RecruitingPhase 2NCT05883540

Lysergic Acid Diethylamide (LSD) in Palliative Care

Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study (LPC-Study)


Sponsor

University Hospital, Basel, Switzerland

Enrollment

60 participants

Start Date

Jun 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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 advanced or 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.


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether a carefully controlled dose of LSD can help people in palliative care — those with a terminal illness — manage distress and improve their quality of life in their final months. **You may be eligible if...** - You are 22 years old or older - You have a terminal illness and a life expectancy of between 12 weeks and 2 years - You are willing to follow all study procedures and sign consent forms - You agree not to drive or operate machinery within 24 hours of taking LSD - You have completed an emergency medical directive **You may NOT be eligible if...** - Your life expectancy is less than 12 weeks - You have a known allergy or sensitivity to LSD - You are on certain psychiatric medications that cannot be safely paused - You have a personal or family history of psychosis or schizophrenia - You have certain heart conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLysergic Acid Diethylamide Tartrate

25 μg p.o.

DRUGLysergic Acid Diethylamide Tartrate

100 or 200 μg p.o.


Locations(4)

University Hospital Basel, Division of Clinical Pharmacology and Toxicology

Basel, Switzerland

University Hospital Geneva, Palliative medicine department

Collonge-Bellerive, Switzerland

Spital Uster AG, Division of Internal Medicine

Uster, Switzerland

University Hospital Zurich, Clinic for Radio-Oncology, Competence Centre Palliative Care

Zurich, Switzerland

View Full Details on ClinicalTrials.gov

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NCT05883540


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