Lysergic Acid Diethylamide (LSD) in Palliative Care (LPC)

March 8, 2024 updated by: University Hospital, Basel, Switzerland

Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study (LPC-Study)

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Basel, Switzerland
        • Recruiting
        • University Hospital Basel
        • Contact:
        • Contact:
      • Zürich, Switzerland
        • Recruiting
        • University Hospital Zurich, Clinic for Radio-Oncology, Competence Centre Palliative Care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 25 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, epilepsy with a history of 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
  • concomitant diagnosis of past or present bipolar disorder
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment arm
Subjects in the treatment arm will receive 100 μg LSD (first session) and 100 or 200 μg LSD (second session) per os.
25 μg p.o.
Other Names:
  • LSD
100 or 200 μg p.o.
Other Names:
  • LSD
Active Comparator: control arm
Subjects in the control arm will receive 25 μg LSD (first session) and 25 μg LSD (second session) per os.
25 μg p.o.
Other Names:
  • LSD
100 or 200 μg p.o.
Other Names:
  • LSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo
Time Frame: baseline, 2 weeks after second intervention
State anxiety inventory (STAI-S) scores, 20 items
baseline, 2 weeks after second intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo
Time Frame: baseline, 2 days after each intervention, 4 weeks, 6 weeks, and 9 weeks after second intervention
State anxiety inventory (STAI-S) scores, 20 items
baseline, 2 days after each intervention, 4 weeks, 6 weeks, and 9 weeks after second intervention
Changes in pain levels assessed by questionnaire compared with active placebo
Time Frame: baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
numeric rating scale (NRS) scores ranging from 0 (no pain) to 10 (maximum imaginable pain)
baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
Changes in opioid use (dosages of opioids unified according to equivalent dosages of oral morphine) compared with active placebo
Time Frame: concomitant medication will be assessed several times over whole study duration up to 9 weeks after second intervention
concomitant medication will be assessed several times over whole study duration up to 9 weeks after second intervention
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
Time Frame: baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale (FACIT-Sp-12) scores
baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
Changes in demoralization assessed by questionnaires (Demoralization Scale II (DS-II)) compared with active placebo
Time Frame: baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
Demoralization Scale II (DS-II) scores
baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
Changes in quality of life assessed with a single-item question compared with active placebo
Time Frame: baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
single-item question "how satisfied are you currently with your physical and emotional well-being" rated on a 7-point scale (1 dissatisfied, 7 satisfied)
baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
Changes in anxiety, pain levels, quality of life, demoralization, and spiritual well-being shortly after first intervention compared with scores shortly after second intervention
Time Frame: post drug visit 1-3 compared with post drug visit 4-6
State anxiety inventory (STAI-S), NRS, QoL single-item, Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale (FACIT-Sp-12), and Demoralization Scale II (DS-II) scores
post drug visit 1-3 compared with post drug visit 4-6
Changes in patient's depression, isolation, anxiety, fear and denial of imminence of death, and pre-occupation with pain using investigator-ratings compared with active placebo
Time Frame: baseline, one day before second intervention and 2 and 9 weeks after second intervention
Emotional Condition Rating Scale (ECRS) scores, Hamilton depression (GRID-HAM-D17) and Hamilton anxiety rating scale (HAM-A) scores
baseline, one day before second intervention and 2 and 9 weeks after second intervention
Changes in patient's behaviour and attitudes rated by community observers compared with active placebo
Time Frame: baseline, before second intervention and 2 weeks and 9 weeks after second intervention
community observer rating: rating of the participant's behaviour and attitudes on 11 items by a contact person
baseline, before second intervention and 2 weeks and 9 weeks after second intervention
Changes in caregiver burden assessed by questionnaire compared with active placebo
Time Frame: baseline, before second intervention and 2 weeks and 9 weeks after second intervention
Zarit Burden Inventory (ZBI) scores completed by caregiver, total score
baseline, before second intervention and 2 weeks and 9 weeks after second intervention
Associations between acute LSD effects assessed with questionnaires and long-lasting therapeutic effects assessed with questionnaires
Time Frame: 2,4,6, and 9 weeks after second intervention
acute effects will be assessed using the Mystical experience Questionnaire (MEQ30) and visual analogue scales (VASs)
2,4,6, and 9 weeks after second intervention
Changes in burden of suffering assessed with the Pictorial Representation of Illness and Self-Measure (PRISM) compared with active placebo
Time Frame: baseline, 2 days after each intervention, 2 weeks and 9 weeks after the second intervention
baseline, 2 days after each intervention, 2 weeks and 9 weeks after the second intervention
Qualitative description of subjective changes after intervention assessed with semistructured interviews
Time Frame: baseline, 2 days after each intervention, 2 weeks and 9 weeks after second intervention
baseline, 2 days after each intervention, 2 weeks and 9 weeks after second intervention
Expectancy as a mediator for treatment effects assessed with questionnaire
Time Frame: baseline
modified version of the Credibility / Expectancy Questionnaire (CEQ)
baseline
Assessment of adverse events (AE)
Time Frame: during the whole study duration up to 9 weeks after second intervention
grading according to Common Terminology Criteria for Adverse Events CTCAE Version 5.0, safety measures
during the whole study duration up to 9 weeks after second intervention
Physical and general discomfort during drug sessions using standardized questions (adapted list of complaints)
Time Frame: before and 12 hours after drug administration
adapted list of complaints (LC), safety measures
before and 12 hours after drug administration
Changes in vital signs during drug sessions
Time Frame: before and up to 12 hours after drug administration
monitoring blood pressure and heart rate with an automatic oscillometric device, safety measure
before and up to 12 hours after drug administration
Changes in vital signs during drug sessions
Time Frame: before and up to 12 hours after drug administration
monitoring body temperature using an ear thermometer, safety measure
before and up to 12 hours after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Yasmin Schmid, MD, University Hospital, Basel, Switzerland
  • Principal Investigator: David Blum, Prof, University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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