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Health Canada approves low-dose psilocybin mental health clinical trial  

Diamond Therapeutics will be able to carry out a Phase 1 clinical trial to evaluate psilocybin microdosing as a mental health treatment. 

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Health Canada approves low-dose psilocybin mental health clinical trial  

Diamond Therapeutics has received approval from Health Canada to carry out a clinical trial for the treatment of mental health conditions with low-dose psilocybin. 

Drug development company Diamond Therapeutics has received a No Objection Letter from Health Canada which will enable it to carry out a Phase 1 randomised, placebo-controlled, double-blind human clinical trial to evaluate low doses of psilocybin for the treatment of mental health. 

Unlocking the use of psilocybin

Building on the results of previous animal research conducted by Diamond that demonstrated for the first time that low, non-hallucinogenic doses of psilocybin hold potential for therapeutic use, the study will evaluate the safety and pharmacokinetics of low doses of psilocybin in an estimated 80 study participants.

Diamond says the findings could help unlock the use of low-dose psilocybin to treat psychiatric disorders such as anxiety and depression.

Chair of Diamond’s scientific advisory board, Dr Edward Sellers, said: “This upcoming clinical trial will enable Diamond to gain critical clinical information that will help inform future human trials with psilocybin and other pipeline compounds.”

“We are grateful to Health Canada for their support of this groundbreaking study,” added Judy Blumstock, CEO of Diamond. “We’re very excited to commence our clinical programme. It brings us one step closer to creating therapeutics that can help more people access effective and safe treatments for mental health conditions.

“It’s because of the hard work of our team, partners and advisors that we’ve been able to achieve this significant milestone,” she says.

Diamond will also plans to launch a Phase 2 trial to investigate the efficacy of low-doses of psilocybin in treating anxiety, which will be conducted in both Canada and the US, and to support a study to explore its effects on patients with moderate depression.

See also  Findings give new insight into how psychedelics help mental health

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Designing Safety: Why Trauma-informed Models Must Lead the Psychedelic Renaissance

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This article was submitted by Lucy da Silva, Psychedelic Support Therapist and CEO Silva Wellness, as part of Psychedelic Health’s op-ed program. To submit article ideas, please email news@psychedelichealth.co.uk

 

I once was addicted to alcohol and drugs, which I was lucky enough to overcome through the 12-step programme. This journey was steeped in peer support and a real sense of community. Over the past five or so years, I have also had my fair share of psychedelic healing experiences, most of them in group settings.

Entering this sphere, I was fortunate to come from a place of internal containment and grounding, since my healing journey had begun long before my first psychedelic experience in a ceremonial setting. As a qualified and experienced psychotherapist, I was well versed in self-care, the analytical lens of Jungian interpretation and, most importantly, trauma knowledge and containment.

What these seeds of experience began to sow for me was an awareness of how clinical excitement can sometimes overshadow the slower work of building adequate systems that protect, hold and integrate – striking the delicate balance between respect for indigenous traditions and the demands of medicine-inspired healing. As a therapist, my work often focuses on the healing that takes place after harm has occurred. But my own experiences in medicine ceremonies (some profound and safe, others not so much) led me to wonder: what would it mean to design safety from the ground up?

The psychedelic field has made extraordinary progress in just a few years. Regulatory frameworks are evolving, clinical trials are expanding, and public interest is growing faster than any of us could have predicted. There’s a palpable sense of momentum—of medicine, culture and consciousness beginning to reconnect. The renaissance is not on its way—it is here! 

See also  Study establishes psilocybin microdosing regimen in rats to support research

Come meet the leaders shaping the future of psychedelic medicine. Join PSYCH Symposium: London 2025, December 4 at Conway Hall.

Yet much of this progress still takes place within the same paradigms that shaped twentieth-century psychiatry: models focused on efficacy and access, rather than on the deeper architecture of care. We talk about scaling treatments, but rarely about scaling safety—about designing systems that protect psychological integrity as much as they deliver clinical outcomes.

The conversation about psychedelic medicine often stops at the clinic door. But the next frontier of innovation isn’t pharmacological; it’s relational, community-driven and systemic. It’s about how we build environments that recognise trauma not as an exception, but as the context from which most people seek healing. This is especially relevant when utilising psychedelics for the treatment of substance use disorders.

