We don’t need “belief”; we need evidence, and when it comes to psilocybin there hasn’t yet been a single truly robust RCT. Instead we have an array of manipulated studies, failure to report adverse effects, carpet sweeping of abuse, and proliferation of shamanistic woo purporting to be therapy. It’s a putrid mess.
I just wish I didn’t have to say it so often working in the healthcare and healthtech space. Maybe I should get a tattoo of it to show people when it needs to be said.
Well reasoned. One potential counterargument to parts of this could be that more established therapeutic approaches might not be appropriate in the context of MDMA med sessions. But no one is doing research that varies the psychotherapy instead of the drug (in psychedelics trials), probably because who on earth would sponsor such a thing?
Yeah I wish Lykos had used an established technique like Prolonged exposure and added more preparation and integration as well as psychoeducational elements but had a consistent core. If you look the manual which owen links to it really is a hodgepodge of approaches and seems to be really muddying the waters. They mention PE could be incorporated but also list a bunch of other techniques that could be tried. If you doing a trial to get a specific drug/therapy combo approved I think you need a lot more standardization than what is in that manual
Barbara Rothbaum at Emory is doing this. She is a national authority on PE, she wrote the book. MAPS/Lykos gets all the oxygen but it isn’t the only game in town fortunately.
Excellent piece! One thing I can’t wrap my head around: isn’t the blinding problem by definition, within psychedelic compounds, basically unsolvable? These substances induce dramatic but temporary changes in cognition and perception. Therein lies their potential power.
So there are other medications that can be used to at least approximate an altered state of consciousness like a benzo but in this case the FDA suggested low dose MDMA. This is what was done in the psilocybin compound trials. Lykos rejected this based on some preliminary data they had around the potential of low dose MDMA to worsen anxiety. I am not convinced that data is robust. In that scenario you really would want participants in both group to be MDMA-naive so they wouldn’t have a prior sense of the extent of the effects that would be expected. You could then see a dose response situation
Someone on the PDAC suggested head to head against sertraline or paroxetine as well. That's unusual for a drug company seeking approval though, isn't it?
An SSRI wouldn’t have made sense because you are trying to pick a drug that can alter consciousness to come degree but that does not have the mechanism of action to cause significant neuroplasticity. Some of the spravato studies have used midazolam for example.
This is a chef’s kiss analysis
what about parts II and III?!?
Heading over there now 😁
Please share with your friends
We don’t need “belief”; we need evidence, and when it comes to psilocybin there hasn’t yet been a single truly robust RCT. Instead we have an array of manipulated studies, failure to report adverse effects, carpet sweeping of abuse, and proliferation of shamanistic woo purporting to be therapy. It’s a putrid mess.
Tell us how you really really feel?
"This is why we can't have nice things."
This is a carleneism
I just wish I didn’t have to say it so often working in the healthcare and healthtech space. Maybe I should get a tattoo of it to show people when it needs to be said.
Well reasoned. One potential counterargument to parts of this could be that more established therapeutic approaches might not be appropriate in the context of MDMA med sessions. But no one is doing research that varies the psychotherapy instead of the drug (in psychedelics trials), probably because who on earth would sponsor such a thing?
Yeah I wish Lykos had used an established technique like Prolonged exposure and added more preparation and integration as well as psychoeducational elements but had a consistent core. If you look the manual which owen links to it really is a hodgepodge of approaches and seems to be really muddying the waters. They mention PE could be incorporated but also list a bunch of other techniques that could be tried. If you doing a trial to get a specific drug/therapy combo approved I think you need a lot more standardization than what is in that manual
Barbara Rothbaum at Emory is doing this. She is a national authority on PE, she wrote the book. MAPS/Lykos gets all the oxygen but it isn’t the only game in town fortunately.
Feel free to forward her the newsletter!
Excellent piece! One thing I can’t wrap my head around: isn’t the blinding problem by definition, within psychedelic compounds, basically unsolvable? These substances induce dramatic but temporary changes in cognition and perception. Therein lies their potential power.
So there are other medications that can be used to at least approximate an altered state of consciousness like a benzo but in this case the FDA suggested low dose MDMA. This is what was done in the psilocybin compound trials. Lykos rejected this based on some preliminary data they had around the potential of low dose MDMA to worsen anxiety. I am not convinced that data is robust. In that scenario you really would want participants in both group to be MDMA-naive so they wouldn’t have a prior sense of the extent of the effects that would be expected. You could then see a dose response situation
Someone on the PDAC suggested head to head against sertraline or paroxetine as well. That's unusual for a drug company seeking approval though, isn't it?
An SSRI wouldn’t have made sense because you are trying to pick a drug that can alter consciousness to come degree but that does not have the mechanism of action to cause significant neuroplasticity. Some of the spravato studies have used midazolam for example.