A Milestone for Psychedelic Research in Europe
Earlier this year, in a landmark decision, the European Union has awarded €6.5 million to fund a multi-site randomised controlled trial exploring the potential of psilocybin therapy in palliative care. This grant marks the first time the EU has directly funded clinical research into psychedelic-assisted therapy, signalling a significant shift in the perception and potential of fungal-derived compounds in modern medicine.
Psilocybin: From Mushrooms to Medicine
Psilocybin, the primary psychoactive compound found in certain species of mushrooms, has shown promising results in addressing psychological and existential distress in patients with life-threatening conditions. Previous studies, such as those conducted by Griffiths et al. (2016) and Shnayder et al. (2023), have demonstrated its potential in improving psycho-spiritual wellbeing in cancer patients. Now, this new study, dubbed PsyPal, aims to extend these findings to non-cancer palliative care patients.
Principal investigator Robert Schoevers (UMCG) attends a patient receiving psychedelic-assisted therapy. Credits: University Medical Centre Groningen
A Pan-European Collaboration
The PsyPal project brings together a consortium of 19 European organisations from nine countries, coordinated by the University Medical Centre Groningen in collaboration with HumanKindLabs. This interdisciplinary approach reflects the complex nature of the research and the potential far-reaching implications of its findings.
The study will be conducted across four clinical sites, each focusing on a different progressive, incurable disease:
Chronic obstructive pulmonary disorder (COPD) at the University Medical Centre Groningen in the Netherlands
Atypical Parkinsonism (AP) at the Champalimaud Foundation in Portugal
Multiple sclerosis (MS) at the National Institute of Mental Health in the Czech Republic
Amyotrophic lateral sclerosis (ALS) at the University of Copenhagen and the Bispebjerg Hospital in Denmark
Pushing the Boundaries of Palliative Care
The PsyPal study aims to enrol 100 patients across the four sites, with the trial expected to commence on 1st January 2025. Participants will undergo two dosing sessions, receiving either psilocybin (with a lower dose in the first session) or a placebo. The study protocol includes three preparation sessions and one integration session, with a strong focus on managing the specific healthcare needs of each patient population.
Robert Schoevers, UMGC head of psychiatry and principal investigator of the study, emphasised the potential impact: "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."
Beyond its immediate clinical goals, the PsyPal project aims to establish best practices for psilocybin therapy in palliative care and create a training model for therapists. Tadeusz Hawrot, Founder and Executive Director of the Psychedelic Access and Research European Alliance (PAREA), sees the project as "paving the way for the entire field of psychedelic therapies" and "laying the groundwork for European standards in psychedelic treatments more broadly."
As the study progresses, with results expected in 2027, it could potentially reshape the landscape of palliative care in Europe and beyond. By harnessing the power of psilocybin, a compound that has been used in traditional practices for millennia, modern medicine may find new ways to address the complex psychological needs of patients facing life-altering illnesses.