RecruitingPHASE1INTERVENTIONAL

Treatment of Persisting Symptoms After Concussion With Psilocybin Assisted Therapy

This study aims to discover if a new approach, using psilocybin (a natural substance) alongside talking therapy, can help adults aged 18 to 65 who are still experiencing symptoms long after a concussion. Researchers want to see if this treatment is safe and practical to use, and if it can reduce the burden of these lasting symptoms. Participants will receive either a high or low dose of psilocybin during a session, followed by several weeks of a specific type of talking therapy called Acceptance and Commitment Therapy (ACT). The study will then check their progress at various points over six months to understand how effective the treatment might be for improving their well-being.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

University of Calgary

Enrolment target

Start

27 May 2025

Estimated completion

30 Mar 2027

Persisting Symptoms After Concussion

What is this study about?

If you've had a concussion, sometimes the symptoms — like headaches, dizziness, or trouble concentrating — can last a long time. This can be really frustrating and impact your daily life. This study is exploring a new way to help people aged 18 to 65 who are dealing with these ongoing symptoms after a concussion, sometimes called PSaC.

The research looks at a special type of treatment that combines 'psilocybin' with talking therapy. Psilocybin is a natural compound found in some mushrooms. It's given in a carefully controlled medical setting. The talking therapy, called Acceptance and Commitment Therapy (ACT), helps people develop new ways to handle their thoughts and feelings. The main goals are to see if this combined treatment is safe to use, if it's practical for people to take part in, and most importantly, if it can actually reduce the problems caused by lasting concussion symptoms.

Researchers will compare a higher dose of psilocybin with a very low dose psilocybin to see if there's a difference in how people feel. They'll also be tracking things like headaches, dizziness, mood, anxiety, and overall quality of life over several months to understand the full impact of the treatment. This is a Phase 1 study, which means it's one of the first steps in testing a new treatment, focusing on safety and whether it's possible to do on a larger scale.

Key takeaways

This study explores a combination of psilocybin and talking therapy for long-lasting concussion symptoms.
It's a Phase 1 study, focusing on safety and how practical the treatment is.
Participants will receive either a high or very low dose of psilocybin in a controlled setting.
The treatment involves a special type of talking therapy called Acceptance and Commitment Therapy (ACT).
Participation lasts approximately six months, with follow-up checks.
You won't know if you're getting the high or low dose of psilocybin.

Who may be eligible?

This study is looking for adults between 18 and 65 years old who have been diagnosed with a concussion and are still experiencing bothersome symptoms. Your ongoing concussion symptoms must have started at least three months ago, but not more than five years ago. You also need to be able to read and write in English to participate.

There are certain reasons why you might not be able to join. For example, if you've recently had a serious problem with drug or alcohol misuse (other than nicotine), or if you or a close family member has ever been diagnosed with conditions like schizophrenia or bipolar disorder. Also, if you’ve had recent thoughts of harming yourself, are currently pregnant or breastfeeding, or have certain other medical conditions like epilepsy or uncontrolled diabetes, you wouldn't be able to take part.

The researchers will screen you very carefully to make sure it's safe for you to participate. This includes checking your general health and medical history, as well as if you've recently taken part in another clinical trial.

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 been diagnosed with a concussion, and are still experiencing symptoms that started between 3 months and 5 years ago?
Do you have ongoing bothersome symptoms like headaches or dizziness from your concussion?
Do you feel emotionally well enough, without recent thoughts of harming yourself?
Are you able to speak and understand English?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, your journey will involve a few key steps over about six months:

1. **Screening:** You'll go through a detailed two-part check to make sure the study is right and safe for you. 2. **Initial Assessment:** You'll have a first meeting to take measurements of your symptoms and understand your current health. 3. **Preparation Sessions:** You'll attend one or more sessions to learn about the treatment and how to prepare for the psilocybin session. 4. **Psilocybin Session:** You'll visit the clinic for a single session where you will receive either a higher dose (25mg) or a very low dose (1mg) of psilocybin. You'll be carefully supported during this time. 5. **Talking Therapy:** After the psilocybin session, you'll have five weekly sessions of Acceptance and Commitment Therapy (ACT), a type of talking therapy. 6. **Follow-up:** You'll be asked to provide updates on your symptoms and well-being at 1 week, 4 weeks, 3 months, and 6 months after your psilocybin session. The final 6-month check-in will be done online. The total duration of your active participation will be around six months.

Potential risks and benefits

Taking part in this study could potentially help reduce your ongoing concussion symptoms, possibly improving your mood, anxiety, and overall quality of life. However, it's important to remember that this is a research study, and we don't yet know if this treatment will definitely work or be better than other options. Potential risks related to psilocybin include temporary changes in perception, mood, or anxiety, though these will be managed in a controlled setting. There's also the chance you might not experience any benefit. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

University of Calgary
Verified postcode
Calgary, Canada· Recruiting

Common questions

What is psilocybin?

Psilocybin is a natural substance found in certain types of mushrooms that can temporarily change how you think and feel. In this study, it's given in a controlled medical setting.

What is Acceptance and Commitment Therapy (ACT)?

ACT is a type of talking therapy that helps people learn to accept difficult thoughts and feelings, and then commit to actions that align with their values and goals.

Will I know if I'm getting the high or low dose?

No, you won't know whether you're receiving the high dose (25mg) or the very low dose (1mg) psilocybin. This is to ensure the study results are fair and unbiased.

How long do the concussion symptoms need to have lasted?

Your concussion symptoms need to have been ongoing for at least three months, but not more than five years, since your concussion.

Are there any costs involved in joining the study?

The study aims to cover your participation without cost to you, but specific details regarding travel or other expenses would be discussed during the screening process.

How to find out more

Chantel T Debert, MD MSc FRCPC

cdebert@ucalgary.ca (403) 944-4500 Official trial record

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