Psilocybin for Cognitive Effects in Healthy Subjects

Overseen By Manoj Doss, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Manoj Doss

Must not be taking: Daily medications

Disqualifiers: Psychiatric disorders, Hypertension, Heart disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how psilocybin, a compound found in certain mushrooms, affects memory and thinking skills in healthy individuals. Participants will receive either psilocybin or a placebo (a sugar pill) and complete computer tasks while researchers monitor brain activity using MRI. The trial suits those who have used psychedelics a few times before, are physically and mentally healthy, and can commit to several study sessions. As a Phase 1 trial, this research focuses on understanding psilocybin's effects in people, offering participants a chance to be among the first to explore its impact on cognitive functions.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any daily medications, except for birth control if you are female, to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that psilocybin, the treatment under study, is generally safe when used in a controlled environment. Studies have found that it can increase emotional understanding without significantly affecting social thinking. While it changes brain connections more than substances like methylphenidate, this is part of its intended function.

Regarding side effects, psilocybin can affect thinking and movement, sometimes causing temporary difficulties, especially when its effects peak. However, these effects are short-lived. Other research suggests that psilocybin might aid brain areas involved in learning and memory, potentially benefiting thinking skills.

Overall, psilocybin is considered safe when used in regulated settings with medical supervision. This trial aims to learn more about its effects on memory and thinking in healthy individuals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about psilocybin because it offers a new approach to enhancing cognitive functions. Unlike traditional treatments that often rely on medications like stimulants or cognitive enhancers, psilocybin is a psychedelic compound that could improve cognition by promoting new neural connections. This new mechanism of action sets it apart, as it may lead to different and potentially more profound effects on brain function. Additionally, psilocybin is derived from natural sources, which might result in fewer side effects compared to some synthetic options.

What evidence suggests that psilocybin might be an effective treatment for cognitive effects?

This trial will compare psilocybin with a placebo to study its cognitive effects in healthy subjects. Research has shown that psilocybin can help the brain become more adaptable and open to change. Studies have also found that psilocybin can boost mood and feelings of well-being, especially at higher doses. However, psilocybin might affect some mental skills, such as focusing and decision-making, and can slow reaction times. While psilocybin has been effective in treating depression, its direct effects on memory and thinking in healthy individuals remain not fully understood. Overall, psilocybin seems promising, but its effects can vary based on the dose and the individual. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy individuals who want to participate in a study examining the effects of psilocybin on brain function. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be screened for compatibility with the study's requirements.

Inclusion Criteria

3-30 lifetime psychedelic uses

English as a first language

High school education (or equivalent)

Exclusion Criteria

Current or past diagnosis of psychiatric disorders except panic attacks, depressive disorder, or anxiety disorder from ≥1 year prior

Inability to abstain from alcohol 48 hours prior to an experimental session

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either psilocybin or placebo and undergo computerized tasks and MRI scans

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The trial is testing how a single dose of Psilocybin (15mg) affects cognition, memory, and brain activity compared to a placebo. Participants will undergo computerized tasks and MRI scans to measure these effects.

How Is the Trial Designed?

Group I: psilocybin Experimental Treatment 1 Intervention

Capsule containing 15 mg of psilocybin

Group II: placebo Placebo Group 1 Intervention

Capsule containing microcrystalline cellulose

Who Is Running the Clinical Trial?

Manoj Doss

Lead Sponsor

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11612538/

Impact of psilocybin on cognitive function: A systematic ... Psilocybin was observed to enhance emotional empathy without significantly altering cognitive empathy and social cognition. Cognitive ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05252598

Mood and Cognitive Effects of Psilocybin in Healthy ... Many clinical studies demonstrate the benefit of psilocybin on feelings of depression, mood, and overall feelings of well-being, particularly at higher doses ...

3. nature.com nature.com/articles/s41398-021-01706-y

Psilocybin therapy increases cognitive and neural flexibility ... Psilocybin therapy increased cognitive flexibility for at least 4 weeks post-treatment, though these improvements were not correlated with the previously ...

4. hopkinsmedicine.org hopkinsmedicine.org/psychiatry/research/psychedelics-research

Psychedelics Research and Psilocybin Therapy Previous studies by Johns Hopkins Medicine researchers showed that psychedelic treatment with psilocybin relieved major depressive disorder symptoms in adults ...

5. link.springer.com link.springer.com/article/10.1007/s00213-024-06742-2

Acute effects of psilocybin on attention and executive ... Our meta-analysis shows that psilocybin impairs executive functions and results in a slowing down of RT. We discuss potential neurochemical ...

6. nature.com nature.com/articles/s41586-024-07624-5

Psilocybin desynchronizes the human brain Psilocybin massively disrupted functional connectivity (FC) in cortex and subcortex, acutely causing more than threefold greater change than methylphenidate.

7. mdpi.com mdpi.com/2076-3425/14/3/248

A Systematic Review of the Neurocognitive Effects ... Overall, psilocybin's effects on neurocognitive functions appear to be neutral or impairing, especially in psychomotor tasks during peak drug ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0306987723000646

Psilocybin to promote synaptogenesis in the brains of ... The results of preclinical studies suggest psilocybin may promote synaptogenesis in brain regions associated with learning and memory, possibly facilitated by ...