In a small pilot study, 21 women with anorexia nervosa received three doses of psilocybin (COMP360) over six weeks, combined with talk therapy and usual care. The treatment was well tolerated; common side effects were headache, nausea, and dizziness. Two serious adverse events (suicide attempts) occurred in one participant during the 6–12 month period. Eating disorder symptoms significantly improved at six months, and motivation to change improved at twelve months, though individual responses varied widely. The findings provide preliminary support for the feasibility and safety of psilocybin therapy in this population, but larger, more rigorous studies are needed.
The authors argue that standard placebo-controlled trial designs are poorly suited to psychedelic therapies because the intense subjective effects of psychedelics make blinding nearly impossible and may introduce confounding expectations. They propose alternative methodological approaches, such as active placebo controls, comparative effectiveness designs, and pragmatic trials, to better evaluate the efficacy and safety of psychedelic-assisted treatments for psychiatric conditions.