Skip to content
RecruitingPhase 2

Lysergic Acid Diethylamide (LSD) in Palliative Care

NCT05883540 · LPC · University Hospital, Basel, Switzerland

Recruiting
Status
Accepting participants
Phase 2
Phase
60
Target enrolment
4
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo

    Measured over baseline, 2 weeks after second intervention

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

22 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Age ≥ 22 years. * Advanced or End-stage fatal disease of any cause with a life expectancy ≥ 12 weeks and ≤ 2 years * Sufficient understanding of the study procedures and risks associated with the study. * Participants must be willing to adhere to the study procedures and sign the consent form. * Participants must be willing not to drive a traffic vehicle or to operate machines within 24 h after LSD administration. * Participants must complete an actual "Emergency Medical Directive" * Participants with central nervous system (CNS) involvement of cancer are eligible if the following apply: * treated and stable CNS lesion(s) OR untreated but asymptomatic/stable lesions, defined as clinically and/or radiologically stable for ≥ 4 weeks before screening * no seizures within ≥ 4 weeks; if on antiepileptic medication: stable dose ≥ 4 weeks and no relevant drug-drug interactions expected * no requirement for high-dose corticosteroids, defined as ≤10 mg prednisone equivalent per day on a stable or decreasing dose * no leptomeningeal metastases * no concomitant therapeutic anticoagulation Exclusion Criteria: * Life expectancy \< 12 weeks * Known hypersensitivity to LSD * Requiring ongoing concomitant therapy with a psychoactive prescription drug which might interfere with the study drug, and unable or unwilling to comply with the washout period. * Current use of a potent drug CYP2D6 inhibitor * Women who are pregnant or nursing or intend to become pregnant during the course of the study. * Somatic disorders including CNS involvement of cancer, untreated epilepsy with a history of generalized grand-mal seizures, history of delirium, end-stage heart failure (NYHA IV), untreated hypertension or insufficiently treated hypertension, angina pectoris, severe liver disease or severely impaired renal function, or other that in the judgement of the investigators pose too great potential for side effects. * Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant. * Participation in another study with an investigational drug within the 30 days preceding and during the present study * concomitant diagnosis of past or present psychotic disorder, first-degree relative with psychotic disorders * concomitant diagnosis of past or present bipolar disorder * current delirium * substance use disorder (within the last 2 months, except nicotine, opioids used for analgesia, and benzodiazepine treatment for anxiety). * Weight \< 45 kg * Suicidal ideation with active intent or plan to act on suicidal thoughts as assessed by the treating investigator. * CNS involvement of cancer if * CNS disease is unstable or high-risk, including clinically and/or radiologically progressive lesions, signs of raised intracranial pressure, radiologically uncontrolled edema, need for escalating corticosteroid doses, or any neurological condition judged to pose too excessive risk. * CNS-directed therapy (surgery and/or radiation) within ≤ 4 weeks

Where

4 study sites

FacilityCityRegionCountry
University Hospital Basel, Division of Clinical Pharmacology and ToxicologyBaselSwitzerland
University Hospital Geneva, Palliative medicine departmentCollonge-BelleriveSwitzerland
Spital Uster AG, Division of Internal MedicineUsterSwitzerland
University Hospital Zurich, Clinic for Radio-Oncology, Competence Centre Palliative CareZurichSwitzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05883540 on ClinicalTrials.gov →

Last updated in the registry 2026-04-29. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits