Actively Recruiting
Lysergic Acid Diethylamide (LSD) in Palliative Care
Led by University Hospital, Basel, Switzerland · Updated on 2026-04-29
60
Participants Needed
4
Research Sites
203 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
U
University Hospital, Zürich
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Lysergic Acid Diethylamide (LSD) in Palliative Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older
- Diagnosis of advanced or end-stage fatal disease with life expectancy between 12 weeks and 2 years
- Ability to understand study procedures and risks
- Willingness to follow study procedures and provide consent
- Willingness to avoid driving or operating machinery for 24 hours after LSD use
- Completion of an Emergency Medical Directive
- For CNS cancer involvement: stable lesions treated or asymptomatic/stable for at least 4 weeks before screening
- No seizures within 4 weeks; if on antiepileptic drugs, stable dose for 4 weeks and no expected drug interactions
- No requirement for high-dose corticosteroids (≤10 mg prednisone equivalent daily) on stable or decreasing dose
- No leptomeningeal metastases
- No use of therapeutic anticoagulation
You will not qualify if you...
- Life expectancy less than 12 weeks
- Known allergy to LSD
- Ongoing use of psychoactive prescription drugs that interfere with LSD and inability to comply with washout
- Current use of strong CYP2D6 inhibitors
- Pregnant, nursing, or planning pregnancy during the study
- Somatic disorders posing high risk including unstable CNS cancer involvement, untreated epilepsy with grand-mal seizures, history of delirium, end-stage heart failure (NYHA IV), untreated or insufficiently treated hypertension, angina, severe liver or kidney disease
- Inability to follow study procedures due to language, psychological disorders, or dementia
- Participation in another investigational drug study within 30 days prior or during this study
- Past or present psychotic or bipolar disorders or first-degree relatives with psychotic disorders
- Current delirium
- Substance use disorder within last 2 months except nicotine, opioids for pain, benzodiazepines for anxiety
- Body weight less than 45 kg
- Active suicidal intent or plan
- Unstable or high-risk CNS disease including progressive lesions, raised intracranial pressure, uncontrolled edema, or need for escalating corticosteroids
- CNS-directed therapy (surgery or radiation) within 4 weeks prior to study
AI-Screening
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Trial Site Locations
Total: 4 locations
1
University Hospital Basel, Division of Clinical Pharmacology and Toxicology
Basel, Switzerland, 4031
Actively Recruiting
2
University Hospital Geneva, Palliative medicine department
Collonge-Bellerive, Switzerland, 1245
Actively Recruiting
3
Spital Uster AG, Division of Internal Medicine
Uster, Switzerland, 8610
Actively Recruiting
4
University Hospital Zurich, Clinic for Radio-Oncology, Competence Centre Palliative Care
Zurich, Switzerland
Actively Recruiting
Research Team
Y
Yasmin Schmid, PD Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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