Using LSD to help relieve distress in terminally ill patients
Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study (LPC-Study)
This study is testing if LSD can help reduce pain, anxiety, and depression in people who are terminally ill and improve their overall quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Drugs / interventions | radiation, prednisone |
| Locations | 4 sites (Basel and 3 other locations) |
| Trial ID | NCT05883540 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of lysergic acid diethylamide (LSD) on psychosocial distress in patients with end-stage fatal diseases. It involves a double-blind, placebo-controlled design with 60 participants, who will receive either LSD or a placebo in a 2:1 ratio. The primary focus is on reducing symptoms of pain, anxiety, and depression, while improving overall quality of life and life meaning. Participants will receive two doses of LSD, with careful monitoring and adherence to safety protocols.
Who should consider this trial
Good fit: Ideal candidates are adults aged 22 and older with a life expectancy of 12 weeks to 2 years due to an end-stage fatal disease.
Not a fit: Patients with a life expectancy of less than 12 weeks or those with certain medical conditions or ongoing psychoactive drug therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and emotional well-being of terminally ill patients.
How similar studies have performed: Previous pilot studies have shown promising results with serotonergic hallucinogens like LSD and psilocybin in reducing anxiety and depression in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 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 generalized 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. * 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, or any neurological condition judged to pose too excessive risk. * CNS-directed therapy (surgery and/or radiation) within ≤ 4 weeks
Where this trial is running
Basel and 3 other locations
- University Hospital Basel, Division of Clinical Pharmacology and Toxicology — Basel, Switzerland (Recruiting)
- University Hospital Geneva, Palliative medicine department — Collonge-Bellerive, Switzerland (Recruiting)
- Spital Uster AG, Division of Internal Medicine — Uster, Switzerland (Recruiting)
- University Hospital Zurich, Clinic for Radio-Oncology, Competence Centre Palliative Care — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Yasmin Schmid, PD Dr. med. — University Hospital, Basel, Switzerland
- Study coordinator: Yasmin Schmid, PD Dr. med.
- Email: yasmin.schmid@usb.ch
- Phone: : +41 61 328 68 47
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.