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

NCT ID: NCT04851392

Last Updated: 2021-09-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-11

Study Completion Date

2021-06-16

Brief Summary

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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).

Detailed Description

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Conditions

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Cannabis Cannabis Intoxication Cannabis Use Cannabis Dependence Marijuana THC CBD Adolescent Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind

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.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Cannabis with THC without CBD

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Placebo cannabis

Intervention Type DRUG

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

Intervention Type DRUG

Cannabis with THC without CBD

Cannabis with THC without CBD - inhaled and vaporised cannabis flower

Intervention Type DRUG

Placebo cannabis

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical Research Council

OTHER_GOV

Sponsor Role collaborator

Invicro

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

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.

Reference Type DERIVED
PMID: 38416223 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36750134 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36642667 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35032682 (View on PubMed)

Other Identifiers

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5929/005

Identifier Type: -

Identifier Source: org_study_id

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