Depression is among the most researched indications for psilocybin therapy. As Healthline previously reported last year, psilocybin therapy was given “breakthrough therapy” designation (a review fast track) by the FDA for the treatment of depression.
The Usona Institute, a psychedelic research center, is currently in the planning stages of their phase III trial, which will likely begin this year.
Smoking Cessation and Other Addictions
In a small pilot study from Johns Hopkins University, researchers found that psilocybin therapy significantly improved abstaining from smoking over a 12-month follow-up period.
Matthew Johnson, PhD, associate professor of psychiatry and behavioral sciences at Johns Hopkins University School of Medicine, led that study.
According to him, psilocybin also has potential to treat other substance use disorders, including alcohol and cocaine addiction.
“The general idea is that the nature of these disorders is a narrowed mental and behavioral repertoire,” he told Healthline. “So, [psilocybin] in well-orchestrated sessions [has] the ability to essentially shake someone out of their routine to give a glimpse of a larger picture and create a mental plasticity with which people can step outside of those problems.”
In fact, a small open-label study on psilocybin and alcohol dependence found that following treatment, both drinking and heavy drinking declined.
Researchers in Alabama are also currently conducting trials for psilocybin therapy on cocaine addiction.
Cancer-related Psychological Distress
“There’ve been some promising preliminary results in such areas such as the treatment of overwhelming existential anxiety in people who are facing the end of life,who have diagnoses of advanced-stage cancer,” Dr. Charles Grob, professor of psychiatry at the UCLA David Geffen School of Medicine, told Healthline.
Grob, who’s also affiliated with the Heffter Research Institute, has studied psilocybin extensively and authored research on the subject, including, among other things, a pilot study in 2011 on psilocybin treatment for anxiety in people with cancer.
A randomized, double-blind trial from Johns Hopkins in 2016 found that a single dose of psilocybin substantially improved quality of life and decreased depression and anxiety in people with life-threatening cancer diagnoses.
“The thing that we have the most evidence for is cancer-related depression and anxiety. That seems really strong, and I’d be surprised if those results didn’t hold up,” Johnson said, who was part of that research.
Will Psilocybin Ever Be Approved by the FDA?
Despite promising research, there’s no realistic timeline for when, or if, psilocybin will ever be approved by the FDA.
All three experts interviewed by Healthline stress that the substance can be dangerous for a host of different reasons if administered incorrectly.
“It will only be administered in a clinic by specially trained and certified therapists, physicians. It’s never gonna be available out on the street where people can sell it or take too much, or take too many of their pills from a prescription,” Greer said.
Psilocybin affects the cardiovascular system and can lead to increased blood pressure or irregular heartbeat.
It also has the potential to cause serious and permanent psychological problems.
“Psilocybin is a lot more psychologically dangerous than cannabis, and it’s especially dangerous for a small percentage of the population who have had an episode of psychosis or mania, manic episode, or even, say, a close family member whose had those problems, because it can trigger a psychosis or manic episode in a person who is vulnerable to that,” Greer said.
And there’s always the chance of a “bad trip,” or negative experience while taking the drug. There are rare but documented cases of individuals jumping to their deaths or otherwise behaving erratically in such a way that endangers themselves or those around them.
As Grob puts it: “Taken in uncontrolled settings, honestly, all bets are off. You don’t know what you’re gonna get.”
But psilocybin therapy is nothing like taking shrooms at a party. It’s meant to be a meticulously controlled environment to ensure that nothing unexpected happens.
“You name the risk, and we have really good mechanisms for addressing it,” Johnson said.
He further explained, “There are risks, but they are dramatically reduced in medical research and potentially in approved medical use, and I would argue that those risks and our ability to address them fairs very reasonably compared to many procedures that are routinely used in medicine.”
Nonetheless, the safety and efficacy of psilocybin treatment must still be satisfactorily proved to the FDA, which, thus far, it has not.
While some are optimistic that psilocybin may follow in the footsteps of MDMA therapy and potentially even have approval within the next 5 to 10 years, its pathway is far from clear and very uncertain.
When asked if there’s a realistic timeline for approval, Grob told Healthline, “I don’t think so. Even though the research we’re talking about has by and large been very positive and encouraging, there hasn’t been enough research.”
“There needs to be more FDA-approved clinical research with psychedelics,” he added, “exploring both how to optimize their therapeutic potential but also trying to get a better understanding of the range of medical effects, which may be problematic… There’s still some questions that need to be answered.”
Written by Gigen Mammoser on February 12, 2019