Clinical research on psychedelics gets a boost from new study
Consensus on how mindset and surroundings shape therapy outcomes is an important step toward regulatory approval for use of drugs like MDMA and psilocybin in treatment of debilitating mental health conditions
McGill University
As psychedelics gain traction as potential treatments for mental health disorders, an international study led by researchers at McGill University, Imperial College London, and the University of Exeter stands to improve the rigour and reliability of clinical research.
Up to now, psychedelic clinical trials have had what has been widely acknowledged as a critical flaw: the failure to properly account for how a person’s mindset and surroundings influence the effects of psychedelics such as MDMA and psilocybin. This gap has led to inconsistent study results, making regulatory approval more difficult.
To address this, the researchers conducted a Delphi consensus study, bringing together 89 experts from 17 countries for a multi-round debate. The result is the Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) guidelines, published in Nature Medicine, a 30-item checklist, representing the first global agreement on which psychosocial factors have the greatest impact on a psychedelic experience.
“For decades, we’ve known that psychedelics don’t work in isolation. The person’s mindset, the therapy room, even the music playing all influence outcomes,” said co-lead author Chloé Pronovost-Morgan, a researcher at McGill University and Imperial College London. “Two trials using the same psychedelic drug, at the same dose, can produce completely different results depending on the environment.”
This approach challenges the way psychoactive drugs are typically studied, where scientists try to control or eliminate outside variables to isolate a drug’s effects. These guidelines recognize that context is crucial and should be studied directly.
Why guidelines matter
By offering a standard framework for evaluating and reporting these variables, the guidelines aim to make trial outcomes more consistent and comparable across studies.
Leor Roseman from the University of Exeter is co-senior author and said: “Having clear guidelines for contextual considerations is essential to understand the effects of psychedelics and how they work differently from other psychiatric medications. Our guidelines will also help in replicating results and understanding the true therapeutic potential of psychedelics.”
The lack of standards has had consequences beyond the research lab, Pronovost-Morgan explained. The U.S. Food and Drug Administration recently rejected MDMA-assisted therapy for post-traumatic stress disorder, citing inconsistent reporting across trials as a key reason for the decision.
“There is immense public interest in psychedelic therapies, particularly for individuals suffering from debilitating mental health conditions like PTSD, depression and anxiety, which have not responded to existing treatments,” said co-senior author Kyle Greenway, Assistant Professor in McGill’s Division of Social and Transcultural Psychiatry and a researcher at the Lady Davis Institute for Medical Research.
“Our guidelines offer a new gold standard for psychedelic research, helping bring these treatments to those who need them most.”
The research team is organizing a three-day workshop in October, funded by McGill’s Healthy Brains, Healthy Lives initiative, where leading experts in psychedelics and neuroscience will discuss how the guidelines can be integrated into research and clinical practice.
About the study
“The Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) Guidelines: An international Delphi consensus study” by Chloé Pronovost-Morgan, Kyle Greenway and Leor Roseman was published in Nature Medicine.
This research was supported by the Imperial College London Societal Engagement Seed Fund.
Journal
Nature Medicine
Method of Research
Survey
Subject of Research
People
Article Title
The Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) Guidelines : An international Delphi consensus study
Article Publication Date
3-Jun-2025
Psilocybin enters gastroenterology: First-ever psychedelic study targets treatment-resistant IBS
Massachusetts researcher explores how childhood trauma becomes "somatically encoded" in gut disorders
Genomic Press
image:
Erin Mauney, MD, Tufts University, USA.
view moreCredit: Erin Mauney
BOSTON, Massachusetts, USA, 3 June 2025 – In a comprehensive Genomic Press Interview published today, Dr. Erin E. Mauney reveals how her pioneering research brings psychedelic medicine into gastroenterology for the first time, potentially transforming treatment for millions suffering from intractable irritable bowel syndrome (IBS).
The assistant professor of pediatrics at Tufts University, who maintains a research appointment at Massachusetts General Hospital, leads the first clinical trial examining psilocybin's effects on treatment-resistant IBS. Her work addresses a critical gap in medicine: the substantial population of IBS patients who find no relief through conventional therapies.
Breaking New Ground in Gut-Brain Medicine
Dr. Mauney's research explores how psilocybin modulates interoception – the way people perceive their body and gastrointestinal symptoms. The study protocol involves two doses of psilocybin with integrated therapy sessions before and after dosing, combined with neuroimaging via fMRI to track brain changes.
"I became very interested in the applicability of this emerging field of psychedelic-assisted medicine to patients who seem to be at war with their bodies," Dr. Mauney explains in the interview. Her approach recognizes that many patients with severe, unexplained somatic symptoms have experienced significant trauma, particularly in early life.
The research emerges from Dr. Mauney's observation that medicine, especially gastroenterology and obesity medicine, often fails to meaningfully understand and address the cumulative effects of toxic stress over the lifespan. This insight led her to investigate how early-life trauma becomes "somatically encoded" and how psychedelic therapy might create pathways for emotional release and functional improvement.
From Personal Curiosity to Professional Innovation
Dr. Mauney's journey into psychedelic research began during the pandemic when she read Michael Pollan's "How to Change Your Mind" while deciding to specialize in pediatric gastroenterology. Her background combines bacteriology research, including work on immune tolerance-inducing bacteria, with clinical expertise in integrative gastroenterology.
