Collonge Bellerive

Researchers are evaluating the effects of lysergic acid diethylamide (LSD) on psychosocial distress in 60 patients with advanced or end-stage fatal diseases who have a life expectancy between 12 weeks and 2 years. The study focuses on symptoms such as depressed mood, anxiety, pain, demoralization, fear of death, existential distress, and overall quality of life. This phase II trial uses an active placebo-controlled, double-blind, parallel design to assess how LSD may impact these challenging symptoms in palliative care. Participants will be randomly assigned in a 2:1 ratio to receive either two moderate to high oral doses of LSD (100 µg followed by 100 µg or 200 µg) or two low doses of LSD (25 µg followed by 25 µg) as an active placebo. The dosing schedule involves two interventions, and the study monitors the effects of these different LSD dose levels to understand their impact on the patients' condition. During the study, researchers will assess changes in state anxiety using a questionnaire called the State Anxiety Inventory (STAI-S) at baseline and two weeks after the second intervention. Participants must follow safety guidelines, including not driving or operating machinery within 24 hours after LSD administration. The study involves careful monitoring and evaluations to measure anxiety changes and other psychosocial outcomes, with attention to safety and adherence to study procedures throughout the trial.