HealthyPhase 1/2NCT07079852
The Acute Effects of Psilocybin on Cognition, Memory, and Brain Function
A Phase 1/2 study testing Psilocybin 15mg in people with Healthy, run by Manoj Doss at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Psilocybin 15mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas at Austin Dell Medical School
Austin, Texas, 78712
Manoj Doss, PhD, 512-495-5856, manoj.doss@austin.utexas.edu
Manoj Doss, PhD
About this study
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.
- Conditions
- Healthy
- Being tested
- Placebo, Psilocybin 15mg
- Keywords
- psilocybin, memory, cognition, psychedelics, fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
This is an inactive control condition.
Psilocybin 15mgDrug
This is a moderate psychoactive dose.
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | Capsule containing microcrystalline cellulose Receives: Drug: Placebo |
| psilocybin | Experimental | Capsule containing 15 mg of psilocybin Receives: Drug: Psilocybin 15mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Neural correlates of memory as measured from fMRI
Participants will be scanned with fMRI to measure brain responses associated with memory.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will receive both interventions in counterbalanced order.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manoj Doss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manoj Doss, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079852
- Sponsor's protocol ID
- mindflux
- Status last verified
- Jun 2026
- First submitted
- 10 Jul 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified behavioral and fMRI data
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 38942147Doss 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Psilocybin on Cognition, Memory, and Brain Function
- ClinicalTrials.gov ID
- NCT07079852
- Acronym / sponsor ID
- mindflux
- Conditions
- Healthy
- Keywords
- psilocybin, memory, cognition, psychedelics, fMRI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Manoj DossUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will receive both interventions in counterbalanced order.
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: PlaceboCapsule containing microcrystalline cellulose |
| psilocybin | Experimental | Drug: Psilocybin 15mgCapsule containing 15 mg of psilocybin |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (17 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThis is an inactive control condition. | Drug | placebo |
| Psilocybin 15mgThis is a moderate psychoactive dose. | Drug | psilocybin |
Primary outcome
Memory accuracy from performance on a recognition memory test
Time frame: 8 weeks
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
Neural correlates of memory as measured from fMRI
Time frame: 8 weeks
Participants will be scanned with fMRI to measure brain responses associated with memory.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Background: PubMed 38942147Doss 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.
- Background: PubMed 38095937Doss 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.
- Individual participant dataSharing planned: Yes. De-identified behavioral and fMRI data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Psilocybin 15mg in people with Healthy, run by Manoj Doss at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manoj Doss, PhD (512-495-5856, manoj.doss@austin.utexas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory accuracy from performance on a recognition memory test (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07079852, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.