This multisite cohort study (OPEN) enrolled 346 adults receiving Oregon state-regulated psilocybin services at 24 licensed centers (Nov 2024–Mar 2026), supervised by 83 facilitators. It tracked safety events, and participant-reported depression (PHQ-9), anxiety (HADS), PTSD (PCL-6), mental well-being, and life satisfaction at baseline, 1 week, 1 month, and 3 months post-session.
Serious adverse behavioral reactions requiring medical attention occurred in 4 of 346 participants (1.2%), all psychedelic-naive. At 3 months, moderate-to-severe depression fell by 60% (RR 0.40; 95% CI 0.32–0.50), anxiety by 71% (RR 0.29; 95% CI 0.22–0.38), and PTSD symptoms by 65% (RR 0.35; 95% CI 0.27–0.45) vs. baseline. Life satisfaction improved (RR 1.31; 95% CI 1.19–1.44) and mental well-being scores rose by 3.21 points (95% CI 2.66–3.76). At 1 month, 92.2% reported benefit and 58.6% ranked the session among the 10 most meaningful experiences of their life.
- No control group; pre–post changes may partly reflect regression to the mean, natural history, or expectancy effects. - Sample was highly educated (76.6% college graduates), predominantly White (86.7%), and high-income (29% >$200K/year), limiting generalizability. - Outcomes are entirely self-reported; no blinding or independent outcome verification.
In this real-world Oregon cohort, regulated psilocybin sessions appeared safe for most adults, with serious adverse reactions concentrated in psychedelic-naive users—clinicians counseling patients considering these services should flag psychedelic-naive status as a key risk factor. Large self-reported improvements in depression, anxiety, and PTSD are encouraging but must be interpreted cautiously given the uncontrolled design.
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