Psychedelic medicine relies on set and setting, but the specific therapeutic frameworks used alongside the drugs are rarely studied. Analyzing a treatment manual and post-session reports from a pilot psilocybin-assisted smoking cessation study, this article shows how therapeutic frameworks interact with psilocybin to rapidly reshape participants' identity and sense of self. Multiple domains of identity shift were identified that appear to serve as mechanisms for quitting smoking, each present in the manualized treatment. As psychedelic medicine becomes mainstream, consensual, evidence-based approaches to identity shift that respect patient autonomy and encourage empowerment should become key in psychedelic bioethics.
Double-blind, randomized, controlled trials (DB-RCTs) are often considered the gold standard for establishing causal efficacy in medical research, but they face unique challenges when applied to psychedelic-assisted therapy (PAT). Participants can often guess whether they received a psychedelic due to its psychoactive effects, which may bias results through expectancy and experimenter behavior. This paper argues that the DB-RCT design should be abandoned as the assumed gold standard in PAT research because its logic is undermined by the intervention and it neglects important extrapharmacological factors. Instead, DB-RCTs should be seen as producing complementary, not superior, results to other research designs, allowing a more holistic study of PAT.