Evaluating Moderate to High Doses of LSD for Reducing Distress in Patients with Advanced or End-Stage Fatal Illness in Palliative Care

What this Trial Is About

Researchers are evaluating the effects of lysergic acid diethylamide LSD on psychosocial distress in patients with advanced or end-stage fatal diseases who have a life expectancy between 12 weeks and 2 years. This phase II, randomized, double-blind, active placebo-controlled study aims to assess changes in depressive symptoms, anxiety, pain, quality of life, spiritual well-being, demoralization, and caregiver burden among 60 participants. Participants will be randomly assigned in a 21 ratio to one of two groups. The treatment group will receive two moderate to high oral doses of LSD 100 g followed by either 100 g or 200 g, while the control group will receive two low doses of LSD 25 g for both sessions as an active placebo. The study involves two dosing sessions with assessments at multiple time points. During the study, participants will complete various questionnaires and evaluations measuring anxiety state anxiety inventory, pain levels, opioid use, spiritual well-being, demoralization, quality of life, and other psychological and behavioral factors. Assessments occur before and after each intervention, including follow-ups up to 9 weeks after the second dose. Researchers will also monitor adverse events, vital signs during dosing sessions, and collect qualitative data through interviews. Total participation duration extends up to about 9 weeks after the last intervention.

Lysergic Acid Diethylamide (LSD) in Palliative Care