Actively Recruiting

Phase 2
Age: 22Years +
All Genders
NCT05883540

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

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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Lysergic Acid Diethylamide (LSD) in Palliative Care | DecenTrialz