Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

Cannabidiol for treatment of non-affective psychosis and cannabis use

This research is investigating a natural substance from the cannabis plant, called cannabidiol (CBD), to see if it can help people who experience a mental health condition called psychosis and who also use cannabis. Psychosis can cause people to see, hear, or believe things that aren't real. The study aims to find out if taking CBD can make these symptoms less severe. It also wants to check if CBD can help people reduce how much cannabis they use, or even stop using it altogether. Researchers will compare CBD to a dummy treatment (placebo) or a common medication for psychosis (Risperidone) to understand its effects more clearly. They will also look at how CBD affects overall well-being, thinking skills, and sleep.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Region Hovedstaden

Enrolment target

Start

08 Oct 2024

Lifetime cannabis use Non-affective psychosis

What is this study about?

This study is exploring a new way to help people who are dealing with a mental health condition called psychosis, especially if they also use cannabis. Psychosis is a serious condition where a person might have trouble telling what's real and what isn't. This can include seeing or hearing things others don't, or having unusual beliefs.

The researchers are focusing on a substance called cannabidiol (CBD). CBD is found in the cannabis plant, but it's different from the part that makes people feel high. Instead, CBD is being studied for its potential to help with various health issues. In this study, they want to see if CBD can make the symptoms of psychosis less severe for people who use cannabis.

The study will also look at whether CBD can help people cut down on their cannabis use, or even stop using it completely. This research is important because it could lead to new ways to support people facing these challenges, improving their mental health and overall quality of life.

Key takeaways

This study explores if CBD can help people with psychosis who also use cannabis.
It aims to reduce psychosis symptoms and help with cannabis use.
Participants will receive CBD, a common medication, or a dummy treatment.
The study also looks at well-being, thinking, and sleep.
Participation involves regular check-ups and assessments.

Who may be eligible?

To join this study, people must be 18 years old or older. The study is open to both men and women.

Participants must have a diagnosis of 'non-affective psychosis', which is a specific type of mental illness where a person experiences psychosis but it's not mainly driven by extreme mood swings. They also need to have used cannabis at some point in their lives.

There might be other health conditions or medications that would prevent someone from joining, even if they meet these basic requirements. That's why it's always important to discuss your full medical history with the study team.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of 'non-affective psychosis'?
Have you used cannabis at some point in your life?
Are you willing to attend regular study appointments?
Are you able to understand and provide informed consent?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would be given either a liquid form of CBD (Epidyolex), a dummy liquid (placebo), or a tablet form of Risperidone (a common medication for psychosis), or a dummy tablet. Which one you get will be decided by chance, like flipping a coin – neither you nor the doctors will choose. This is to make the study fair and accurate.

Throughout the study, you would attend regular appointments where doctors and nurses would check your symptoms, ask about your cannabis use, and monitor your general health. You might be asked to fill out questionnaires about how you're feeling, your thinking abilities, and your sleep patterns. There would also be regular check-ups to make sure the treatment is safe for you. The exact number of visits and the total length of time you'd be in the study would be explained in detail by the research team.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new treatment that might improve your mental health symptoms or help reduce cannabis use. You would also receive close medical attention and monitoring. However, there are also potential risks; for example, the treatment might not work for you, or you could experience side effects. It's also possible you could be given a dummy treatment (placebo). You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Denmark

Common questions

What is Epidyolex?

Epidyolex is a medicine that contains cannabidiol (CBD), a substance found in the cannabis plant. It's used in this study to see if it can help with psychosis and cannabis use.

What is psychosis?

Psychosis is a mental health condition where a person might have difficulty telling what's real and what isn't, potentially seeing, hearing, or believing things others don't.

Will I get high from the CBD treatment?

The CBD used in this study (Epidyolex) is designed not to make you feel 'high', as it contains very little of the component of cannabis that causes that effect.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare the real drug's effects.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, for any reason, without affecting your medical care.