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From promise to practice: A dose of reality for psychedelic therapies

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Psychedelics stand at a pivotal crossroads in mental health, offering the prospect of novel therapeutic avenues to address multiple mental conditions, from treatment-resistant depression to post-traumatic stress disorder (PTSD). However, their mind-altering properties present unique ethical and clinical challenges. 

In a newly published article in Nature Medicine, leading psychiatrists, psychologists and psychotherapists highlight the importance of protecting patients during these vulnerable states of altered consciousness. They also emphasise the imperative for regulatory frameworks and collaborative efforts to fully realise the potential benefits of psychedelics.

The exploration of alternative therapeutics for hard-to-treat mental health disorders has brought into focus an array of psychedelics such as psilocybin, present in ‘magic mushrooms’, and LSD, substances once associated more with counterculture than clinical practice. 

See also  ARC: an ethical framework for the delivery of psychedelic therapy

Alongside ‘atypical’ psychedelics like ketamine and MDMA, these substances are increasingly being recognised for their potential therapeutic attributes. For example, synthetic psilocybin has shown promising results in alleviating symptoms of depression and anxiety associated with cancer diagnosis, while its efficacy is being investigated in relation to conditions such as obsessive-compulsive disorder, eating disorders, and substance use disorders.

Moreover, while the subjective experiences they elicit may differ, both typical and atypical psychedelics are generally deemed safe with limited potential for abuse. However, a seamless transition from clinical trials to regular clinical practice is by no means guaranteed. 

As Albino Oliveira-Maia, senior author of the article and head of the Champalimaud Foundation’s Neuropsychiatry Unit, notes: “Up until now, psychedelic therapies have largely been confined to the realm of research and clinical studies. But this looks set to change. 

“We’re already witnessing off-label use of ketamine, once solely viewed as an anaesthetic, in treating depression and substance use disorders, despite the lack of clear guidelines, formal approval from regulatory agencies, and recommendations regarding psychological support.”

Unlike most drug treatments, psychedelics are typically coupled with psychotherapy to safeguard patients and potentially enhance clinical effectiveness through shaping the drug-induced subjective experiences. 

The authors emphasise the necessity of assessing the clinical effectiveness of the accompanying therapy.

“If psychotherapy during the psychedelic experience offers substantial additional benefits to the patient, defining and standardising optimal therapeutic procedures for these dosing sessions becomes essential,” says Oliveira-Maia. 

“Our goal is also to ensure that the promise of psychedelics does not come at the expense of patient safety.”

Potential for abuse

Psychedelics can provoke heightened suggestibility or feelings of intimacy, which may increase vulnerability to potential abuse and boundary transgressions in the therapist-patient relationship.

An alleged example of such a transgression occurred in a Canadian clinical trial of MDMA-assisted therapy for PTSD, where a participant and her unlicensed therapist were involved in an out-of-court settlement for a sexual assault claim. 

Such incidents underscore the necessity for certified and professionally trained practitioners, regulatory oversight, and enhanced informed consent procedures to address possible use of touch and patient susceptibility during altered states of mind.

“This will demand a collective effort,” states co-author Ana Matos Pires, Director of the Mental Health Department at Unidade Local de Saúde do Baixo Alentejo and Member of the Board of Psychiatrists at the Portuguese Medical Association. 

“Not only will it involve the physicians who prescribe the treatment and the psychologists who administer it, but also a range of other stakeholders at national and international levels, from regulatory bodies like the US Food and Drug Administration and European Medicines Agency, to policymakers, ethics boards, pharmacists, nurses, and of course, the patients themselves.”

Regulatory challenges

In Portugal, researchers working with psychedelics are already engaging with professional societies of psychiatrists and clinical psychologists, as well as ethical authorities, to preemptively address the regulatory challenges that may surface if these psychedelic treatments become mainstream. 

“We see our proactive approach serving as a blueprint for other countries preparing for the potential incorporation of psychedelic treatments into clinical practice,” says Matos Pires. 

“Health literacy is also critical in this area. It’s crucial that we clearly inform the public about this kind of treatment. Psychedelic therapies are not a panacea but another tool with which to treat mental illness.”

Many aspects remain to be clarified, from determining appropriate dosages and antipsychotics to counter adverse effects, to identifying the ideal settings for treatment, whether within traditional hospital environments or alternative therapeutic spaces. 

Time, though, is of the essence. Recently, Australia declared its intent to authorise the therapeutic use of MDMA and psilocybin starting July 2023, while the FDA could approve the use of MDMA for treating PTSD as early as 2024.

“We agree on the potential benefits of psychedelics”, says co-author Luís Madeira, President-elect of the Portuguese Society of Psychiatry and Mental Health, and Counsellor of the National Council of Ethics for the Life Sciences. 

“Nevertheless, it’s vital to acknowledge the associated challenges and avoid rushing the process. Given that trials typically pair psychedelics with therapy, further research will be needed to better understand the individual effects of both the drug and the therapy. It’s plausible that one may prove more efficacious than the other.”

Research challenges

One notable challenge Madeira brings up is the difficulty of conducting unbiased double-blind studies, as the distinct psychoactive effects make it obvious to both participant and researcher who has received the treatment or placebo. 

Additionally, the question of accessibility in the public health system arises, given that each psychedelic experience can last eight hours and usually involves two trained therapists. 

“A potential solution”, explains Madeira, “might be group therapy, allowing therapists to treat multiple patients simultaneously, thereby reducing costs and making the treatment more feasible within public health systems.”

The article’s first author Carolina Seybert, Clinical Psychologist at the Champalimaud Clinical Centre, stresses the need for an agile process: “These protocols need to be flexible and dynamic as our understanding of these therapies evolves. In a rapidly changing field like this, in which our knowledge base is constantly updating, it’s key that our guidelines and regulations are not just robust, but also adaptable. 

“We need a uniform framework in place that can be modified as new information comes in. If we leave this process to the self-regulation of individuals, the patient’s experience may vary substantially from one case to the next.

“In a sense, our exploration of psychedelics in mental health mirrors the very nature of the treatment itself, a venture into uncharted territory and new possibilities.”

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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! 

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.

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.

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.

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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Evegreen

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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