Marking a historic first for Europe, the European Union has funded research into psychedelic therapy as part of its Horizon Europe programme.
Published on 24th January 2024
By Stephanie Price
The EU has awarded €6.5 million to a consortium of 19 partners from nine different European countries for a clinical trial – the PsyPal trial.
The trial will study psilocybin-assisted psychotherapy for psychological and existential distress in people who are diagnosed with either chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) or atypical Parkinson’s disease (APD).
The consortium includes psychiatrists, palliative care physicians, psychologists, experts in psilocybin therapy, researchers focusing on spiritual care and representatives from religious institutions.
Throughout the trial, the PsyPal consortium will be engaging with the Psychedelic Access and Research Europe Alliance (PAREA), a non-profit reform group that has been campaigning for access to psychedelic therapy in Europe.
Tadeusz Hawrot, Executive Director of PAREA, told Psychedelic Health: “I couldn’t be happier with this development. Advocating for EU-funded research on psychedelics is part of PAREA’s DNA.
“It is particularly crucial to explore their potential in areas with significant unmet mental health needs, where commercial interest is lacking, such as in palliative care. With a growing body of promising results in the medical use of psychedelics, what we urgently need now are more European multisite studies.
“We require clinical trials involving larger and more diverse patient populations to further establish their efficacy and safety. Generating more clinical data on the safety and efficacy of psychedelic compounds will pave the way for the marketing authorization process in Europe, accelerating the delivery of these medicines to patients who are often in desperate need of more treatment options.
“Jeremy Farrar – a former Director of Wellcome Trust and current WHO Chief Scientist – once said about Horizon Europe that it is globally regarded as the best internationally co-operative endeavor anywhere in the world.
“Importantly, this new EU project will not only advance our understanding of psychedelic therapies but also help establish psychedelics as legitimate, emerging mental health treatments.”
The PsyPal Trial
Following in the footsteps of previous research which has demonstrated the potential benefits of psychedelic-assisted therapy for people living with terminal cancer, the study is the first clinical trial to investigate the safety and effects of psilocybin in non-oncology palliative care patients.
The trial will be led by the University Medical Centre Groningen (UMCG) in the Netherlands in collaboration with HumanKindLabs and will begin early this year. Locations for the trial include the UMCG, the Champalimaud Foundation in Portugal, the National Institute of Mental Health in the Czech Republic, and the University of Copenhagen and the Bispebjerg Hospital in Denmark.
During the trial, participants will take part in two psychedelic therapy sessions – receiving either psilocybin or a placebo.
In a statement, Robert Schoevers, head of psychiatry at the UMCG and principal investigator of PsyPal, stated: “We are eager to see if we can ease the suffering of these patients whilst also examining longer-term patient and family outcomes of this treatment, something that often gets overlooked but that is of enormous importance.”
As well as immediate clinical outcomes, the trial will be studying whether or not the therapy can help sustain the well-being of patients and their families post-treatment.
The trial will utilise peer support and online tools to “enhance coping mechanisms and alleviate distress as people approach the end of their lives.”
Established in 2021 the Horizon Europe programme was launched to accelerate research and innovation in Europe and is running with a budget of €95.5 billion.
Schoevers added: “We are absolutely thrilled that the EU is supporting this ambitious collaborative study. There is growing recognition that psychedelic treatments may help patients for whom alternatives are not effective, and I am very glad we are receiving support from this highly prestigious funding program.
“It really helps to strengthen the collaboration between researchers from different countries and disciplines, focusing on potentially transformative interventions for severe, currently treatment-resistant mental disorders.”
Principal investigator Robert Schoevers (UMCG) attends a patient receiving psychedelic-assisted therapy.’