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New treatment option for Palliative Care
Official title Lysergic Acid Diethylamide (LSD) in Palliative Care
ClinicalTrials.gov ID: NCT05883540
What this study is testing
What is Lysergic Acid Diethylamide Tartrate?
Lysergic Acid Diethylamide Tartrate is an investigational medicine, being studied as a potential treatment for palliative care.
Also referred to as LSD.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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"
- 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
- 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...
- 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...
- CNS-directed therapy (surgery and/or radiation) within ≤ 4 weeks
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
- Collonge-Bellerive, Switzerland
- Uster, Switzerland
- Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland; Collonge-Bellerive, Switzerland; Uster, Switzerland; Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.