A matter of months after possession of psilocybin mushrooms was decriminalized in Denver, Colorado and Oakland, California, another major step has been made in their road to public accessibility. The U.S. Food and Drug Administration (FDA) has given the entheogenic a “Breakthrough Treatment” designation, opening doors for further research into the substance’s benefits for sufferers of major depressive disorder (MDD), better known simply as depression.
The designation acknowledges the strong preliminary evidence showing psilocybin’s treatment potential for depression and offers “intensive guidance” from the FDA. It’s the second time in just over a year that psilocybin was granted such a status; the last time was in October of 2018 after COMPASS Pathways determined the compound to aid those suffering from treatment-resistant depression.
Nonprofit research organization Usona Institute recently commenced a Phase 2 clinical trial in which 80 people will take a single, one-time dose of psilocybin orally. The purpose of the trial will be to determine how effectively the compound treats depression.
Researchers have been quick to point out that those with depression should not self-medicate with psilocybin as it is easy to confuse mushroom strains and difficult to determine proper dosage. Even in decriminalized cities, psilocybin mushrooms are still technically illegal by state and federal law throughout the U.S.
H/T: Popular Science