“ For one thing, the experts, along with the FDA, found that the double-blind trials were essentially unblinded—both therapists and participants knew whether participants received MDMA, given the potent effects of the drug”
How was this not known or discussed before hand when evaluating the trial setup. And how could this ever be avoided?
These programs take years and a significant amount of money to conduct. Yet it seems like this was DOA due to its psycho active effects.
> How was this not known or discussed before hand when evaluating the trial setup
It was. The problem here is that the FDA requires double blind studies for this kind of thing, but it's well known to be pretty much impossible to double blind studies on psychedelics. So they just kinda... tried their best at an impossible requirement and hoped the data would be so good that the FDA would consider it valid despite the obvious unblinding issues.
That’s the desired effect; getting sleepy is what the study is trying to measure.
The problem is when side effects are so severe that people know whether they’ve had a placebo or not, tainting measurements of the actual effect.
Eg if a sleeping med caused you to turn purple, the control group knows they haven’t taken it because they aren’t purple, so there’s no placebo effect. Meanwhile the experimental group knows they got the real med because they’re purple, so they have a stronger than normal placebo effect.
Because the control group is tainted, you can’t use them to measure and disintermediate the placebo effect of the experimental group.
This is very unfortunate for many PTSD sufferers ( I am one of them). This therapy, at least anecdotally, was leaps and bounds better than current therapies. I hope the FDA reconsiders this decision.
p.s. for those interested in this topic I highly recommend the Netflix documentary and book "How to change your mind" by Michael Pollan
As someone who has take MDMA many times in the past I very sceptical about it's therapeutic value in treating PTSD. The high is incredible, but that comes with a comedown of the opposite feelings; including depression, anxiety, fatigue, and can last from hours to days. Those effects are of course dose dependant.
AFAIK the point of using MDMA for PTSD isn't that it makes you high and happy and then you don't have PTSD - it's that it makes you high and able to talk about experiences you couldn't without MDMA. The therapy is a big part of the process.
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[ 4.0 ms ] story [ 31.7 ms ] threadHow was this not known or discussed before hand when evaluating the trial setup. And how could this ever be avoided? These programs take years and a significant amount of money to conduct. Yet it seems like this was DOA due to its psycho active effects.
It was. The problem here is that the FDA requires double blind studies for this kind of thing, but it's well known to be pretty much impossible to double blind studies on psychedelics. So they just kinda... tried their best at an impossible requirement and hoped the data would be so good that the FDA would consider it valid despite the obvious unblinding issues.
The problem is when side effects are so severe that people know whether they’ve had a placebo or not, tainting measurements of the actual effect.
Eg if a sleeping med caused you to turn purple, the control group knows they haven’t taken it because they aren’t purple, so there’s no placebo effect. Meanwhile the experimental group knows they got the real med because they’re purple, so they have a stronger than normal placebo effect.
Because the control group is tainted, you can’t use them to measure and disintermediate the placebo effect of the experimental group.
p.s. for those interested in this topic I highly recommend the Netflix documentary and book "How to change your mind" by Michael Pollan