3 ms·
“ For one thing, the experts, along with the FDA, found that the double-blind trials were essentially unblinded—both therapists and participants knew whether pa
by navaed01 2y ago
“ 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.
- bhaney 2y ago> 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.
- davidguetta 2y agoHow does it work for sleeping or anesthetic drugs ? At some point you also know you sleep
- everforward 2y agoThat’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.