RecruitingPHASE1INTERVENTIONAL

Digital Intervention for Psychedelic Preparation (DIPP): Comparing Meditation and Music-Based Programs

This study, called DIPP (Digital Intervention for Psychedelic Preparation), is for healthy adults exploring how to best prepare for a single psilocybin session. Forty volunteers will use a 21-day digital program, either focused on meditation or music. After this, they will have a supervised 25mg psilocybin session at University College London. Researchers want to see if these programs are easy to use, if people stick with them, and how they impact the quality of the psilocybin experience and overall well-being over several months. The aim is to find effective ways to help people get the most out of potential psychedelic treatments in the future, making the experience as positive as possible.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

University College, London

Enrolment target

Start

01 Mar 2025

Estimated completion

01 Dec 2026

Healthy

What is this study about?

This study is called DIPP, which stands for Digital Intervention for Psychedelic Preparation. It's looking into new ways to help people get ready for a supervised session with psilocybin, a substance found in certain mushrooms. While psilocybin is being explored for its potential to help with mental well-being, the experience itself can sometimes be intense. That's why good preparation is thought to be really important, influencing how positive and helpful the psilocybin session can be both during and long afterwards.

Researchers are testing two different digital programs, each lasting 21 days. One program focuses on meditation, which is known to help people manage their thoughts and feelings. The other uses music as its main activity. Both programs are designed to be self-guided, meaning you can do them on your own using a digital platform. The main goal is to see if these digital tools are practical to use, if people complete them, and how they impact how well prepared someone feels for a psilocybin experience.

After completing their 21-day preparation, participants will have a single 25mg psilocybin session under careful supervision at University College London. The study will then follow up with participants for several months to understand how the preparation programs affected their psilocybin experience and their overall mental well-being over time. This research is important because it could help make potential future psychedelic treatments safer and more effective for those who might benefit from them.

Key takeaways

This study explores digital tools to prepare healthy adults for a psilocybin session.
It compares a 21-day meditation program with a music program.
Participants will have one supervised 25mg psilocybin session.
The study helps understand how preparation affects the psychedelic experience and well-being.
It lasts about 9 months, including online and in-person follow-ups.
This is a research study, not a treatment.

Who may be eligible?

This study is looking for healthy adults aged between 21 and 65 years old. To be considered, you should not have much experience with psychedelics – specifically, no more than five full-dose sessions in your lifetime and none in the last six months. Similarly, you should not be an experienced meditator; less than 10 sessions lasting over 30 minutes and no regular practice or retreats.

You'll need to be a native English speaker, have normal colour vision (or corrected vision), and live in the UK, registered with a GP. You also need to have a smartphone and be able to take part in all parts of the study, both in person and online.

There are several reasons why you might not be able to join. For example, if you have a current or recent history of mental health conditions like depression, anxiety, or especially any psychotic or bipolar disorders. If a close family member has had a psychotic or bipolar disorder, or if you have certain serious physical health problems like heart disease or epilepsy, you won't be able to take part. Also, if you're taking medications that might interact with psilocybin (like certain antidepressants), or if you've used other psychoactive drugs (excluding nicotine or caffeine) in the last month, or if you are pregnant, planning a pregnancy, or breastfeeding, you would be excluded.

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 21 and 65 years old?
Have you had very limited (0-5) or no past psychedelic experiences in the last 6 months?
Are you a native English speaker and live in the UK?
Do you have a smartphone and can you travel to University College London for visits?
Do you have good physical health and no history of serious mental health conditions (like psychosis or bipolar disorder)?
Are you not currently pregnant, planning pregnancy, breastfeeding, or taking interacting medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, here's what you can expect:

* **Preparation Program:** You'll spend 21 days following a digital program on your smartphone. Depending on which group you're assigned to by chance, this will involve either daily meditation activities or daily music listening. Both programs have a similar structure. * **Psilocybin Session:** After the 21-day preparation, you'll have one supervised session where you'll receive a 25mg dose of psilocybin. This will take place at University College London. * **Follow-up Visits:** There will be an in-person follow-up appointment about two weeks after your psilocybin session. After that, you'll complete online assessments at 3 months, 6 months, and 9 months. * **Total Duration:** The entire study, from beginning the preparation program to the final online assessment, will last for approximately 9 months.

Potential risks and benefits

Taking part in this study might offer several potential benefits, such as learning new meditation or music-based skills, and having a supervised psychedelic experience. The information gathered could also help future research into mental well-being. However, there are also potential risks; psilocybin can sometimes lead to challenging or uncomfortable thoughts and feelings, though you will be closely monitored. There's also the commitment involved in regularly engaging with the digital program and attending appointments. It's very important to remember that participation is entirely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

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

University College London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is psilocybin?

Psilocybin is a natural compound found in certain types of mushrooms that can affect your mood, thoughts, and senses. It's being studied for its potential effects on mental well-being.

Is this a new treatment for me?

No, this is a research study investigating how best to prepare for a psilocybin session in healthy individuals. It is not offering a treatment for a specific condition.

Will I know if I'm doing meditation or music?

Yes, you will know which type of digital program you are assigned to. You will either be doing daily meditation or daily music listening.

How often will I need to visit the study site?

You will need to visit the University College London site for your psilocybin session and one follow-up visit two weeks later. Other checks will be done online.

What if I feel uncomfortable during the psilocybin session?

You will be closely supervised by trained professionals during your psilocybin session, who are there to support you and ensure your safety and comfort.

How to find out more

Jeremy I Skipper

dipp-project@ucl.ac.uk +44 (0)20 7679 2000 Official trial record

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