The FDA recognized psilocybin, the psychoactive compound in magic mushrooms, with a “Breakthrough Therapy” designation for clinical trials studying its use for treatment-resistant depression. The group plans to treat patients in Europe and North America over the next year in placebo-controlled studies to determine the proper dosage and treatment methods.
Since hallucinogenic drugs were given Schedule I designation in 1966, psilocin and psilocybin have been villainized by the media and politicians who claim it has a high potential for abuse and no medical application. But recent studies from esteemed research institutions, including Johns Hopkins and London’s Imperial College, have helped ease misconceptions and stigma surrounding the drug, and now government regulatory bodies are seeing its potential.
A life sciences company founded in 2016 whose focus is to “accelerate patient access to evidence-based innovation in mental health,” specifically through research with psilocybin, was given the go-ahead by the FDA back in August, but the recent designation was an unexpected acknowledgement, according to some of those involved in its research.
According to the FDA, “Breakthrough Therapy” means it reviewed the findings of researchers it granted use of the drug to and viewed their results as:
“Preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”
Once this designation is given, the FDA expedites the development and review of the drug, hopefully allowing medical professionals to soon begin implementing it as a legal, viable treatment and eventually change the scheduling of the drug.
Dr. Roland Griffiths, one of the foremost researchers in government-sanctioned studies of hallucinogenic drugs, told Inverse he’s hopeful the regulatory approval will change, though he doesn’t envision it becoming available from a pharmacy anytime soon, if ever.
Griffiths and his colleagues have mostly advocated for its use in controlled settings with guided sessions from a trained psychologist. He’s also stated he believes it can be a dangerous drug when taken by those with certain pre-existing mental illnesses, notably schizophrenia.
But now that studies have shown psilocybin to act as a “reset mechanism” in the brain for those suffering from severe forms of depression, this latest recognition from the FDA may allow psilocybin treatment to become available for those desperately needing it. This breakthrough may also pave the way for FDA trials with other psychedelic substances, such as LSD, currently studied by Griffiths and others in his field.
Psilocybin is a hallucinogen that works by activating serotonin receptors, most often in the prefrontal cortex. This part of the brain affects mood, cognition, and perception.
Hallucinogens work in other regions of the brain that regulate arousal and panic responses. Psilocybin does not always cause active visual or auditory hallucinations. Instead, it distorts how some people that use the drug perceive objects and people already in their environment.
The quantity of the drug, past experiences, and expectations of how the experience will take shape can all impact the effects of psilocybin.
After the gut ingests and absorbs psilocybin, the body converts it to psilocybin. The hallucinogenic effects of psilocybin usually occur within 30 minutes of ingestion and last between 4 and 6 hours.
In some individuals, the changes in sensory perception and thought patterns can last for several days
Mushrooms containing psilocybin are small and usually brown or tan. In the wild, people often mistake mushrooms containing psilocybin for any number of other mushrooms that are poisonous.
People usually consume psilocybin as a brewed tea or prepare it with a food item to mask its bitter taste. Manufacturers also crush dried mushrooms into a powder and prepare them in capsule form. Some people who consume these mushrooms cover them with chocolate.
The potency of a mushroom depends on:
- the species
- origin
- growing conditions
- harvest period
- whether a person eats them fresh or dried
The amount of active ingredients in dried mushrooms is about 10 times higher than the amount found in their fresh counterparts.
Extent of use
In the U.S., the National Survey on Drug Use and Health (NSDUH) suggested that, between 2009 and 2015, around 8.5 per cent of people reported using psilocybin at some point in their life.
When people use psilocybin, it is usually at dance clubs or in select groups of people seeking a transcendent spiritual experience.
In medical settings, doctors have tested psilocybin for use in treating cluster headaches, end-stage cancer anxiety, depression, and other anxiety disorders.
However, scientists have questioned its effectiveness and safety as a therapeutic measure.