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Palliative CarePhase 2LPCNCT05883540

Lysergic Acid Diethylamide (LSD) in Palliative Care

A Phase 2 study testing Lysergic Acid Diethylamide Tartrate in people with Palliative Care and Pain, run by University Hospital, Basel, Switzerland at 4 sites in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Palliative Care, Pain, Anxiety
What is being tested?
Lysergic Acid Diethylamide Tartrate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
4 sitesSwitzerland
Study dates
9 Jun 2024to May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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"
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yasmin Schmid, PD Dr. med. contact

: +41 61 328 68 47

yasmin.schmid@usb.ch

Switzerland4 sites, 4 recruiting

  • University Hospital Basel, Division of Clinical Pharmacology and Toxicology

    Basel, 4031

    Yasmin Schmid, PD Dr. med., +41 61 328 68 47, yasmin.schmid@usb.ch

    Melani Zupari, MSc, +41 61 328 77 42, melani.zuparic@usb.ch

    Recruiting

  • University Hospital Geneva, Palliative medicine department

    Collonge-Bellerive, 1245

    Michael Ljuslin, Dr. med., +41 79 553 87 92, michael.ljuslin@hug.ch

    Recruiting

  • Spital Uster AG, Division of Internal Medicine

    Uster, 8610

    Sivan Schipper, MD, +41 44 911 12 91, sivan.schipper@spitaluster.ch

    Recruiting

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

    Zurich

    David Blum, Prof Dr med, +41 44 255 37 42, david.blum@usz.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study (LPC-Study)

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.

Being tested
Lysergic Acid Diethylamide Tartrate
Medical subject headings
Pain, Anxiety Disorders, Depression, Caregiver Burden, Necrophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lysergic Acid Diethylamide TartrateDrug

    Also called LSD

    25 μg p.o.

  • Lysergic Acid Diethylamide TartrateDrug

    Also called LSD

    100 or 200 μg p.o.

Study groups in NCT05883540
Study groupRoleWhat they receive
treatment armExperimentalSubjects in the treatment arm will receive 100 μg LSD (first session) and 100 or 200 μg LSD (second session) per os.
Receives: Drug: Lysergic Acid Diethylamide Tartrate
control armActive comparatorSubjects in the control arm will receive 25 μg LSD (first session) and 25 μg LSD (second session) per os.
Receives: Drug: Lysergic Acid Diethylamide Tartrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: baseline, 2 weeks after second intervention

Secondary outcomes (18)

  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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: baseline

  15. Assessment of adverse events (AE)

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: before and up to 12 hours after drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2023
  2. Study start9 Jun 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05883540
Sponsor's protocol ID
BASEC 2022-01818
Acronym
LPC
Status last verified
Apr 2026
First submitted
8 May 2023
Last updated
29 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lysergic Acid Diethylamide Tartrate in people with Palliative Care and Pain, run by University Hospital, Basel, Switzerland at 4 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yasmin Schmid, PD Dr. med. (: +41 61 328 68 47, yasmin.schmid@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo (time frame: baseline, 2 weeks after second intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05883540, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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