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New treatment option for Investigating the Importance of the Subjective Psychedelic Experience
Official title Subjective Experience Following Psilocybin
ClinicalTrials.gov ID: NCT06768944
What this study is testing
What is Psilocybin high-dose?
Psilocybin high-dose is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for investigating the importance of the subjective psychedelic experience.
Also referred to as PEX010, high-dose psilocybin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine the importance of the acute subjective experience induced by psilocybin (the primary component of "magic mushrooms") in facilitating positive outcomes. Participants in this study will be given psilocybin in combination with either a placebo or risperidone, an atypical antipsychotic that block the subjective effects of psilocybin.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Individuals of all sexes, gender identities, and ethnicities
- Ages 18 to 65 years of age at the time of screening
- Ability to read/write in English
- Agree not to consume psychoactive drugs 24 hours before dosing sessions or consume psychedelics during duration of study participation
You likely can't join if
- Any notable abnormality on electrocardiogram or routine medical blood or urinalysis laboratory tests
- Current psychiatric diagnoses, such as: major depressive disorder, generalized anxiety disorder, panic disorder, social anxiety disorder, obsessive...
- Lifetime or current psychiatric diagnoses of: psychosis, schizophrenia, bipolar disorder
- Family history: a first- or second degree relative with a history of schizophrenia or other psychotic disorders, bipolar I or II
- Medication: Any medication with the potential to interact with the investigational medicinal products, especially those with serotonergic mechanisms...
- Currently pregnancy or nursing, trying to become pregnant, or unwilling to use acceptable method of contraception during the study
See the full eligibility criteria
- Individuals of all sexes, gender identities, and ethnicities
- Ages 18 to 65 years of age at the time of screening
- Ability to read/write in English
- Agree not to consume psychoactive drugs 24 hours before dosing sessions or consume psychedelics during duration of study participation
- Any notable abnormality on electrocardiogram or routine medical blood or urinalysis laboratory tests
- Current psychiatric diagnoses, such as: major depressive disorder, generalized anxiety disorder, panic disorder, social anxiety disorder, obsessive compulsive disorder, moderate to severe substance use disorders, eating...
- Lifetime or current psychiatric diagnoses of: psychosis, schizophrenia, bipolar disorder
- Family history: a first- or second degree relative with a history of schizophrenia or other psychotic disorders, bipolar I or II
- Medication: Any medication with the potential to interact with the investigational medicinal products, especially those with serotonergic mechanisms of actions like SSRIs, SNRIs or MAO-Inhibitors as well as other...
- Currently pregnancy or nursing, trying to become pregnant, or unwilling to use acceptable method of contraception during the study
- Current or recent (within 12 weeks) participation in a clinical trial involving medication administration
- Cognitive impairment (Folsetin Mini Mental State Exam score \< 24)
- A disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- Suffered a traumatic brain injury with one of the following symptoms Loss of consciousness \>30min Alteration of consciousness/mental state \>24h Post-traumatic amnesia \>1 day Glasgow Coma Scale (best available score...
- Any other circumstances that, in the opinion of the investigators, compromises participant safety
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.