There have been rapid changes when it comes to the embracing of psychedelic and hallucinogenic substances by mainstream medicine and municipalities. Marijuana, despite its longtime federal classification as a Schedule I drug, the FDA's most restricted class, is now legal in many U.S. states for medical purposes.1 States are also increasingly legalizing marijuana for recreational use, as Illinois did in 2020.2 Ketamine, a rapid acting anesthetic and established street drug sometimes called "Special K," was approved by the FDA for treating depression last year.3 And now there are signs that psilocybin, the ingredient in so-called "magic" mushrooms and also classified as a Schedule I drug,4 may soon be used medically for depression. Psilocybin has already been decriminalized in Denver,5 Oakland6 and Chicago,7 perhaps paving the way for its consideration in medical uses. Now, in the largest controlled study of psilocybin to date, conducted at Kings College London, the "magic mushroom" substance was found safe for human consumption.8 The Largest Controlled Study of PsilocybinIn 2018, the FDA authorized Compass Pathways, a life sciences firm founded in London, England, to conduct initial clinical trials with psilocybin for possible use in treatment-resistant depression.9 The Phase I trials, as they are called, were designed to test the safety of Compass Pathways' psilocybin preparation, COMP360, not its effectiveness.10 Eighty-nine healthy volunteers who did not suffer from depression were given a 10- or 25-milligram (mg) dose of psilocybin or a placebo and followed up with therapy sessions to assess for adverse effects for up to 12 weeks.11 While some minor adverse effects of a psychedelic nature occurred,12 the effects resolved swiftly within hours,13 and the participants did not suffer residual cognitive or emotional effects or hallucinatory flashbacks in the weeks after taking psilocybin, said the researchers.14 The King's College London researchers and Compass Pathways representatives announced the results at the annual meeting of the American College of Neuropsychopharmacology in December 2019. The results establish the feasibility of using psilocybin to treat chronic depression, said the researchers. The Next Step in Psilocybin TrialsHaving established COMP360 to be well tolerated, Compass is now running a Phase II b clinical trial with 216 patients diagnosed with treatment-resistant depression to determine clinical efficacy of COMP360 and the correct therapeutic dose range.15 If the Phase II b clinical trial proves successful, Phase III studies will follow, which will compare the psilocybin preparation with conventional treatments, such as antidepressants.16 In 2018, the FDA designated Compass' psilocybin treatment as a "breakthrough therapy," a vote of confidence label that can fast track a drug's review and approval and usually means the drug is thought to have benefits over existing treatments.17 In January 2020, Compass announced that the U.S. Patent and Trademark Office had granted it a patent for its synthesized investigational psilocybin formulation.18 "Too many people are suffering with treatment resistant depression," said CEO and co-founder of Compass George Goldsmith.19 "We are committed to developing innovations, such as psilocybin therapy, to address this rapidly growing problem." More Psilocybin Clinical Trials Are in ProgressThe Compass trials are not the only studies to look at the possible effects of psilocybin on human conditions. A Phase II clinical trial with 80 participants at seven different U.S. sites is also planned by the Usona Institute, a Madison, Wisconsin-based nonprofit medical research organization.20 The group says it is "dedicated to supporting and conducting preclinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines."21 Like the drug used in the Compass trials, the Usona psilocybin compound has been granted "breakthrough therapy" status by the FDA.22 Unlike the Compass trials, however, which address treatment-resistant depression, the Usona trial will examine psilocybin's use in major depressive disorder (MDD).23 Usona's director of clinical and translational research Charles Raison said that MDD represents a much larger group of sufferers with an "unmet medical need" and that "psilocybin may offer a substantial clinical improvement over existing therapies." While it is certainly true that many people suffer from sad and depressed moods, antidepressants including selective serotonin reuptake inhibitors (SSRIs) like Prozac and antipsychotics like Seroquel are not always the best option. Simple, healthy lifestyle practices can often lift depression. Antidepressant drugs may not work at all and can cause serious and paradoxical side effects. If a natural substance such as psilocybin could help people avoid these strong psychiatric drugs, it is certainly a good a thing. Here is how the British paper, Independent, casts the issue:24
A Psilocybin Clinical Trial at a Psychedelic Research CenterBefore the Compass trial, there have been several studies that support psilocybin benefits, some at Imperial College London, which launched the first formal center for psychedelic research in the world — the Imperial Centre for Psychedelic Research — in 2019.25 Imperial was the first research center to investigate the effects of psilocybin on severe depression and, using modern brain imaging, the effects of LSD on the brain.26 In a psilocybin study led by Dr. Robin Carhart-Harris, head of psychedelic research at Imperial, 20 participants who were suffering from severe depression were treated with the compound. After three months, they experienced greater antidepressant effects than from typical antidepressants and therapy, said reports.27,28
The new connectedness sensations are thought to come from deactivation of the default mode network (DMN) of the brain that is active when not focused on the outside world. Here is how Carhart-Harris' study, published in Scientific Reports, explains the DMN phenomenon apparently induced by psilocybin:30
Putting the research in laypeople's terms, Carhart-Harris says, "If you ask people who are taking SSRIs chronically, they often say 'I feel blunted.' With psilocybin therapy they say the opposite, they talk about an emotional release, a reconnection, and this key emotional center being more responsive."31 More Theories About Psilocybin EffectsThe actions behind the apparent benefits of psilocybin may involve the same neurotransmitters that traditional SSRIs are said to affect, but possibly in different ways. Says Newsweek:32
Research published in Biological Psychiatry further analyzes the apparent ability of psilocybin to dramatically change behavior:33
More Encouraging Psilocybin StudiesSmaller studies than the large Compass study have also yielded encouraging results. A 2006 study at the University of Arizona found that psilocybin helped temporarily reduce symptoms of obsessive-compulsive disorder in nine subjects.34 A 2016 study by New York University and Johns Hopkins University researchers published in the Journal of Psychopharmacology found a single dose of psilocybin decreased symptoms of anxiety in cancer patients for eight months when compared to a placebo.35 Testing psilocybin on those with eating disorders is also being planned at London's Imperial College.36 A kind of "psychedelic renaissance"37 is occurring in which hallucinogenic compounds like psilocybin are viewed as potential therapeutic agents to treat serious mental illnesses like post-traumatic stress disorder, obsessive compulsive disorder and eating disorders as well as depression and anxiety. Hopefully, psilocybin will continue to prove its safety and become more widely accepted and available for relieving the symptoms with which many suffer and freeing them from harsh medications. from http://articles.mercola.com/sites/articles/archive/2020/01/27/psilocybin-benefits.aspx
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