Safety, Feasibility, and Tolerability of Psilocybin Treatment for Individuals With Functional Impairment Related to Mood, Anxiety, Trauma and/or Addiction Symptoms: An Open-label Proof-of-concept Study
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. The investigators will recruit individuals with mood, anxiety, trauma, addictive, or related symptomatology, and who have functional impairment associated with these symptoms. A DSM-5 diagnosis is not required (nor is it an exclusion). The investigators will allow for comorbidity and only exclude based on psychological and physiological 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-5 conditions. The investigators will employ an open-label study where participants will be given one dose of oral psilocybin 25mg. The investigators 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.
- Status
- recruiting
- Phase
- Phase 1
- Institution
- Yale University
- Principal investigator
- Benjamin Kelmendi, MD
- Start date
- 2024-10-17
- End date
- 2027-12-01
- Registry ID
- NCT06442423
Tracked by the DMT Code Clinical Trials Observatory, an open record of DMT-related clinical research.