Psychedelic Mushroom Trials Approved By FDA

By Spencer Kellogg | @TheNewTreasury

COMPASS Pathways, a mental health startup funded by tech pioneer Peter Thiel, has quietly gained approval from the FDA to begin phase IIb clinical trials utilizing psilocybin mushrooms as a potential treatment for depression. More commonly referred to as ‘psychedelic’ or ‘magic’ mushrooms, psilocybin fungus has been studied previously for its physical and mental properties but has recently seen a renewed resurgence in interest and research.

The trial will feature 216 patients spanning across countries in Europe and North America throughout up to 15 different research sites. The therapy will combine an active dose of the mushroom along with psychological support from mental health practitioners. So far, the testing has seen positive results as a safe treatment for depression in the U.K. George Goldsmith, Chairman of COMPASS Pathways pointed to the more than 100 million people globally that suffer from mental illness as a need and reason for new research.

The scientific team that COMPASS has assembled is impressive and includes both Tom Insel and David Nutt as board advisors and a steady supply of venture capital from libertarian-leaning entrepreneurs like Thiel. Limited research in the field of using psychedelics to treat depression has already produced positive results that could radically change the healthcare options for those that are struggling with mental illness or terminally ill. In cancer patients, psychedelic mushrooms have been shown to relieve anxiety and stress and in Denver, activists have advocated for the drug as an end-of-life treatment.

In a Business Insider article from 2017, a patient named Martin told how his participation in an experimental psilocybin trial helped him cope with cancer that had plagued him for years. “With the psilocybin, you get an appreciation — it’s out of time — of well-being, of simply being alive and a witness to life and to everything and to the mystery itself.” Martin went on to explain how taking psychedelic mushrooms had made him more cognizant of how to live present in social situations. He suggested that his experience for a few hours with psilocybin had created a sea change in his outlook on life.

This is most likely because psychedelic drugs operate as a sort of low key “reboot” in for users, resetting tension and anxiety that exists in a person’s everyday experience. Researchers at Johns Hopkins and NYU confirmed this very hypothesis when they found that ‘a single dose of psilocybin decreased anxiety in cancer patients for eight months when compared to a placebo.’ Other scientists have found that using psilocybin-assisted psychotherapy can help curb cigarette smoking.

Mushrooms aren’t the only drug that is being hailed as a possible new therapeutical avenue for suffering patients. Ecstasy, which has been used as an experimental substance in couple therapy for years, is now also being trialed to help treat veterans with PTSD. COMPASS Pathways, which has already produced over 20,000 doses of magic mushrooms, is hopeful that these new treatments will become available in the near future and have suggested that we could see psychedelics being used as legal therapy as early as 2027.

In recent years, microdosing psychedelics as a way to improve physical stamina, mental acuity, and overall happiness has become vogue in intellectual and celebrity circles. Joe Rogan has spoken extensively about the benefits of eating magic mushrooms and Janet Chang wrote a beautiful essay on how a year of microdosing helped different aspects of her life. In a 2016 research paper released by a team of scientists at John Hopkins, the conclusion read simply: “In conjunction with psychotherapy, single moderate-dose psilocybin produced rapid, robust and enduring anxiolytic and antidepressant effects in patients with cancer-related psychological distress.”

About COMPASS Pathways

COMPASS Pathways is a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health

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