Open-Label Psilocybin

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

The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms.The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing. We will recruit individuals with mood, anxiety, trauma, addictive, or related symptomatology, and who have functional impairment associated with these symptoms. We will not limit recruitment to any particular DSM diagnosis; we allow for comorbidity and only exclude based on safety considerations. Critically, this approach will allow us to assess the tolerability of our interventions in individuals who would typically be excluded from efficacy studies due to various comorbid DSM conditions. We will employ an open-label study where participants will be given one dose of oral psilocybin 25mg. We will also have follow-up visits at 1, 4, and 6 weeks and an optional long-term follow-up at 3, 6, and 12 months.

NCT Number NCT06442423

Data attribution

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