Lysergic Acid Diethylamide (LSD) in Palliative Care

NCT05883540 | Recruiting Phase 2

• 1 other identifier: BASEC 2022-01818
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Palliative Care; Pain; Anxiety; Depression; Demoralization; Psychological Distress; Quality of Life; Caregiver Burden; Fear of Death; Existential Distress

Outcome Measures

Primary Outcomes (1)

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

  State anxiety inventory (STAI-S) scores, 20 items

  baseline, 2 weeks after second intervention

Secondary Outcomes (18)

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

  baseline, 2 days after each intervention, 4 weeks, 6 weeks, and 9 weeks after second intervention

• Changes in pain levels assessed by questionnaire compared with active placebo

  baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention

• Changes in opioid use (dosages of opioids unified according to equivalent dosages of oral morphine) compared with active placebo

  concomitant medication will be assessed several times over whole study duration up to 9 weeks after second intervention

• Changes in spiritual well-being assessed by questionnaires (Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale (FACIT-Sp-12)) compared with active placebo

  baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention

• Changes in demoralization assessed by questionnaires (Demoralization Scale II (DS-II)) compared with active placebo

  baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention

Study Arms (2)

treatment arm

EXPERIMENTAL

Subjects in the treatment arm will receive 100 μg LSD (first session) and 100 or 200 μg LSD (second session) per os.

Drug: Lysergic Acid Diethylamide Tartrate

control arm

ACTIVE COMPARATOR

Subjects in the control arm will receive 25 μg LSD (first session) and 25 μg LSD (second session) per os.

Drug: Lysergic Acid Diethylamide Tartrate

Interventions

Lysergic Acid Diethylamide Tartrate DRUG

25 μg p.o.

Also known as: LSD

control arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University Hospital, Zürich: collaborator
• Spital Uster AG, Uster, Switzerland: collaborator
• University Hospital, Geneva: collaborator

Study Sites (4)

University Hospital Basel, Division of Clinical Pharmacology and Toxicology

Basel, 4031, Switzerland

RECRUITING

University Hospital Geneva, Palliative medicine department

Collonge-Bellerive, 1245, Switzerland

RECRUITING

Spital Uster AG, Division of Internal Medicine

Uster, 8610, Switzerland

RECRUITING

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

Zurich, Switzerland

RECRUITING

Related Publications (1)

• Schipper S, Nigam K, Schmid Y, Piechotta V, Ljuslin M, Beaussant Y, Schwarzer G, Boehlke C. Psychedelic-assisted therapy for treating anxiety, depression, and existential distress in people with life-threatening diseases. Cochrane Database Syst Rev. 2024 Sep 12;9(9):CD015383. doi: 10.1002/14651858.CD015383.pub2.

  PMID: 39260823 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders; Depression; Caregiver Burden; Necrophobia

Interventions

Lysergic Acid Diethylamide

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior; Stress, Psychological

Intervention Hierarchy (Ancestors)

Lysergic Acid; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yasmin Schmid, PD Dr. med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmin Schmid, PD Dr. med.

CONTACT

: +41 61 328 68 47; yasmin.schmid@usb.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 1, 2023
• Study Start: June 9, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

CH (4)