Are We Finally Reawakening to the Profound Healing Properties of Psychedelics?
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So, there’s a series of questions that we need to address in these Phase 2 studies. These are all small pilot studies. And then, in a couple years, we’re going to have what’s called the end of Phase 2 meeting with FDA, and that’s where you present your design for the large-scale Phase 3 studies. And if they agree with that, then you march that out, and that takes another five, six years. And that’ll probably be about 600 subjects, we’re guessing.
We have to figure out the magnitude and the variance of the effect in order to size these studies. We have to figure out if the cause of PTSD is related to our treatment, which we think it’s not. We have to figure out how to train therapists. We have to figure out how to do a double-blind study. That’s one of the biggest issues that we’re trying to figure out. And so, that’s where these Phase 2 pilot studies are going. So our main focus is MDMA, PTSD.
We’ve just completed the first study with LSD in over 35 years, in Switzerland, which was LSD for end-of-life. And we’ve gotten good results. Eleven out of those 12 people had never done LSD before. And, so we’ve shown safety. And we didn’t get significant results, but we got a good trend toward safety.
And this is the very last thing. We’re also doing work with Ibogaine and ayahuascain the treatment of addiction. Observational studies. And we’ve tried to do a marijuana post-traumatic stress disorder We have FDA approval. And NIDA, the National Institute on Drug Abuse, that has the monopoly on the marijuana, won’t sell it to us. So we’re still trying to work through that.
Amanda Feilding: Hello. My name’s Amanda Feilding. I’m the director of the Beckley Foundation, which is a charitable foundation I set up in 1998, with the purpose of discovering what is the neurophysiological explanation of changes in consciousness, and how, by increasing our understanding of how they work, can we use them to the benefit of ourselves and mankind. It’s a very fascinating topic, and I also concentrate on how to change global drug policy. But, of the two, I find the science very much more exciting.
So, my first move was to get 10 very distinguished scientists to come onto my advisory board. And, since then, I’ve worked in two different directions. One is in collaborating and initiating clinical study. And the most exciting one happening at present is with Roland Griffiths and his wonderful team at Johns Hopkins, which is a study, the first study, to see how, with the aid of a psychedelic … i.e., in this case, psilocybin … treatment therapy can help the overcoming of an intractable addiction. And that is, in this case, nicotine. And so far, four patients have completed the research, and all four are nicotine-free. Two of them one year later, and the other two six months later.
Now, this is a small study, without sufficient double-blind placebo. So, it’s an indication more than a strong scientific study. But the indication is quite excellent, because no addiction treatment has ever got such a high success rate. And we are hoping, by completing this study, then to go on to a much more advanced and expensive study, where we have a double-blind.
So, on the other side, my interest is in discovering how these substances work. Because I think that’s the best way of overcoming the taboo on this category of substances, and also knowing with sureness why they are useful in the different areas. And, for many years, I looked for suitable scientists to collaborate with, and had one or two efforts, which, sadly, didn’t produce fruit.