Trials / Recruiting
RecruitingNCT05883540
Lysergic Acid Diethylamide (LSD) in Palliative Care
Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study (LPC-Study)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- University Hospital, Basel, Switzerland · Academic / Other
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
- Palliative Care
- Pain
- Anxiety
- Depression
- Demoralization
- Psychological Distress
- Quality of Life
- Caregiver Burden
- Fear of Death
- Existential Distress
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lysergic Acid Diethylamide Tartrate | 25 μg p.o. |
| DRUG | Lysergic Acid Diethylamide Tartrate | 100 or 200 μg p.o. |
Timeline
- Start date
- 2024-06-09
- Primary completion
- 2027-09-01
- Completion
- 2028-05-01
- First posted
- 2023-06-01
- Last updated
- 2025-07-23
Locations
3 sites across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT05883540. Inclusion in this directory is not an endorsement.