Are We Finally Reawakening to the Profound Healing Properties of Psychedelics?
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So, we’ve done that. And we’ve even got DEA and an Institutional Review Board to sign off for that, and we’ve already treated the first therapist, subject, who’s come over from Israel, and we’ve got another one coming in December and another one in January. So we can take people from all over the world and train them in this way.
So, what we’ve done, then, is also identified the patient population that we most want to work with, and that’s veterans. Or, women survivors of childhood sexual abuse, and adult rape and assault. So, these are patient populations that people are sympathetic with. They have post-traumatic stress disorder. It’s a national crisis. And MDMA is ideal for that. So we’ve picked MDMA for PTSD.
We’ve completed the first study that was published in the Journal of Psychopharmacology, a small pilot study with 20 subjects. And what we showed is that people who had post-traumatic stress disorder for an average of over 20 years, and who were treatment-resistant, had failed on pharmacotherapy and on psychotherapy, that, after our treatment with MDMA-assisted psychotherapy, over 80 percent of them no longer had PTSD. So it’s a remarkable situation.
And, what we’ve just done, and what I was working on the plane coming here, and yesterday a little bit, is that we have now done a long-term follow-up study of the people in our initial study. So, the results that I just proposed to you were after two months.
And, what we’ve now done is an average of 41 months … after almost three and a half years … we re-interviewed these people. We got 16 out of the 19 who got MDMA to fill out the CAPS, the Clinician-Administered PTSD Scale. And what we’ve shown is that, on average, the treatment benefits have sustained over time. They’ve actually gotten slightly better.
But something fundamental changes when they have gone through this therapy, and it lasts. Now, a few of these people have relapsed, and have PTSD again. You can’t prevent people from having lives that present them with trauma and stressors. So we’ve gone back to the FDA, and we have a new protocol now, where we can give one MDMA session open label … meaning that it’s not a double-blind study … to people who have relapsed in our study. So we’re thinking that we’ll be able to sort of help them back with just one session. That’s what we’re going to investigate.
We’ve conducted a study in Switzerland that we’re working on the results right now, and the results there were about half as powerful as the results in the U.S. We’re trying to figure out all the reasons why, but it’s still better than Zoloft and Paxil, the drugs that are approved. So that, even that study is enough to move it through the system.
And now we’re doing a study in the United States. The first study was mostly women survivors of childhood sexual abuse and rape. Now we’re working entirely with veterans, mostly from Iraq and Afghanistan, and a few from Vietnam. And we’re getting excellent results there.
And we’re about to start a study sometime soon in Canada. We’ve been working three and a half years to get permission there. We’ve got another study in the U.S. that we’re starting [...] And so, we’re going to be pairing, in the male/female team, one will be a trained therapist. The other will be an intern, who’s learning to be a psychologist or a psychiatrist or a social worker or a nurse. And they have to do all these free hours. So we’re going to give them credit in working on their free hours.