flower
Cannabis with THC without CBD
Cannabis with THC without CBD - inhaled and vaporised cannabis flower
Placebo cannabis
Placebo cannabis, without THC and without CBD - inhaled and vaporised
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
16 Years
29 Years
ALL
Yes
Sponsors
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Medical Research Council
OTHER_GOV
Invicro
OTHER
University College, London
OTHER
Responsible Party
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Locations
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University College London
London, , United Kingdom
Countries
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References
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Hall D, Lawn W, Ofori S, Trinci K, Borissova A, Mokrysz C, Petrilli K, Bloomfield MAP, Wall MB, Freeman TP, Curran HV. The acute effects of cannabis, with and without cannabidiol, on attentional bias to cannabis related cues: a randomised, double-blind, placebo-controlled, cross-over study. Psychopharmacology (Berl). 2024 Jun;241(6):1125-1134. doi: 10.1007/s00213-024-06543-7. Epub 2024 Feb 28.
Lawn W, Trinci K, Mokrysz C, Borissova A, Ofori S, Petrilli K, Bloomfield M, Haniff ZR, Hall D, Fernandez-Vinson N, Wang S, Englund A, Chesney E, Wall MB, Freeman TP, Curran HV. The acute effects of cannabis with and without cannabidiol in adults and adolescents: A randomised, double-blind, placebo-controlled, crossover experiment. Addiction. 2023 Jul;118(7):1282-1294. doi: 10.1111/add.16154. Epub 2023 Feb 26.
Skumlien M, Freeman TP, Hall D, Mokrysz C, Wall MB, Ofori S, Petrilli K, Trinci K, Borissova A, Fernandez-Vinson N, Langley C, Sahakian BJ, Curran HV, Lawn W. The Effects of Acute Cannabis With and Without Cannabidiol on Neural Reward Anticipation in Adults and Adolescents. Biol Psychiatry Cogn Neurosci Neuroimaging. 2023 Feb;8(2):219-229. doi: 10.1016/j.bpsc.2022.10.004. Epub 2022 Oct 28.
Dhami P, Quilty LC, Schwartzmann B, Uher R, Allen TA, Kloiber S, Lam RW, MacQueen G, Frey BN, Milev R, Muller DJ, Strother SC, Blier P, Soares CN, Parikh SV, Turecki G, Foster JA, Rotzinger S, Kennedy SH, Farzan F. Response Inhibition and Predicting Response to Pharmacological and Cognitive Behavioral Therapy Treatments for Major Depressive Disorder: A Canadian Biomarker Integration Network for Depression Study. Biol Psychiatry Cogn Neurosci Neuroimaging. 2023 Feb;8(2):162-170. doi: 10.1016/j.bpsc.2021.12.012. Epub 2022 Jan 13.
Other Identifiers
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5929/005
Identifier Type: -
Identifier Source: org_study_id
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