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Clinical Trial into Psilocybin Therapy for Psychological Distress in Palliative Care, PsyPal, Receives Medical Ethical Authorisation, with Conditions

December 20, 2024 / Mushrooms / Psilocybin, Palliative Care+, Policy, Law & Economics / By

Key takeaways

  • Clinical study authorisation milestone achieved: The Clinical Trial PsyPal has been authorised in the participating member states, with conditions. Sign up to the PsyPal newsletter to stay informed.
  • Groundbreaking research: PsyPal is the first fully EU-funded study to evaluate psilocybin therapy for depression / psychological distress in patients with palliative care needs, focusing on COPD, MS, ALS, and APD.
  • Collaborative effort: Coordinated by the University Medical Centre Groningen and supported by 19 partners across nine countries, this €6.5 million Horizon Europe-funded project combines psychotherapy and psilocybin treatment to address critical gaps in end-of-life care.

A small but significant step toward the commencement of a trial of psychedelic therapy in palliative care has been achieved in the PsyPal project

The PsyPal consortium is proud to announce that the clinical trial PsyPal has been authorised according to the Clinical Trials Regulation (CTR) in the participating member states, with conditions. PsyPal is working on finalising the process to ensure compliance with CTR and collaborating with the funding agency in the context of a planned independent Ethics Review procedure which is not yet concluded. Only then, will the study be able to kick-off. By working together with regulators and competent ethics committees, PsyPal wants to ensure full compliance and commit to the highest EU ethical standards.

This milestone marks a significant step forward for the first fully EU-funded study of psilocybin therapy in palliative care, set to begin recruiting patients in 2025.

Coordinated by the University Medical Centre Groningen (UMCG) in the Netherlands, the PsyPal project is supported by Horizon Europe with €6.5M in funding. It aims to evaluate the safety and efficacy of psilocybin therapy in alleviating psychological distress for patients with progressive, incurable diseases. This multi-site clinical trial will focus on four specific conditions: chronic obstructive pulmonary disease (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), and atypical Parkinson’s disease (APD).

This authorisation reflects a year of collaborative effort across the PsyPal consortium, which includes contributions from 35 co-authors from 19 partners from nine European countries.

The consortium is supported by an industry partner, Avextra, who are providing the study drug psilocybin for the clinical study and are supporting the regulatory process.

“This achievement is a testament to the dedication and expertise of our team,” said Robert Schoevers, Principal Investigator of PsyPal and Head of Psychiatry at UMCG. “We are eager to start enrolling patients for the clinical trial, which has the potential to transform care for patients facing severe psychological and existential distress once all approvals are in place.”

Error in previous communication about study which has authorisation according to the Clinical Trials Regulation and not EMA approval

  • Some regrettable miscommunication arose last week with a press release arising from our pharmaceutical partner which suggested that the study drug had received EMA approval. Please note that this is incorrect. The Clinical Trials Regulation harmonises the processes for assessment and supervision of clinical trials throughout the EU. It is this authorisation that was sought and given.

Stay informed

Disclaimer: PsyPal is funded by the European Union. Views and opinions expressed are those of the authors and do not necessarily reflect those of the European Union or the Health and Digital Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.

Do Psychedelic States merely create comforting delusions?

October 17, 2024 / Philosophy & Religious Studies, Psychology / Leave a Comment / By

Chris Letheby’s “Philosophy of Psychedelics” explores the relationship between the philosophy of psychedelics and the mechanisms of psychedelic therapy.

Through this curation of a few sections from chapters 7 and 8 of Letheby’s work, the reader is invited to think along.

The Comforting Delusion Objection to Psychedelic Therapy

Central to Letheby’s book is the provision of an appropriate response to the ‘Comforting Delusion Objection to psychedelic therapy’ — it says that psychedelics induce their salutary psychological effects mainly by inducing metaphysical beliefs that are comforting but probably false.

Is it the case that psychedelics merely create comforting delusion? Are therapeutic outcomes a result of false metaphysics? Let’s take a step back.

a transient and dramatic experience that Uncovers New Modes of Perception and Being

Source: Unbinding the self — Philosophy of Psychedelics by Chris Letheby, Chapter 7 — p. 124-5

Letheby starts this chapter by pointing to the aim of many psychiatric treatments:

“Many psychiatric disorders feature deleterious changes to self-related beliefs and many treatments aim at “resetting” these beliefs — at changing them for the better.”

“Phenomenologically speaking, the interpersonal world simply is threatening, or the self simply is powerless: they are not merely believed to be so.”

Psychedelics’ ability to induce a transient and dramatic experience may become relevant in a similar therapeutic process of shifting habitual beliefs and identity:

“Through radically altered forms of self-experience, subjects discover the contingency, mutability, and stimulatory nature of their own sense of identity and habitual modes of attention. They learn directly that there are other ways of being and other ways of seeing because their ordinary ways of being and seeing result from a malleable modeling process.

