A NEW landmark study into the effects of cannabidiol (CBD) on psychosis is scheduled to be launched ‘later this year’.
Led by Oxford University and coordinated by the Prince of Wales International Centre for SANE Research, the study will involve 1,000 patients and take place in 35 centres across Europe and North America.
Aiming to build upon ‘strong preliminary evidence’, the research will seek to definitively establish whether CBD could be a viable alternative to opioids in treating psychosis, potentially opening up a whole new field for which cannabis-based medicines could be prescribed.
While the study has been widely celebrated as a significant step forward in bringing cannabis-based medicine into mainstream research, the fact that it will focus only on isolate CBD via GW Pharmaceuticals’ Epidyolex has been described as a ‘missed opportunity’.
On February 16, Oxford’s Department of Psychiatry announced that it had been awarded a £16.5m grant to launch its STEP (Stratification & Treatment in Early Psychosis) programme.
Oxford’s Professor of Psychiatry Phillip McGuire will head up the ambitious research project, which hopes to recruit 1,000 participants at a ‘clinically high risk for psychosis, people with first-episode psychosis, and people with psychosis who have not responded to conventional treatment’.
This will be a randomised control trial, with half the participants being treated with CBD and the other half receiving a placebo, both alongside standard medical treatments for psychosis.
Those taking part will be assessed before and after treatment to ‘clarify how cannabidiol acts to produce its effects and to identify factors that predict the response to treatment’.
According to Lynsey Bilsland, Head of Mental Health Translation at Wellcome, which provided the £16.5m grant for the study, researchers will also be aiming to identify ‘biological signposts which would indicate a patient might respond well to the treatment’, allowing for greater personalisation of treatment in the future.
A Wellcome spokesperson told BusinessCann that it is currently also funding a second randomised control study into CBD and psychosis in Australia.
This study, led by Orygen, the Centre for Youth Mental Health at The University of Melbourne, is focused on exploring the efficacy of CBD in treating subthreshold symptoms at clinical risk/ultra-high risk (UHR) of psychosis.
“Wellcome is helping to drive a step-change in mental health science to find more effective mental health solutions. We support the development of new and improved ways to predict, identify and intervene as early as possible for anxiety, depression and psychosis,” the company explained.
“We are supporting this trial because it will help us find out if cannabidiol is effective at treating psychosis at various stages by testing it at scale. Cannabidiol (CBD) is a non-psychoactive cannabinoid which has strong preliminary evidence in support of its efficacy for psychosis.”
Wellcome, one of the largest private funders of medical research in the UK, has funded a number of studies into CBD and other cannabis-based compounds, including a number of studies looking at the relationship between cannabinoids and dopamine, particularly in relation to schizophrenia.
A new field of treatment for CBD
Across Europe, cannabis-based medicines dominant in CBD are approved and prescribed to treat a very limited number of conditions.
These include severe forms of drug-resistant childhood epilepsy, such as Lennox-Gastaut syndrome and Dravet syndrome, alongside seizures associated with tuberous sclerosis complex (TSC).
In the EU and the UK, Jazz Pharmaceuticals’ Epidyolex, which is ‘more than 99% cannabidiol’, is the only product to be approved to treat these conditions, giving the company a near monopoly on the market.
This new research, while still in the very early stages, suggests there could soon be an entirely new range of conditions for which CBD could potentially be used to treat.-
Professor Mike Barnes, head of the Cannabis Industry Council and The Medical Cannabis Clinicians Society, told BusinessCann: “I think it is very exciting that ‘mainstream’ research is beginning to take cannabis seriously as a medicine. There are certainly studies that show that CBD is anti-psychotic, and this large-scale research should go a long way to confirming or refuting this hypothesis.”
However, some have raised concerns that the Oxford study is set to use a formulation identical to Epidyolex, supplied ‘at no cost’ by Jazz Pharma.
Aside from concerns this would mean a large portion of data relating to CBD and psychosis will be related to a single already-market-leading compound, potentially enabling Jazz to expand its dominance, the use of Epidyolex has also been criticised for another reason.
Professor Barnes explained: “My only criticism is the use of isolate (or 99% isolate) CBD, as it is clear in other contexts that full-spectrum cannabis, which contains the full variety of cannabinoids and terpenes, works more effectively and with less side effects. Using isolate is a missed opportunity.”
BusinessCann has contacted Oxford University for comment on the study, including whether it would have implications for compounds other than Epidyolex, but has not received a response at the time of writing.
Jazz Pharma told BusinessCann: “Outside of providing cannabidiol for investigational use in the studies, Jazz will not be involved in the setup and execution of the trials, and so we are unable to comment any further on the programme itself. It is also important to note that the cannabidiol being used in these trials is for investigational use and is not licensed for psychosis.
“We believe passionately in the possible therapeutic benefits of the cannabis plant and firmly believe that cannabis-based medicines have the potential to improve the lives of patients and families.
“We encourage others to follow our lead in research into cannabinoids – the more substantial, high-quality evidence that can be gathered in support of the medical uses of cannabis, before subsequent assessment via the existing medicines’ regulatory route, the better for those patients who may benefit, and the physicians that treat them.”