RecruitingPHASE2INTERVENTIONAL

Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder

This research is investigating if a single dose of psilocybin, given together with a specific type of talking therapy called motivational enhancement therapy (MET), can help adults who struggle with alcohol reduce their heavy drinking. Participants, aged 22-65, have been diagnosed with an alcohol use disorder. They will be split into two groups: one receiving a higher dose of psilocybin and another receiving a very low dose. Everyone will attend five weekly therapy sessions. Researchers will track how much alcohol participants drink over 12 weeks to see if the psilocybin and therapy combination is effective in helping them cut down on heavy drinking days. The study includes brain scans and other checks.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of Calgary

Enrolment target

128

Start

20 Mar 2024

Estimated completion

01 Oct 2027

Alcohol Use Disorder Alcoholism

What is this study about?

This study is looking into new ways to help people who are finding it hard to control their drinking. It’s focusing on whether a substance called psilocybin, which is found in certain mushrooms, could be helpful when combined with talking therapy. The therapy used in this study is called motivational enhancement therapy, or MET, which helps people find their own reasons and motivation to make changes.

The main aim is to see if a single dose of psilocybin, alongside these therapy sessions, can help people with alcohol use disorder reduce how often they drink heavily. They want to compare a higher dose of psilocybin with a very low dose, which acts as a comparison. Everyone in the study will get the therapy, so researchers can understand if the psilocybin itself adds an extra benefit.

They're inviting men and women between the ages of 22 and 65 who have been diagnosed with an alcohol use disorder. The study will track participants' drinking habits over a few months to see if the combination of psilocybin and therapy makes a positive difference in reducing heavy drinking days.

Key takeaways

Exploring if psilocybin with therapy can help reduce heavy drinking.
For adults aged 22-65 with alcohol use disorder.
Involves a single psilocybin dose and five therapy sessions.
Participation includes health checks and follow-ups over 12 weeks.
Contributes to understanding new treatment options.
Your health and safety are the top priority throughout.

Who may be eligible?

To join this study, you would need to have been diagnosed with an alcohol use disorder, which means you've been having problems with alcohol that are causing issues in your life. You also need to have been drinking heavily in the past month and genuinely want to cut down on how much alcohol you consume.

There are certain reasons why you wouldn't be able to take part. For example, if you have recently had serious issues with other substances (besides nicotine or alcohol), or if you've been diagnosed with certain mental health conditions like schizophrenia or bipolar disorder. If you've had recent thoughts about harming yourself, or if you are pregnant, breastfeeding, or trying to get pregnant, you also wouldn't be eligible.

Finally, the research team will do medical checks, including an ECG (heart tracing), a physical exam, and blood tests. If any of these show significant problems, you might not be able to participate. They also ask about any past use of hallucinogenic drugs and may have limits on who can join based on that.

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 22 and 65 years old?
Have you been told you have an alcohol use disorder?
Have you been drinking heavily in the last month?
Do you genuinely want to drink less alcohol?
Are you able to attend appointments for about 12 weeks?
Do you have a personal or family history of schizophrenia or bipolar disorder? (If yes, you likely can't join.)

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is a thorough check-up to make sure the study is right for you. This will include medical and psychological assessments, blood tests, and possibly brain scans.

If you're eligible, you'll be randomly assigned to receive either a higher dose of psilocybin or a very low dose. You won't know which dose you're getting. After this single dose, you'll have five weekly talking therapy sessions (Motivational Enhancement Therapy).

Throughout the study, which lasts about 12 weeks, the research team will regularly check your drinking habits at 1, 4, and 12 weeks after you receive the psilocybin dose. You'll also have follow-up brain scans and other assessments. The total duration of your active participation, including all follow-ups, will be around 12 weeks.

Potential risks and benefits

Taking part in a research study has potential benefits and risks. You might benefit from receiving therapy and focused support for your alcohol use, and you could potentially reduce your heavy drinking. You would also be contributing to important research that could help others in the future. However, taking psilocybin can have psychological effects, and while you'll be carefully monitored by trained professionals, there's always a possibility of uncomfortable feelings or experiences. The research team will explain all known risks to you. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it will not affect 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 affect your mood, thoughts, and senses. In this study, it's given in a controlled medical setting.

What is Motivational Enhancement Therapy (MET)?

MET is a type of talking therapy designed to help you explore your own motivation to make positive changes, like reducing your drinking habits.

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

No, you won't know which dose you're getting. This is a common practice in research called 'blinding' to make sure the results are fair and unbiased.

How long will I be in the study?

The study involves a single dosing session, five weekly therapy sessions, and follow-up checks over about 12 weeks in total.

Can I stop participating if I want to?

Yes, you are free to leave the study at any time, for any reason, and it won't affect your medical care.

How to find out more

Kaitlin O'Grady

pactlab@ucalgary.ca 587-893-0257 Official trial record

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