Lysergic Acid Diethylamide (LSD) in Palliative Care

Psilocybin LSD

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.

Intervention / Treatment

  • Lysergic Acid Diethylamide Tartrate (DRUG)
    100 or 200 μg p.o.

Condition or Disease

  • Palliative Care
  • Pain
  • Anxiety
  • Depression
  • Demoralization
  • Psychological Distress
  • Quality of Life
  • Caregiver Burden
  • Fear of Death
  • Existential Distress

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Recruiting
    Study results: No Results Available
    Enrollment: 60 (ESTIMATED)
    Allocation: Randomized
    Primary Purpose: Supportive Care

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Sep 01, 2023 ESTIMATED
    Primary Completion: Sep 01, 2027 ESTIMATED
    Completion Date: Sep 01, 2027 ESTIMATED
    Study First Posted: Jun 01, 2023 ACTUAL
    Last Updated: Aug 10, 2023

    Sponsors / Collaborators

    Lead Sponsor: University Hospital, Basel, Switzerland
    Lead sponsor is responsible party
    Responsible Party: N/A

    Participant Groups

    • 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.

    Eligibility Criteria

    Sex: All
    Minimum Age: 25
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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.

    This clinical trial is recruiting

    Are you interested in participating in this trial or others? We'd love to help.

    Primary Outcomes

    • State anxiety inventory (STAI-S) scores, 20 items

    Secondary Outcomes

    • State anxiety inventory (STAI-S) scores, 20 items

    • 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 concomitant medication will be assessed several times over whole study duration up to 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

    • Demoralization Scale II (DS-II) scores

    • 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)

    • 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

    • Emotional Condition Rating Scale (ECRS) scores, Hamilton depression (GRID-HAM-D17) and Hamilton anxiety rating scale (HAM-A) scores

    • community observer rating: rating of the participant's behaviour and attitudes on 11 items by a contact person

    • Zarit Burden Inventory (ZBI) scores completed by caregiver, total score

    • 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 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 baseline, 2 days after each intervention, 2 weeks and 9 weeks after second intervention

    • modified version of the Credibility / Expectancy Questionnaire (CEQ)

    • grading according to Common Terminology Criteria for Adverse Events CTCAE Version 5.0, safety measures

    • adapted list of complaints (LC), safety measures

    • monitoring blood pressure and heart rate with an automatic oscillometric device, safety measure

    • monitoring body temperature using an ear thermometer, safety measure

    More Details

    NCT Number: NCT05883540
    Other IDs: BASEC 2022-01818
    Study URL: https://clinicaltrials.gov/study/NCT05883540
    Last updated: Sep 29, 2023