This open-label, Phase Ib clinical trial (n=50) will investigate the safety, feasibility, and tolerability of a single dose of oral psilocybin (25mg) in individuals with functional impairment due to psychiatric symptoms, including mood, anxiety, trauma, or addiction.
Conducted by Yale University and the Usona Institute, the study aims to assess whether psilocybin can lead to statistically significant reductions in psychiatric symptoms and improvements in functional status. Participants will be followed up at 1, 4, and 6 weeks post-dosing, with optional long-term assessments at 3, 6, and 12 months.
This trial will use a single treatment arm, and all participants will receive the psilocybin dose without any blinding. The study seeks to address limitations of previous research by including a diverse population with various comorbid conditions, reflecting real-world clinical scenarios.
Trial Details
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Sponsors & Collaborators
Yale UniversityThe Yale Psychedelic Science Group was established in 2016.