RecruitingPHASE2INTERVENTIONAL

Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder

This study is investigating a new treatment for Generalised Anxiety Disorder (GAD) using a swallowed liquid form of psilocybin. The main goals are to check its safety, see if people experience uncomfortable side effects, and find out if it can help reduce anxiety symptoms. This is a "Phase 2" study, meaning it's an earlier stage of research, testing if the treatment works and if it's safe enough to study further. Participants will go through a screening process, a four-week initial treatment phase where everyone knows what they're getting, and then a four-week phase where some get psilocybin and others get a dummy treatment (placebo) without knowing which one they have.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Queen's University

Enrolment target

Start

06 May 2025

Estimated completion

30 Aug 2026

Generalized Anxiety Disorder (GAD)

What is this study about?

Many people struggle with Generalised Anxiety Disorder (GAD), which causes ongoing worry and tension that can be hard to control. Researchers are always looking for new and better ways to help those affected. This study is exploring a specific medication called psilocybin, given as a liquid you swallow, to see if it could be a helpful treatment for GAD.

The main purpose of this study is to learn more about how safe psilocybin is, if people can take it without too many unwanted side effects, and if it shows early promise in reducing anxiety symptoms. It's important to remember that this is an early-stage study, so it's about gathering information rather than knowing for sure if it's a widely effective treatment yet. Comparing it to a placebo (a dummy treatment) helps us understand if any improvements are truly due to the psilocybin or just other factors.

By taking part, you would be contributing to understanding potential new treatments for anxiety. The information gathered from people like you will help doctors and scientists decide if this treatment should be studied on more people in the future, potentially leading to new options for those living with GAD.

Key takeaways

This study explores psilocybin as a potential new treatment for anxiety.
It's a Phase 2 study, focused on safety and early signs of effectiveness.
You might receive psilocybin or a 'dummy' treatment (placebo).
Participation involves regular clinic visits, assessments, and phone/email check-ins.
The study lasts several months, with different treatment stages.
You can leave the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be an adult between 18 and 60 years old. You must have been diagnosed with Generalised Anxiety Disorder (GAD) for at least a year and have a certain level of anxiety that your doctor will measure. Your scores on two specific anxiety questionnaires need to be 14 or higher.

If you're currently taking medication for anxiety, you might need to stop it at least four weeks before the study starts. Women who could become pregnant will need to use effective birth control during the study and for a month afterwards. This also applies to men who could father children.

It's important that you're able to give your full written consent to take part after you understand everything about the study. A full medical check-up will also be done to make sure it's safe for you to participate.

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 60 years old?
Do you have a diagnosis of Generalised Anxiety Disorder (GAD) for at least one year?
Do you have moderate to severe anxiety symptoms, as measured by a doctor?
Are you able to stop any current anxiety medications (if applicable) at least 4 weeks before the study starts?
Are you able to use suitable birth control if you could father a child or become pregnant?

Answer every question to see your result.

What does participation involve?

Taking part in this study involves several stages over a few months. First, there's a "Screening Phase" that can last up to four weeks. During this time, you'll have medical checks, a chat with a mental health professional, and some questionnaires to see if the study is right for you.

If you qualify, you'll enter a "Run-in Phase" which lasts four weeks. During this phase, you'll come to the clinic once a week, and the study team will also contact you by phone or email weekly. You'll have safety checks, some tests to measure your thinking skills, brainwave tests (EEG), and you'll fill out questionnaires about how you're feeling.

After this, if your GAD symptoms have shown enough improvement, you'll move to a "Double-blind Treatment Phase" for another four weeks. In this phase, you'll either receive the psilocybin liquid or a dummy treatment (placebo) through a process like a lottery – neither you nor your doctors will know which one you're getting. You'll continue with safety checks, cognitive tests, EEGs, and questionnaires at different points during this time. The study finishes with a final check-up two weeks after your last treatment to see how you're doing.

Potential risks and benefits

Participating in this study might offer a potential benefit of an improvement in your anxiety symptoms, especially if you receive the active psilocybin treatment. However, there's also a possibility you might receive the placebo and not experience any direct benefit from the study medication. As with any medication, there could be potential risks including side effects from psilocybin, which the study will carefully monitor. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Kingston General Health Research Institute
Verified postcode
Kingston, Canada· Recruiting

Common questions

What is psilocybin?

Psilocybin is a natural substance found in certain types of mushrooms that can affect your thoughts, feelings, and senses when taken.

What does 'Phase 2' mean for a clinical trial?

Phase 2 means this is an earlier stage of research where doctors are mainly checking if the treatment is safe, if people can tolerate it, and if it shows any signs of working to help the condition.

What is a 'placebo'?

A placebo is adummy treatment that looks exactly like the real medication but contains no active drug. It helps researchers see if the real drug is truly effective.

How long will I be in the study?

The study involves a screening phase of up to 4 weeks, followed by an initial 4-week treatment phase, another 4-week treatment phase with either psilocybin or placebo, and then a final check-up 2 weeks later. So, it could be around 3-4 months in total.

Will I know if I'm getting the actual medication or the placebo?

During the main treatment phase, it's a 'double-blind' study, meaning neither you nor the doctors will know if you're receiving the psilocybin or the placebo. This helps make the study results fair and accurate.

How to find out more

Claudio N Soares, MD, PhD, FRCPC, MBA

claudio.soares@kingstonhsc.ca 1-613-548-3232 Official trial record

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