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

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ClinicalTrials.gov Identifier: NCT03736980
Recruitment Status : Active, not recruiting
First Posted : November 9, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
University of Zurich

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Placebo Drug: Psilocybine Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Four independent study groups
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Beyond the Self and Back: Neuropharmacological Mechanisms Underlying the Dissolution of the Self
Actual Study Start Date : October 1, 2013
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Arm Intervention/treatment
Experimental: Psilocybin Group 1
Group 1: randomized, placebo-controlled, double-blind, cross-over design
Drug: Placebo
100% lactose

Drug: Psilocybine
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

Experimental: Psilocybin Group 2
Group 2: randomized, placebo-controlled, double-blind, cross-over design
Drug: Placebo
100% lactose

Drug: Psilocybine
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

Experimental: Psilocybin Group 3
Group 3: randomized, placebo-controlled, double-blind, cross-over design
Drug: Placebo
100% lactose

Drug: Psilocybine
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

Experimental: Psilocybin Group 4
Group 4: randomized, placebo-controlled, double-blind, matched group design
Drug: Placebo
100% lactose

Drug: Psilocybine
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




Primary Outcome Measures :
  1. fMRI resting state activity (BOLD signal) [ Time Frame: 60 minutes ]
  2. EEG measurement (ERPs) [ Time Frame: 60 minutes ]

Secondary Outcome Measures :
  1. Subjective effects will be assessed with the 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) [ Time Frame: 7 hours ]
    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).

  2. Mood changes will be assessed with the Positive and Negative Affect Schedule (PANAS) [ Time Frame: 7 hours ]
    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.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Further inclusion criteria for the Study Group 4:

  • 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)

Exclusion Criteria:

  • 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

Further exclusion criteria for the Study Group 2, 3 and 4:

  • Inability to lie still for about 60 minutes (e.g. because of sneezing, itching, tremor, pain)
  • Metal parts in the body (piercings, brain aneurysm clip, implanted neural stimulator/cardiac pacemaker/defibrillator/Swan Ganz catheter/insulin pump, cochlear implant); metal shrapnel or bullet, ocular foreign body (e.g. metal shavings); current or previous job in metalworking industry
  • Claustrophobia

The presence of any one of the above mentioned exclusion criteria will lead to exclusion of the subject.


Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03736980     History of Changes
Other Study ID Numbers: 124
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psilocybin
Hallucinogens
Physiological Effects of Drugs
Psychotropic Drugs