FDA, Penicillin, Depression discussed on Raw Talk Podcast
This? Did you expect after treatment for this? And would you repeat the experience and and volunteers? Spine large indicated very challenging experiences. Some individuals indicated experiences that were very intense, but very brief others indicated they had experiences that were moderate to severe intensity, but very long duration. Roughly ten percent of individuals who completed the study indicated that they. Had exposed themselves or others to harm a smaller percentage of individuals did seek medical attention for experiences during their bad trip, a number of people also did seek psychological psychiatric treatment after the experience or negative affect during Zayed's. Or depression or panicker or other types of negative experiences that persisted beyond the effects of the drug that they attributed to the drug and them the curious aspect of this many people also indicate that they would repeat the experience with all of the aspects of the bad trip involves because there are a number of people who did feel that they learned from the experience, but some of that could be. Hey, if I could survive, Zadok survive anything right like almost like a crucible, and the question then becomes well. Is it necessary is really necessary to have that that crucible experience? In order to grow, you know maybe maybe not, but what was clear from the surveys that there are really quite myriad of of challenges risks for self administering these drugs outside of controlled set. Now that we've heard both sides. Where do we go from here? We asked Ulmer guests the same question. The. Question of accessibility has to be preempted by the right discussion of therapeutic misconceptions, so to talk about the accessibility of these therapies. We have to acknowledge that they're not approved therapies yet. We have to acknowledge that while there's some really exciting preliminary studies, a ton of press built up around this while while everybody is, you know promising that these drugs are going to fundamentally change. That might be true, but it hasn't happened yet, and and we haven't had large controlled trials to determine their the real gold standard of efficacy in any disorder, whatsoever and we and we haven't really mapped out in fine detail limits of the efficacy and unlimited safety trucks. We have some preliminary ideas, but there's a lot we don't know and and frankly I like to say that. If you give the wrong person as a wrong time, a large dose of penicillin remarks is selling. You'll kill them right there, so people who are allergic to this, but if you give the right person, the right dose of Penicillin, the right contacts, you may save their life. That, we need to make such drastic statement about sex dialects, but at the same principle holds. This is going to work for some people, and it's simply not going to work for other people. We shouldn't expect that. PSYCHEDELIC drugs will be appropriate for everyone. In one of the things we need to understand better before this. It's rolled out as an approved therapeutic as well. What are the boundaries of that? Can we get any sense of of? WHO This drug should not be given to in in possibly why so? When you're when when a person signs up for a research study with PSYCHEDELIC drug, they have to understand that. The, still research and it's still research because we're still trying to really come definitive, and whether we think a second dose worked for one another, so that one of the reasons that we're running so many. Proof of concept or initial pilot studies in the Center for second consciousness research here at Hopkins is because we WANNA to start to begin to kind of map, the boundaries of space like what what works and what doesn't so within that context, and with the clear understanding that these drugs are still preliminary stages of research accessibility to research studies is really the limit to accessibility to. To the substances, and so as as I kind of mentioned in someone alluded to. There are a number of studies popping up around the world. Really that will be a potential possibility for people to inquire about an in screen in and try to enroll to into but really research context is the only approved legal way to to access these these in therapeutic context moment. One of the best ways to figure out where and what and how and win. In terms of accessibility is to go to a website called clinical trials dot. Gov this is a website that all federally funded research in the United States needs to to register ad. It's become the gold standard for pre registration of a research study. So that means that when on a person that's going to want. An investigator at an institution is going to plan in initialized study. They put the study. They put the whole plan up on clinical trials, so they can say in a public form here. Here's what we're going to try to do. Here's what we think. We're. GonNa find. So that, when the studies over people can look back at that record, and then they can compare it to what was found and they can. They can determine whether people were essentially doing what they said in really sticking to the original plan, but it also comes a recruitment tool, so you can go on there, and you can search for a suicide, or you can search for LSD. Search for depression or search for alcohol, disorder or PTSD whatever and you can find all of the active and recruiting studies. In the world since many many research institutions around the world adopted this also gold standard for reporting what they plan to study so. The best answer for accessibility is checkout. Clinical trials dot, Gov see anything near you or accessible to you, but it's really limited to research studies. For the reason that. Were still in the in the nascent stages of understanding how and when and why and where these drugs may work, the exciting part in the promising part is that there are now two separate organizations who are working with both the FDA in Ama to design duct face three. Registration trials which are you know? Trials with the express purpose of? Coming into to a determination of whether or not, there's sufficient efficacy or evidence of of drug to train in -cation that they can be approved for medical use and these trials to take a number of years to complete. Once. They're complete. They will likely take a number of years to pour over to have analyzed to discussions with the FDA and a, and if these trials either of these trials is successful, that may lead to the approval of suicide. For the treatment of some form of crashes once that happens. There are a number of other players in the field who who are thinking now about how to come up with the infrastructure role. These medicines out. May Happen within the context of specific Sills Evans. Therapy clinics than they happen in some other contexts, but. I'd say that reasonable guess what timeline might be you know within ten years we may see the approval of. I, some treatments, some form of depression, and some people think that's a really conservative estimate. Some people some liberal estimate who knows? So one of.