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

Switzerland (ICTRP)

ICTRP Studien-ID
NCT05883540 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
Lysergic acid diethylamide (LSD) in palliative care: a randomised, double-blind, active-placebo controlled phase II study (LPC-Study) (BASEC)

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

Öffentlicher Titel
Lysergic Acid Diethylamide (LSD) in Palliative Care (ICTRP)

Untersuchte Krankheit(en)
Palliative CarePainAnxietyDepressionDemoralizationPsychological DistressQuality of LifeCaregiver BurdenFear of DeathExistential Distress (ICTRP)

Untersuchte Intervention
Drug: Lysergic Acid Diethylamide TartrateDrug: Lysergic Acid Diethylamide Tartrate (ICTRP)

Studientyp
Interventional (ICTRP)

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

Ein-/Ausschlusskriterien
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:

- 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 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. (ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
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 demoralization assessed by questionnaires (Demoralization Scale II (DS-II)) 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 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)

Registrierungsdatum
nicht verfügbar

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
University Hospital, Z�rich;Spital Uster AG, Uster, Switzerland (ICTRP)

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

Sekundäre IDs
BASEC 2022-01818 (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT05883540 (ICTRP)