Co-Design Workshops: Trauma-Informed Care and Community Integration in Psychedelic Therapy

When we had the opportunity to apply for a government-backed R&D grant, it offered the chance to formalise what I had personally seen and encountered in group settings—as well as what I had heard through anecdotal conversations with individuals I met along the way, including clients who needed help processing uncontained trauma after group experiences.

With the grant focusing on individuals suffering from substance use disorders, I was motivated to propose a trauma-informed model in a group setting supported by community integration initiatives. I also wanted to address the elephant in the room: expanding access. With ketamine treatment via IV costing around £10,000 in the UK, affordability remains a serious issue. My goal was to explore how we can scale treatment options safely. We need to ensure that the very systems we design to help people heal do not inadvertently replicate harm.

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Rather than studying participants, we’ll be studying systems, and asking what those systems need to look like to prevent harm before it happens.

Our study (scheduled to kick off in November 2025), Co-Design Workshops: Trauma-Informed Care and Community Integration in Psychedelic Therapy, aims to explore how safety can be intentionally designed into emerging psychedelic care models before they become mainstream. It will run as follows:

  1. Three stakeholder groups (clinicians, peer facilitators and mental health service designers) will participate in a series of co-design workshops.
  2. Using journey mapping and system mapping, the sessions will explore how trauma-informed principles can guide safe, accessible models for group-based ketamine lozenge therapy (KLT).
  3. The aim is to co-create conceptual frameworks that integrate ethical design, accessibility and community wisdom from the outset.

What we hope to learn is that safety is relational, shaped by culture and trust just as much as by clinical control. Trauma-informed practice, emotional readiness, education, and attention to set and setting before any medicine is ingested should form vital components of integration.

Promoting integration as preparation—as the precursor to treatment, as a modality in itself—mirrors what the 12-step programme does so well. Peer-led community, robust support and follow-up systems could become the scaffolding that extends care beyond the session, supporting longevity in healing.

This also ties into the concept of reducing hierarchy by amplifying lived expertise and modelling the inclusivity that psychedelic care must embody. It can help individuals lean towards treatment rather than resist it—a common challenge in both community-led and private addiction treatment programmes.

As the long-term aim of this project is to align proposed frameworks with voluntary sector and NHS infrastructure, we envisage that it could inform future service delivery and policy development. Most importantly, we hope to begin a wider discussion about how future frameworks can be wrapped in nurturing ethics and, above all, safety.

See also  What we know about the effect of psychedelics on women’s health

If we can integrate trauma-informed principles from the outset, the future of psychedelic therapy could look very different. We might see small, community-based groups supported by skilled facilitators who understand containment as much as chemistry. Integration models could become embedded within peer networks, where shared experience is part of the medicine itself.

Services could evolve through co-design rather than correction, shaped by lived wisdom as much as professional expertise. In this vision, innovation means not just expanding access, but building safety, inclusion and care by design.

Because the psychedelic renaissance will only ever be as safe as the systems that hold it and designing those systems is the real frontier.

As this project begins, we have a rare opportunity to slow down—to listen, collaborate and build the ethical foundations before psychedelic care becomes fully mainstream. Trauma-informed design reminds us that safety is not simply the absence of harm, but the presence of trust, transparency and relationship.

If we can weave those qualities into the structures that support psychedelic work, from the clinic to the community, we stand a chance of creating a field that heals without replicating old wounds.

This study is just the first step, but it marks an invitation to the wider field: to design consciously, collectively and with care at the centre.

Because the question is no longer whether psychedelics can heal, it’s whether we can design the systems that allow that healing to endure.

Image by andreas160578 from Pixabay

 

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Is Ketamine Therapy Only Reaching The Wealthy? Dr. Celia Morgan On Expanding Equitable Access

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Dr. Celia Morgan is one of the UK’s leading figures in ketamine and psychedelic research, especially in the domain of addiction and mental health.

Based at the University of Exeter, she holds the Chair of Psychopharmacology and leads trials exploring how ketamine, paired with psychotherapy, can break cycles of relapse in substance misuse.

Morgan has led some of the largest clinical trials on ketamine-assisted therapy for alcohol use disorder and will be speaking at the upcoming PSYCH Symposium: London 2025, to be held at Conway Hall on December 4.

