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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Cannabidiol as an Add-on Treatment to substance abuse in juvenile patients with PSYchosis: a double-blind randomized placebo-controlled study.

This research is investigating if a medicine called Cannabidiol (CBD) can help young people who have experienced temporary mental health difficulties, known as psychosis, because of their substance use. The main goal is to see if CBD, when added to their regular care, can help to reduce the chances of them relapsing into cannabis use over a six-month period. Participants will either receive the CBD treatment or a dummy treatment (placebo), and their progress will be carefully observed. Researchers also want to see if CBD can improve other symptoms, thinking skills, and even brain patterns, all while ensuring the study is safe and helpful for those involved. The study is particularly looking for young people aged 18 and over, of any gender.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Enrolment target
60
Start
17 Sep 2024

What is this study about?

This study is looking into a medicine called Cannabidiol, or CBD for short, which comes from the cannabis plant but doesn't cause a 'high'. The research wants to find out if giving CBD to young people who have experienced temporary mental health problems, called psychosis, due to using substances like cannabis, can help them.

The main aim is to see if CBD can reduce the chances of these young people going back to using cannabis again. They will be comparing a group receiving CBD with another group receiving a dummy treatment (called a placebo) to see if there's a difference over six months. This type of study is called 'double-blind,' which means neither the participants nor the doctors will know who is getting the real CBD and who is getting the dummy treatment. This helps make the study as fair and accurate as possible.

Beyond just looking at cannabis use, the researchers also want to explore other benefits. They'll be checking if CBD can help improve overall mental health, reduce other symptoms, and even boost thinking skills and brain function. They're hoping to understand if CBD could make a real difference in helping these young people recover and stay well.

Key takeaways

  • This study is testing CBD for young people with substance-induced psychosis.
  • The main aim is to see if CBD can prevent relapse in cannabis use.
  • It's a 'double-blind' study, meaning you might get CBD or a dummy treatment.
  • The study also looks at improving mental health, thinking skills, and brain function.
  • Participation lasts for six months, with regular checks.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, participants must be at least 18 years old. There is no upper age limit, meaning adults of any age above 18 can potentially take part. The study is open to both males and females.

More specific details about your medical history and current health will be discussed with the study team to make sure it's safe and suitable for you. For example, they will need to confirm that you have experienced psychosis related to substance use.

It's important to have a conversation with your doctor or the study team to understand all the requirements and confirm if you are a good fit for this research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you experienced mental health problems (psychosis) linked to substance use?
  3. Are you willing to attend regular appointments for six months?
  4. Are you comfortable with the possibility of receiving a dummy treatment (placebo)?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be part of it for about six months. You'll be asked to attend a number of visits at the study centre. During these visits, the study team will carry out health checks, ask questions about your wellbeing, and perform some tests to see how you're feeling and thinking.

You will receive either the CBD treatment or a placebo (a dummy treatment that looks just like the real one). Neither you nor your doctors will know which one you are getting, to keep the results unbiased. All study medications will be given to you by the research team.

Throughout the six months, your progress will be regularly monitored to see how the treatment is affecting you and if it's helping with your symptoms and substance use. After the main treatment period, there will be follow-up checks to understand the long-term effects.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as receiving close medical attention and a new treatment (CBD) that might help reduce the chance of returning to cannabis use and improve your overall well-being. However, there's also a chance you could receive the placebo and not the active CBD. As with all medications, there might be some side effects from CBD, which will be carefully explained to you by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Italy

Common questions

What is psychosis?

Psychosis is a temporary mental health condition where a person might have difficulty telling what is real and what isn't. It can involve seeing or hearing things that aren't there, or having strong beliefs that aren't based on reality.

Is CBD the same as cannabis that makes you high?

No, CBD (Cannabidiol) is a component of the cannabis plant but it doesn't cause the 'high' that is associated with recreational cannabis. It's being studied for its potential medicinal properties.

What is a 'double-blind' study?

A double-blind study means that neither the patient nor the doctors treating them know whether they are receiving the active treatment (in this case, CBD) or a dummy treatment (placebo). This helps make the study results fair and accurate.

What is a placebo?

A placebo is a dummy treatment that looks exactly like the real medicine but contains no active ingredients. It's used in studies to compare the effects of the active drug against no drug effect.

How long will I be in the study?

If you join the study, your participation will last for a total of six months, including regular check-ups and monitoring.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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