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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05883540
Other study ID # BASEC 2022-01818
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 11, 2024
Est. completion date September 2027

Study information

Verified date June 2024
Source University Hospital, Basel, Switzerland
Contact Yasmin Schmid, MD
Phone +41613286847
Email yasmin.schmid@usb.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 2027
Est. primary completion date September 2027
Accepts healthy volunteers No
Gender All
Age group 25 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Lysergic Acid Diethylamide Tartrate
25 µg p.o.
Lysergic Acid Diethylamide Tartrate
100 or 200 µg p.o.

Locations

Country Name City State
Switzerland University Hospital Basel Basel
Switzerland University Hospital Zurich, Clinic for Radio-Oncology, Competence Centre Palliative Care Zürich

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland University Hospital, Zürich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo State anxiety inventory (STAI-S) scores, 20 items baseline, 2 weeks after second intervention
Secondary Changes in state anxiety assessed by questionnaire (state anxiety inventory, STAI-S) compared with active placebo State anxiety inventory (STAI-S) scores, 20 items baseline, 2 days after each intervention, 4 weeks, 6 weeks, and 9 weeks after second intervention
Secondary Changes in pain levels assessed by questionnaire compared with active placebo numeric rating scale (NRS) scores ranging from 0 (no pain) to 10 (maximum imaginable pain) baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
Secondary 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
Secondary 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 Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being; The 12-item Spiritual Well-Being Scale (FACIT-Sp-12) scores baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
Secondary Changes in demoralization assessed by questionnaires (Demoralization Scale II (DS-II)) compared with active placebo Demoralization Scale II (DS-II) scores baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
Secondary Changes in quality of life assessed with a single-item question compared with active placebo 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) baseline, 2 days after each intervention and 2 weeks after second intervention; 4 weeks, 6 weeks, and 9 weeks after second intervention
Secondary Changes in anxiety, pain levels, quality of life, demoralization, and spiritual well-being shortly after first intervention compared with scores shortly after second intervention 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 post drug visit 1-3 compared with post drug visit 4-6
Secondary 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 Emotional Condition Rating Scale (ECRS) scores, Hamilton depression (GRID-HAM-D17) and Hamilton anxiety rating scale (HAM-A) scores baseline, one day before second intervention and 2 and 9 weeks after second intervention
Secondary Changes in patient's behaviour and attitudes rated by community observers compared with active placebo community observer rating: rating of the participant's behaviour and attitudes on 11 items by a contact person baseline, before second intervention and 2 weeks and 9 weeks after second intervention
Secondary Changes in caregiver burden assessed by questionnaire compared with active placebo Zarit Burden Inventory (ZBI) scores completed by caregiver, total score baseline, before second intervention and 2 weeks and 9 weeks after second intervention
Secondary Associations between acute LSD effects assessed with questionnaires and long-lasting therapeutic effects assessed with questionnaires acute effects will be assessed using the Mystical experience Questionnaire (MEQ30) and visual analogue scales (VASs) 2,4,6, and 9 weeks after second intervention
Secondary 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
Secondary 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
Secondary Expectancy as a mediator for treatment effects assessed with questionnaire modified version of the Credibility / Expectancy Questionnaire (CEQ) baseline
Secondary Assessment of adverse events (AE) grading according to Common Terminology Criteria for Adverse Events CTCAE Version 5.0, safety measures during the whole study duration up to 9 weeks after second intervention
Secondary Physical and general discomfort during drug sessions using standardized questions (adapted list of complaints) adapted list of complaints (LC), safety measures before and 12 hours after drug administration
Secondary Changes in vital signs during drug sessions monitoring blood pressure and heart rate with an automatic oscillometric device, safety measure before and up to 12 hours after drug administration
Secondary Changes in vital signs during drug sessions monitoring body temperature using an ear thermometer, safety measure before and up to 12 hours after drug administration
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