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The Acute Effects of Psilocybin on Cognition, Memory, and Brain Function

The Acute Effects of Psilocybin on Cognition, Memory, and Brain Function

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07079852
Enrollment
48
Registered
2025-07-23
Start date
2026-09-01
Completion date
2028-08-01
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

psilocybin, memory, cognition, psychedelics, fMRI

Brief summary

This study will test the effects of psilocybin on memory and cognition in healthy participants using computerized tasks and magnetic resonance imaging (MRI).

Detailed description

In a double-blind, placebo-controlled, repeated measures design in healthy participants, this study will test the effects of psilocybin on memory and cognition in healthy individuals using computerized tasks and magnetic resonance imaging (MRI). A better understanding of the basic neurocognitive effects of psilocybin may allow for minimizing potential harms and maximizing potential benefits of psilocybin therapy.

Interventions

DRUGPlacebo

This is an inactive control condition.

This is a moderate psychoactive dose.

Sponsors

Manoj Doss
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-blind, placebo-controlled, crossover masking

Intervention model description

All participants will receive both interventions in counterbalanced order.

Eligibility

Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Memory accuracy from performance on a recognition memory test8 weeksParticipants will be presented with a series of pictures, and their recognition memory for these pictures will be tested by presenting pictures that they previous saw (targets) intermixed with new pictures (lures). Their task will be to respond whether a picture is "old" or "new." Hit rate = p("old"\|target), False alarm rate = p("old"\|lure). Memory accuracy = hit rate - false alarm rate
Neural correlates of memory as measured from fMRI8 weeksParticipants will be scanned with fMRI to measure brain responses associated with memory.

Countries

United States

Contacts

CONTACTManoj Doss, PhD
manoj.doss@austin.utexas.edu512-495-5856

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026