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CannabisCannTeenANCT04851392

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

A study testing Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and Cannabis with THC without CBD in people with Cannabis and Cannabis Intoxication, run by University College, London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 to 29 yearsHealthy volunteers can take part
Conditions the study is for
Cannabis, Cannabis Intoxication, Cannabis Use
What is being tested?
Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and Cannabis with THC without CBD
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteUnited Kingdom
Study dates
11 Mar 2019to 16 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 29 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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 locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University College London

    London, WC1E 7HB

Other trials in United Kingdom

About this study

Official title: Do Adolescents and Adults Differ in Their Acute Subjective, Behavioural and Neural Responses to Cannabis, With and Without Cannabidiol?

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).

Being tested
Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), Cannabis with THC without CBD, Placebo cannabis
Keywords
Cannabis, Marijuana, THC, CBD, Adolescence, fMRI, Cognition, Subjective effects, Psychotomimetic effects
Medical subject headings
Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

  • Cannabis with THC without CBDDrug

    Cannabis with THC without CBD - inhaled and vaporised cannabis flower

  • Placebo cannabisDrug

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

Study groups in NCT04851392
Study groupRoleWhat they receive
THC conditionExperimentalTHC 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.
Receives: Drug: Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)
THC+CBD conditionExperimentalTHC+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.
Receives: Drug: Cannabis with THC without CBD
PLA conditionPlacebo comparatorPLA condition: Placebo cannabis with no THC or CBD. Route of administration: vaporised and inhaled. Frequency: once. Duration: inhaled in < 18 minutes.
Receives: Drug: Placebo cannabis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psychotomimetic effect

    Measured by total Psychotomimetic States Inventory (PSI) score

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

  2. Verbal episodic memory

    Measured by delayed prose recall performance

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

  3. Strength of subjective drug effect

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

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

Secondary outcomes (11)
  1. Self-reported subjective effects

    Feel drug effect, like drug effect, dislike drug effect, alert, want to have cannabis, happy, relaxed, anxious, paranoid, mentally impaired, stoned, dry mouth, unmotivated, intensified sensory perception, want to listen to music, want food, want to see friends, rated from 0 (not at all) to 10 (extremely)

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

  2. Functional magnetic resonance imaging (fMRI) measured neural correlates

    Reward anticipation and reward feedback, response inhibition, spatial working memory, and resting-state

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

  3. Magnetic resonance spectroscopy

    Measuring glutamate levels in the dorsal striatum

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

  4. Positive and negative syndrome scale

    Kay et al. (1987). Higher scores reflect stronger positive and negative symptoms.

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

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

    Measured by the physical effort task ('apple-gathering' task) as described in Husain \& Roiser (2018)

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

  6. Pleasure processing

    Measured by subjective liking in response to chocolate, music and cartoons, rated from 0 (not at all) to 10 (extremely), similar to Lawn et al. (2015)

    Measured: Measured 2 hours & 30 minutes after the start of drug administration, on each drug condition

  7. Visual attentional bias to cannabis and food stimuli

    Measured by the visual dot-probe task, as described in Morgan et al. (2010)

    Measured: Measured 2 hours & 10 minutes after the start of drug administration, on each drug condition

  8. Heart rate

    Measuring heart rate

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

  9. Blood pressure

    Measuring systolic and diastolic blood pressure.

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

  10. Exogenous and endogenous cannabinoid levels in plasma

    Measuring THC and CBD and metabolites; and endocannabinoids

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

  11. Dissociative states scale

    Bremner et al. (1998). Higher scores reflect greater dissociation.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2021
  2. Study start11 Mar 2019
  3. Primary completion16 Jun 2021
  4. Study completion16 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04851392
Sponsor's protocol ID
5929/005
Acronym
CannTeenA
Status last verified
Sep 2021
First submitted
5 Apr 2021
Last updated
29 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38416223
  • 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.

    PubMed 36750134
  • 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.

    PubMed 36642667
  • 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.

    PubMed 35032682

Questions about this trial

What is this clinical trial studying?

A study testing Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and Cannabis with THC without CBD in people with Cannabis and Cannabis Intoxication, run by University College, London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychotomimetic effect (time frame: Measured once, 2 hours after the start of drug administration, on each drug condition). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04851392, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.

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