An international panel of 89 experts from 17 countries has developed new guidelines—Reporting of Setting in Psychedelic Clinical Trials (ReSPCT)—to standardize how psychedelic clinical trials report ‘set and setting,’ the mindset and environment in which psychedelic experiences occur. Published in Nature Medicine, the guidelines outline 30 variables across four key areas: physical environment, dosing session procedures, therapeutic framework, and participants’ subjective experiences.

The aim is to improve consistency in trial design and reporting, enhancing the ability to interpret and replicate findings. A lack of standardized reporting has previously posed challenges for regulatory approval, as highlighted by the FDA’s recent rejection of 3,4-methylenedioxymethamphetamine-assisted therapy for PTSD. By capturing critical non-drug factors that influence safety and efficacy, the ReSPCT guidelines may help advance future approval processes. The initiative was partly funded by the National Institute for Health and other organizations.

From Medscape