Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2024-06-09
2028-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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treatment arm
Subjects in the treatment arm will receive 100 μg LSD (first session) and 100 or 200 μg LSD (second session) per os.
Lysergic Acid Diethylamide Tartrate
100 or 200 μg p.o.
control arm
Subjects in the control arm will receive 25 μg LSD (first session) and 25 μg LSD (second session) per os.
Lysergic Acid Diethylamide Tartrate
25 μg p.o.
Interventions
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Lysergic Acid Diethylamide Tartrate
25 μg p.o.
Lysergic Acid Diethylamide Tartrate
100 or 200 μg p.o.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
22 Years
ALL
No
Sponsors
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University Hospital, Zürich
OTHER
Spital Uster AG, Uster, Switzerland
UNKNOWN
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Yasmin Schmid, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Schipper S, Nigam K, Schmid Y, Piechotta V, Ljuslin M, Beaussant Y, Schwarzer G, Boehlke C. Psychedelic-assisted therapy for treating anxiety, depression, and existential distress in people with life-threatening diseases. Cochrane Database Syst Rev. 2024 Sep 12;9(9):CD015383. doi: 10.1002/14651858.CD015383.pub2.
Other Identifiers
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BASEC 2022-01818
Identifier Type: -
Identifier Source: org_study_id
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