FDA Gives Psilocybin Clinical Studies Breakthrough Therapy Status
The FDA recognized psilocybin, the psychoactive compound in magic mushrooms, with “Breakthrough Therapy” designation for clinical trials studying its use for treatment-resistant depression by a company called Compass Pathways. The group plans to treat patients in Europe and North America over the next year in placebo-controlled studies to determine 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.
Compass Pathways, 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 acknowledgment, 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.
For more on Dr. Roland Griffith’s and other cutting edge work studying clinical treatments with psychedelic substances, check out this episode of Psychedelica:
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Brain Scans of Shamans Show Ability to Alter Consciousness Naturally
A new study is the first to investigate what occurs in an alternate state of consciousness by looking inside the brain of a shaman.
Shamanism is considered to be the most ancient form of healing and spiritual practice. While science has been studying the healing benefits of the psychoactive plants used by shamans to enter into an altered state of consciousness, there have been very few studies to look at the neurological nature of the state itself. A groundbreaking new study investigated the shamanic state of consciousness accessed without the use of psychedelics.
Carlos Tanner is a longtime student of traditional shamanism and the director of the Ayahuasca Foundation. an educational and ceremonial center in Peru. “Shamanism refers to an alternate dimension, a dimension where spirits reside, where communication is possible, where greater insights can be acquired and brought back to the waking-day life,” Tanner said. “So a shaman would be someone who can enter into a different dimension and then pull that back.”
The process by which shamans access this state is rooted in the rich tradition of what Tanner calls, a ‘science of consciousness enhancement.’
“Oftentimes, there is the term ‘ceremony’ to describe the intentional entrance into this shamanic state. So there would be a preparation where there might be rituals to essentially prepare, certain clothing might be worn, and the use of certain tools, oftentimes a musical instrument, might be used,” Tanner said.
“All of those are a beautiful science of consciousness enhancement that, I think, has been developed through the continual use of a psychotropic substance, although to a point where, in many cases, the psychotropic substance is no longer needed to enter that state because the consciousness enhancement that was provided by the psychotropic substance can be accomplished without it.”
Richard Harris Ph.D. is a researcher at the University of Michigan who conducted the recent study on the shamanic state of consciousness. Dr. Harris and his team were interested in investigating this state in its purest form, unaffected neurologically by the use of any exogenous substances. To facilitate the entrance into the altered state without the use of psychedelics, the practitioners all listened to a recording of shamanic drumming.
“So, we did a study with 24 shamanic practitioners and 24 normal, control individuals and we collected EEG data (electroencephalogram data), you know brain activity data, while each participant had their eyes closed while they were listening to classical music which was the control condition, and then while they were listening to shamanic drumming music which was the more experimental condition,” Dr. Harris said. “So, what we’re doing with the shamanic drumming, we’re using the person’s own physiology to engender the state.”
