Healthy ParticipantsPhase 1PSILOBIOMARKERNCT07433452
The Effects of Psilocybin in Healthy Volunteers: Psychological, Biochemical and Electrophysiological Biomarkers.
A Phase 1 study testing Psilocybin (drug) in people with Healthy Participants and Placebo - Control, run by Gabriella Gobbi.
Trial summary
In this study, participants will received either psilocybin (the active ingredient found in certain mushrooms) or an inactive placebo (a look-alike tablet with no active drug). The psilocybin is supplied by Filament Health (Burnaby, British Columbia). Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Placebo - Control, Psilocybin
- What is being tested?
- Psilocybin (drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or Female adults ages 21-65 at the time of screening.
- Females of childbearing potential must have a negative pregnancy test at all designated visits.
- Have a self-reported interest in psychedelic drugs and altered states of consciousness.
- Never have used a classic, serotonergic psychedelic (such as psilocybin, psilocybin, LSD, or ayahuasca) or a dissociative anesthetic such as ketamine or PCP), or maximum one experience 5 years before the study starting without untoward effects.
- Participants must be free of current or past substance use dependence or disorders, as determined by a semi-structured clinical interview for DSM-5 diagnoses (SCID-DSM-5).
- Have a Body Max Index (BMI) 18-34 kg/m2 and an abdomen circumference ≤ 90 for women and 97 for men.
- In the investigator's opinion, participants are reliable and willing and able to comply with the protocol requirements and procedures.
- In addition to meeting the inclusion criteria outlined, it is important to develop a positive rapport between all individuals both participating in and coordinating the study.
Who cannot join
- Any psychiatric, cardiovascular, neurological, or other disorders that may be aggravated by participation in the study, or complicate interpretation of the study's results.
- Any substance use disorder.
- For women, a positive pregnancy test, or not using a reliable method of birth control.
- Personal or family history of severe psychiatric disorders (schizophrenia, bipolar disorder, addiction, ASD) and/or psychosis in the first and second degree.
- During the interview family history is asked in detail. Example: Did your parents or grandparents received a diagnosis of schizophrenia, bipolar disorder, depression.... Did somebody die by suicide? ...Did somebody was hospitalized in a psychiatric hospital? Did somebody in the family was judged "strange"? Different? Even if 40 years ago the diagnosis of depression or bipolar disorder was less precise, do you have the impression that somebody was sick?
- A resting blood pressure > 140 systolic and 90 diastolic (mmHg).
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- Cardiovascular diseases including valvulopathy.
- Current tricyclic antidepressant, lithium, SSRIs, first- and second-generation ketamine antipsychotics, or MAOI prescription regimen.
- Current dietary supplementation of 5-hydroxytryptophan and St. John's Wort.
- Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure e.g. CLRC < 30 ml/min etc.).
- History of serious suicide attempts requiring hospitalization.
- Significant history of mania (determined by study psychiatrist and medical records).
- Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin, e.g. borderline personality disorder.
- Blood or needle phobia.
- Participants who do not agree to use an acceptable contraceptive method throughout their participation in study.
- Use of contraindicated medication.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
In this study, participants will received either psilocybin (the active ingredient found in certain mushrooms) or an inactive placebo (a look-alike tablet with no active drug). The psilocybin is supplied by Filament Health (Burnaby, British Columbia).
After psilocybin ingestion, the body quickly converts it into psilocin, which is the form that produces the temporary psychological effects. Psilocin mainly works by interacting with serotonin receptors in the brain, especially a type called the 5-HT2A receptor.
Read more
This study will be done in healthy volunteers using a single oral dose of 25 mg (one tablet by mouth), consistent with doses used in previous clinical research.
The goal is to understand the biological, psychological, and high-density EEG (hd-EEG) changes that can happen after a one-time dose of psilocybin.
- Conditions
- Healthy Participants, Placebo - Control, Psilocybin
- Being tested
- Psilocybin (drug), Placebo
- Keywords
- psychdelics, biomarkers, hd-EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (drug)Drug
Also called Placebo
One arm will receive psilocybin 25 mg
PlaceboDrug
One group will receive a placebo pill
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Active comparator | Not described Receives: Drug: Psilocybin (drug) |
| Placebo | Placebo comparator | Psilocybin vs Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
2 AG (pmol/mL) , 2 OG (pmol/mL) , AEA (pmol/mL) , OEA (pmol/mL) , PEA (pmol/mL)
Plasmatic Endocannabinoids
Measured: Baseline to 7 days post-dose
Trp (μg/mL) , Kyn (ng/mL) , Kyn/Trp*1000 , 5 HT (ng/mL)
Tryptophan Pathways
Measured: Baseline to 7 days post-dose
Secondary outcomes (4)
Interpersonal Reactivity Index (IRI)
Interpersonal Reactivity Index (IRI, 28 items): A multidimensional assessment of empathy. There are 4 subitems measuring Perspective Taking, the tendency to spontaneously adopt the psychological point of view of others; Fantasy, one's tendency to transpose themselves imaginatively into the feelings and actions of fictitious characters; Empathic Concern, feelings of sympathy and concern for unfortunate others; and Personal Distress, feelings of personal anxiety and unease in tense interpersonal settings.
Measured: Baseline to 7 days post-dose
Multifaceted Empathy Test (MET) Scores
The Multifaceted Empathy Test (MET) is used to measure empathy competence. It consists of a series of photorealistic images showing people in emotionally charged situations. The test yields two primary sub-scores: 1) Cognitive Empathy: Participants infer the mental state of the person in the image; 2) Emotional Empathy: Participants rate their own emotional reaction to the image (e.g., "How much do you feel for this person?"). Responses are typically recorded on a Likert scale (e.g., 1-9), where 1 represents "not at all" and 9 represents "very strong." Scores are summed for each component, with higher scores indicating higher levels of empathy.
