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Not yet recruitingNCT07079852Updated Jun 15, 2026

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

A Phase 1/2 interventional study of Placebo and Psilocybin 15mg in Healthy, sponsored by Manoj Doss. Not yet recruiting at 1 site in United States. Open to participants aged 21 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Manoj Doss · Phase 1/2, Interventional, and Basic science

Phase
Phase 1/2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
21 Years to 45 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Healthy

Keywords

  • psilocybin
  • memory
  • cognition
  • psychedelics
  • fMRI
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In context

Lead sponsor

This is the only study on the registry with Manoj Doss as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 45 Years
Sexes eligible
All
Accepts 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

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).
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Placebo comparator
    placebo

    Capsule containing microcrystalline cellulose

    Drug: Placebo

  • Experimental
    psilocybin

    Capsule containing 15 mg of psilocybin

    Drug: Psilocybin 15mg

Interventions

  • DrugPlacebo

    This is an inactive control condition.

  • DrugPsilocybin 15mg

    This is a moderate psychoactive dose.

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What researchers measure

Primary outcomes

  1. Memory accuracy from performance on a recognition memory test

    Participants 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

    Time frame: 8 weeks

  2. Neural correlates of memory as measured from fMRI

    Participants will be scanned with fMRI to measure brain responses associated with memory.

    Time frame: 8 weeks

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Study locations

1 site
  • The University of Texas at Austin Dell Medical School
    Austin, Texas 78712, United States
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References and documents

Publications

  • Doss MK, Mallaroni P, Mason NL, Ramaekers JG. Psilocybin and 2C-B at Encoding Distort Episodic Familiarity. Biol Psychiatry Cogn Neurosci Neuroimaging. 2024 Oct;9(10):1048-1057. doi: 10.1016/j.bpsc.2024.06.008. Epub 2024 Jun 26. PubMed 38942147 ↗
  • Doss MK, Samaha J, Barrett FS, Griffiths RR, de Wit H, Gallo DA, Koen JD. Unique effects of sedatives, dissociatives, psychedelics, stimulants, and cannabinoids on episodic memory: A review and reanalysis of acute drug effects on recollection, familiarity, and metamemory. Psychol Rev. 2024 Mar;131(2):523-562. doi: 10.1037/rev0000455. Epub 2023 Dec 14. PubMed 38095937 ↗

Individual participant data

Plan to share: Yes — De-identified behavioral and fMRI data

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07079852
Lead sponsor
Manoj Doss
Responsible party
Manoj Doss (Assistant Professor, University of Texas at Austin) — Sponsor-investigator
First posted
Jul 23, 2025
Start date
Sep 2026 (estimated)
Primary completion
Aug 2028 (estimated)
Completion
Aug 2028 (estimated)
Last update
Jun 15, 2026

Study contacts

Manoj Doss, PhD
Contact
manoj.doss@austin.utexas.edu
512-495-5856

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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