Double-Blind Study
ClinicalA trial design where neither participants nor researchers know who received the drug versus placebo — the gold standard for eliminating bias, and a genuine methodological problem for drugs with obvious subjective effects.
Example: The FDA's rejection of MDMA therapy cited exactly this — both pivotal trials (90 and 104 participants) were positive, but reviewers noted "dramatic functional unblinding," since patients could tell whether they'd gotten MDMA. See where that program stands now.
What is a double-blind study?
A trial design where neither participants nor researchers know who received the drug versus placebo — the gold standard for eliminating bias.
Why is double-blinding hard for psychedelic trials?
Drugs with obvious subjective effects are hard to blind. The FDA's rejection of MDMA therapy cited exactly this: both pivotal trials (90 and 104 participants) were positive, but reviewers noted "dramatic functional unblinding," since patients could tell whether they'd gotten MDMA. See where that program stands now.