“I think that the most promising findings from our work with ketamine are of the sense of agency and autonomy in their recovery that the people we are working with experience,” she told Psychedelic Health in a written interview.

Still, she thinks several key challenges need to be tackled for these treatments to be able to reach more people. One of the biggest of such challenges is ensuring equitable access to these treatments.

“We see a relatively homogenous and privileged group in most studies, our work has tried to address this,” she said.

Building the infrastructure to safely deliver these treatments in public healthcare systems is another big challenge for the industry, she said.

Yet the healthcare sector can also take advantage of Ketamine’s regulated status to allow for a faster roll-out, when compared to other psychedelics like MDMA or psilocybin.

“Some of the recent recommendations by the Royal College fo Psychiatrists are steps on the way towards more widespread use,” she said.

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What distinguishes Morgan in the psychedelics field is her dual commitment. She studies the risks and harms of recreational ketamine use while simultaneously designing controlled, clinical applications for it.

One of her flagship projects is Exeter’s KARE trial (Ketamine for Reduction of Alcohol Relapse), which blends ketamine infusions with psychotherapy for patients with alcohol use disorder. Early published data show dramatic improvements in abstinence rates during six-month follow-ups, far exceeding baseline relapse rates. Morgan has also worked on trials for gambling disorder and other behavioral addictions, expanding the frontier of what ketamine-assisted therapy might treat.

Morgan also plays a role in academia’s response to the psychedelic renaissance, she’s a co-lead on Exeter’s postgraduate certificate in psychedelic studies, a program designed to train clinicians, researchers, and therapists in the science and ethics of psychedelic medicine.

“I think its important to keep on with our efforts to study, regulate and roll out these treatments principally for the patients who might benefit from psychedelics as I have seen first hand in my work,” she said.

Picture is extracted from an interview with Dr. Morgan at PSYCH Symposium’s 2022 edition.

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Did Psychedelics Influence Early Christianity? A New Review Examines the Evidence

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A newly published academic review has revisited one of the most sensational — and disputed — theories in psychedelic history: that early Christianity emerged from fertility cults using psychoactive mushrooms.

Released 9 August in the journal Religions, Richard S. Ascough’s paper, John Allegro and the Psychedelic Mysteries Hypothesis, takes a fresh look at the 1970 book The Sacred Mushroom and the Cross by Semitic philologist John M. Allegro.

Allegro claimed that Christian theology, symbols and even the figure of Jesus could be traced back to ancient rituals involving the psychoactive mushroom Amanita muscaria. His argument rested on bold linguistic links between Sumerian and Semitic languages — links that experts swiftly dismissed as unsubstantiated.

Discredited but enduring

Ascough’s review details how Allegro’s thesis was rejected almost immediately in academic circles. Mainstream scholars pointed out that Sumerian is a language isolate, making the connections Allegro proposed linguistically impossible. The fallout was severe — the book damaged Allegro’s reputation and ended his academic career.

Yet, as Ascough points out, the theory refused to disappear. In the decades since, it has surfaced repeatedly in psychedelic counterculture, cited by authors such as Carl Ruck and Terence McKenna. While scholars abandoned the thesis, parts of the public embraced it as part of a broader fascination with the potential spiritual role of entheogens.

Three key takeaways

Ascough distils his reassessment into three main findings:

  • Reception – Universally dismissed by academics, the theory nonetheless gained a cult following in popular psychedelic discourse.

  • Methodology – Allegro’s linguistic analysis is fundamentally flawed; modern scholarship offers no evidence for the deep language connections he claimed.

  • Legacy – The thesis’ real impact lies in how it helped spark public interest in the idea that psychoactive substances may have shaped religious traditions.

In short, Ascough frames Allegro’s work as “a historical curiosity” — important for its cultural footprint but not as a credible piece of entheogenic research.

Why it matters now

The review lands at a time when psychedelics are being investigated for regulated medical use in treating depression, PTSD, and end-of-life anxiety. By separating historical speculation from scientific evidence, Ascough’s work helps keep the conversation grounded.

It also highlights a longer lineage of public fascination with psychedelics — one that stretches from ancient myth to 20th-century counterculture, and now into 21st-century clinics and labs.

For those following the evolution of psychedelic medicine, the review is both a look back at one of the field’s most colourful controversies and a reminder of how far the evidence base has advanced.

Article picture is an illustration made using generative AI tools.

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Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

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