An interventional study of Placebo and Psilocybine in Healthy, sponsored by University of Zurich. Completed. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by University of Zurich · Not applicable, Interventional, and Basic science
The aim of the study is to identify neural signatures, behavioral and phenomenological expressions of self-related processes including: sense of agency, semantic distinction between self and other, selflessness (altruism), social agency, embodied self (interoception), perceptual functioning of dissolved self including hallucinations and crossmodal processing, and finally the mystical type dissolution of the self.
Four placebo-controlled, double blind sets of procedures using psilocybin with four independent study groups will be conducted. The number of subjects, testing procedures and dose of psilocybin for each group are as follows: group 1 (20 subjects, EEG, questionnaires, 0.200 mg/Kg body weight), group 2 (30 subjects, functional magnetic resonance imaging (fMRI), questionnaires, 0.200 mg/Kg body weight), group 3 (10 subjects, fMRI, questionnaires, 0.215 mg/Kg body weight), study group 4 (80 subjects, blood serum and saliva parameters, questionnaires, fMRI (only in 20 subjects from this group), 0.315 mg/Kg body weight). The groups 1, 2 and 3 involve healthy volunteers. The group 4 involves healthy volunteer long-term and short-term meditators during a 5-day group meditation retreat. Together, 140 subjects will participate in the study.
University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.
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Further inclusion criteria for the Study Group 4:
Exclusion Criteria:
Further exclusion criteria for the Study Group 2, 3 and 4:
The presence of any one of the above mentioned exclusion criteria will lead to exclusion of the subject.
Group 1: randomized, placebo-controlled, double-blind, cross-over design
Drug: Placebo · Drug: Psilocybine
Group 2: randomized, placebo-controlled, double-blind, cross-over design
Drug: Placebo · Drug: Psilocybine
Group 3: randomized, placebo-controlled, double-blind, cross-over design
Drug: Placebo · Drug: Psilocybine
Group 4: randomized, placebo-controlled, double-blind, matched group design
Drug: Placebo · Drug: Psilocybine
100% lactose
Study Group 1: 0.250 mg/Kg weight Study Group 2: 0.200 mg/Kg body weight Study Group 3: 0.215 mg/Kg body weight Study Group 4: 0.315 mg/Kg body weight
fMRI resting state activity (BOLD signal)
Time frame: 60 minutes
EEG measurement (ERPs)
Time frame: 60 minutes
Subjective effects will be assessed with the 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)
Total score of the 5D-ASC (5-Dimensional Altered States of Consciousness Rating Scale). Consists of 94 items which are rated on a visual analogue scale (100 millimeters in length). The scale ranges from 0 (no alterations) to 100 (maximum alterations). The items are scored by measuring the millimeters from the low end of the scale to the participant's mark (from 0 to 100).
Time frame: 7 hours
Mood changes will be assessed with the Positive and Negative Affect Schedule (PANAS)
The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of 10 positive and 10 negative valence word items. Each item is rated on a 5-point likert scale with a range from 1 (not at all) to 5 (very much). The final score of the PANAS Scale is the sum of the 10 terms on the positive scale in which a higher score indicates increased positive affect, with a subscale range of 10 to 50 and the sum of the 10 terms on the negative scale in which a higher score indicates more negative affect, with a subscale range of 10 to 50.
Time frame: 7 hours
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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University of Zurich