Connect with us

Insight

Exploring the placebo effect in psychedelic studies

Published

on

Exploring the placebo effect in psychedelic studies
Photo by Diana Polekhina on Unsplash

The placebo effect is the mysterious power our minds have to make us feel better, even when we are taking just a sugar pill instead of real medicine. 

Several studies have shown that this effect is a legitimate biopsychosocial phenomenon that is an integral part of the overall treatment response.

Research has found that the placebo effects can be as strong as the effect of the actual medicine in randomized controlled trials (RCTs).

When scientists want to test a new drug, they use what’s called a double-blind RCT.

In this trial design, two groups of people are tested, one gets the real medicine and the other gets a fake one (the placebo).

The twist? Neither the people taking the medicine nor the ones giving it know which is which. This helps to make sure that the results are trustworthy and not biased.

Even with this careful setup, it’s tough to uphold the true integrity of the double blind information and sometimes the secret of who got the drug and who didn’t gets out.

This is especially true in psychedelic studies.

The RCT design assumes that the effects of a drug being studied can be isolated, added, and/or subtracted from the “nonspecific effect” of context and person, studied by the placebo.

However, despite the goal of blinding, it is rare for trials to uphold blinding integrity and incorporate this information into the results.

While these trials are great for assessing the added benefit of novel drugs, they don’t always show us the full power of the placebo effect.

It’s a hidden superpower we are still trying to understand.

The History of placebo in the clinic

In 1772, a Scottish doctor named William Cullen reported prescribing a remedy to a patient despite believing it to be inefficacious. He explains that sometimes “it is necessary to give a medicine and [this is] what I call a placebo.”

The role of the placebo was to give patients hope and to make doctors’ work easier in difficult or desperate cases.

Placebos were considered as inert substances with “fake” psychological but benign effects. They were believed that they cannot cause harm, but may relieve symptoms.

See also  Beyond Psilocybin: the fascinating world of functional mushrooms

It was only in the 1950s, with the rise of informed consent and autonomy as pillars of medical ethics, that the practice of deceiving patients “for their own good” was put into question. Today, the deceptive use of placebos is seen as a relic of an older era.

However, despite this change in mindset, 46-95% of doctors prescribed placebos in 2018.

Placebos in research

In the 20th century, placebos began to be used in research to assess the added benefit of drugs and to discard harmful or ineffective treatments. By 1946 the comparative experimental framework was advocated for in clinical trials.

The placebo effect

In 1955  Dr. Henry Beecher wrote an article called The Powerful Placebo, which catapulted the ideas on the placebo into popularity and changed the way researchers thought about the placebo effect.

He found that about one-third of participants in clinical trials were experiencing relief from their symptoms.

Before, placebos were often just given to patients to make them feel better, and many brushed them off as just “all in the mind.”

However, in research, the placebo effect led to discerning between useful and non-useful treatments. This insight from Dr. Beecher helped scientists figure out which treatments really worked and which didn’t.

In 1962, the RCT design comparing the effects of treatment and placebo groups became the gold standard for pharmaceutical manufacturers to demonstrate efficacy and safety to regulators.

Placebo in Psychedelic Studies

Using a placebo in psychedelic studies is a challenge. It is very obvious to the recipient who receives a placebo versus a psychedelic.

And placebo effects have been shown to be enhanced by the setting of the psychedelic study.

A recent study looked at placebo psychedelics alone in the context of a psychedelic party. Researchers threw a party for 33 students. They gave them placebo, telling them it was similar to psilocybin, the hallucinogenic molecule found in psychedelic mushrooms.

The party had music, colorful lights, mesmerizing paintings and visual projections.

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

Some of the people at the party were in on the secret. They were there to act like they were feeling the effects of “the drug” and to make the study participants believe that there was no placebo control group.

The results indicated that context and expectations can promote psychedelic-like effects.

The party vibes and expectations made the participants feel like they had a psychedelic trip, even without taking any real drugs.

The individual variability within the placebo effects was considerable.

Some felt nothing, while others felt like they’d taken a strong dose of psilocybin.

In psychedelic studies, it is much more difficult to use the traditional framework for assessing the effectiveness of a drug against a placebo. The environment and mindset, often referred to as “set and setting” can play a huge role in the effects of the drug.

The effects can be synergetic. The drug influences the “set and setting” and the “set and setting” influences the drug effect. Since the party setting can itself be a game changer on the effects of the drug, these elements should be seen as factors central to psychedelic science, and cannot be disregarded as noise.

How to control for the placebo effect in psychedelic studies?

A group of drug experts including Prof. David Nutt, Robin Carhartt-Harris, Balázs Szigeti and David Erritzoe, recently wrote a preprint (an article shared prior to peer-review) on the fallibility of placebo control.

When people think they are getting the true drug but aren’t, their expectations can mess with the results of the trial.

They call this combination of weak blinding and positive treatment expectancy, activated expectancy bias (AEB).

The effect of AEB is an uneven distribution of expectancy effects between placebo and drug due to patients recognizing what they received in psychedelic randomized controlled trials.

To counteract the bias, the researchers proposed the Correct Guess Rate Curve (CGRC), a computational model and novel analytical tool that can estimate what the results of the trial would look like if everyone was completely in the dark about whether they got the real drug or a placebo.

See also  INSIGHT: exploring clinical developments in psychedelics 

Results from the CGRC suggest that placebo-controlled studies are more fallible than conventionally assumed leading to researchers thinking a drug works when in fact it does not.

The CGRC can help fix this bias, and it is cost effective and less resource intensive.

Most solutions to improve blinding are difficult to implement and resource intensive. Thanks to these experts, we now have a useful tool to make drug research more reliable.

With the resurgence of psychedelic research in randomized controlled trials, it has highlighted the antiquated system we have used for the last century to evaluate drug effectiveness.

The idea of “set and setting” should not stand alone for use in psychedelic research. Perhaps more treatments could benefit from improved set and setting.

Furthermore, in psychedelic studies the psychedelics are given in a treatment regime that involves psychotherapy, resulting in the name psychedelic-assisted therapy.

The idea is not to give the treatment to the patient and send them on their way. The psychotherapist will prepare the patient for treatment, be with them during treatment, and help them integrate in follow-up sessions.

It would be interesting if more treatments used the structure as described above. Most treatments are given after a very brief talk with a doctor, and then usually results in a “give me a call if you don’t improve.”

What if the doctor said: “call me if you improve or if you don’t.” Perhaps it could strengthen the doctor-patient relationship. Even “the placebo effect” could be integrated into a person’s recovery.

The holistic approach of psychedelic-assisted therapy, where the journey is as important as the treatment itself, offers a promising blueprint for future medical practices.

By fostering deeper doctor-patient relationships and harnessing the power of the placebo effect, we could revolutionize the way we heal and care.

This article was first published on Nina’s Notes and is republished on Psychedelic Health with permission.

Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Insight

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

Published

on

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

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.

See also  Cognitive neuroscientists bring new rigour to psychedelics, says Johns Hopkins

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  MDMA therapy training launched by TheraPsil

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

 

Continue Reading

Insight

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

Published

on

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.

See also  Psychedelic-assisted therapy for treating PTSD in Ukraine brings hope

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.

Continue Reading

Evegreen

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

Published

on

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.

See also  This is your brain on ketamine
Continue Reading

Trending

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.

Copyright © 2025 PP Intelligence Ltd.