Clinical TrialPalliative & End-of-Life DistressLSDLSDRecruiting

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

Randomised, quadruple-blind, active-placebo controlled parallel trial (n=60) testing two oral LSD sessions (100 µg then 100/200 µg) versus low-dose LSD active-placebo (25 µg ×2) for psychosocial distress in patients with end-stage disease.

Target Enrollment
60 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

This parallel, randomised, quadruple-blind trial will evaluate the effects of two moderate-to-high doses of LSD compared with two low-dose active-placebo sessions on psychosocial distress in patients with end-stage fatal disease (life expectancy ≥12 weeks to ≤2 years).

Participants are allocated 2:1 to experimental or active-placebo arms, receiving two oral LSD sessions; the experimental arm receives 100 µg at session one and 100 or 200 µg at session two, the control arm receives 25 µg at both sessions. Primary outcomes assess depressive and anxiety symptoms, demoralization, quality of life and existential distress; safety and tolerability are monitored throughout.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

LSD high-dose

experimental

Two moderate-to-high oral LSD doses: 100 µg (session 1) and 100 or 200 µg (session 2).

Interventions

  • LSD100 - 200 µg
    via Oral• two sessions• 2 doses total

    Second session 100 or 200 µg

LSD low-dose

active comparator

Active-placebo: two low oral LSD doses (25 µg each).

Interventions

  • LSD25 µg
    via Oral• two sessions• 2 doses total

Participants

Ages
22 – 99
Sexes
Male & Female

Inclusion 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

  • 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 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 or insufficiently treated hypertension, angina pectoris, severe liver disease or severely impaired renal function, or other conditions that in the judgement of the investigators pose too great potential for side effects.
  • Inability to follow the procedures of the study (e.g., language problems, psychological disorders, dementia).
  • 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.

Study Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment60 participants
  • Timeline
    Start: 2023-09-01
    End: 2027-09-01
  • Compounds
    LSDLSD
  • Topic
    Palliative & End-of-Life Distress

Locations

Spital Uster AG — Uster, Canton of Zurich, Switzerland
University Hospital Basel — Basel, Switzerland
University Hospital Zurich, Clinic for Radio-Oncology, Competence Centre Palliative Care — Zurich, Switzerland

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