Exploring The Effect Of Cannabidiol On Cannabis Tolerance Using A Novel Vaporiser Device In Heavy Users (Stage 1)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorKing's College London

About this trial

Cannabis contains delta-9-tetrahydrocannabinol (THC), which causes intoxication. People who use cannabis frequently often develop tolerance, meaning they need to use more THC to feel the same effects. Cannabidiol (CBD) is another compound found in cannabis that is not intoxicating and may influence how THC affects the body and brain.

This study will examine whether taking CBD changes how much THC heavy cannabis users consume to reach their usual level of intoxication. The study will also develop a new laboratory method that allows participants to safely and gradually self-administer THC using a vaporiser, similar to how cannabis is used in real-world settings.

The study will include around 30 adults who use cannabis heavily. In the first stage, participants will take part in pilot sessions to help refine the THC administration procedure. In the second stage, participants will attend two study sessions and receive a single oral dose of CBD or placebo, in a random order. After this, they will inhale THC using a vaporiser and decide when to stop based on how intoxicated they feel.

Researchers will measure how much THC is used, along with mood, mental health symptoms, thinking abilities, physical measures such as heart rate and blood pressure, and blood levels of THC and CBD. The results will help improve understanding of cannabis tolerance and whether CBD alters responses to THC in heavy cannabis users.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults, between 18 and 45 years old

Heavy and frequent cannabis user: using 7-14 grams of high potency cannabis per week over the past month, and using cannabis on at least 5 days per week over the past month

Positive urine drug screen (UDS) for cannabis

Willing to abstain from cannabis use for 4 hours before any experimental session.

Disqualifiers

Dependent use of alcohol or illicit drugs (apart from cannabis or tobacco/nicotine)

Not able to provide a UDS which is negative for illicit drugs (apart from cannabis)

Not able to provide a negative alcohol breath test

Personal or family history (first-degree) of psychosis or mania

Trial design

Design model

Single group

Treatments tested in this trial

  • delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)

    Drug

    Vida T400:C20 Blueberry Cookies Medical Cannabis Cartridge (400mg delta-9-tetrahydrocannabinol and 20mg cannabidiol per cartridge)

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Delta-9-tetrahydrocannabinol/CannabidiolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Cannabis tolerance

Change in THC cartridge weight

Time frame
From initiation of use until the participant reaches their desired level of intoxication (self-titrated), assessed up to 4 hours.

Secondary outcomes

1

Cannabis tolerance (maximum)

Change in THC cartridge weight

Time frame
From initiation of use until the participant reaches their maximum tolerated level of intoxication (self-titrated), assessed up to 4 hours.
2

Drug effects questionnaire (DEQ)

Five-item questionnaire on drug effects

Time frame
Baseline; The timepoint at which the participant reaches their desired level of intoxication (self-titrated); The timepoint at which the participant reaches their maximum tolerated level of intoxication (self-titrated), assessed up to 4 hours.
3

Visual analogue scales

* Relaxed/Anxious * Sad/Happy * Not paranoid/Paranoid * Thinking clearly/confused * Tired/Energetic

Time frame
Baseline; The timepoint at which the participant reaches their desired level of intoxication (self-titrated); The timepoint at which the participant reaches their maximum tolerated level of intoxication (self-titrated), assessed up to 4 hours.
4

Observer Rated Cannabis Intoxication Scale (ORCIS)

A Likert scale to rate the participant's level of intoxication

Time frame
Baseline; The timepoint at which the participant reaches their desired level of intoxication (self-titrated); The timepoint at which the participant reaches their maximum tolerated level of intoxication (self-titrated), assessed up to 4 hours.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King's College London

Lead sponsor

South London and Maudsley NHS Foundation Trust

Collaborator

This trial is not recruiting at the moment. You can still explore other options: