RecruitingNot ApplicableInterventional

Sleep Blinding Psilocybin, a feasibility study: Examining if participants can tell if they received psilocybin or a placebo when medication is given to act in sleep

Depression affects many people, and current treatments don't always work for everyone. Psilocybin, found in 'magic mushrooms', is being explored as a potential new treatment. Normally, drug studies compare a real drug to an inactive dummy pill, with participants unaware of what they've received. This is hard with psilocybin due to its obvious effects. This study aims to find a way to give psilocybin as a tablet during sleep, so participants don't know if they're getting the active drug or a dummy pill. This will help researchers understand how psilocybin works. It involves healthy people who have used psilocybin before and takes place at King's College London.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

King's College London

Enrolment target

Start

01 Jun 2026

Estimated completion

01 Jun 2028

Depression

What is this study about?

Depression is a very common and serious health condition in the UK. Unfortunately, for about one in three people, current treatments don't work as well as hoped. Researchers are looking into new potential treatments, and one of these is psilocybin, which comes from 'magic mushrooms'. While it shows promise, we don't fully understand *how* it helps people.

There are a few ideas about why psilocybin might work. Some think it's because people expect it to help, leading to a positive outcome. Others believe the dream-like experiences it can cause might encourage people to make positive life changes. And finally, some theories suggest psilocybin could cause real changes in the brain, like helping new brain cells grow. Usually, in drug trials, some people get the active drug and others get a dummy pill (placebo), and nobody knows which they've received. This helps researchers see if the drug itself is making a difference, rather than expectations. However, with psilocybin, its effects are very noticeable, making it difficult to 'blind' participants to what they've taken.

This study proposes a clever solution: what if psilocybin could be given to people while they're asleep? The main goal of this research is to develop and test a method where psilocybin is given as a tablet that starts working while participants are asleep. This way, the researchers can see if the effects of psilocybin still happen without the person being fully aware they've taken it, which could help us understand its true impact. This is a "feasibility study," meaning it's testing if this new approach is possible and safe.

Key takeaways

This study explores a new way to test psilocybin (from 'magic mushrooms') for depression.
The main aim is to give psilocybin while people sleep, to understand how it truly works.
It involves healthy volunteers who have used psychedelics before.
Participation includes screening, dosing visits, and follow-up checks.
You won't know if you're getting psilocybin or a dummy pill in the main phase.
The study runs from June 2026 to January 2029 at King's College London.

Who may be eligible?

This study is looking for healthy people aged between 18 and 65 years old. To take part, you must have experience with psychedelics or other mind-altering substances (like ketamine) in the past. You should be willing to attend all study visits and follow the study instructions.

There are several reasons why someone might not be able to participate. You cannot take part if you are pregnant or breastfeeding. You also can't join if you currently have a mental health diagnosis or a history of certain conditions like bipolar disorder, personality disorder, or psychotic disorder. Significant suicidal thoughts in the past or any current suicidal thoughts would also prevent participation, as would certain physical health issues or problems with sleep.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Have you used psychedelics or similar mind-altering substances before?
Are you currently in good physical health?
Do you have no current mental health diagnosis, or a history of certain serious mental health conditions?
Are you not pregnant or breastfeeding?
Are you willing and able to attend all study visits and procedures?

Answer every question to see your result.

What does participation involve?

If you are eligible, the study involves two main phases. The first phase has three stages, each with different participants to test various aspects of giving psilocybin during sleep. Each stage includes an initial screening visit to check if you're suitable, a dosing visit where you'll receive medication, and then remote follow-up calls or online check-ins 7 and 14 days later.

In Stage 1, you'll take psilocybin that is designed to start working after a delay, while you are awake. Researchers will observe how long it takes for the effects to begin. In Stage 2, you'll either receive psilocybin or a dummy pill before you go to sleep at the study site. If it affects your sleep, the researchers might test giving you mild sleeping aids to help you stay asleep. Stage 3 will involve awake participants taking psilocybin and mild sleeping aids together, to understand how these substances interact.

The second phase of the study will involve 16 participants. You will have two separate sessions, six weeks apart. In one session, you will receive psilocybin, and in the other, you will receive an inactive dummy pill. You won't know which you're getting each time. This phase will likely involve taking the medication before sleep, similar to Stage 2. You'll have screening visits, dosing visits, and follow-up checks for each session. The entire study is expected to run from June 2026 to January 2029.

Potential risks and benefits

Participating in this study means you'll be contributing to important medical research that could help people with depression in the future. Some individuals might also experience positive feelings from the psilocybin. However, it's really important to understand the potential risks. Not everyone will be eligible, and even if you are, the study team can decide not to give you psilocybin if they think it's unsafe. Psilocybin might make you feel worse or cause new, unwanted symptoms. While rare in clinical settings, some people using 'magic mushrooms' recreationally have reported long-lasting visual disturbances or unpleasant feelings. The study will also ask personal questions about your life, which could be upsetting. You'll need blood tests, which might cause some pain, bruising, or a small risk of infection. You are free to withdraw from the study at any time without giving a reason.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

South London and Maudsley NHS Foundation Trust
Unverified
Beckenham, England

Common questions

What is psilocybin?

Psilocybin is a natural substance found in certain types of mushrooms, often called 'magic mushrooms'. It can affect your mind and senses.

Why is the study trying to give psilocybin to people while they sleep?

This is to see if psilocybin still works without people knowing they've taken it, which helps researchers understand its true effects better, rather than effects due to expectation.

Will I know if I'm getting psilocybin or a dummy pill?

In the main part of the study, you will not know whether you have received psilocybin or the inactive dummy pill. This is an important part of how research is done.

What kind of follow-up will there be after taking the medication?

After each dosing session, there will be remote follow-up checks (likely phone calls or online forms) at 7 and 14 days to see how you are doing.

Where is this study taking place and who is running it?

The study is being run from King's College London in the UK, and it is funded by the Medical Research Council (UK).

How to find out more

Raphael Rifkin-Zybutz

sleepy@kcl.ac.uk - Official trial record

Always speak to your GP or specialist before deciding to take part in a study.