AuthorisedPhase II and Phase III (Integrated)Interventional

THE EFFECT OF ROPINIROLE ON FUNCTIONAL CONNECTIVITY AND METACOGNITION IN HEALTHY SUBJECTS

This study wants to understand how a medicine called ropinirole affects the brain and a person's confidence in their own thinking. Ropinirole is a licensed medicine already known to be safe in humans. Researchers will give a single dose of 1mg ropinirole or a dummy pill (placebo) to healthy men. They will then test how well these men remember things and how confident they are in their answers. The study will also use brain scans (fMRI) to see if the medicine changes how different parts of the brain communicate with each other. The main aim is to see if ropinirole changes how well people judge their own memory and understanding.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Universita' Degli Studi Di Modena E Reggio Emilia

Enrolment target

Start

10 Dec 2025

What is this study about?

This research study is looking into how a common medicine, called ropinirole, affects the healthy brain. Ropinirole is a medicine that's already approved for use and is known to be safe. Researchers are interested in how a single, small dose of this medicine might influence specific brain functions.

Specifically, the study wants to understand two main things: firstly, how ropinirole affects what we call 'metacognition'. This is really about your ability to think about your own thinking – for example, how confident you are in your memory or how well you've understood something. To test this, you'll be asked to do some memory tasks and then rate how confident you are in your answers. Secondly, the study will use special brain scans (fMRI) to observe how different parts of your brain communicate with each other, looking for any changes after taking the medicine.

By comparing the effects of ropinirole to a dummy pill (a placebo), the researchers hope to learn more about how this medicine works in the brain and whether it could potentially help us understand how our brains make decisions and how confident we feel about them. This kind of research helps us learn more about the brain and how medicines interact with it, which can be useful for future medical developments.

Key takeaways

This study explores how a single dose of ropinirole affects healthy men's brains.
It focuses on 'metacognition' (confidence in one's own thinking) and brain connections.
Participants will receive either ropinirole or a dummy pill, and undergo memory tests and brain scans.
Ropinirole is a licensed medicine known to be safe.
Only healthy adult men aged 18 and over can take part.

Who may be eligible?

This study is looking for volunteers who are healthy adult men. You need to be at least 18 years old to take part, and there's no upper age limit, as long as you're in good general health.

The researchers are specifically interested in healthy individuals for this study. This means you shouldn't have any major ongoing health conditions or be taking medicines that might interfere with the study drug.

It's important to note that this study is only open to men. If you are a woman or do not identify as male, you would not be able 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 an adult aged 18 or older?
Do you identify as male?
Are you generally healthy with no major ongoing medical conditions?
Are you not currently taking any regular medicines that might affect the study drug?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit the study centre for a few appointments. During these visits, you'll be given either a single tablet of ropinirole (1mg) or a single dummy pill (placebo). You won't know which one you receive, and neither will the study team, to make sure the results are fair.

You'll be asked to complete some computer-based memory and thinking tests. After answering, you'll also be asked to rate how confident you are in your answers. There will also be some special brain scans (fMRI) to look at your brain activity. The study team will explain everything in detail, including how long each visit will take and when you'll need to attend. There won't be any long-term follow-up after your study visits, as this is a short-term study looking at the immediate effects.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be contributing to important scientific knowledge about how medicines affect the brain. You might also find the experience of learning about research interesting. As ropinirole is an approved medicine, it's generally considered safe, but like all medicines, it can have side effects, which will be fully explained before you agree to take part. These might include feeling sick or dizzy. You are free to ask any questions at any time and can withdraw from the study at any point without giving a reason, and this will not affect your routine medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is ropinirole normally used for?

Ropinirole is commonly used to treat conditions like Parkinson's disease and restless legs syndrome.

What does 'metacognition' mean?

Metacognition is your ability to understand and control your own thinking – like knowing how confident you are in your memory or decisions.

Will I get paid for taking part?

The study information will detail if there is any compensation for your time and travel expenses. This is usually typical for volunteer studies.

Will I know if I received the medicine or the dummy pill?

No, you won't know if you received ropinirole or the placebo until after the study is complete, which is standard practice to ensure fair results.

How long will my involvement in the study last?

This study involves single doses and specific assessments, so your participation will likely involve a few sessions without long-term follow-up.