Double-blind, randomized, parallel-group Phase III study (n=30) comparing single 25 mg oral psilocybin + psychotherapy vs 250 mg niacin active placebo with pre- and post-dose psychotherapy for depression and burnout in frontline healthcare clinicians.
This single-site, double-blind randomized controlled trial tests whether a single 25 mg oral dose of psilocybin administered with structured pre- and post-dose psychotherapy reduces depressive symptoms and burnout in physicians and nurses exposed to frontline COVID-19 clinical work.
Participants are randomised 1:1 to receive psilocybin 25 mg or an active placebo (niacin 250 mg) with outcomes assessed at 1 day, 1 week and the primary endpoint at 4 weeks post-dose; placebo participants may receive open-label psilocybin after primary outcome assessment.
Primary outcome is change in clinician-administered MADRS score at 4 weeks; secondary measures include burnout, PTSD-related symptoms and safety/tolerability assessments.
Psychedelic-assisted psychotherapy (PAP) + single 25 mg oral psilocybin dose.
Usona Institute psilocybin, single 25 mg session with pre- and post-dose psychotherapy.
PAP + 250 mg niacin active placebo; participants unblinded after primary outcome and placebo group offered open-label psilocybin.
Niacin 250 mg active placebo