Lysergic Acid Diethylamide (LSD) in Palliative Care

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · May 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a substance called lysergic acid diethylamide (LSD) on people who are facing serious, life-threatening illnesses. Many patients in this situation deal with significant emotional distress, such as anxiety, depression, and a fear of death, which can greatly affect their quality of life. The aim of the study is to see if LSD can help reduce these feelings and improve overall well-being. The trial will involve 60 patients who have a life expectancy of at least 12 weeks but no more than 2 years. Participants will receive either higher doses of LSD or lower doses that are used as a comparison to see how effective the treatment is.

To be eligible for this trial, participants must be at least 25 years old and have a terminal illness. They should be able to understand the study and be willing to follow the guidelines, which include not driving or operating machinery for 24 hours after taking LSD. However, individuals with certain health issues, like severe heart problems or a history of specific mental health disorders, cannot participate. During the trial, participants will have regular check-ins and assessments to monitor their health and emotional state. This study is important because it explores new ways to support patients who are experiencing profound distress at the end of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 22 years.
• • 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"
• Exclusion Criteria:
• • 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 grand-mal seizures, history of delirium, end-stage heart failure (NYHA IV), untreated hypertension or insufficiently treated hypertension, angina pectoris, severe liver disease or severely impaired renal function, or other that in the judgement of the investigators pose too great potential for side effects.
• • 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.