The Acute Effects of Psilocybin on Cognition, Memory, and Brain Function
Launched by MANOJ DOSS · Jul 18, 2025
Trial Information
Current as of August 19, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how psilocybin, a substance found in certain mushrooms, affects memory, thinking skills, and brain activity in healthy adults. To do this, participants will complete computer-based memory and thinking tests and have brain scans using MRI, which is a safe imaging method that takes pictures of the brain.
To be eligible, participants need to be between 21 and 45 years old, have used psychedelic substances between 3 and 30 times in their life, speak English as their first language, have at least a high school education, and be both mentally and physically healthy. They should also be willing to attend all study visits and follow the study rules, including avoiding alcohol and other drugs before sessions. The study is not yet recruiting, and people with certain medical conditions, psychiatric disorders, or who are pregnant will not be able to join. If you meet these criteria and are interested, you can expect to participate in memory and thinking tests and have brain scans while under careful supervision.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 21 to 45-years-old.
- • 3-30 lifetime psychedelic uses.
- • English as a first language.
- • High school education (or equivalent)
- • Psychiatrically healthy (as assessed by the SCID-5).
- • Medically healthy (as assessed by a physical examination and ECG).
- • Willingness to attend all study sessions and complete all procedures.
- • BMI between 19 and 30.
- Exclusion Criteria:
- • Current or past diagnosis of psychiatric disorders except panic attacks, depressive disorder, or anxiety, or disorder from ≥1 year prior.
- • Current or past medical conditions that might interfere with study participation or be contraindicated for psilocybin administration (e.g., hypertension, history of stroke, cardiovascular disease, etc.)
- • Current daily medications except birth control (females).
- • Pregnant, nursing, or planning to become pregnant (assessed with urine pregnancy test).
- • Ingestion of a psychedelic \<2 months prior to an experimental session (with the exception of psilocybin administered in the context of the current study's repeated measures design).
- • History of serious adverse event with a psychedelic and/or self-reported hypersensitivity to psychedelics.
- • Inability to abstain from alcohol 48 hours prior to an experimental session.
- • Use of other psychoactive drugs (other than caffeine or nicotine) 1 week prior to an experimental session.
- • Positive urine drug screening for drugs of abuse during experimental sessions.
- • Self-reported ferrous metal, metallic implants, or implanted medical devices that would preclude participation in MRI procedures, including but not limited to cochlear implants, implanted brain stimulators, and aneurysm clips.
- • Self-reported past penetrating brain injury or any head injury resulting in a loss of consciousness for 30 minutes or more or post-concussive symptoms for more than seven days following a head injury.
- • Self-reported claustrophobia (prohibiting MRI acquisition).
- • Any other factors such as unstable housing or life-threatening circumstances, erratic behavior, etc. that are judged by the investigators to be a significant barrier to participation in the study protocol and/or to establishing rapport necessary for safe administration of psilocybin.
- • Participant unwillingness to not ingest or use additional serotonergic psychedelics outside the context of study procedures for the duration of the study.
- • Resting blood pressure \>140/90 mm hg at study entry.
- • Lifetime history of cardiomyopathy, stroke, heart disease, heart attack, tachycardia, elongated QT-interval corrected by Friderichia (\> 450ms for men and \> 470ms for women); clinically significant cardiac arrhythmia within 1 year of study entry; and/or abnormal electrocardiogram on study entry.
- • Left-handedness (given that functional lateralizations may differ from those of right-handed individuals).
About Manoj Doss
Manoj Doss is a clinical trial sponsor dedicated to advancing medical research through the facilitation and support of innovative clinical studies. With a commitment to improving patient outcomes, Manoj Doss focuses on overseeing the design, implementation, and management of trials that contribute to the development of new therapies and medical interventions. Their role ensures compliance with regulatory standards and promotes ethical conduct throughout the research process.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Austin, Texas, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported