Actively Recruiting

Phase 1
Age: 21Years +
All Genders
Healthy Volunteers
NCT05265546

Investigating the Mechanisms of the Effects of Psilocybin on Visual Perception and Visual Representations in the Brain

Led by University of California, Berkeley · Updated on 2025-10-21

80

Participants Needed

1

Research Sites

94 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The long-term objective of this project is to characterize how psilocybin affects visual perception and the brain's representation of the visual environment. It is known that psilocybin alters aspects of visual perception, but the underlying brain mechanisms contributing to these effects are poorly understood. The proposed work will address these questions in a large, diverse sample of healthy human subjects by using functional magnetic resonance imaging (fMRI) to measure the brain's responses to visual stimuli. The proposed research will document which brain areas mediate the effects of psilocybin. The technique of fMRI will be employed to measure brain activity in different brain areas while subjects are performing a visual perceptual task.

CONDITIONS

Official Title

Investigating the Mechanisms of the Effects of Psilocybin on Visual Perception and Visual Representations in the Brain

Who Can Participate

Age: 21Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Are 21 years of age or older at the time of informed consent
  • Are able and willing to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations
  • Are able to swallow capsules
  • Women of childbearing potential must agree to use effective birth control throughout the study
  • Provide written informed consent and are able to comply with study requirements
  • Have an identified support person and agree to be accompanied home or to a safe destination following dosing
  • Agree to inform investigators within 48 hours of any new or changed medical conditions during participation
Not Eligible

You will not qualify if you...

  • Are breastfeeding, have a positive pregnancy test at screening or any time during the study, or unwilling to use birth control
  • Have a current psychiatric disorder, general medical condition, or other issues that could affect safety or study compliance as judged by study clinician or PI
  • Have contraindications to MRI such as metal implants, pacemakers, or claustrophobia
  • Have uncontrolled hypertension (Systolic BP >139mmHg or Diastolic BP >89mmHg) or tachycardia (average HR >90 bpm) based on at least two measurements
  • Have significant cardiovascular disease or prolonged QT/QTc intervals
  • Have inadequate liver function based on specific lab values, except those with Gilbert syndrome
  • Have inadequate kidney function based on estimated glomerular filtration rate or creatinine clearance
  • Use psychotropic medications such as antidepressants, antipsychotics, or mood stabilizers
  • Are taking psilocybin with known UGT1A10 and UGT1A9 inhibitors
  • Use prohibited medications including SSRIs, SNRIs, TCAs, MAOIs, atypical antidepressants, antipsychotics, anti-epileptics, certain other drugs affecting serotonin or vasoactive drugs within 48 hours of study drug administration
  • Are unable to agree to lifestyle restrictions around alcohol, cannabinoids, prescription drugs, and recreational drug use before and after dosing
  • Have a recent history of suicidal ideation or attempts deemed risky by study clinician or PI
  • Have used an investigational drug or psychedelic within 30 days before screening
  • Have allergies or intolerances to any components of the study drug product

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of California, Berkeley

Berkeley, California, United States, 94720

Actively Recruiting

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Research Team

B

BCSP Staff

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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