Psychedelic-assisted therapy for treating anxiety, depression, and existential distress in people with life-threatening diseases.
Sivan Schipper, Kabir Nigam, Yasmin Schmid...
https://pubmed.ncbi.nlm.nih.gov/39260823Actively Recruiting
Phase 2
Age: 22Years +
All Genders
ID05883540
Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study
Led by University Hospital, Basel, Switzerland · Updated on 2026-04-29
60
Participants Needed
4
Research Sites
34 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
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 2:1 ratio to one of two groups. The treatment group will receive two moderate to high oral doses of LSD (100 µg followed by either 100 µg or 200 µg), while the control group will receive two low doses of LSD (25 µg 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.
CONDITIONS
Brief Title
Lysergic Acid Diethylamide (LSD) in Palliative Care
Who Can Participate
Age: 22Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 22 years or older
- Advanced or end-stage fatal disease with life expectancy between 12 weeks and 2 years
- Sufficient understanding of study procedures and risks
- Willingness to follow study procedures and sign consent
- Willingness not to drive or operate machines for 24 hours after LSD use
- Completion of an Emergency Medical Directive
- CNS cancer involvement allowed only if treated and stable or asymptomatic/stable for at least 4 weeks
- No seizures in past 4 weeks; stable antiepileptic medication dose if applicable
- No need for high-dose corticosteroids (≤10 mg prednisone equivalent per day)
- No leptomeningeal metastases
- No therapeutic anticoagulation
You will not qualify if you...
- Life expectancy less than 12 weeks
- Known allergy to LSD
- Ongoing use of psychoactive drugs interfering with study drug and unwillingness/inability for washout
- Current use of strong CYP2D6 inhibitors
- Pregnant, nursing, or intending to become pregnant during study
- Untreated epilepsy with history of grand-mal seizures
- History of delirium
- End-stage heart failure (NYHA IV)
- Untreated or poorly controlled hypertension
- Angina pectoris
- Severe liver disease or severe kidney impairment
- Inability to follow study procedures due to language, psychological disorders, dementia, etc.
- Participation in another investigational drug study within 30 days
- Past or present psychotic disorders or first-degree relative with psychotic disorders
- Past or present bipolar disorder
- Current delirium
- Substance use disorder within last 2 months (except nicotine, opioids for pain, benzodiazepines for anxiety)
- Weight under 45 kg
- Suicidal ideation with active intent or plan
- Unstable or high-risk CNS cancer involvement
- CNS-directed therapy within 4 weeks prior to screening
AI-Screening
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Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 9 weeks after second intervention
Participants receive two sessions of oral lysergic acid diethylamide (LSD) at specified doses.
2 drug administration sessions with assessments before and up to 12 hours after each session, plus multiple follow-up visits up to 9 weeks after second intervention
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.
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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