LSD (Lysergic acid diethylamide) - Application in patients in palliative care

Switzerland (ICTRP)

ICTRP Trial ID
NCT05883540 (ICTRP)

Official title (approved by ethics committee)
Lysergic acid diethylamide (LSD) in palliative care: a randomised, double-blind, active-placebo controlled phase II study (LPC-Study) (BASEC)

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

Public title
Lysergic Acid Diethylamide (LSD) in Palliative Care (ICTRP)

Disease under investigation
Palliative CarePainAnxietyDepressionDemoralizationPsychological DistressQuality of LifeCaregiver BurdenFear of DeathExistential Distress (ICTRP)

Intervention under investigation
Drug: Lysergic Acid Diethylamide TartrateDrug: Lysergic Acid Diethylamide Tartrate (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

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 (ICTRP)

not available

Primary and secondary end points
Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo (ICTRP)

Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo;Changes in pain levels assessed by questionnaire compared with active placebo;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;Changes in demoralization assessed by questionnaires (Demoralization Scale II (DS-II)) compared with active placebo;Changes in quality of life assessed with a single-item question compared with active placebo;Changes in anxiety, pain levels, quality of life, demoralization, and spiritual well-being shortly after first intervention compared with scores shortly after second intervention;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;Changes in patient's behaviour and attitudes rated by community observers compared with active placebo;Changes in caregiver burden assessed by questionnaire compared with active placebo;Associations between acute LSD effects assessed with questionnaires and long-lasting therapeutic effects assessed with questionnaires;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;Assessment of adverse events (AE);Physical and general discomfort during drug sessions using standardized questions (adapted list of complaints);Changes in vital signs during drug sessions;Changes in vital signs during drug sessions (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
University Hospital, Z�rich;Spital Uster AG, Uster, Switzerland;University Hospital, Geneva (ICTRP)

Additional contacts
Yasmin Schmid, MD;Yasmin Schmid, MD, yasmin.schmid@usb.ch, +41613286847, University Hospital, Basel, Switzerland, (ICTRP)

Secondary trial IDs
BASEC 2022-01818 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/study/NCT05883540 (ICTRP)