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The FDA Just Authorized a Pioneering Experiment in Psychedelic Neuroscience

Psychedelic biotechnology company Cybin Inc. announced on Tuesday that it has been granted Investigational New Drug authorization by the U.S. Food and Drug Administration to study the effects of ketamine on cerebral cortex hemodynamics.

While most results from psychedelic therapy and clinical trials rely on simple observation and patient self-reporting, Cybin’s previously announced partnership with neuroscience startup Kernel means that it can now utilize Kernel’s Flow headset to gather real-time quantitative data on neurological processes of psychedelic experiences.

“The word psychedelic means ‘mind-manifesting,’ but what has been missing is useful ‘mind-imaging’—the ability to dynamically trace the neural correlates of human conscious experience. Conventional neuroimaging just isn’t dynamic enough to study the psychedelic experience in the brain as it happens. This study of ketamine’s psychedelic effects while wearing headgear equipped with sensors to record brain activity could open up new frontiers of understanding,” said Dr. Alex Belser, Cybin’s Chief Clinical Officer in Tuesday’s press release. 

“Quantitatively measuring the brain within the context of a psychedelic experience is a promising frontier,” added Bryan Johnson, founder and Chief Executive Officer of Kernel. “With Kernel Flow, Cybin’s researchers can start putting numbers and quantification to subjective states of mind, including altered ones.” 

Ketamine, while technically a dissociative anesthetic, has the advantage of already being FDA approved for therapeutic use, as well as being more frequently employed in clinical settings in several forms. 

In 2016, the U.K.-based Beckley Foundation, in partnership with Imperial College London and psychedelic research luminary Robin Carhartt-Harris, made history with the first images of the brain on LSD, published in the paper ‘Neural correlates of the LSD experience revealed by multimodal neuroimaging’.

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While these results were achieved with a combination of conventional neuroimaging methods, including MEG and fMRI scans, accurate, cost-effective, and portable imaging and reporting of real-time neurological actions for psychedelic substances has the potential to significantly improve the quality and quantity of data collected by Cybin in its proprietary research. 

“We hope this feasibility study can bridge the gap of real-time quantitative data collection during psychedelic treatments to further understand the correlation of effects from these powerful molecules. The ability to access real-time brain activity data during a psychedelic experience has tremendous potential for the development of future psychedelic therapeutics,” stated Doug Drysdale, Chief Executive Officer of Cybin. 

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