RE:Big Pharma A report was published in the Journal of Psychopharmacology detailing two small studies that noted the ingredient in "magic mushrooms" - psilocybin - can reverse the feeling of "existential distress" that patients often feel after being treated for cancer. Reportedly, cancer can leave patients with this type of psychiatric disorder, feeling that life has no meaning. Typical treatments such as antidepressants may not be effective. However, use of a single dose of synthetic psilocybin reversed the distress felt by the patients and was a long-term effect. Some advanced cancer patients described the effect from the drug as if "the cloud of doom seemed to lift."
Two additional studies using psilocybin were completed: one at New York University (NYU) Langone Medical Center in New York City and one at Johns Hopkins Medical School in Baltimore. For both studies, trained monitors were with patients as they experienced the effects of the drug, which can lead to hallucinations.
- In the NYU study, 29 patients with advanced cancer were given either a single dose of psilocybin or the B vitamin known as niacin, both in conjunction with psychotherapy. After seven weeks, the patients switched treatments (a cross-over study). In 60% to 80% of the patients receiving psilocybin, a relief from distress occurred rapidly and lasted over six months. The long-term effect was evaluated by researchers looking at test scores for depression and anxiety.
- In the Johns Hopkins study, researchers treated 51 adults with advanced cancer with a small dose of psilocybin followed five weeks later with a higher dose, with a 6-month follow-up. As with the NYU study, about 80% of participants experienced clinically significant relief from their anxiety and depression that lasted up to six months.
At the Center for Psychedelic and Consciousness Research at Johns Hopkins University in Baltimore, Maryland, researchers are focusing on how psychedelics affect behavior, mood, cognition, brain function, and biological markers of health. This research group was the first to obtain U.S. regulatory approval to continue research with psychedelics in healthy volunteers.
Additional studies with psilocybin are expected, and one is comparing the chemical against a leading traditional antidepressant.
As reported by Johns Hopkins, upcoming studies will evaluate the use of psilocybin as a new therapy for opioid addiction, Alzheimer's disease, post-traumatic stress disorder (PTSD), post-treatment Lyme disease syndrome (formerly known as chronic Lyme disease), anorexia nervosa and alcohol use in people with major depression. A focus on precision medicine tailored to the individual patient is expected.
In November 2019, the FDA designated psilocybin therapy as a "breakthrough therapy" for depression to the Usona Institute, an action the agency uses to speed up development and review of investigational drugs. Breakthrough therapies are expected to provide a major improvement over currently available agents for an unmet medical need.
Usona’s PSIL201 psilocybin U.S. clinical trial is a Phase 2 study evaluating psilocybin as a treatment for Major Depressive Disorder (MDD). This research will use a randomized, double-blind, placebo-controlled study design to measure the antidepressant effects of a single dose of psilocybin in 80 patients between 21 to 65 years of age with MDD. According to the manufacturer, "psilocybin potentially offers a novel paradigm in which a short-acting compound imparts profound alterations in consciousness and could enable long-term remission of depressive symptoms."