RecruitingPhase IIInterventional

A trial to investigate if psilocybin therapy is effective in improving outcomes for people with opioid use disorder

This research explores if psilocybin therapy can help people move on from opioid addiction. Opioid addiction is a big challenge in the UK, and current treatments don't always stop people from relapsing. The study gives a single dose of psilocybin, alongside psychological support, to people aged 18-64 who have recently stopped using opioids. Researchers will check for changes in opioid use, cravings, and mental well-being for up to three months after the psilocybin dose, and will also look at brain scans. The aim is to understand if this new approach can lead to better long-term recovery and potentially help others with similar struggles.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

Imperial College London

Enrolment target

Start

13 Nov 2025

Estimated completion

06 Jan 2027

Opioid use disorder

What is this study about?

This study is looking into a new way to help people who have recovered from opioid addiction. Opioid addiction is a serious health issue that affects many people in the UK. While there are treatments available, it's common for people to start using opioids again within a year. This research hopes to find a more effective way to support long-term recovery.

The study focuses on something called 'psilocybin therapy'. Psilocybin is a natural compound found in certain mushrooms. Early research suggests it might be helpful for other addictions, like smoking or alcohol. In this trial, people will receive a single dose of psilocybin along with regular talking therapy sessions. The researchers want to discover if this combination helps people stay off opioids and how it might affect their minds and brains.

By taking part, you would be helping us understand if psilocybin therapy can be a valuable new treatment option for opioid addiction. If successful, this research could lead to improved support for many individuals facing similar challenges in the future.

Key takeaways

Exploring psilocybin therapy for opioid addiction recovery.
Combines a single psilocybin dose with ongoing talking therapy.
Aims to understand effectiveness and how it works in the brain.
Could lead to improved future treatments for addiction.
Requires regular hospital visits and detailed assessments.
You can withdraw from the study at any time.

Who may be eligible?

Generally, this study is for adults aged 18 to 64 who have been diagnosed with a moderate to severe opioid use disorder. You must have recently completed a detox from all types of opioids, whether they were illegal (like heroin) or prescribed medications used for treatment (like methadone).

You should also be able to understand and speak English, and be willing to follow the study's instructions. You'll need to have a local doctor (GP) who looks after your general health. If you are able to have children, you and your partner must agree to use effective contraception during the study and for 28 days afterwards.

There are also reasons why you might not be able to join. For example, if you currently have or have had certain serious mental health conditions like psychosis or bipolar disorder, or if you've recently had thoughts or attempts of self-harm. You also can't be suffering from other serious substance use disorders (besides opioids, nicotine, or cannabis) at the time of screening. The study team will check your full medical history to make sure it's safe for you to take part.

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 64 years old?
Have you recently detoxed from all opioids (prescribed or illegal)?
Do you speak and understand English?
Are you currently under the care of a local GP?
Do you have a history of moderate to severe opioid use disorder?
Do you have certain serious mental health conditions (like psychosis or bipolar disorder)?

Answer every question to see your result.

What does participation involve?

If you join this study, your journey will involve a few steps. First, there's a screening process to make sure the study is right and safe for you. If you're eligible, you'll come to Hammersmith Hospital in London for a single dose of the psilocybin medicine. During this time, you'll have trained therapists with you to provide support.

Before and after receiving the psilocybin, you'll have regular talking therapy sessions and check-ups for up to three months. At these appointments, researchers will ask you about your opioid use, any cravings you might have, and your general mental health and well-being using questionnaires and interviews. You'll also have a special type of brain scan called an MRI before the psilocybin dose and again 7 days afterwards, to help researchers understand how it affects the brain. The study team will then contact you after 6 months to see how you're doing. The study is expected to run from July 2024 to June 2027.

Potential risks and benefits

Taking part in this study could offer several potential benefits. You'd be one of the first people to be part of this cutting-edge research, and while we can't promise it will help you directly, psilocybin therapy might be helpful for some. You'll also receive ongoing psychological support, which could provide valuable insights and emotional benefits. By participating, you'll be contributing to scientific knowledge that could lead to better treatments for opioid addiction in the future. However, there are also some potential drawbacks. It will mean more trips to the hospital, which can be time-consuming. You might also feel a bit anxious when you take the psilocybin, or feel uncomfortable during discussions about sensitive life experiences, or when shown drug-related images during the MRI. The study team has measures in place, including therapists and medical staff, to support you through these experiences. If any unexpected medical findings appear on your MRI scan, you will be informed, which could potentially affect future medical insurance. Remember, you can choose to leave the study at any time.

Locations (1)

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

NIHR Imperial Clinical Research Facility
City only
London, England

Common questions

What is psilocybin?

Psilocybin is a natural substance found in certain types of mushrooms, sometimes called 'magic mushrooms'. In this study, it's used alongside therapy.

Will I be monitored closely during the study?

Yes, you will be closely looked after by trained therapists and the medical team, especially when you receive the psilocybin dose and during follow-up appointments.

What happens if I feel uncomfortable during the study?

The study team has support in place, including therapists and medical staff, to help if you feel uncomfortable or upset at any point. You can also discuss your feelings with them.

Do I have to stop all my current medications to join?

You must have completed detoxification from all opioids to join. The study team will review all your medications during the screening process to ensure it's safe for you to participate.

Where is the study taking place?

The study is being run from Imperial College London, with appointments at Hammersmith Hospital.

How to find out more

Hannah Thurgur

h.thurgur@imperial.ac.uk - Official trial record

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