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.
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.
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
Parallel
Lysergic Acid Diethylamide Tartrate
Drug25 μg p.o.
Lysergic Acid Diethylamide Tartrate
Drug100 or 200 μg p.o.
Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo
State anxiety inventory (STAI-S) scores, 20 items
Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo
State anxiety inventory (STAI-S) scores, 20 items
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)
Changes in opioid use (dosages of opioids unified according to equivalent dosages of oral morphine) compared with active placebo
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
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University Hospital, Basel, Switzerland
Lead sponsor
University Hospital, Zürich
Collaborator
Spital Uster AG, Uster, Switzerland
Collaborator
University Hospital, Geneva
Collaborator
