Randomised, quadruple-blind, active-placebo controlled parallel trial (n=60) testing two oral LSD sessions (100 µg then 100/200 µg) versus low-dose LSD active-placebo (25 µg ×2) for psychosocial distress in patients with end-stage disease.
This parallel, randomised, quadruple-blind trial will evaluate the effects of two moderate-to-high doses of LSD compared with two low-dose active-placebo sessions on psychosocial distress in patients with end-stage fatal disease (life expectancy ≥12 weeks to ≤2 years).
Participants are allocated 2:1 to experimental or active-placebo arms, receiving two oral LSD sessions; the experimental arm receives 100 µg at session one and 100 or 200 µg at session two, the control arm receives 25 µg at both sessions. Primary outcomes assess depressive and anxiety symptoms, demoralization, quality of life and existential distress; safety and tolerability are monitored throughout.
Two moderate-to-high oral LSD doses: 100 µg (session 1) and 100 or 200 µg (session 2).
Second session 100 or 200 µg
Active-placebo: two low oral LSD doses (25 µg each).