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An Update on Medical Research and Legal Battles for Psilocybin
Tuesday, February 13, 2024

Scientists continue to research psilocybin as an alternative treatment for multiple neuropsychiatric disorders, including anxiety, depression, and PTSD. We previously highlighted this research in 2021. One area of research is psilocybin’s effectiveness in terminally ill patients, including those with cancer.

In a 2020 study, subjects with life-threatening cancer participated in psilocybin-assisted psychotherapy. The subjects were contacted over an average of 3.2-to-4.5-year period after the administration of psilocybin. 96% of participants rated the experience as the single or top five most spiritually significant experience(s) of their lives, 86% had an increase in life satisfaction or wellbeing, and 100% reported “moderate”, “strong”, or “extreme” positive behavioral change attributed to the psilocybin experience. While the study did not separate the effects of psilocybin from those of the psychotherapeutic session, the results suggest persistent, long-term effects of psilocybin-assisted psychotherapy. Encouraging results were also seen in a 2023 study, wherein cancer subjects experienced sustained improvement in symptoms of depression over eight weeks following a single treatment of psilocybin therapy. 

These recent studies build upon the positive findings reported in a 2016 double-blind, placebo controlled study. In this study, 29 cancer patients suffering from depression and anxiety received treatment with single dose psilocybin or placebo. After a 6.5 month follow-up, approximately 60-80% of the participants showed significant reductions in depression and anxiety as well as improved attitudes towards death. 

Psilocybin, however, is not approved by the FDA for treatment and is strictly banned as a Schedule I controlled substance. While there are clinical trials and studies that show reports of the positive effects, roadblocks to making psilocybin legal and rescheduling the drug to the less restrictive Schedule II category remain.

In 2022, Senators Cory Booker, D-N.J. and Rand Paul, R-Ky. proposed bipartisan legislation, the Breakthrough Therapies Act, that would permit the DEA to make findings to reclassify psilocybin as a Schedule II drug. A companion bill was also introduced in the House by Representatives Madeleine Dean, D-Pa. and Nancy Mace, R-S.C. Schedule II is reserved for drugs with currently accepted medical uses with severe restrictions. The legislation is intended to fast-track research and expand access to psilocybin under the care of a physician.

At the state level, there has been an uptick in the introduction of bills in support of the psychedelic reform movement. Bills introduced include removing psilocybin from a state’s controlled substance list (Iowa), promoting research into the therapeutical potential of psychedelics (Missouri), and legalizing the possession and use of psychedelics by adults 21 and older (New Hampshire). There are also additional psychedelic reform efforts in progress in multiple other states, including, but not limited to, North Carolina, Arizona, California, Colorado, Illinois, Massachusetts, Minnesota, Montana, New Jersey, and Oregon.

We will continue evaluate clinical studies on psilocybin and monitor developments in pending legislation.

This article was authored by Lindsey Snyder, Legal Nurse Consultant.

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