Ohio State professor: Psychedelic therapy likely to get FDA approval – The Columbus Dispatch

Buckeyes may be synonymous with Ohio State University, but it’s magic mushrooms being studied by researchers there that could unlock new treatments for mental illnesses within the next few years.
Psilocybin, the naturally occuring psychedelic component of magic mushrooms, and a synthetic version of it coupled with intensive therapy is in clinical trials at Ohio State, said Dr. Alan Davis, an associate professor and director of the Center for Psychedelic Drug Research and Education at the university.
The trials, Davis said, have the potential to revolutionize the way doctors treat things like depression and post-traumatic stress disorder (PTSD) if approved by the federal Food and Drug Administration.
Davis is set to give a free public lecture on the use of psychedelics to treat depression at 4 p.m. on Feb. 26 at Gravity Events Center, 480 W Broad St., in Columbus’ Franklinton neighborhood.
But before the talk, Davis spoke with The Dispatch about where the research trials stand and the potential for treatment to become available in the near future. The following interview with Davis has been edited for length and clarity.
A: These are very high doses that we are giving with two trained professionals in medically observed circumstances. We have 13 hours of therapy that’s associated with these treatments. …
You have this high dose of a psychedelic, and then we have therapy in the days and weeks after each of the dosing sessions in order to help people integrate these experiences that they’ve had under the psychedelic effect into their daily life. …
We know from some studies that have been completed that there are different parts of the brain that psilocybin affects.
Some people describe it as like a reset. When you introduce psilocybin into the brain, what you see is that different parts of the brain might start communicating in new ways.
A: We’re actually in the final stages of this process.
It is currently under Phase 3 trials. From an FDA standpoint, you have to go through Phase 1, 2 and 3 trials before you can apply for FDA approval. This is currently in the last stage of Phase 3 trials.
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If (those trials are) successful and if the FDA agrees with the success of those studies, then the FDA could be making a determination about psilocybin therapy being available to the public within the next two to three years. …
We believe that there’s already enough writing on the wall about the data around this topic, and it’s a very strong likelihood that it’s going to be approved by the FDA.
A: This is an emerging area because there’s a huge unmet need by our current treatment system and people with depression.
Often — even if they have access to treatment — those who do often cycle through a variety of medications, sometimes with little to no effect.
Even if medications work, they often come with side effects that are unacceptable and intolerable to people. … Some treatments don’t work for people, even if they’ve tried multiple things. People need more options and psychedelic therapy might be one of those options. …
Once it’s approved, we need to start training not only clinicians and providers to be able to conduct these treatments, but we also need to start training and helping to educate communities and people and families who might have loved ones get these treatments. …
Those folks are going to need to have a better understanding about what psychedelics are and accurate science and data that’s not been misreported by government. and policy.
A: This is something that people get one to two doses of this substance under very controlled psychological and medical infrastructure, and it’s done in the context of really deep thoughtful psychotherapy.
So, yes, people have a drug experience, but I would think of that question as more of a question that comes from the system that we currently live in that stigmatizes substance use and getting high as somehow negative.
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Actually, substances have been used for thousands of years … Psychoactive drugs have been used to guide spiritual exploration and psycho spiritual and personal development and rites of passage.
It’s only been the last 100 years, and really the last 50 of which in particular, where we have changed the cultural significance of psychoactive substance experiences and started pathologizing it.
A: The good news is that (in order to) be able to launch clinical trials here, we’ve already had those conversations.
I actually had to go all the way through having meetings with Gov. Mike DeWine to educate him on the topic of psychedelic therapy.
OSU wasn’t going to jeopardize their standing as a university here in Ohio for this controversial work unless we had that buy in. So the good news is we have buy in from a lot of different levels of government here in Ohio.
Surprisingly as well, it seems to have less of a political divide than you might think because folks on both sides of the political aisle view this as something that has a potential to positively affect people that they care about.
We’re definitely going to deal with the stigma of drug policy and how that’s unfortunately led to a lot of misinformation about psychedelic substances. But hopefully, once we start getting approval of things in the next couple of years, that will slowly start to change that narrative.
mfilby@dispatch.com
@MaxFilby

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