Measured: Baseline to 7 days post-dose
Profile of Mood States (POMS)
POMS is a 65 item scales which assesses transient mood states in individuals 18 and older. The scale has been widely used within clinical psychiatric and psychotherapeutic environments for the purpose of assessing individuals' mood-related treatment responses. There are 6 subscales, including Tension-Anxiety, Depression, Anger-Hostility, Fatigue, Confusion-Bewilderment, and Vigour-Activity. The scale has been validated widely and possesses test-retest reliability.
Measured: From Baseline to 1 week after treatment
High Density Electroecephalogram (hd-EEG)
High-density electroencephalography (hd-EEG) is a non-invasive method used to record electrical brain activity from multiple electrodes placed on the scalp. This technique provides detailed information about brain function and neural activity. In this study, hd-EEG will be used to assess changes in brain activity following study drug administration. The procedure is painless and involves wearing an electrode cap for approximately 20-40 minutes.
Measured: Before the administration of psilocybin or placebo and during the effect of the drug (about 6 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gabriella Gobbi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gabriella Gobbi, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433452
- Sponsor's protocol ID
- PSILO-2026-11722
- Acronym
- PSILOBIOMARKER
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Psilocybin in Healthy Volunteers: Psychological, Biochemical and Electrophysiological Biomarkers.
- ClinicalTrials.gov ID
- NCT07433452
- Acronym / sponsor ID
- PSILOBIOMARKER / PSILO-2026-11722
- Conditions
- Healthy Participants, Placebo - Control, Psilocybin
- Keywords
- psychdelics, biomarkers, hd-EEG
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gabriella GobbiUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 25 Feb 2026 (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.
In this study, participants will received either psilocybin (the active ingredient found in certain mushrooms) or an inactive placebo (a look-alike tablet with no active drug). The psilocybin is supplied by Filament Health (Burnaby, British Columbia).
After psilocybin ingestion, the body quickly converts it into psilocin, which is the form that produces the temporary psychological effects. Psilocin mainly works by interacting with serotonin receptors in the brain, especially a type called the 5-HT2A receptor.
This study will be done in healthy volunteers using a single oral dose of 25 mg (one tablet by mouth), consistent with doses used in previous clinical research.
The goal is to understand the biological, psychological, and high-density EEG (hd-EEG) changes that can happen after a one-time dose of psilocybin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psilocybin | Active comparator | Drug: Psilocybin (drug) |
| Placebo | Placebo comparator | Drug: PlaceboPsilocybin vs Placebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or Female adults ages 21-65 at the time of screening.
- Females of childbearing potential must have a negative pregnancy test at all designated visits.
- Have a self-reported interest in psychedelic drugs and altered states of consciousness.
- Never have used a classic, serotonergic psychedelic (such as psilocybin, psilocybin, LSD, or ayahuasca) or a dissociative anesthetic such as ketamine or PCP), or maximum one experience 5 years before the study starting without untoward effects.
- Participants must be free of current or past substance use dependence or disorders, as determined by a semi-structured clinical interview for DSM-5 diagnoses (SCID-DSM-5).
Key exclusion criteria (16 listed)
- Any psychiatric, cardiovascular, neurological, or other disorders that may be aggravated by participation in the study, or complicate interpretation of the study's results.
- Any substance use disorder.
- For women, a positive pregnancy test, or not using a reliable method of birth control.
- Personal or family history of severe psychiatric disorders (schizophrenia, bipolar disorder, addiction, ASD) and/or psychosis in the first and second degree.
- During the interview family history is asked in detail. Example: Did your parents or grandparents received a diagnosis of schizophrenia, bipolar disorder, depression.... Did somebody die by suicide? ...Did somebody was hospitalized in a psychiatric hospital? Did somebody in the family was judged "strange"? Different? Even if 40 years ago the diagnosis of depression or bipolar disorder was less precise, do you have the impression that somebody was sick?
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 |
|---|---|---|
| Psilocybin (drug)Also: PlaceboOne arm will receive psilocybin 25 mg | Drug | Psilocybin |
| PlaceboOne group will receive a placebo pill | Drug | Placebo |
Primary outcome
2 AG (pmol/mL) , 2 OG (pmol/mL) , AEA (pmol/mL) , OEA (pmol/mL) , PEA (pmol/mL)
Time frame: Baseline to 7 days post-dose
Plasmatic Endocannabinoids
Trp (μg/mL) , Kyn (ng/mL) , Kyn/Trp*1000 , 5 HT (ng/mL)
Time frame: Baseline to 7 days post-dose
Tryptophan Pathways
4 secondary outcomes
Interpersonal Reactivity Index (IRI)
Time frame: Baseline to 7 days post-dose
Multifaceted Empathy Test (MET) Scores
Time frame: Baseline to 7 days post-dose
Profile of Mood States (POMS)
Time frame: From Baseline to 1 week after treatment
High Density Electroecephalogram (hd-EEG)
Time frame: Before the administration of psilocybin or placebo and during the effect of the drug (about 6 hours).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin (drug) in people with Healthy Participants and Placebo - Control, run by Gabriella Gobbi.
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 16 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: opening soon, as of the sponsor's last update on 25 Feb 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryam Oraei, MD (+1-514-3984650, maryam.oraei@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 AG (pmol/mL) , 2 OG (pmol/mL) , AEA (pmol/mL) , OEA (pmol/mL) , PEA (pmol/mL) (time frame: Baseline to 7 days post-dose). 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 25 Feb 2026.