search
Back to results

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

Primary Purpose

Palliative Care, Pain, Anxiety

Status
Recruiting
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Lysergic Acid Diethylamide Tartrate
Lysergic Acid Diethylamide Tartrate
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Palliative Care

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital BaselRecruiting
  • University Hospital Zurich, Clinic for Radio-Oncology, Competence Centre Palliative CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

treatment arm

control arm

Arm Description

Subjects in the treatment arm will receive 100 μg LSD (first session) and 100 or 200 μg LSD (second session) per os.

Subjects in the control arm will receive 25 μg LSD (first session) and 25 μg LSD (second session) per os.

Outcomes

Primary Outcome Measures

Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo
State anxiety inventory (STAI-S) scores, 20 items

Secondary Outcome Measures

Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo
State anxiety inventory (STAI-S) scores, 20 items
Changes in pain levels assessed by questionnaire compared with active placebo
numeric rating scale (NRS) scores ranging from 0 (no pain) to 10 (maximum imaginable pain)
Changes in opioid use (dosages of opioids unified according to equivalent dosages of oral morphine) compared with active placebo
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
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale (FACIT-Sp-12) scores
Changes in demoralization assessed by questionnaires (Demoralization Scale II (DS-II)) compared with active placebo
Demoralization Scale II (DS-II) scores
Changes in quality of life assessed with a single-item question compared with active placebo
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)
Changes in anxiety, pain levels, quality of life, demoralization, and spiritual well-being shortly after first intervention compared with scores shortly after second intervention
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
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
Emotional Condition Rating Scale (ECRS) scores, Hamilton depression (GRID-HAM-D17) and Hamilton anxiety rating scale (HAM-A) scores
Changes in patient's behaviour and attitudes rated by community observers compared with active placebo
community observer rating: rating of the participant's behaviour and attitudes on 11 items by a contact person
Changes in caregiver burden assessed by questionnaire compared with active placebo
Zarit Burden Inventory (ZBI) scores completed by caregiver, total score
Associations between acute LSD effects assessed with questionnaires and long-lasting therapeutic effects assessed with questionnaires
acute effects will be assessed using the Mystical experience Questionnaire (MEQ30) and visual analogue scales (VASs)
Changes in burden of suffering assessed with the Pictorial Representation of Illness and Self-Measure (PRISM) compared with active placebo
Qualitative description of subjective changes after intervention assessed with semistructured interviews
Expectancy as a mediator for treatment effects assessed with questionnaire
modified version of the Credibility / Expectancy Questionnaire (CEQ)
Assessment of adverse events (AE)
grading according to Common Terminology Criteria for Adverse Events CTCAE Version 5.0, safety measures
Physical and general discomfort during drug sessions using standardized questions (adapted list of complaints)
adapted list of complaints (LC), safety measures
Changes in vital signs during drug sessions
monitoring blood pressure and heart rate with an automatic oscillometric device, safety measure
Changes in vital signs during drug sessions
monitoring body temperature using an ear thermometer, safety measure

Full Information

First Posted
May 8, 2023
Last Updated
August 10, 2023
Sponsor
University Hospital, Basel, Switzerland
Collaborators
University Hospital, Zürich
search

