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

Randomized, double-blind, placebo-controlled multi-group study (n=140) using single oral doses of psilocybin (0.20–0.315 mg/kg) to probe neural and phenomenological signatures of self-dissolution in healthy volunteers and meditators.

Target Enrollment
140 participants
Study Type
Phase NA interventional
Design
Randomized, double Blind

Detailed Description

Four placebo-controlled, double-blind study groups test single oral doses of psilocybin to characterise neural, behavioural and phenomenological aspects of self-related processes across EEG, fMRI and biological measures.

Groups 1–3 are healthy volunteer cohorts (EEG or fMRI) and Group 4 compares long-term and novice meditators during a 5-day retreat; outcomes include neuroimaging, psychometrics and blood/saliva biomarkers.

Study Arms & Interventions

Psilocybin Group 1

experimental

Randomized, placebo-controlled, double-blind, crossover design; EEG cohort.

Interventions

  • Psilocybin0.25 mg/kg
    via Oral• single dose• 1 doses total

    EEG, questionnaires

  • Placebo
    via Oral• single dose• 1 doses total

    100% lactose placebo

Psilocybin Group 2

experimental

Randomized, placebo-controlled, double-blind, fMRI cohort.

Interventions

  • Psilocybin0.2 mg/kg
    via Oral• single dose• 1 doses total

    fMRI, questionnaires

  • Placebo
    via Oral• single dose• 1 doses total

    100% lactose placebo

Psilocybin Group 3

experimental

Randomized, placebo-controlled, double-blind, fMRI cohort (higher dose).

Interventions

  • Psilocybin0.215 mg/kg
    via Oral• single dose• 1 doses total

    fMRI, questionnaires

  • Placebo
    via Oral• single dose• 1 doses total

    100% lactose placebo

Psilocybin Group 4

experimental

Randomized, placebo-controlled, double-blind, meditator vs novice cohort; blood/saliva and subset fMRI.

Interventions

  • Psilocybin0.315 mg/kg
    via Oral• single dose• 1 doses total

    Blood/saliva, questionnaires; fMRI in 20 subjects

  • Placebo
    via Oral• single dose• 1 doses total

    100% lactose placebo

Participants

Ages
20 – 60
Sexes
Male & Female

Inclusion 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

  • 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, azole-derivative 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.

Study Details

Locations

Switzerland

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