Summary: MD Magazine provides a brief history of psychedelics in psychiatry and psychotherapy, highlighting MAPS’ MDMA-assisted psychotherapy for PTSD clinical trials receiving Breakthrough Therapy Designation from the FDA. “They are really now on the edge of starting the types of larger clinical trials that, if they’re successful, would actually get these agents – would get that agent changed from a schedule 1, which is illegal, to something that could be carefully prescribed under a set of circumstances in the United States,” explains Charles L. Raison, M.D., of MD Magazine.
Originally appearing here.
In many ways psychiatry – biologic psychiatry or pharmacologic psychiatry – started with psychedelics.
There were about 1,000 studies done of psychedelics before they were classified as schedule 1 around 1970. There’s a huge old literature, looking at psychedelics, and looking at them in 2 different ways.
One, early on, there was this thought that maybe they were good models for psychosis. Maybe they are. But there were also a lot of studies looking at them as therapeutics agents and interestingly, a lot of those studies focused on alcoholism and people dying of cancer.
Back then studies weren’t done the way they are now. They were much more descriptive, they weren’t as rigorous. But the results were pretty consistent that these things often seem to help people immensely.
Many people that had drinking problems found that it helped them stay abstinent. People with cancer found that it helped give them acceptance of mortality.
The field pretty much stopped in 1970 except for a few people that sort of kept a couple lights on and did some animal studies. And then in the 1990s it very, very gradually began to gain ground again. A guy named Rick Strassman in New Mexico began to do some studies with a molecule called DMT.
But it was really around 2000 that a group of people got together and began to privately fund this research – try to get back into it. And really the father of this work in the United States was a man named Roland Griffiths at Hopkins. They began to do very small, careful studies where they exposed, in the beginning, normal volunteers to various doses of psilocybin. Psilocybin is the active ingredient in “magic mushrooms,” right, it’s a psychedelic, a classic psychedelic.
It’s a serotonin 5HD2 agonist and it produces these very powerful emotional sort of hallucinogenic experiences. They began to notice that these experiences seemed to have long term impacts on people. People – even normal folks – seemed to feel better afterwards. They seemed to begin to take better care of themselves, and there was a study suggesting that it changed their personalities in some ways – that a year and a half after an exposure to the psilocybin that people were sort of more open, and less sort of closed down into their personalities.
Over time this work led to the idea that it should be tried for clinical conditions, and so NYU and Hopkins were really the 2 world leaders in looking at – re-looking at this question of whether or not a psychedelic, in this case psilocybin – might be useful for people who are very anxious and depressed about having cancer.
There were 2 studies done. They were both randomized, placebo-controlled, double-blind studies where people were blindly given either an active psilocybin or different placebos, but each study had a placebo. They got one treatment, and then they were followed for about a month and a half, and then they did what’s called a crossover. So the people who got psilocybin got placebo and vice versa, and then they followed them for another 6 months.
The results were amazing. One treatment just completely reduced depression and anxiety scores. They took people from very clinical to being in remission. No other treatment, and 6 months later, you know, people are 60-70% are in complete remission from a single treatment.
Similar results have been found in a small study in the UK, and this has just launched this whole interest in whether or not this may be an absolutely novel treatment modality where you expose people – instead of taking a medicine every day you expose them to one treatment that has this powerful psychological effect that then produces this long-term change.
The other group that is actually really at the forefront in terms of pursuing FDA approval for these agents is something called the Multidisciplinary Association for Psychedelic Studies, or MAPS. They’ve spent 30 years very, very intelligently and cautiously building up a rigorous research program looking at MDMA, which is on the street known as ecstasy.
It’s not quite a psychedelic, it can have psychedelic effects, it’s sometimes called an empathogen, it induces in most people very, very positive emotional states where you feel very interconnected with people. Now, a number of years ago MAPS began working on the idea that this may be of value for PTSD. They’ve now done a number of small studies where they have 12 week psychotherapy program that includes 3 MDMA sessions.
They’re finding the same things that their investigators found with psilocybin, which is that if you do this therapy program, a huge percentage of people months and months later are essentially in remission from their post traumatic stress disorder symptoms.
So they’ve just gotten what’s called breakthrough therapy designation from the FDA. They are really now on the edge of starting the types of larger clinical trials that, if they’re successful, would actually get these agents – would get that agent changed from a schedule 1, which is illegal, to something that could be carefully prescribed under a set of circumstances in the United States.