Global scientific consensus sets new standards for psychedelic therapy research

International researchers have collaborated on the first global agreement defining what specific psychosocial factors pose the “greatest impact” on psychedelic therapy, which is increasingly gaining momentum as an aid for mental health disorders.

Offering a standard framework for evaluating and reporting these variables, the guidelines aim to make trial outcomes more consistent and comparable across studies. Ultimately, the scientists seek to improve the rigor and reliability of clinical research in this emergent field.

“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,” says 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.”

McGill University (Canada), Imperial College London (UK), and the University of Exeter (UK) led the study.

Consolidating expert advice

Previous research backs psychedelic therapy as an effective treatment for symptoms of depression — in some cases, more than controls. However, researchers acknowledge knowledge gaps when it comes to standardized experiment conditions.

The researchers conducted a Delphi consensus study, bringing together 89 experts from 17 countries for a multi-round debate.

“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,” details the study brief.

“This gap has led to inconsistent study results, making regulatory approval more difficult.”

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.

Essential guidelines

Having clear guidelines for contextual considerations is essential to understanding the effects of psychedelics and how they work differently from other psychiatric medications, stresses co-senior author Leor Roseman from the University of Exeter. “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 explains. The US FDA 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,” says 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.

The “Reporting of Setting in Psychedelic Clinical Trials (ReSPCT)” guidelines were published in Nature Medicine as a 30-item checklist, supported by the Imperial College London Societal Engagement Seed Fund.

Spotlight on psychedelics

Last month, US FDA Commissioner Dr. Martin Makary publicly stressed the importance of accelerating and prioritizing research on the clinical benefits of psychedelic therapeutics, signaling a more positive regulatory sentiment leaning toward nationwide adoption.

A recent study in Nature found that psychedelic compounds interact with brain-immune system pathways and “fundamentally reshape” immunity responses tied to fear and stress. As such, the study reveals that psychedelics can do more than change perception — they can help dial down inflammation and reset brain-immune interactions.

In April, scientists found a single dose of a psychedelic compound boosted cognitive flexibility for weeks, with potential impacts on treatments for depression, post-traumatic stress disorder, and neurodegenerative diseases such as Alzheimer’s disease.

Meanwhile, a separate paper revealed that the natural compound psilocybin can boost mood and brain health for patients with Parkinson’s disease.