Beyond the Self and Back: Neuropharmacological Mechanisms Underlying the Dissolution of the Self

NCT03736980 | Completed

• 1 other identifier: 124
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• fMRI resting state activity (BOLD signal)

  60 minutes

• EEG measurement (ERPs)

  60 minutes

Secondary Outcomes (2)

• Subjective effects will be assessed with the 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)

  7 hours

• Mood changes will be assessed with the Positive and Negative Affect Schedule (PANAS)

  7 hours

Study Arms (4)

Psilocybin Group 1

EXPERIMENTAL

Group 1: randomized, placebo-controlled, double-blind, cross-over design

Drug: Placebo; Drug: Psilocybine

Psilocybin Group 2

EXPERIMENTAL

Group 2: randomized, placebo-controlled, double-blind, cross-over design

Drug: Placebo; Drug: Psilocybine

Psilocybin Group 3

EXPERIMENTAL

Group 3: randomized, placebo-controlled, double-blind, cross-over design

Drug: Placebo; Drug: Psilocybine

Psilocybin Group 4

EXPERIMENTAL

Group 4: randomized, placebo-controlled, double-blind, matched group design

Drug: Placebo; Drug: Psilocybine

Interventions

Placebo DRUG

100% lactose

Psilocybin Group 1; Psilocybin Group 2; Psilocybin Group 3; Psilocybin Group 4

Psilocybine DRUG

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

Psilocybin Group 1; Psilocybin Group 2; Psilocybin Group 3; Psilocybin Group 4

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female volunteers at the age of 20-40 y (Group 1, 2 and 3) and 20-60 y (Group 4)
• Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
• Willing to refrain from drinking alcohol the day before testing session, from drinking alcohol and caffeinated drinks at the testing days and from consuming psychoactive substances 2 weeks before testing days and for the duration of the study.
• Able and willing to comply with all study requirements
• Informed consent form was signed
• over 5000 hours of meditation experience (40 participants)
• meditation naive (with no experience in meditation) or with a low experience in meditation (as a criterium the total amount of less than \<100 hours of meditation experience will be used) (40 participants)

You may not qualify if:

• Poor knowledge of the German language
• Previous significant adverse response to a hallucinogenic drug
• Participation in another study where pharmaceutical compounds will be given
• Self or first-degree relatives with present or antecedent psychiatric disorders
• History of head trauma or fainting
• Recent cardiac or brain surgery
• Current use of medication known to affect brain function (e.g. benzodiazepines, antihistamines, aspirin, beta blockers, theophylline, azetazolamide, etc.)
• Concomitant therapy with potent inhibitors of cytochrome P-450 isoenzyme 3A4 (HIV protease inhibitors, macrolide antibiotics, azolederivative anti-infective agents)
• Presence of major internal or neurological disorders (including sepsis, pheochromocytoma, thyrotoxicosis, drug-induced fibrosis, familiar or basilar artery migraine)
• Cardiovascular disease (hypertonia, coronary artery disease, heart insufficiency, myocardial infarction within the past 6 months, coronary spastic angina)
• Peripheral vascular disease (thromboangiitis obliterans, luetic arteritis, severe arteriosclerosis, thrombophlebitis, Raynaud's disease)
• Liver or renal disease
• Pregnant or breastfeeding women (a urine pregnancy test will be done for all women capable of bearing children)
• Women of childbearing potential who are not using effective, established contraception, such as oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
• Inability to lie still for about 60 minutes (e.g. because of sneezing, itching, tremor, pain)

Sponsors & Collaborators

• University of Zurich: lead

MeSH Terms

Interventions

Psilocybin

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Four independent study groups

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: November 9, 2018
• Study Start: October 1, 2013
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share