18 Participants NeededMy employer runs this trial

Psilocybin for Hallucinations

(PsilBlock1 Trial)

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Overseen ByZarmeen Zahid, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how psilocybin affects sleep and dreaming, particularly when combined with a medication that blocks specific brain receptors. Participants will receive either psilocybin with a placebo or psilocybin with pindolol, a beta-blocker. The study seeks healthy individuals who are psychologically stable, fluent in English, and can refrain from using certain substances before the trial sessions. Participants should not have major psychiatric conditions or heart issues. As an Early Phase 1 trial, this research aims to understand how psilocybin works in people, offering participants the chance to contribute to groundbreaking insights.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before participating in the trial. Specifically, you must not take medications that interact with pindolol, have a serotonergic effect, or are used for sleep. Additionally, you must avoid certain medications like sildenafil within 72 hours of drug sessions and refrain from using psychoactive substances before psilocybin administration.

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

Research has shown that psilocybin, the active ingredient in "magic mushrooms," has been studied for its safety in people. Studies have found it to be generally safe, with few serious long-term side effects. Common short-term effects may include a faster heart rate, higher blood pressure, and mild psychological effects like paranoia, but these typically do not last long.

Limited safety information exists on using psilocybin with pindolol. However, psilocybin alone has been tested in various settings, and its safety record is generally positive. While taking psilocybin, some individuals might experience headaches, nausea, or anxiety, but these effects are usually mild and temporary.

As this trial is in its early stages, it aims to understand the basic safety and effects of the treatment. This means the treatment has not been tested as extensively as it will be in later stages, so the safety information might not be as detailed.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for hallucinations, which often include antipsychotic medications targeting dopamine pathways, psilocybin works differently by affecting serotonin receptors in the brain. Researchers are excited about this treatment because psilocybin has the potential to rapidly alter perceptions and consciousness, offering a novel approach to managing hallucinations. Additionally, the trial explores psilocybin in combination with pindolol, a 5-HT1A antagonist, which may enhance its effects by modulating serotonin pathways more precisely. This dual approach could lead to more effective and faster-acting treatments for individuals experiencing hallucinations.

What evidence suggests that this trial's treatments could be effective for hallucinations?

Research has shown that psilocybin may help reduce symptoms of depression and anxiety, particularly for those experiencing cancer-related stress. Many studies have found that users often experience long-term relief from these conditions. Psilocybin is believed to boost mood and assist with other mental health issues, such as addiction and PTSD (post-traumatic stress disorder). In this trial, participants will receive psilocybin either with a placebo or with pindolol, a medication that affects certain brain receptors. Researchers are still studying the effects of psilocybin when used with pindolol, and data on this combination remains limited. Overall, psilocybin is seen as a promising treatment for mood disorders, and research continues to fully understand its effects.678910

Who Is on the Research Team?

SM

Sandeep M Nayak, MD

Principal Investigator

Center for Psychedelics and Consciousness Research

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 21-60 who are psychologically stable, fluent in English, and not pregnant or nursing. Participants must use effective birth control, avoid psychoactive substances before dosing, have no major heart issues, seizures, serious psychiatric disorders, or sleep problems.

Inclusion Criteria

Females of child-bearing potential must use highly effective birth control methods
I use contraception and will not donate sperm for 90 days after treatment.
Must give written or electronic informed consent
See 7 more

Exclusion Criteria

I do not have serious heart or blood vessel problems.
I have a history of epilepsy or seizures.
I have insulin-dependent diabetes and have had low blood sugar episodes.
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive psilocybin with either pindolol or placebo, with subjective and EEG assessments

10 days
2 dosing sessions

Post-acute Monitoring

Participants complete sleep and dream diaries and wear a sleep EEG device

10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Pindolol
  • Psilocybin

Trial Overview

The study tests how blocking a specific brain receptor (5-HT1A) with pindolol affects the effects of psilocybin compared to placebo. It uses surveys and EEGs to measure immediate experiences and later effects on sleep and dreaming.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Psilocybin co-administered with pindololExperimental Treatment2 Interventions
Group II: Psilocybin co-administered with placeboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Citations

Potential Therapeutic Effects of Psilocybin: A Systematic Review

According to three controlled studies, psilocybin may reduce symptoms of depression and anxiety in the context of cancer-related psychological discomfort.

Survey Illuminates Effects of Real-World Psilocybin Use

A majority of participants experienced persistent reductions in anxiety, depression and alcohol misuse; increased cognitive flexibility, emotion ...

U.S. Psychedelic Use and Microdosing in 2025

This report presents top-line results on the use of 11 psychedelic substances and detailed information about microdosing (i.e., taking a small ...

Efficacy and safety of psychedelics for the treatment ...

Our analyses suggest that psychedelics reduce negative mood, and have potential efficacy in other mental disorders, such as substance-use disorders and PTSD.

Psilocybin for Mental Health and Addiction: What You Need ...

This fact sheet summarizes research on the effectiveness and safety of psilocybin for mental health and addiction.

Psilocybin

The psychological consequences of psilocybin use include hallucinations and an inability to discern fantasy from reality. Panic reactions and a psychotic-like ...

Psilocybin (Magic Mushrooms) | National Institute on Drug ...

There is no data on the safety of taking psilocybin during pregnancy ... psilocybin being studied for safety and efficacy as a medical treatment ...

Psilocybin and magic mushrooms: Effects and risks

Hallucinogenic drugs may cause unpredictable, potentially dangerous behavior, which can lead to injuries. Dried hallucinogenics may also contain ...

Psilocybin (Magic Mushrooms): Side Effects, Benefits, Risks

Magic mushrooms can be harmful if they lead to distressing hallucinations, agitation, or psychosis. So far, no serious long-term side effects have been ...

Psilocybin and psilocin (Magic mushrooms)

For individuals with cardiac diseases, short-term effects such as increased blood pressure and heart rate could potentially be harmful.