AugmENtation witH cAnnabidiol iN first episode psyChosis: a doublE blind randomised controlled trial (STEP-ENHANCE Trial)
The STEP-ENHANCE trial is investigating whether adding cannabidiol (CBD) to standard care helps adults experiencing a first episode of psychosis. Psychosis is a mental health condition that can cause people to hear voices, see things that others cannot, or hold strong unusual beliefs. While standard medicines help many people, they do not work for everyone and can cause unwanted side effects. In this UK trial, participants will receive either CBD liquid or a dummy liquid (placebo) twice daily for six weeks alongside their usual mental health treatment. Neither the participants nor the research team will know who receives the real medicine. Researchers will monitor changes in symptoms, mood, anxiety, and daily quality of life. The main goal is to see whether CBD offers safe, extra relief to help people recover more quickly.
At a glance
What is this study about?
Experiencing psychosis for the first time can be a confusing and frightening experience. It often involves hallucinations, such as hearing or seeing things that are not there, or delusions, which are beliefs that feel completely real but are not shared by others. NHS doctors typically treat psychosis with antipsychotic medicines and psychological support. While these treatments are effective for many, some people continue to struggle with symptoms or experience difficult side effects like fatigue and weight gain.
The STEP-ENHANCE study is testing a new way to support recovery by adding cannabidiol, or CBD, to routine treatment. CBD is a natural compound extracted from the cannabis plant. Unlike THC, the ingredient in cannabis that alters mood and causes a 'high', purified medical CBD does not cause any intoxicating effects and is not addictive. Early research suggests CBD may calm brain pathways involved in psychosis.
During this trial, doctors will compare people taking CBD alongside their regular medicine with people taking a placebo (a matching liquid with no active ingredients). By comparing these two groups over six weeks and during follow-up visits, researchers can accurately measure whether CBD eases symptoms, reduces anxiety, and improves general wellbeing. If the results are positive, this trial could help bring a new, gentler treatment option to the NHS.
Key takeaways
- Tests whether adding CBD liquid to standard psychiatric care helps treat first-time psychosis.
- Open to adults aged 18 and over who are early in their treatment.
- Involves taking a daily liquid medicine for six weeks alongside your normal care.
- The medical CBD used is non-addictive and does not cause a high.
- Participation is completely voluntary and will not disrupt your regular NHS support.
Who may be eligible?
This study is open to adults aged 18 and older who are experiencing their first episode of psychosis. Both men and women are eligible to join.
To take part, you will usually need to be under the care of a mental health team and taking, or about to start, standard treatment. The study specifically focuses on early-stage psychosis rather than long-term illness, so participants should be near the beginning of their treatment journey.
Certain health conditions, current medications, or allergies may mean this trial is not the right fit for everyone. The trial doctors will carry out a thorough health check and review your medical history to make sure it is completely safe for you to take part.
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.
- You are aged 18 or older.
- You are experiencing your first episode of psychosis.
- You are currently receiving care from a mental health team.
- You are willing to take a liquid medicine twice daily for six weeks.
- You are able to attend regular clinic appointments and health checks.
What does participation involve?
Taking part in the trial begins with a six-week treatment period. You will be randomly assigned to take either CBD liquid or a dummy liquid (placebo) by mouth twice each day. You will continue to take all your usual prescribed medications throughout the study. Neither you nor your doctor can choose which liquid you receive, which keeps the trial fair.
During the six weeks, you will have regular clinic visits so the team can see how you are feeling. These visits will include questionnaires about your thoughts, anxiety, and everyday activities, as well as routine health checks like blood pressure and blood tests. You may also be invited to complete memory tasks or brain scans, such as an MRI. After the treatment phase ends, there will be follow-up check-ins over the coming months to track your long-term health and wellbeing.
Potential risks and benefits
Locations (6)
- —UnverifiedNetherlands
- —UnverifiedGreece
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedAustria
- —UnverifiedSpain
Common questions
Will taking CBD make me feel high?
No. The trial uses pure medical cannabidiol (CBD). It does not contain THC, which is the substance in cannabis that causes a high.
Do I have to stop taking my regular medication?
No. You will continue taking your normal prescribed antipsychotics and other treatments just as before.
What is a placebo?
A placebo is a harmless dummy medicine that looks and tastes identical to the real treatment but contains no active drug. It helps scientists prove whether CBD really works.
What does double-blind mean?
It means neither you nor the doctors know if you are receiving CBD or the placebo. This stops expectations from accidentally influencing the study results.
Does it cost anything to take part?
No. The study treatment and all trial appointments are free, and help with travel costs is usually provided.
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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