NCT04851392

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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2019

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2021

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

2.3 years

First QC Date

April 5, 2021

Last Update Submit

September 28, 2021

Conditions

CannabisCannabis IntoxicationCannabis UseCannabis DependenceMarijuanaTHCCBDAdolescent Development

Keywords

CannabisMarijuanaTHCCBDAdolescencefMRICognitionSubjective effectsPsychotomimetic effects

Outcome Measures

Primary Outcomes (3)

  • Psychotomimetic effect

    Measured by total Psychotomimetic States Inventory (PSI) score

    Measured once, 2 hours after the start of drug administration, on each drug condition

  • Verbal episodic memory

    Measured by delayed prose recall performance

    Measured once, 2 hours after the start of drug administration, on each drug condition

  • Strength of subjective drug effect

    Measured by self-reported 'feel drug effect', rated from 0 (not at all) to 10 (extremely)

    Measured 20 minutes after the start of drug administration, on each drug condition

Secondary Outcomes (11)

  • Self-reported subjective effects

    Measured -30 minutes, 20 minutes, 30 minutes, 2 hours, and 2 hours & 40 minutes after the start of drug administration, on each drug condition

  • Functional magnetic resonance imaging (fMRI) measured neural correlates

    Measured between 40 minutes and 1 hour & 20 minutes after the start of drug administration, on each drug condition

  • Magnetic resonance spectroscopy

    Measured 1 hour & 30 minutes after the start of drug administration, on each drug condition

  • Positive and negative syndrome scale

    Measured 2 hours & 40 minutes after the start of drug administration, on each drug condition

  • Effort-related decision-making (i.e. amotivation)

    Measured 2 hours & 20 minutes after the start of drug administration, on each drug condition

  • +6 more secondary outcomes

Study Arms (3)

THC condition

EXPERIMENTAL

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.

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

THC+CBD condition

EXPERIMENTAL

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.

Drug: Cannabis with THC without CBD

PLA condition

PLACEBO COMPARATOR

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

Drug: Placebo cannabis

Interventions

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

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

THC condition
Cannabis with THC without CBDDRUG

Cannabis with THC without CBD - inhaled and vaporised cannabis flower

THC+CBD condition
Placebo cannabisDRUG

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

PLA condition

Eligibility Criteria

Age16 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, WC1E 7HB, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 38416223DERIVED

  • 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.

    PMID: 36750134DERIVED

  • 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.

    PMID: 36642667DERIVED

  • 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.

    PMID: 35032682DERIVED

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximolsDronabinolCannabidiol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double-blind
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2021

First Posted

April 20, 2021

Study Start

March 11, 2019

Primary Completion

June 16, 2021

Study Completion

June 16, 2021

Last Updated

September 29, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)