
Reseach & Trials


Phase 2b trial shows 71% of participants experiencing significant symptom reduction
Oct 15, 2024

Phase 2b trial shows 71% of participants experiencing significant symptom reduction
Oct 15, 2024

Phase 2b trial shows 71% of participants experiencing significant symptom reduction
Oct 15, 2024

Phase 2b trial shows 71% of participants experiencing significant symptom reduction
Oct 15, 2024


Open-Label Psilocybin Study in Transdiagnostic Population
ClinicalTrials.gov : ID NCT06442423
Sponsor: Yale University
Information provided by: Benjamin Kelmendi, MD, Yale University (Responsible Party)
Last Update Posted: 2025-10-30
What we Do
Beyond our direct research initiatives, ENACT serves as the operational foundation for the Yale Program for Psychedelic Science. We provide the structural support, methodological frameworks, and collaborative environment that enables the incubation of specialized research divisions. This catalytic role is central to what we do—transforming isolated expertise into interconnected knowledge networks that collectively advance the field."
At ENACT, research is not simply conducted—it is lived, activated, and set in motion. In this dynamic interplay of possibility and action, suspended potential transforms into living reality, where knowledge flows into practice and principles come alive through purpose. Here, ENACT catalyzes research that moves with intention, resonates with meaning, and brings knowledge to life in embrace of the whole person.
Study Overview
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.
ā
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.
Study Team