1. Study Identification

Unique Protocol Identification Number
NCT05883540
Brief Title
Lysergic Acid Diethylamide (LSD) in Palliative Care
Acronym
LPC
Official Title
Lysergic Acid Diethylamide (LSD) in Palliative Care: a Randomised, Double-blind, Active-placebo Controlled Phase II Study (LPC-Study)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
University Hospital, Zürich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Palliative Care, Pain, Anxiety, Depression, Demoralization, Psychological Distress, Quality of Life, Caregiver Burden, Fear of Death, Existential Distress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Experimental
Arm Description
Subjects in the treatment arm will receive 100 μg LSD (first session) and 100 or 200 μg LSD (second session) per os.
Arm Title
control arm
Arm Type
Active Comparator
Arm Description
Subjects in the control arm will receive 25 μg LSD (first session) and 25 μg LSD (second session) per os.
Intervention Type
Drug
Intervention Name(s)
Lysergic Acid Diethylamide Tartrate
Other Intervention Name(s)
LSD
Intervention Description
25 μg p.o.
Intervention Type
Drug
Intervention Name(s)
Lysergic Acid Diethylamide Tartrate
Other Intervention Name(s)
LSD
Intervention Description
100 or 200 μg p.o.
Primary Outcome Measure Information:
Title
Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo
Description
State anxiety inventory (STAI-S) scores, 20 items
Time Frame
baseline, 2 weeks after second intervention
Secondary Outcome Measure Information:
Title
Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo
Description
State anxiety inventory (STAI-S) scores, 20 items
Time Frame
baseline, 2 days after each intervention, 4 weeks, 6 weeks, and 9 weeks after second intervention
Title
Changes in pain levels assessed by questionnaire compared with active placebo
Description
numeric rating scale (NRS) scores ranging from 0 (no pain) to 10 (maximum imaginable pain)
Time Frame
baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
Title
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
Title
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
Description
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale (FACIT-Sp-12) scores
Time Frame
baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
Title
Changes in demoralization assessed by questionnaires (Demoralization Scale II (DS-II)) compared with active placebo
Description
Demoralization Scale II (DS-II) scores
Time Frame
baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
Title
Changes in quality of life assessed with a single-item question compared with active placebo
Description
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)
Time Frame
baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
Title
Changes in anxiety, pain levels, quality of life, demoralization, and spiritual well-being shortly after first intervention compared with scores shortly after second intervention
Description
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
Time Frame
post drug visit 1-3 compared with post drug visit 4-6
Title
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
Description
Emotional Condition Rating Scale (ECRS) scores, Hamilton depression (GRID-HAM-D17) and Hamilton anxiety rating scale (HAM-A) scores
Time Frame
baseline, one day before second intervention and 2 and 9 weeks after second intervention
Title
Changes in patient's behaviour and attitudes rated by community observers compared with active placebo
Description
community observer rating: rating of the participant's behaviour and attitudes on 11 items by a contact person
Time Frame
baseline, before second intervention and 2 weeks and 9 weeks after second intervention
Title
Changes in caregiver burden assessed by questionnaire compared with active placebo
Description
Zarit Burden Inventory (ZBI) scores completed by caregiver, total score
Time Frame
baseline, before second intervention and 2 weeks and 9 weeks after second intervention
Title
Associations between acute LSD effects assessed with questionnaires and long-lasting therapeutic effects assessed with questionnaires
Description
acute effects will be assessed using the Mystical experience Questionnaire (MEQ30) and visual analogue scales (VASs)
Time Frame
2,4,6, and 9 weeks after second intervention
Title
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
Title
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
Title
Expectancy as a mediator for treatment effects assessed with questionnaire
Description
modified version of the Credibility / Expectancy Questionnaire (CEQ)
Time Frame
baseline
Title
Assessment of adverse events (AE)
Description
grading according to Common Terminology Criteria for Adverse Events CTCAE Version 5.0, safety measures
Time Frame
during the whole study duration up to 9 weeks after second intervention
Title
Physical and general discomfort during drug sessions using standardized questions (adapted list of complaints)
Description
adapted list of complaints (LC), safety measures
Time Frame
before and 12 hours after drug administration
Title
Changes in vital signs during drug sessions
Description
monitoring blood pressure and heart rate with an automatic oscillometric device, safety measure
Time Frame
before and up to 12 hours after drug administration
Title
Changes in vital signs during drug sessions
Description
monitoring body temperature using an ear thermometer, safety measure
Time Frame
before and up to 12 hours after drug administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yasmin Schmid, MD
Phone
+41613286847
Email
yasmin.schmid@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasmin Schmid, MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Blum, Prof
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasmin Schmid, MD
Phone
+41613286847
Email
yasmin.schmid@usb.ch
First Name & Middle Initial & Last Name & Degree
Aaron Klaiber, MSc
Phone
+41613284567
Email
aaron.klaiber@usb.ch
Facility Name
University Hospital Zurich, Clinic for Radio-Oncology, Competence Centre Palliative Care
City
Zürich
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Blum, Prof
Phone
+41442553742
Email
david.blum@usz.ch

12. IPD Sharing Statement

Learn more about this trial

Lysergic Acid Diethylamide (LSD) in Palliative Care

We'll reach out to this number within 24 hrs