New Study Improves Accuracy and Reliability of Psychedelic Clinical Trials

New Study Improves Accuracy and Reliability of Psychedelic Clinical Trials

With psychedelics emerging as potential treatments for mental health disorders, an international study led by researchers from McGill University, Imperial College London and the University of Exeter is being conducted to improve the accuracy and reliability of clinical research.

To date, psychedelic clinical trials have had what has been widely recognized as a critical flaw: the failure to determine a person's attitude and environment to influence the effects of psychedelics such as MDMA and psilocybin. This gap has resulted in inconsistent study results, making regulatory approval difficult.

To address this, researchers conducted a Delphi consensus study that brought together 89 experts from 17 countries for a multiple debate. The result is the reporting of the Psychedelic Clinical Trials Guidelines (RePCT), which will be published inNatural medicinea 30-point checklist that represents the first global agreement on which psychosocial factors have the greatest influence on a psychedelic experience.

We've known for decades that psychedelics don't work in isolation. The person's mindset, the therapy room, even the music that plays all influence outcomes. Two studies using the same psychedelic drug at the same dose can produce completely different results depending on the environment. “

Chloé Pronovost-Morgan, co-lead author, researcher at McGill University and Imperial College London

This approach challenges the way psychoactive drugs are typically studied, with scientists attempting to control or eliminate extraneous variables to isolate a drug's effects. These guidelines recognize that context is critical and should be examined directly.

Why policies are important

By offering a standard framework for assessing and reporting these variables, the guidelines aim to make study results more consistent and comparable across studies.

Leor Roseman from the University of Exeter is co-senior author and said: "Clear guidelines for contextual considerations are important for understanding the effects of psychedelics and how they work differently than other psychiatric medications. Our guidelines will also help replicate results and understand the true therapeutic potential of psychedelics."

The lack of standards has had consequences beyond the research laboratory, 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 the main reason for the decision.

"There is immense public interest in psychedelic therapies, particularly among individuals suffering from debilitating mental illnesses such as PTSD, depression and anxiety who have not responded to existing treatments," said co-senior author Kyle Greenway, an assistant professor in McGill's Department of Social and Transcultural Psychiatry and a research investigator at the Lady Davis Institute for Medical Research.

“Our guidelines provide a new gold standard for psychedelic research and 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

“Reporting the Guidelines for Psychedelic Clinical Trials (RePCT): An International Delphi Consensus Study” by Chloé Pronovost-Morgan, Kyle Greenway, and Leor Roseman was published inNatural medicine.

This research was supported by the Imperial College London Societal Engagement Seed Fund.

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