What should constitute a control condition in psychedelic drug trials?
Nature. Mental health October 1, 2024 Luana Colloca, Maurizio Fava 9 citations
Placebo-controlled trials of MDMA and classical psychedelics like psilocybin, LSD, and DMT for neuropsychiatric disorders have increased, but their success depends on trial design, control conditions, and blinding. Without appropriate controls, placebo and expectation effects are hard to separate from medication effects. This paper explores the neurobiology of placebo and expectation effects and methodological considerations for selecting suitable control conditions, examining advantages and disadvantages of various options and proposing new directions to enhance trial validity and regulatory science.