A setback that proved fortuitous occurred when Dr. Mauney wasn't accepted to her top fellowship choice at Boston Children's Hospital. Instead, she matched at Massachusetts General Hospital, where she gained access to mentors including Dr. Franklin King at the Center for the Neuroscience of Psychedelics and Dr. Brad Kuo at the Center for Neurointestinal Health – connections that would prove instrumental in launching her psychedelic research program.
Addressing the Mind-Body Divide
The study's significance extends beyond IBS treatment. Dr. Mauney hopes her work will help heal what she describes as "the schism between mind and body that so many physicians practice within." This artificial separation has long hindered effective treatment for functional gastrointestinal disorders, where psychological and physical symptoms intertwine.
Her research methodology combines quantitative measures – including patient-reported abdominal pain scores – with qualitative patient reflections and neuroimaging data. This multi-faceted approach aims to capture both the subjective experience of healing and objective biological changes. Could this integrated methodology become a model for studying other functional disorders where conventional treatments fall short?
Implications for Pediatric Medicine
While Dr. Mauney's current research focuses on adults, her pediatric background deeply informs her perspective. She notes that witnessing inequality and injustice daily in pediatrics, particularly regarding childhood obesity, motivates her broader vision for medicine. Her interest in pediatric obesity prevention requires what she calls "a full-scale realignment of our society's priorities," including food subsidies, urban design, educational approaches, and technology's impact on childhood.
This systemic thinking raises important questions: How might early intervention with trauma-informed approaches prevent the development of chronic functional disorders? What role could psychedelic therapy eventually play in addressing treatment-resistant conditions across the lifespan?
Personal Philosophy Shapes Scientific Approach
The interview reveals how Dr. Mauney's personal values influence her research approach. She emphasizes cultivating "honest, genuine relationships with each person you work with" and creating environments where people can bring their whole selves to work. Her motto, "We are what we repeatedly do," reflects her commitment to meticulous, persistent research that prioritizes patient wellbeing.
When asked about her greatest passion, Dr. Mauney responds: "Restoring humanity to the practice of medicine." This philosophy permeates her research design, which treats patients as whole persons rather than collections of symptoms. Her approach suggests a paradigm shift in how we conceptualize and treat functional disorders – moving from symptom suppression to addressing root causes, including psychological trauma.
Looking Forward: Scalable Solutions
Dr. Mauney's research aims not just to prove efficacy but to develop scalable therapeutic options. She envisions optimizing psychedelic therapy protocols to make them accessible in clinical settings, potentially offering hope to the millions of IBS patients worldwide who have exhausted conventional treatment options.
The timing of this research is particularly significant as psychedelic medicine gains mainstream acceptance. With multiple psychedelic compounds in late-stage clinical trials for various conditions, Dr. Mauney's work positions gastroenterology at the forefront of this therapeutic revolution. What other specialty areas might benefit from similar innovative approaches to treatment-resistant conditions?
Dr. Erin E. Mauney's Genomic Press interview is part of a larger series called Innovators & Ideas that highlights the people behind today's most influential scientific breakthroughs. Each interview in the series offers a blend of cutting-edge research and personal reflections, providing readers with a comprehensive view of the scientists shaping the future. By combining a focus on professional achievements with personal insights, this interview style invites a richer narrative that both engages and educates readers. This format provides an ideal starting point for profiles that delve into the scientist's impact on the field, while also touching on broader human themes. More information on the research leaders and rising stars featured in our Innovators & Ideas – Genomic Press Interview series can be found in our publications website: https://genomicpress.kglmeridian.com/.
The Genomic Press Interview in Psychedelics titled "Erin Mauney: Psychedelics as modulators of the gut-brain interaction," is freely available via Open Access on 3 June 2025 in Psychedelics at the following hyperlink: https://doi.org/10.61373/pp025k.0020.
About Psychedelics: Psychedelics: The Journal of Psychedelic and Psychoactive Drug Research (ISSN: 2997-2671, online and 2997-268X, print) is a peer reviewed medical research journal published by Genomic Press, New York. Psychedelics is dedicated to advancing knowledge across the full spectrum of consciousness altering substances, from classical psychedelics to stimulants, cannabinoids, entactogens, dissociatives, plant derived compounds, and novel compounds including drug discovery approaches. Our multidisciplinary approach encompasses molecular mechanisms, therapeutic applications, neuroscientific discoveries, and sociocultural analyses. We welcome diverse methodologies and perspectives from fundamental pharmacology and clinical studies to psychological investigations and societal-historical contexts that enhance our understanding of how these substances interact with human biology, psychology, and society. Visit the Genomic Press Virtual Library: https://issues.genomicpress.com/bookcase/gtvov/ Our full website is at: https://genomicpress.kglmeridian.com/
Erin Mauney: Psychedelics as modulators of the gut-brain interactions
Credit
Erin Mauney
Journal
Psychedelics
Method of Research
News article
Subject of Research
People
Article Title
Erin Mauney: Psychedelics as modulators of the gut-brain interactio
Article Publication Date
3-Jun-2025
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