Federal Health Agency Clarifies Guidelines, Priorities for Psychedelic Research

November 30, 2022 13:24:19

The past couple of years have proven to be a boon for the psychedelics industry. After being outlawed decades ago and subjected to years of prohibition, psychedelics have seen a significant surge in interest among the mainstream and scientific communities.

Research and clinical studies have revealed that these drugs have the potential to treat debilitating mental health conditions such as treatment-resistant depression and eating disorders.

However, much of this research is in its infancy, mostly due to decades of federal prohibition. The consensus is that more research is needed before psychedelic therapies can be deployed for mass use by the public.

Last week, the National Institute of Mental Health revealed in a public notice that it is interested in funding psychedelic studies for the development of hallucinogenic drugs to address mental health conditions. The institute issued guidance that outlined the types of psychedelic studies it could fund, the limitations of using animal subjects in research and rules for clinical trials that involve children.

The notice also provided extra information about the psychedelic research criteria as well as the priorities for future studies on psychedelic drugs. It essentially lays out ground rules for researchers who would like to use its grant funds on psychedelic studies. The institute noted that the pharmaceutical industry has already begun evaluating whether psychedelics such as LSD, psilocybin and mescaline can be effective in treating mental illnesses such as PTSD.

The notice also listed factors such as the inaccurate predictive ability of animal studies for mental illness treatments and the psychoactive effects of psychedelics, as well as how they impact the overall psychotherapeutic process that would require careful consideration of the possible research questions animal studies could reliably answer.

The institute also stated that studies that leverage animal systems weren’t ideally suited to research the therapeutic potential of psychedelics, noting that those studies could be more effective in linking underlying mechanisms of receptor activation to adaptive changes in the brain which affected mental health. It then added that it would prioritize animal model proposals that identified brain activity patterns which were linked to mental function improvements induced by psychedelics in human subjects. Such studies could then be used to inform future research on how drug use affects the brain at the cellular, molecular and circuit-level processes in the brain.

Overall, the agency stated that animal studies should only be used to analyze how psychedelics affect brain circuits and processes. Furthermore, the report cautioned against using its new guidelines in studies that involve “pediatric populations,” because researching the effect of psychedelic use in pediatrics would also require pediatric bridging studies.

As more federal agencies get involved in funding psychedelic research, there will be more reputable data backing up the findings of private actors such as Seelos Therapeutics Inc. (NASDAQ: SEEL) in their attempts to develop medicinal formulations from these substances.

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