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

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

Treatments tested in this trial

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

Treatment groups

10 Participants
are divided into 1 treatment group

Sponsors and collaborators

King's College London

Lead sponsor

South London and Maudsley NHS Foundation Trust

Collaborator