The US Food and Drug Administration (FDA) is taking a new step in contributing to psychedelic research, publishing its first draft of guidance measures outlining recommendations to the pharmaceutical industry for designing clinical trials on psychedelic drugs.
This new set of recommendations covers studies including what the FDA defines as “classic” psychedelics like Psylocibin (the psychoactive component found in magic mushrooms) and LSD (aka “Acid”) as well as the empathogen MDMA.
While commonly associated with recreational use in settings like clubs and music festivals, the scientific community has taken up renewed interest in studying these substances’ potential therapeutic uses in recent years.
As more entities conduct studies and dip their toes into providing psychedelic-assisted treatments to select members of the public, the FDA hopes to provide guidance that would allow researchers to navigate the complex process of further designing thorough psychedelic drug development programs.
According to the European Pharmaceutical Review, the FDA states that “Designing clinical studies to evaluate the safety and effectiveness of psychedelic drugs is uniquely challenging and a process that requires careful consideration.”
Some of these challenges include ensuring that clinical trials and drug development programs operate within the parameters of current drug enforcement laws, as well as monitoring data collection, safety measures for therapy settings, dose regulation, and observing the long-term effects of the studies.
The new regulations ultimately aim to streamline these processes in order to pave the path for more growth in psychedelic research.
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