CBD-SIB - Efficacy of cannabidiol in the management of Self-Injurious Behavior in children and adolescents with severe neurodevelopmental disorders
This study, called CBD-SIB, is exploring if a specific medicine, Epidyolex (a type of cannabidiol), can help children and teenagers who have severe neurodevelopmental disorders and injure themselves. These are conditions that affect how the brain develops, leading to learning difficulties and challenges in daily life. The research aims to find out if taking Epidyolex can reduce how often these young people hurt themselves. We'll be carefully monitoring their self-injuries over approximately eight weeks. This is an early stage of research (Phase II) to see if the treatment is promising before larger studies are done. The main goal is to see a significant drop in how often self-injuries happen.
At a glance
What is this study about?
This research study, known as CBD-SIB, is looking into a medicine called Epidyolex. Epidyolex contains cannabidiol, which comes from the cannabis plant but doesn't cause a 'high'. The study focuses on children and teenagers who have severe neurodevelopmental disorders. These are conditions that affect how the brain grows and works, often leading to significant learning difficulties and other challenges, including self-injurious behaviour.
The main aim of this study is to see if Epidyolex can help reduce how often these young people injure themselves. Self-injurious behaviour can be very distressing for both the child and their family. Researchers want to find out if taking Epidyolex for about eight weeks can lead to a noticeable decrease in these behaviours. This is an exploratory study, meaning it's an early step to understand if this treatment could be helpful.
Throughout the study, the research team will carefully track any changes in self-injuries. They will also look at other important things, like how the treatment affects different types of behaviour (like repetitive actions or aggressive behaviour), the family's stress levels, and the child's overall ability to do daily activities. They will also watch closely for any side effects the medicine might cause, such as tummy upsets or feeling sleepy, to make sure the treatment is as safe as possible.
Key takeaways
- This study explores a medicine called Epidyolex for self-injury in children and teens.
- It's for young people with severe neurodevelopmental disorders.
- The main goal is to see if Epidyolex reduces how often self-injuries occur.
- The treatment period lasts about eight weeks.
- Researchers will monitor behaviours and side effects carefully.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for children and teenagers who have a severe neurodevelopmental disorder. This means they have a condition that affects how their brain develops, which can lead to significant learning challenges and other difficulties. A doctor involved in the study would confirm this diagnosis.
There are no specific age limits; young people of any age group are being considered. Both boys and girls can take part in this research.
Beyond having a severe neurodevelopmental disorder, other specific medical details would be checked by the study team to ensure the study is safe and appropriate for each potential participant.
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.
- Is the person a child or teenager?
- Do they have a severe neurodevelopmental disorder (like severe learning difficulties)?
- Do they experience self-injurious behaviours?
- Are they able to attend regular clinic visits for about two months?
- Is the family willing to provide information about behaviours and stress levels?
What does participation involve?
If you or your child join this study, it will involve several visits to the study clinic over about two months. At the start, there will be an initial visit to check if you or your child can take part. If eligible, you'll have another visit where the study medication, Epidyolex, will begin.
Throughout the study, you will be asked to give information about how often self-injurious behaviours occur, and how severe they are. The study team will use special questionnaires to assess this, as well as looking at other behaviours, how daily activities are affected, and parental stress levels. There will be at least two follow-up visits, one at about four weeks and another at about eight weeks, to check on progress and any side effects. The total duration of the active treatment part of the study is about 56 days (eight weeks), with initial screening visits before this.
Potential risks and benefits
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Common questions
What is Epidyolex?
Epidyolex is a medicine that contains cannabidiol, a substance found in the cannabis plant, but it does not cause a 'high'.
What are neurodevelopmental disorders?
These are conditions that affect how the brain develops, leading to learning difficulties and other challenges in daily life, such as autism or intellectual disability.
What does 'self-injurious behaviour' mean?
This refers to actions where a person causes harm to their own body, such as hitting themselves or biting.
How long does the study treatment last?
The main treatment period for the study drug lasts for about eight weeks (56 days).
Will my child get a 'high' from Epidyolex?
No, Epidyolex contains cannabidiol, which is not the part of the cannabis plant that causes a 'high'.
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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