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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Are Supernatural Entities Encountered on DMT Healing People?
Could supernatural entities encountered during a psychedelic trip be responsible for the dramatic psychological healing that many reports? New research seeks to find out.
DMT or N, N-Dimethyltryptamine is widely considered the Earth’s most powerful hallucinogen. It is the latest psychedelic to be clinically studied for its potential to treat mental health issues like major depression and PTSD.
One frequently occurring phenomenon of the DMT trip researchers are particularly interested in is the appearance of entities whom experiencers often credit with the healing they receive.
Jay Waxenberg is the director of the DMTx program at the Center for Medicinal Mindfulness. Based in Boulder, CO, it was one of the first centers to offer legal psychedelic therapy in the U.S.
“The entities are really this unique aspect of DMT and they play different roles for different people in that space. What’s very common is, one, you’re going to encounter one of these things, and two, that you’re going to feel like they’re giving you some piece of information to take back to the regular consensus reality. Also, that they are benevolent — lots of love and kindness, these are very common elements for the entities — and we have linguistic models to kind of relate to those spaces, whether they’re elves or imps or fairies, they could be angels, bodhisattvas, aliens, interdimensional beings — these are kind of like the things that people will come back and say ‘[T]hat’s kind of what that felt like, that’s kind of what that thing is.’”
The groundwork for current research on the topic was laid by Dr. Rick Strassman- a psychiatrist and pioneering psychedelic researcher who first described these entities in his book ”DMT: the Spirit Molecule.”
“The beings were beneficent, they did healing, they gave advice, some predicted or showed volunteers the future, some were examining the volunteers. But one of the hallmarks of the interaction was the strength of those beings,” Strassman said.
A recent study surveyed 2,500 individuals who encountered entities after taking DMT. The researchers found that “[T]he experiences were rated as among the most meaningful, spiritual, and psychologically insightful lifetime experiences, with persisting positive changes in life satisfaction, purpose and meaning attributed to the experiences.”
