Not yet recruitingPHASE2INTERVENTIONAL

Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder

This study is investigating a new treatment called psilocybin-assisted therapy for adults who are struggling with both major depression and alcohol addiction. Researchers aim to find out how safe and practical this therapy is by comparing it to a dummy treatment (placebo). They will monitor participants closely to see if there are side effects or if people stop participating. The main goal is to understand if this therapy could be a helpful option for these conditions, looking at things like how well people tolerate it and any significant differences between the treatment and placebo groups.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Centre for Addiction and Mental Health

Enrolment target

Start

01 Mar 2026

Estimated completion

01 Jun 2028

Major Depressive Disorder (MDD)Alcohol Use Disorder (AUD)

What is this study about?

This study is a clinical trial looking into a new way to help people who are experiencing both depression and alcohol problems at the same time. It's called psilocybin-assisted therapy. Psilocybin is a substance that, in a controlled medical setting, is being explored for its potential therapeutic effects. The therapy involves carefully guided sessions to help participants explore their thoughts and feelings.

The main aim of this research is to understand if this therapy is safe and if it could be an effective treatment for these two challenging conditions. Researchers want to see how easy it is to carry out this type of treatment, how well people tolerate it, and if there are any major side effects. They will be comparing the real treatment with a 'placebo' – a dummy treatment that looks just like the real thing, but without the active substance. This helps them understand what effects are truly due to the psilocybin.

By comparing these two groups, scientists hope to learn if psilocybin-assisted therapy can make a real difference for people with major depression and alcohol use disorder. They are looking for clear answers on whether it's a helpful and manageable treatment option for the future.

Key takeaways

This study explores a new therapy for depression and alcohol problems.
It uses psilocybin in a guided therapy setting.
You might receive real psilocybin or a placebo (dummy treatment).
Participation involves 14 visits, some in-person, some remote.
You would need to stop certain current medications if deemed safe by your doctor.
The study aims to understand its safety and effectiveness.

Who may be eligible?

This study is looking for adults aged between 18 and 65 years old. To join, you need to understand the study and be able to provide your agreement to take part. You should also be able to read and communicate in English well enough to understand the study materials.

You must have a diagnosis of both major depression (without psychotic features) and a moderate or severe alcohol use disorder. It's important that you're not currently taking antidepressant, antipsychotic, or certain anti-alcohol medications, and you must be willing to stop other specific medications if your doctor confirms it's safe for you to do so.

For women who could become pregnant, you would need to use effective contraception before and during the study. You should also be generally healthy enough for the study procedures and willing to follow the treatment plan.

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?
Do you have a diagnosis of both major depression and alcohol dependence?
Are you willing and able to stop certain medications if your doctor says it's safe?
Can you understand and speak English well enough for the study?
Are you able to use effective contraception if you could become pregnant?
Are you generally healthy enough to take part?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to either receive the psilocybin treatment or a placebo (a dummy treatment). You will have a total of 14 visits, which will be a mix of in-person appointments and remote check-ins. During these visits, you'll complete various tasks related to the study.

The psilocybin-assisted therapy itself will happen at five different times throughout the study. This means you won't be taking the treatment every day, but at specific appointments. The total duration of your participation will include these visits and follow-ups to monitor your progress and safety.

Potential risks and benefits

Taking part in this study could offer the potential benefit of a new therapeutic approach for your depression and alcohol use disorder, though there's no guarantee of personal benefit as it's a research study. Potential risks include side effects from the study medication, emotional challenges during therapy sessions, and the need to stop other medications, which your doctor must confirm is safe. You will be closely monitored by medical staff for your safety. Remember, participating is entirely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it won't affect your future medical care.

Locations (1)

Centre for Addiction and Mental Health
Verified postcode
Toronto, Canada

Common questions

What is psilocybin-assisted therapy?

It's a treatment under study where psilocybin, a substance from certain mushrooms, is given in a controlled medical setting alongside therapy sessions to help with mental health conditions. It's not the same as recreational use.

Will I know if I'm getting the real drug or a placebo?

No, you won't know because the study is 'blinded.' This is important so researchers can accurately measure the true effects of the psilocybin compared to the dummy treatment.

Can I keep taking my current depression or alcohol medication?

Generally no, you would need to stop certain medications before and during the study. Your doctor would need to agree that it's safe for you to do this.

What does 'comorbid' mean?

Comorbid means having two medical conditions at the same time. In this study, it refers to experiencing both major depression and alcohol use disorder.

How many times will I visit the clinic?

You will have 14 visits in total, which will include both in-person appointments and remote (online or phone) check-ups.

How to find out more

Bernard Le Foll

bernard.lefoll@camh.ca +14165358501 Official trial record

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