Psilocybin for Enhanced Analgesia in Chronic nEuropathic PAIN
This research is investigating if a substance called psilocybin, sometimes found in 'magic mushrooms', can help ease ongoing nerve pain. Many people talk about psychedelics as 'miracle cures', but there isn't much scientific proof yet. This study aims to bridge that gap by being one of the first to properly test psilocybin's effects on chronic neuropathic pain. The study involves 30 volunteers from St. Michael's Hospital. Some will receive psilocybin, and others will get an 'active placebo' (dextromethorphan), all given as a single dose. Researchers will closely monitor for safety, how well people tolerate it, and any pain relief. The main goal is to figure out if it's possible and practical to plan a much larger study in the future. It's not about finding a cure yet, but gathering important early information.
At a glance
What is this study about?
This research is called the PEACE-PAIN Trial, and it's looking into whether a substance called psilocybin might help people who have chronic neuropathic pain. This is a type of long-lasting pain that comes from nerve damage. You might have heard of psilocybin because it's naturally found in what are sometimes called 'magic mushrooms'. While some people talk a lot about psychedelics as potential 'miracle cures', there isn't much proper scientific evidence yet to back this up, especially for pain relief. This study aims to help fill that gap by taking a closer look.
This is a Phase 2 study, which means it's an early-stage trial. The main purpose right now isn't to prove that psilocybin is a definite treatment, but rather to see if it's safe, if people can tolerate it well, and if it's practical to carry out a bigger study down the line. Researchers are particularly interested in how easy it is to find suitable participants, if people stick with the study, and if there are any unexpected problems. They will also be looking for early signs of whether psilocybin has any effect on pain levels.
To do this, 30 participants will be recruited from St. Michael's Hospital. They will be randomly placed into one of two groups: one receiving psilocybin and the other receiving something called an 'active placebo' (dextromethorphan). Neither the participants nor the healthcare team will know who is getting which substance. This helps make the study as fair and unbiased as possible. Everyone involved will also receive psychological support. The study will monitor participants for about three months after they take their single dose, checking in regularly to see how they are doing.
Key takeaways
- This is an early study exploring psilocybin for chronic nerve pain.
- It aims to see if a larger study is practical and safe.
- Participants will receive a single dose of either psilocybin or an active placebo.
- Regular follow-up appointments will occur over three months.
- Both psychological support and close monitoring will be provided.
Who may be eligible?
To be considered for this study, you need to be an adult between 18 and 65 years old and have a confirmed diagnosis of moderate-to-severe chronic nerve pain from a pain specialist. You should have tried at least two recommended pain medications in the past without much improvement. You also need to be able to understand and speak English well enough to take part in talking therapies.
There are also reasons why you might not be able to join. For example, if you have a history of certain mental health conditions like a primary psychotic disorder, bipolar disorder, or if you've had issues with substance abuse in the last year. You also can't participate if you've used any similar psychedelic drugs before, or if you are pregnant or breastfeeding. People with certain serious medical conditions, or those taking medications that could react badly with the study drugs, would also not be eligible.
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 18 to 65 years old?
- Do you have moderate-to-severe chronic nerve pain diagnosed by a specialist?
- Have you tried at least two different nerve pain medications without much success?
- Can you speak and understand English well enough for talking therapies?
- Have you never used psychedelic drugs before?
- Are you not pregnant or breastfeeding?
What does participation involve?
If you decide to take part in this study, you'll be part of a 'randomised controlled double-blinded trial'. This means you'll be randomly assigned to one of two groups: one will receive a single dose of 25mg psilocybin, and the other will receive a single dose of 400mg dextromethorphan (the active placebo). Neither you nor the study team will know which you've received. Both groups will also receive psychological support.
After taking the dose, you'll have follow-up check-ins on days 1, 7, 14, 30, and 90. These check-ins will help the researchers understand how you're feeling, if there are any changes in your pain, and if you're experiencing any side effects. The total duration of your active participation, including the dose day and follow-ups, will be about three months.
Potential risks and benefits
Locations (2)
- St. Michael's Hospital. Unity Health TorontoVerified postcodeToronto, Canada· Not yet recruiting
- St. Michael's Hospital. Unity Health TorontoVerified postcodeToronto, Canada· Recruiting
Common questions
What is chronic neuropathic pain?
It's a type of long-lasting pain caused by damage to the nerves.
What is psilocybin?
Psilocybin is a natural substance found in certain types of mushrooms, sometimes called 'magic mushrooms'.
What is an 'active placebo'?
It's a substance, in this case dextromethorphan, that can also have noticeable effects, so participants might not easily guess if they've received the actual study drug or not.
Will I be given 'magic mushrooms'?
No, you will be given a carefully measured dose of pure psilocybin in a controlled medical setting, not whole mushrooms.
What does 'double-blinded' mean?
It means neither you nor the doctors and nurses involved in your care will know whether you are receiving psilocybin or the placebo. This helps prevent bias.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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