HealthyNCT03736980
Beyond the Self and Back: Neuropharmacological Mechanisms Underlying the Dissolution of the Self
A study testing Psilocybine in people with Healthy, run by University of Zurich.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Psilocybine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2013to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Placebo, Psilocybine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
100% lactose
PsilocybineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin Group 1 | Experimental | Group 1: randomized, placebo-controlled, double-blind, cross-over design Receives: Drug: Placebo; Drug: Psilocybine |
| Psilocybin Group 2 | Experimental | Group 2: randomized, placebo-controlled, double-blind, cross-over design Receives: Drug: Placebo; Drug: Psilocybine |
| Psilocybin Group 3 | Experimental | Group 3: randomized, placebo-controlled, double-blind, cross-over design Receives: Drug: Placebo; Drug: Psilocybine |
| Psilocybin Group 4 | Experimental | Group 4: randomized, placebo-controlled, double-blind, matched group design Receives: Drug: Placebo; Drug: Psilocybine |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI resting state activity (BOLD signal)
Measured: 60 minutes
EEG measurement (ERPs)
Measured: 60 minutes
Secondary outcomes (2)
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).
Measured: 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.
Measured: 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Oct 2013
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Four independent study groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736980
- Sponsor's protocol ID
- 124
- Status last verified
- Nov 2020
- First submitted
- 11 Oct 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond the Self and Back: Neuropharmacological Mechanisms Underlying the Dissolution of the Self
- ClinicalTrials.gov ID
- NCT03736980
- Acronym / sponsor ID
- 124
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Four independent study groups
| Arm | Type | Receives |
|---|---|---|
| Psilocybin Group 1 | Experimental | Drug: Placebo, Drug: PsilocybineGroup 1: randomized, placebo-controlled, double-blind, cross-over design |
| Psilocybin Group 2 | Experimental | Drug: Placebo, Drug: PsilocybineGroup 2: randomized, placebo-controlled, double-blind, cross-over design |
| Psilocybin Group 3 | Experimental | Drug: Placebo, Drug: PsilocybineGroup 3: randomized, placebo-controlled, double-blind, cross-over design |
| Psilocybin Group 4 | Experimental | Drug: Placebo, Drug: PsilocybineGroup 4: randomized, placebo-controlled, double-blind, matched group design |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo100% lactose | Drug | Psilocybin Group 1, Psilocybin Group 2, Psilocybin Group 3, Psilocybin Group 4 |
| PsilocybineStudy 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 | Drug | Psilocybin Group 1, Psilocybin Group 2, Psilocybin Group 3, Psilocybin Group 4 |
Primary outcome
fMRI resting state activity (BOLD signal)
Time frame: 60 minutes
EEG measurement (ERPs)
Time frame: 60 minutes
2 secondary outcomes
Subjective effects will be assessed with the 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)
Time frame: 7 hours
Mood changes will be assessed with the Positive and Negative Affect Schedule (PANAS)
Time frame: 7 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Psilocybine in people with Healthy, run by University of Zurich.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI resting state activity (BOLD signal) (time frame: 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.