(Press-News.org) 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.
END
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
2025-06-03
ELSE PRESS RELEASES FROM THIS DATE:
Experimental Drug Development Centre announces the presentation of updated data from the phase 1 study of antibody-drug conjugate EBC-129 at the 2025 Annual Meeting of the American Society of Clinical
2025-06-03
EBC-129 is an antibody-drug conjugate (ADC) that selectively targets a novel, tumour-specific N-glycosylated epitope found on both CEACAM5 and CEACAM6.
The expansion cohort for pancreatic ductal adenocarcinoma (PDAC) in the ongoing Phase 1 trial has completed enrolment. Notably, 82% of patients had tumours expressing the antigen at levels considered treatable with EBC-129.
EBC-129 demonstrated positive overall response rates and prolonged progression-free survival in PDAC patients that have been heavily pre-treated, including those ...
African swine fever not recently imported to Europe, has been around for years
2025-06-03
A new study in Genome Biology and Evolution, published by Oxford University Press, finds that the African Swine Fever virus, currently circulating in Europe, is not the result of a recent introduction. Instead, the virus has been present in the region since 2007. Its current dramatic spread appears to be driven largely by people within Europe traveling longer distances.
African Swine Fever virus is a highly virulent DNA virus that causes a severe hemorrhagic disease of the same name affecting both domestic pigs and wild boars. The disease is characterized by high mortality rates, leading to significant economic losses in the pork industry. According to estimates ...
APA calls for guardrails, education, to protect adolescent AI users
2025-06-03
The effects of artificial intelligence on adolescents are nuanced and complex, according to a report from the American Psychological Association that calls on developers to prioritize features that protect young people from exploitation, manipulation and the erosion of real-world relationships.
“AI offers new efficiencies and opportunities, yet its deeper integration into daily life requires careful consideration to ensure that AI tools are safe, especially for adolescents,” according to the report, entitled “Artificial Intelligence and Adolescent Well-being: An APA ...
Wendelstein 7-X sets new performance records in nuclear fusion research
2025-06-03
On the path toward a fusion power plant, stellarators are among the most promising concepts. In the future, they could generate usable energy by fusing light atomic nuclei. This reaction must take place in a plasma — a hot gas of ionized particles heated to many tens of millions of degrees Celsius. Stellarators use magnetic confinement to hold the plasma: the plasma is trapped by a complex and powerful magnetic field, floating inside a donut-shaped vacuum chamber. With Wendelstein 7-X (W7-X), the Max Planck Institute for Plasma Physics (IPP) in Greifswald, with support from the European fusion consortium EUROfusion, is operating the world's ...
Brain connections at 3 months predict infant emotional development
2025-06-03
PITTSBURGH, Pennsylvania, USA, 3 June 2025 – In a comprehensive Genomic Press research article, scientists have uncovered remarkable insights into how the earliest brain connections shape infant emotional development, potentially offering new ways to identify children at risk for future behavioral and emotional challenges.
The groundbreaking study, led by Dr. Yicheng Zhang and Dr. Mary L. Phillips at the University of Pittsburgh School of Medicine, examined 95 infant-caregiver pairs using advanced brain imaging techniques. Researchers discovered that the microstructure of white matter ...
Listening to life: Speech technology transforms clinical research
2025-06-03
ATLANTA, Georgia, USA, 3 June 2025 – In a comprehensive Genomic Press interview published today in Psychedelics, Dr. Deanna M. Kaplan reveals how her journey from journalism student to clinical psychologist led to revolutionary advances in capturing human experiences through voice technology. As Assistant Professor at Emory University School of Medicine and Director of Health Technologies for Spiritual Health at Emory Healthcare, Dr. Kaplan has transformed how researchers understand the impact of clinical ...
ECT sessions shape depression treatment outcomes
2025-06-03
HEFEI, Anhui, China, 3 June 2025 – In a comprehensive peer-reviewed Genomic Press Thought Leaders Invited Review, researchers have unveiled critical insights into how the number of electroconvulsive therapy (ECT) sessions influences treatment outcomes for depression, potentially transforming clinical decision-making for one of psychiatry's most effective yet controversial treatments.
