This randomized, double-blind, active-placebo controlled trial (n=60) will evaluate the effects of LSD on psychosocial distress in patients suffering from an end-stage fatal disease with a life expectancy of 12 weeks to 2 years. Participants will be allocated in a 2:1 ratio to one of two intervention arms.
One arm will receive two moderate to high doses of LSD (100 µg and 100 µg or 100 µg and 200 µg), and the other arm will receive two low doses of LSD (25 µg and 25 µg) as an active-placebo control. The study is expected to begin in September 2023 and conclude in September 2027.
The main objective of the trial is to investigate whether LSD can alleviate depressive symptoms, anxiety, and improve the quality of life in terminally ill patients, based on evidence from pilot studies suggesting that serotonergic hallucinogens, including LSD and psilocybin, can have these effects.
Trial Details
Background: Terminally ill patients often experience significant psychosocial distress having depressed mood, death anxiety, pain, and an overall poor quality of life. Recent evidence from pilot studies suggests that serotonergic hallucinogens including lysergic acid diethylamide (LSD) and psilocybin produce significant and sustained reductions of depressive symptoms and anxiety, along with increases in quality of life, and life meaning in patients suffering from life-threatening diseases. Additionally, serotonergic hallucinogens may produce antinociceptive effects. Objective and Design: The study aims to evaluate effects of LSD on psychosocial distress in 60 patients suffering from an end-stage fatal disease with a life expectancy ≥12wks and ≤2yrs in an active placebo-controlled double-blind parallel study. Patients will be allocated in a 2:1 ratio to one of the two intervention arms receiving either two moderate to high doses of LSD (100 µg and 100 µg or 100 µg and 200 µg) as intervention and two low doses of LSD (25 µg and 25 µg) as active-placebo control.NCT Number NCT05883540
Sponsors & Collaborators
University of BaselThe University of Basel Department of Biomedicine hosts the Liechti Lab research group, headed by Matthias Liechti.