This double-blind, randomised, placebo-controlled trial (n=120) will investigate the interaction between psilocybin (up to 25 mg, oral) and the context of its administration in healthy volunteers with moderate-to-lower-than-average mental well-being.
The study, led by Dr Robin Carhart-Harris at the University of California, San Francisco, will use a 2×2 factorial design, randomly assigning participants to receive either psilocybin or placebo in one of two different contexts.
The primary aim is to evaluate how contextual factors (‘set and setting’) influence the acute and post-acute effects of psilocybin. Key outcome measures include changes in psychological well-being (WEMWBS), connectedness (WCS), emotional breakthrough (EBI), and challenging experiences (CEQ). The trial is expected to run from October 2024 to November 2028.
Trial Details
Trial Number
Sponsors & Collaborators
University of California San FranciscoAt UCSF, there are two research teams dedicated to the study of psychedelics; the Neuroscape Psychedelic Division and the Translational Psychedelic Research Program.