By disrupting the neurocognitive substrates of the brain’s high-level beliefs, psychedelics can change this situation transiently but dramatically resulting in:

1. Subjects experiencing new phenomenal worlds inconsistent with and previously precluded by those beliefs.

2. As a corollary, the beliefs themselves become phenomenally opaque as their representational nature becomes more vividly apparent.”

Hallucination or Revelation? Navigating the Epistemic Uncertainty of Psychedelic States

Source: Epistemology — Philosophy of Psychedelics by Chris Letheby, Chapter 8 — p.160-2

However, how can one be certain that these newly experienced phenomenal worlds are something to be learned from?

”Some psychedelic users claim sincerely to encounter genuinely existing disembodied entities, spirit realms, and transcendent Grounds of Being.”

Should those claims simply be rejected?

“On principled philosophical grounds, naturalists reject these claims as arising from compelling drug-induced hallucinations — misrepresentations of reality.”

“The key to understanding the epistemic profile of the psychedelic state comes from Andy Clark’s dictum that prior knowledge in the predictive brain is always both constraining and enabling.”

  1. “Certain epistemic benefits available in the sober state become unavailable, such as rational and critical thought and the ability to deploy much prior knowledge.
  2. Others unavailable in the sober state become available — principally, the opportunity to access information otherwise filtered out by overweighted priors, as well as the ability to represent certain kinds of information in novel and epistemically useful formats.”

is a sense of certainty epistemically justified?

”A second guiding principle comes from Jennifer Windt’s observation that ‘phenomenal certainty — the experience of persuasion or knowing — is not the same as epistemic justification’.”

“Having a psychedelic experience in which some proposition P seems true, accompanied by a strong phenomenal feeling of certainty, does not constitute sufficient justification for believing that P is true.”

Chris Letheby’s Conclusion “Epistemic Innocence”

“Many psychedelic states are, in Lisa Bortolotti’s parlance, epistemically innocent. This means that despite having real epistemic flaws, they also have significant epistemic benefits that are not available by any alternative means. In sum, psychedelics’ overall epistemic profile is neither as dire as some skeptical naturalists might assume, nor as pristine as some entheogenic enthusiasts would like.

Looking back on ICPR 2024 – the leading interdisciplinary conference on psychedelic research

September 13, 2024 / Anthropology & Sociology, Biology & Ethnobotany, Ethics, Humanities & Art, Neuroscience, Pharmacology & Chemistry, Philosophy & Religious Studies, Policy, Law & Economics, Psychiatry & Medicine, Psychology, Technology / By

It’s been 2 months since the leading conference on psychedelic research in Europe, ICPR 2024, took place in Haarlem, the Netherlands. Despite having taken steps to integrate it all, the OPEN foundation team has accepted that we still lack the words to convey what the whole event felt like and meant to us.

Pia Dijkstra – Minister of Healthcare, The Netherlands – Opening ICPR 2024

From combating prejudice and stigma back in 2007 to having not one but two subsequent Ministers of Healthcare lining up to inaugurate ICPR, our mission to advance psychedelic research to benefit science, healthcare and society has come a long way.

At ICPR 2024, we had it all, from Minister from the Netherlands, Pia Dijkstra’s moving opening speech to the heartfelt realities shared by trial participants Maryam Zahra Jabir and Patty B., the Wet Blanket Award for presentations representing rigor and critical thinking’ awarded to Dr. Jamila Hokanson, M.D, MBA, the kind of deep thinking showcased by Leor Roseman, Erik Davis’ magnificent storytelling and accompanying visuals, the important discussions around decolonization curated by Yogi H., and so so so much more.

Access ICPR 2024 talk recordings & more

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You might imagine why the OPEN Foundation & ICPR team was unable to attend most talks on-site. Yet, via the high-quality recordings (more on this will follow), we didn’t miss out. What we saw was consistently great.

Immense effort went into crafting ICPR’s mind-blowing programme. And no doubt those efforts have been worth it. ICPR embodied the true spirit of interdisciplinarity: from clinical trial design, neuroscience, archaeology, integration, psychotherapy, adverse events, spirituality, literary analysis—it was all there.

The programme and ICPR 2024 fulfilled their purpose: to gather and facilitate conversation and connection between open-minded, committed, curious, and caring individuals whose collective perspective creates a critical and constructive narrative for what psychedelics mean moving forward in 21st-century Europe.

Vibrant lunch breaks @ICPR

We are honored and humbled by the ICPR 2024, the progress in the field of psychedelic research and therapy, and what lies ahead. Lastly, gratitude. Gratitude, for our co-creation, persists. Fortunately so, as it’s our fuel to do our part in this ongoing process of integrating psychedelics safely and responsibly into healthcare and society.

Thank you,
The OPEN & ICPR team

And please, a big applause for….. the rockstar volunteers who made ICPR 2024 possible!

