Psilocybin for Mental Health

MG
Overseen ByMichele Gassman, MA
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Wisconsin, Madison

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how psilocybin, a psychedelic drug, can enhance mood and wellbeing. Researchers seek to understand whether improvements stem from the psychedelic experience itself or direct effects on the brain. Participants will receive psilocybin while awake or asleep, or a placebo, to compare the effects. Ideal candidates are those who feel their overall wellbeing is not optimal and have no serious medical or sleep issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any psychotropic or CNS-altering medications at least 3 months before the screening for this trial.

Is there any evidence suggesting that psilocybin is likely to be safe for humans?

Research has shown that psilocybin, the treatment under study, is generally safe in controlled settings. Studies have found that psilocybin can alter perceptions, leading to changed states without serious harm. It can cause changes in brain activity, but these are not considered dangerous.

When taken while awake, psilocybin can enhance mood and well-being. Some individuals report mild side effects, such as changes in perception or temporary confusion, but these typically resolve on their own.

For those given psilocybin while asleep, studies have shown changes in sleep patterns, such as a longer time to enter REM sleep (the stage where dreams occur). Mild side effects are more common, but serious issues are rare.

Overall, psilocybin is generally well-tolerated in supervised settings. Mild side effects may occur, but they are usually temporary.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for mental health conditions, which often include SSRIs, SNRIs, or psychotherapy, psilocybin offers a novel approach by targeting serotonin receptors in a unique way. Researchers are excited about psilocybin because it may induce rapid and profound changes in mental states, potentially offering relief from symptoms in just a few sessions rather than over weeks or months. Additionally, the ability to administer psilocybin while participants are asleep is a distinctive feature that could enhance the treatment's effectiveness or patient comfort. This innovative use of psychedelics could revolutionize the way mental health conditions are treated, providing a new avenue for those who haven't found success with existing options.

What evidence suggests that psilocybin might be an effective treatment for mental health?

Research has shown that psilocybin can greatly improve mood and help with depression and anxiety. Studies have found that psilocybin works quickly and has long-lasting effects on these symptoms. In many studies, more than half of the participants experienced a decrease in their depression symptoms. Although some research suggests psilocybin might not work for everyone, the overall evidence supports its potential to improve mood. In this trial, participants will receive psilocybin under different conditions: some while awake and others while asleep, to evaluate its effectiveness in various settings.36789

Who Is on the Research Team?

CR

Charles Raison, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

The CoPEWell study is for individuals interested in exploring the effects of psilocybin on mood and well-being. Participants should be willing to potentially experience psychedelic states or receive treatment while asleep, over a period of up to 4 months.

Inclusion Criteria

No exclusionary sleep condition
I am physically healthy with no major medical conditions.
English-speaking (able to provide consent and complete questionnaires)
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Exclusion Criteria

Clinically significant electrocardiogram (ECG)
Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
I do not have any medical or sleep conditions that would exclude me.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive psilocybin or placebo by intravenous infusion while awake or asleep during an overnight dosing visit

4 weeks
1 overnight visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

Long-term follow-up

Participants are assessed for persisting effects of psilocybin on wellbeing and social connectedness

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Psilocybin

Trial Overview

This trial investigates if improvements in mood from psilocybin are due to the 'trip' or direct brain effects. It involves giving participants psilocybin under different conditions (awake/asleep) and comparing results with those given clonidine or a saline placebo.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Psilocybin While Awake, Placebo While AsleepExperimental Treatment3 Interventions
Group II: Placebo While Awake, Psilocybin While AsleepExperimental Treatment3 Interventions
Group III: Placebo While Awake, Placebo While AsleepPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials
1,249
Recruited
3,255,000+

Tiny Blue Dot Foundation

Collaborator

Trials
10
Recruited
660+

Citations

Control Group Outcomes in Trials of Psilocybin, SSRIs, or ...

Meaning The poor control treatment outcomes in psilocybin trials suggest that it may not be as broadly effective for depression as estimated.

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 ...

Psilocybin for major depressive disorder: a systematic review ...

Psilocybin was effective in improving depressive symptoms in over half of the included studies and reduced anxiety symptoms in patients with MDD.

Efficacy and safety of psychedelics for the treatment ...

Clinical trials have revealed that psilocybin has a large, rapid, and persistent effect in the improvement of symptoms of depression and anxiety. The safety ...

Efficacy of psilocybin for treating symptoms of depression

In our meta-analysis we found that psilocybin use showed a significant benefit on change in depression scores compared with placebo. This is ...

The Effects of Daytime Psilocybin Administration on Sleep - PMC

The results revealed prolonged REM sleep latency after psilocybin administration and a trend toward a decrease in overall REM sleep duration. No ...

NCT05592379 | Consciousness, Psilocybin, and Well-Being

The updated protocol entails 2 mg of psilocybin administered via IV infusion combined with 0.2 mg oral clonidine in sleeping subjects. If either the 2-minute or ...

Psilocybin-Induced Psychedelic Experiences During Sleep ...

This trial aims to administer psilocybin (a psychedelic substance) intravenously to people while they sleep, without waking them.

Efficacy and Safety of Psychedelics in Mental Disorder Cases

Psilocybin was associated with a higher risk of adverse events, though no significant increase in serious adverse events was observed. Common ...