CClinicalTrials.gg
Sign In
RecruitingNCT05883540LPCUpdated Apr 29, 2026

Lysergic Acid Diethylamide (LSD) in Palliative Care

A Phase 2 interventional study of Lysergic Acid Diethylamide Tartrate and Lysergic Acid Diethylamide Tartrate in Palliative Care, Pain and Anxiety, sponsored by University Hospital, Basel, Switzerland. Recruiting at 4 sites in Switzerland. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.

Sponsored by University Hospital, Basel, Switzerland · Phase 2, Interventional, and Supportive care

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
22 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Palliative Care
  • Pain
  • Anxiety
  • Depression
  • Demoralization
  • Psychological Distress
  • Quality of Life
  • Caregiver Burden
  • Fear of Death
  • Existential Distress
03

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    treatment arm

    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

  • Active comparator
    control arm

    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

  • DrugLysergic Acid Diethylamide Tartrate

    25 μg p.o.

    Also known as: LSD

  • DrugLysergic Acid Diethylamide Tartrate

    100 or 200 μg p.o.

    Also known as: LSD

05

What researchers measure

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

    Time frame: baseline, 2 weeks after second intervention

Secondary 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

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

  2. Changes in pain levels assessed by questionnaire compared with active placebo

    numeric rating scale (NRS) scores ranging from 0 (no pain) to 10 (maximum imaginable pain)

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

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

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

  4. 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

    Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale (FACIT-Sp-12) scores

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

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

    Demoralization Scale II (DS-II) scores

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

  6. Changes in quality of life assessed with a single-item question compared with active placebo

    single-item question "how satisfied are you currently with your physical and emotional well-being" rated on a 7-point scale (1 dissatisfied, 7 satisfied)

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

  7. Changes in anxiety, pain levels, quality of life, demoralization, and spiritual well-being shortly after first intervention compared with scores shortly after second intervention

    State anxiety inventory (STAI-S), NRS, QoL single-item, Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale (FACIT-Sp-12), and Demoralization Scale II (DS-II) scores

    Time frame: post drug visit 1-3 compared with post drug visit 4-6

  8. Changes in patient's depression, isolation, anxiety, fear and denial of imminence of death, and pre-occupation with pain using investigator-ratings compared with active placebo

    Emotional Condition Rating Scale (ECRS) scores, Hamilton depression (GRID-HAM-D17) and Hamilton anxiety rating scale (HAM-A) scores

    Time frame: baseline, one day before second intervention and 2 and 9 weeks after second intervention

  9. Changes in patient's behaviour and attitudes rated by community observers compared with active placebo

    community observer rating: rating of the participant's behaviour and attitudes on 11 items by a contact person

    Time frame: baseline, before second intervention and 2 weeks and 9 weeks after second intervention

  10. Changes in caregiver burden assessed by questionnaire compared with active placebo

    Zarit Burden Inventory (ZBI) scores completed by caregiver, total score

    Time frame: baseline, before second intervention and 2 weeks and 9 weeks after second intervention

  11. Associations between acute LSD effects assessed with questionnaires and long-lasting therapeutic effects assessed with questionnaires

    acute effects will be assessed using the Mystical experience Questionnaire (MEQ30) and visual analogue scales (VASs)

    Time frame: 2,4,6, and 9 weeks after second intervention

  12. Changes in burden of suffering assessed with the Pictorial Representation of Illness and Self-Measure (PRISM) compared with active placebo

    Time frame: baseline, 2 days after each intervention, 2 weeks and 9 weeks after the second intervention

  13. Qualitative description of subjective changes after intervention assessed with semistructured interviews

    Time frame: baseline, 2 days after each intervention, 2 weeks and 9 weeks after second intervention

  14. Expectancy as a mediator for treatment effects assessed with questionnaire

    modified version of the Credibility / Expectancy Questionnaire (CEQ)

    Time frame: baseline

  15. Assessment of adverse events (AE)

    grading according to Common Terminology Criteria for Adverse Events CTCAE Version 5.0, safety measures

    Time frame: during the whole study duration up to 9 weeks after second intervention

  16. Physical and general discomfort during drug sessions using standardized questions (adapted list of complaints)

    adapted list of complaints (LC), safety measures

    Time frame: before and 12 hours after drug administration

  17. Changes in vital signs during drug sessions

    monitoring blood pressure and heart rate with an automatic oscillometric device, safety measure

    Time frame: before and up to 12 hours after drug administration

  18. Changes in vital signs during drug sessions

    monitoring body temperature using an ear thermometer, safety measure

    Time frame: before and up to 12 hours after drug administration

06

Study locations

4 of 4 sites recruiting
  • University Hospital Basel, Division of Clinical Pharmacology and Toxicology
    Basel, 4031, Switzerland
    • Yasmin Schmid, PD Dr. med. · Contact · yasmin.schmid@usb.ch · +41 61 328 68 47
    • Melani Zupari, MSc · Contact · melani.zuparic@usb.ch · +41 61 328 77 42
    • Yasmin Schmid, PD Dr. med. · Principal investigator
    • Matthias Liechti, Prof. Dr. med. · Sub investigator
    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
07

References and documents

Publications

  • 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. PubMed 39260823 ↗
08

Registry details

Key details

Study ID
NCT05883540
Lead sponsor
University Hospital, Basel, Switzerland
Collaborators
University Hospital, Zürich, Spital Uster AG, Uster, Switzerland, University Hospital, Geneva
Responsible party
Sponsor
First posted
Jun 1, 2023
Start date
Jun 9, 2024
Primary completion
Sep 2027 (estimated)
Completion
May 2028 (estimated)
Last update
Apr 29, 2026

Study contacts

Yasmin Schmid, PD Dr. med.
Contact
yasmin.schmid@usb.ch
: +41 61 328 68 47
Yasmin Schmid, PD Dr. med.
principal investigator · University Hospital, Basel, Switzerland

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Pain→

Other studies from this sponsor

University Hospital, Basel, Switzerland

Start the discussion