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Key Insights from the Dutch state commission MDMA Report: Beyond Ecstasy

September 13, 2024 / MDMA, Policy, Law & Economics / 1 Comment / By

In a landmark moment for drug policy, the Dutch State Commission on MDMA has released its highly anticipated report, “Beyond Ecstasy“. Spanning over 200 pages, this document explores the multifaceted dimensions of MDMA, including its recreational use, potential therapeutic benefits, and broader implications for public health and policy. We aim to provide you with the key highlights of this thorough examination aimed at guiding the Dutch government in its future decisions regarding MDMA.

Context of the Dutch State Commission on mdma

The formation of the State Commission on MDMA was a response to a coalition government promise to re-evaluate the drug’s status within the Dutch Opium Act. The commission, which included experts from various fields such as addiction psychiatry, criminology, emergency medicine, and drug prevention, worked from April 2023 to May 2024. This multidisciplinary approach ensured a holistic understanding of MDMA’s impact.

report presentation by wim van den brink, md, phd

Wim van den Brink, professor of Addiction Psychiatry at the Amsterdam University Medical Centers presented the report 2 days after its release at the ICPR conference in Haarlem, June 2024.

Discover more talks from ICPR 2024 talks, symposia, lectures & Q&A!

the Potential of MDMA assisted therapy

A central aspect of the report is its exploration of MDMA’s potential therapeutic benefits, particularly in the treatment of PTSD. The commission reviewed existing research and concluded that MDMA-assisted therapy shows promise for patients with treatment-resistant PTSD. 

efficacy and Safety in Treating PTSD

The report discussed current research and clinical trials, highlighting the effectiveness of MDMA-assisted therapy in treating PTSD. To ensure safety and efficacy of MDMA-assisted therapy, the report highlights the importance of context.

“MDMA-assisted therapy has shown significant promise in the treatment of PTSD, particularly for patients who have not responded to traditional therapies. This could represent a major advancement in psychiatric treatment”  — MDMA /// Beyond Ecstasy Report

“The therapeutic use of MDMA must be conducted under strict medical supervision to ensure safety and efficacy.” — MDMA /// Beyond Ecstasy Report

Need for Further Research: state commission Proposing a Naturalistic Study in the Netherlands

“Further research is needed to explore the long-term effects and potential applications of MDMA in various psychiatric and neurological conditions.” — MDMA /// Beyond Ecstasy Report

To facilitate the use of MDMA in therapy to treat PTSD, the commission proposes a large naturalistic study in the Netherlands. This study would help gather more data and refine treatment protocols. Wim van den Brink highlighted, “A large naturalistic study will provide the necessary data to support the safe and effective use of MDMA in clinical settings”

education and training to meet the need

“Investing in training programs and specialized centers is essential for the successful implementation of MDMA-assisted therapy.” — MDMA /// Beyond Ecstasy Report

Establishing specialized centers and training therapists are critical steps for implementing MDMA-assisted therapy. While some qualified therapists are already available, more are needed to meet the potential demand. 

Prevalence and Risks of Recreational MDMA Use

“The prevalence of MDMA use in the Netherlands is among the highest in the world, yet the number of MDMA-related deaths remains relatively low, highlighting a unique consumption pattern and harm reduction practices in place” — MDMA /// Beyond Ecstasy Report

The second central theme of the report is the prevalence and associated risks of recreational MDMA use in the Netherlands. Despite the high prevalence, the report highlights that the frequency of use and the number of pills consumed per session are relatively low compared to other countries. This pattern may contribute to the lower number of MDMA-related deaths observed in the Netherlands.

The Dutch approach to drug policy heavily emphasizes harm reduction, which is reflected in the safety measures implemented at events where MDMA use is common. As noted in Wim van den Brink’s presentation at ICPR 2024, who emphasized the importance of “set and setting” in minimizing harm during MDMA use, factors such as the availability of care facilities, water, and first aid services at events significantly reduce the risks associated with MDMA use. 

The report calls for improved postmortem evaluations to better understand the exact causes of MDMA-related risks. Currently, the lack of comprehensive postmortem studies makes it difficult to determine the precise role of MDMA in fatalities, especially when other substances or external factors might be involved.

Public Health and Drug Policy

The report emphasizes a public health-focused approach to drug policy, advocating harm reduction overcriminalization. It criticizes the current lack of a cohesive national drug policy and calls for an integrated prevention program. The importance of targeted drug education and continuous monitoring of drug trends is also highlighted.

“The Dutch drug policy should remain primarily aimed at public health, avoiding the criminalization of users. Prevention strategies must be evidence-based, focusing on harm reduction rather than punitive measures.”  — MDMA /// Beyond Ecstasy Report

to conclude

The Dutch State Commission on MDMA’s report “Beyond Ecstasy” is a pivotal document that could shape the future of drug policy and medical treatment in the Netherlands. By addressing the risks and potential benefits of MDMA and MDMA-assisted therapy, the report aims to provide a framework for policymakers.

As the Dutch government considers these recommendations, patients in need, therapists, researchers and the general public will be paying attention. At OPEN Foundation, we are hopeful that this may be a step toward responsible, safe, and beneficial integration of psychedelics into society and healthcare.

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