The European Union has green lit a groundbreaking clinical trial to explore the potential benefits of psychedelic therapy for patients in palliative care.
Scientists at the University Medical Center Groningen (UMCG) in the Netherlands will begin a trial this week examining the effects of psilocybin, the psychedelic substance in more than 100 types of mushrooms, on patients suffering from chronic obstructive pulmonary disease, multiple sclerosis, amyotrophic lateral sclerosis, and atypical Parkinson’s disease.
This initiative marks the first time the European Union has fully financed a study on psychedelics, allocating over €6.5 million through the E.U.’s Horizon Europe program. The move comes as previous research has shown psilocybin’s promise in treating severe depression and aiding individuals grappling with terminal cancer. The study’s protocol is being finalized this year in collaboration with regulators and health technology assessment bodies.
The trial involves around 100 patients across the Netherlands, Portugal, the Czech Republic, and Denmark. Along with the consumption of the psychedelic substances, each patient will work with therapists considering each participant’s specific medical conditions during several therapy sessions.
This trial differs from previous studies by administering two psilocybin sessions to patients. The first session involves a lower dose, allowing patients to acclimate to the experience, followed by a full dose in the second session. To maintain scientific rigor, some participants will receive a placebo instead of psilocybin.
Robert Schoevers, a psychiatrist from UMCG and the study’s lead investigator, highlights a critical research question: the number of psychedelic experiences required for effective treatment. “Is this a sort of one-time fix, and then you go on with psychotherapy? We need to explore what is needed,” he 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.”
The news comes as researchers say the AI tool AlphaFold has identified “hundreds of thousands” of potential new psychedelic molecules. This marks the first instance where AlphaFold’s predictions, which are readily accessible, have been as effective as experimentally derived protein structures for drug discovery, a process that traditionally takes months or years. AlphaFold, developed by London-based DeepMind, has significantly impacted biology with its public database of nearly every known protein structure.
Despite initial skepticism about AlphaFold’s utility in drug discovery, recent findings have been promising. Brian Shoichet, a pharmaceutical chemist at the University of California, San Francisco, told Scientific American that there is “a lot of hype.”
“Whenever anybody says ‘such and such is going to revolutionize drug discovery,’ it warrants some scepticism,” he said. However, Shoichet’s team, in collaboration with Bryan Roth, a structural biologist at the University of North Carolina at Chapel Hill, discovered that AlphaFold’s predictions yielded completely different drug candidates compared to experimental structures, yet with nearly identical hit rates.
Jens Carlsson, a computational chemist at the University of Uppsala in Sweden, praises AlphaFold and its potential. “AlphaFold is an absolute revolution. If we have a good structure, we should be able to use it for drug design,” she said. The research team’s experiments revealed that AlphaFold structures identified the most potent drugs activating the serotonin receptor, an avenue for potential non-hallucinogenic antidepressants.
Despite these advances, challenges remain. Predicted structures may still require experimental refinement during later stages of drug development. Karen Akinsanya, president of research and development for therapeutics at Schrödinger, a New York-based drug-software company, cautions that predicted structures are not universally applicable. This is not a panacea,” she said.
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