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
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with central nervous system (CNS) involvement of cancer are eligible if the following apply:
Exclusion Criteria:
CNS involvement of cancer if
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
25 μg p.o.
Also known as: LSD
100 or 200 μg p.o.
Also known as: LSD
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Expectancy as a mediator for treatment effects assessed with questionnaire
modified version of the Credibility / Expectancy Questionnaire (CEQ)
Time frame: baseline
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
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
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
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
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Studies of the drug tested here: Lysergic Acid Diethylamide
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