The review, published in Brain Medicine, synthesizes decades of research to address a fundamental question that has long puzzled clinicians: How many ECT sessions are optimal for treating severe depression while minimizing cognitive side effects?
"ECT is like a powerful ...
Psilocybin enters gastroenterology: First-ever psychedelic study targets treatment-resistant IBS
2025-06-03
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 ...
Renowned psychiatrist illuminates biological roots of mental illness through pioneering research
2025-06-03
MILANO, Italy, 3 June 2025 – In a comprehensive Genomic Press Interview published in Brain Medicine, Professor Francesco Benedetti shares his transformative journey from confronting childhood awareness of mental illness to becoming a leading figure in psychiatric research. As founder and leader of the Psychiatry & Clinical Psychobiology research unit at IRCCS Ospedale San Raffaele, Dr. Benedetti has dedicated decades to reclaiming psychiatry's rightful place within medical science.
Professor ...
Ancient collagen can help identify a “wombat the size of a hippo” in the fossil record
2025-06-03
What happened to all the megafauna? From moas to mammoths, many large animals went extinct between 50 and 10,000 years ago. Learning why could provide crucial evidence about prehistoric ecosystems and help us understand future potential extinctions. But surviving fossils are often too fragmented to determine the original species, and DNA is not always recoverable, especially in hot or damp environments. Now scientists have isolated collagen peptide markers which allow them to identify three key megafauna ...
LAST 30 PRESS RELEASES:
Have female earwigs evolved their forceps as weapons in battles for mates?
Baby's microbiome may protect against childhood viral infection
Diabetes drug shows benefits for patients with liver disease
P2Y12 drugs may be better than aspirin to prevent heart attack and stroke in patients with coronary artery disease
Long-term data show sustained efficacy and safety of zigakibart in patients with IgA nephropathy
Landmark study reveals survival limits of kidney transplantation in older and high-risk patients
Targeting mitochondria to fight leukemia: Rice University-led research team pursues new treatment strategies
Antibiotics taken during pregnancy may reduce preterm births
Vigilance and targeted public health measures are essential in the face of the diphtheria epidemic that has affected vulnerable populations in Western Europe since 2022
New study: Personalized exercise boosts health for people with neuromuscular disease
FAMU-FSU College of Engineering researchers discover universal law of quantum vortex dynamics
AI analysis of ancient handwriting provides new age estimates for Dead Sea Scrolls
As many as 1 in 5 women with a history of pregnancy or testing for pregnancy report using crisis pregnancy centers across 4 US states
Six decades of data on North Atlantic phytoplankton reveal that their biomass has decreased up to 2% annually across most of the Atlantic Ocean, with potentially widespread implications for the wider
GPT-generated educational materials for urological cancer patients, translated by AI into five languages, are rated by doctors as easier to read than human-authored versions while being just as clear,
Ethical considerations for closing projects "well" in the context of withdrawal of USAID
How male mosquitoes target females—and avoid traps
Unlocking the timecode of the Dead Sea Scrolls
Heatwaves greatly influence parasite burden; likely spread of disease
Biggest boom since Big Bang: Hawaiʻi astronomers uncover most energetic explosions in universe
Electrifying results shed light on graphene foam as a potential material for lab grown cartilage
Global team tracks unusual objects in Milky Way galaxy
Surgical ablation during CABG linked to improved survival in patients with preexisting atrial fibrillation, new study finds
New research finds specific learning strategies can enhance AI model effectiveness in hospitals
INRS and ELI deepen strategic partnership to train the next generation in laser science
Cambridge chemists discover simple way to build bigger molecules – one carbon at a time
Scientists build first genetic "toggle switch" for plants, paving the way for smarter farming
Researchers unveil a groundbreaking clay-based solution to capture carbon dioxide and combat climate change
A game-changing way to treat stroke
Which mesh is best? Outcomes for abdominal ventral hernia repair patients projected by new research model
[Press-News.org] Clinical research on psychedelics gets a boost from new studyConsensus 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