Psychedelics have been gaining attention as potential treatments for mental health disorders, but clinical trials in this area have faced a significant challenge. The failure to account for the influence of a person’s mindset and surroundings on the effects of psychedelic drugs like MDMA and psilocybin has led to inconsistent study results, making it harder to gain regulatory approval.
To address this issue, researchers from McGill University, Imperial College London, and the University of Exeter conducted an international study involving 89 experts from 17 countries. The result of this study is the “Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) guidelines,” published in Nature Medicine. This 30-item checklist represents the first global agreement on which psychosocial factors have the greatest impact on a psychedelic experience.
According to co-lead author Chloé Pronovost-Morgan, the guidelines are essential because psychedelics do not work in isolation. Factors such as a person’s mindset, the therapy room environment, and even the music playing can all influence the outcomes of psychedelic therapy. This approach challenges the traditional method of studying psychoactive drugs, where outside variables are typically controlled or eliminated to isolate the drug’s effects. The ReSPCT guidelines recognize the importance of studying the context directly.
The guidelines aim to provide a standard framework for evaluating and reporting these variables, with the goal of making trial outcomes more consistent and comparable across studies. Co-senior author Leor Roseman emphasizes the importance of clear guidelines for contextual considerations in understanding the effects of psychedelics and their therapeutic potential.
The lack of standards in reporting these variables has had real-world consequences, such as the recent rejection of MDMA-assisted therapy for PTSD by the U.S. FDA due to inconsistent reporting across trials. The researchers hope that the ReSPCT guidelines will set a new gold standard for psychedelic research, ultimately making these treatments more accessible to those who need them most.
To further discuss the implementation of these guidelines in research and clinical practice, the research team is organizing a three-day workshop in October. Leading experts in psychedelics and neuroscience will come together to explore how the guidelines can be integrated into future studies and treatment approaches.
In conclusion, the ReSPCT guidelines represent a significant step forward in improving the rigor and reliability of psychedelic clinical research. By addressing the critical issue of set and setting factors in psychedelic therapy, these guidelines have the potential to advance the field and bring much-needed treatments to individuals suffering from mental health disorders.
