Lysergic Acid Diethylamide Tartrate
Drug25 μg p.o.
Other names: LSD
NCT Number: NCT05883540
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.
Interested in participating?
Request Info22 year and older
All sexes
Interventional
Phase 2
University Hospital Basel, Division of Clinical Pharmacology and Toxicology, Basel, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
25 μg p.o.
Other names: LSD
Time frame: baseline, 2 weeks after second intervention
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
State anxiety inventory (STAI-S) scores, 20 items
Time frame: baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
numeric rating scale (NRS) scores ranging from 0 (no pain) to 10 (maximum imaginable pain)
Time frame: concomitant medication will be assessed several times over whole study duration up to 9 weeks after second intervention
Time frame: baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
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
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
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: post drug visit 1-3 compared with post drug visit 4-6
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: baseline, one day before second intervention and 2 and 9 weeks after second intervention
Emotional Condition Rating Scale (ECRS) scores, Hamilton depression (GRID-HAM-D17) and Hamilton anxiety rating scale (HAM-A) scores
Time frame: baseline, before second intervention and 2 weeks and 9 weeks after second intervention
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
Zarit Burden Inventory (ZBI) scores completed by caregiver, total score
Time frame: 2,4,6, and 9 weeks after second intervention
acute effects will be assessed using the Mystical experience Questionnaire (MEQ30) and visual analogue scales (VASs)
Time frame: baseline, 2 days after each intervention, 2 weeks and 9 weeks after the second intervention
Time frame: baseline, 2 days after each intervention, 2 weeks and 9 weeks after second intervention
Time frame: baseline
modified version of the Credibility / Expectancy Questionnaire (CEQ)
Time frame: during the whole study duration up to 9 weeks after second intervention
grading according to Common Terminology Criteria for Adverse Events CTCAE Version 5.0, safety measures
Time frame: before and 12 hours after drug administration
adapted list of complaints (LC), safety measures
Time frame: before and up to 12 hours after drug administration
monitoring blood pressure and heart rate with an automatic oscillometric device, safety measure
Time frame: before and up to 12 hours after drug administration
monitoring body temperature using an ear thermometer, safety measure
Contact information is provided by the study sponsor or research team.
University Hospital, Basel, Switzerland
Other
Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study (LPC-Study)
Acronym: LPC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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