Status:
COMPLETED
Precision Functional Brain Mapping in Psilocybin
Lead Sponsor:
Washington University School of Medicine
Conditions:
Psilocybin
Eligibility:
All Genders
18-40 years
Phase:
EARLY_PHASE1
Brief Summary
This project will employ functional brain imaging to study the mechanism and immediate and long-term effects of psilocybin, a serotonin receptor 2A agonist, on cortical and cortico-subcortical brain n...
Detailed Description
Psilocybin shows promise as a safe, transformational therapeutic across several psychiatric conditions. However, little is know about its mechanism of action. This study aims to establish a neuroimagi...
Eligibility Criteria
Inclusion
- men and woman between 18 and 40 years of age;
- Have used a psychedelic substance within the previous 5 years but not within the last 6 months
- No active psychiatric conditions requiring treatment with psychotropic medications (may be included if psychiatric condition is stable and participant is willing to discontinue medication for 1 month prior to participation with permission from their treating provider);
- Able to provide informed consent.
Exclusion
- Presence of medical conditions that may confound results of imaging study or that are contraindications to psilocybin exposure (e.g. neurological, renal, hypertension, metabolic or cardiovascular disease or pregnancy);
- No prior exposure to classic psychedelics (psilocybin, LSD, ayahuasca, mescaline);
- Presence of psychiatric conditions that may confound interpretation of results or that are contraindications to psilocybin exposure (e.g. major mood disorder, current substance use disorder, personal or immediate family history (parents, siblings) of any schizophrenia spectrum disorders);
- Use of psychotropic medication during the study;
- Presence of contraindications to MRI scanning (implantable devices, bone hardware, IUD).
- Prior adverse reactions to psychedelics, based on the Challenging Experiences Questionnaire administered during initial screening
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04501653
Start Date
June 1 2021
End Date
March 19 2023
Last Update
October 31 2025
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110