Not yet recruitingPHASE3INTERVENTIONAL

Stratification and Treatment in Early Psychosis Study - PROMOTE

This research, called PROMOTE, is for young people between 12 and 35 who are at a higher chance of developing psychosis. We want to see if a medicine derived from cannabis, called Cannabidiol (CBD), can help reduce early symptoms and if it's safe to use. Some participants will take CBD and others a dummy pill (placebo) for two years. We'll also do tests like blood samples and brain scans to learn more about psychosis and how CBD works. We hope to better understand who might benefit most from future treatments.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

University of Oxford

Enrolment target

586

Start

01 May 2026

Estimated completion

01 Dec 2031

Clinical High Risk for Psychosis (CHR)Clinical High Risk for Psychosis Clinical High Risk for Developing Psychosis

What is this study about?

The PROMOTE study is looking into a condition called 'clinical high risk for psychosis.' This means some young people (from age 12 to 35) show early signs that suggest they might be more likely to develop psychosis. Psychosis is a serious mental health condition where a person can sometimes find it hard to tell what's real and what isn't.

In this study, we're particularly interested in a medicine called Cannabidiol (CBD). CBD comes from the cannabis plant, but it's different from the part that makes people feel 'high.' We want to find out if taking CBD can help reduce these early signs of psychosis and if it's safe for people at this high risk. Half the participants will get the actual CBD medicine, and the other half will get a dummy pill (called a placebo) to see if CBD has a real effect. This is a common way to test new medicines.

Researchers will also collect samples like blood, and some participants will have brain scans. This helps us understand more about how the brain works in people at high risk for psychosis and why some people might respond better to treatment than others. There will also be a group of healthy volunteers who don't have these risks, which helps us compare and learn even more.

Key takeaways

Tests a cannabis-based medicine (CBD) for early signs of psychosis.
Ages 12-35 who are at high risk of developing psychosis.
Compares CBD to a dummy pill (placebo) for 2 years.
Involves regular assessments, blood/stool samples, and optional scans/tests.
Aims to find out if CBD is safe and effective, and understand brain health.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for young people between 12 and 35 years old who have been identified as being at a higher chance of developing psychosis. You might be eligible if you're willing to follow the study's instructions carefully. You shouldn't be part of any other medical or talking therapy trial at the same time.

If you're a female who could become pregnant, you'll need to use very effective birth control during the study and for three months after. This is because we don't know enough about how CBD might affect an unborn baby. For certain optional parts of the study, like MRI scans or a spinal fluid test (lumbar puncture), there are additional health checks to make sure it's safe for you to take part.

Quick self-check

Are you between 12 and 35 years old?
Have you been told you are at high risk for psychosis?
Are you able to attend regular appointments and follow study instructions for about two years?
If you could become pregnant, are you willing to use effective contraception during the study and for 3 months after?
Are you currently NOT taking part in any other medical or talking therapy research studies?

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

What does participation involve?

If you join this study, you'll be randomly chosen to receive either the CBD medicine or a dummy pill. You won't know which one you're getting, and neither will the study team – this is called a 'double-blind' study. You'll take the medicine or dummy pill, 300mg twice a day, for about two years. Over this time, you'll have regular appointments to see the study team. These visits will involve talking about your symptoms and how you're feeling, and some clinical assessments.

You'll also be asked to provide samples, such as blood and stool. Some participants will be invited to have brain scans (MRIs), and if you're over 18, you might be asked to consider a spinal fluid sample (lumbar puncture). These additional tests are optional and help with the research side of the study. There will also be a group of healthy volunteers who will have similar assessments but won't take the study medication.

Potential risks and benefits

Participating in this study might offer the benefit of receiving a new potential treatment (CBD) that could help with early symptoms of psychosis. Even if you receive the dummy pill, you'll have close monitoring and support from the study team. However, there are potential risks, such as side effects from the CBD (known side effects often include tiredness, diarrhoea, or changes in appetite, though they may vary). There are also small risks associated with blood tests, stool samples, MRI scans, and the optional lumbar puncture. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (19)

MedUni Vienna, Department of Child and Adolescent Psychiatry
Vienna, Austria
Douglas Hospital Research Centre
Montreal, Canada
University Hospital Turku
Turku, Finland
Vivantes Network for Health GmbH
Berlin, Germany
University of Cologne, Faculty of Medicine and University Hospital of Cologne
Cologne, Germany
University Medical Center Schleswig-Holstein
Lübeck, Germany
Ludwig Maximilian University Hospital
München, Germany
National and Kapodistrian University of Athens
Athens, Greece
University of Bari Aldo Moro
Bari, Italy
University of Campania L. Vanvitelli
Naples, Italy
University of Pavia
Pavia, Italy
IRCCS Santa Lucia Foundation
Roma, Italy

+7 more sites — see the official record for the full list.

Common questions

What is psychosis?

Psychosis is a mental health problem where a person might find it hard to tell what's real and what isn't, sometimes experiencing hallucinations or delusions.

What is CBD?

CBD, or Cannabidiol, is a natural substance found in the cannabis plant. Unlike THC, it doesn't make you feel 'high' and is being studied for its potential medical uses.

What is a placebo?

A placebo is adummy pill that looks exactly like the real medicine but contains no active ingredients. It's used in studies to see if the real medicine has a genuine effect.

How long does the study last?

If you join, you will be taking the medicine or dummy pill for about two years.

Can I stop participating at any time?

Yes, you are free to leave the study at any point, and your decision will not affect your future medical care.

How to find out more

Jared Robinson

steptrials@phc.ox.ac.uk +44 7900206137 Official trial record

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