This double-blind, randomised, factorial-design trial (n=120) will investigate the interaction effects between psilocybin (25 mg, oral) and the context of its administration in healthy volunteers with lower-than-average mental well-being.
The study, led by Dr Robin Carhart-Harris at the University of California, San Francisco, will employ a 2×2 factorial design to explore how different contextual factors (‘set and setting’) modulate the acute and post-acute effects of psilocybin.
Participants will be randomly assigned to receive either psilocybin or placebo in one of two distinct environmental conditions. The primary outcomes include changes in psychological well-being, measured by the Warwick-Edinburgh Mental Wellbeing Scales (WEMWBS), emotional breakthrough, and the quality of the acute psychedelic experience. Secondary measures will include neuroimaging and electroencephalography (EEG) assessments to examine brain activity patterns. The study is expected to run from October 2024 to November 2028.
Trial Details
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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.