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A Study Testing How Ropinirole Affects Self-Assessment of Thinking Performance and Brain Activity in Healthy Volunteers

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines the effects of a medication called ropinirole in healthy volunteers rather than in people with a specific disease. The research focuses on understanding how this drug affects a person's ability to judge their own thinking and performance, which is called metacognition. Metacognition means being aware of how well one is doing on mental tasks and being able to accurately assess one's own abilities. The study will compare the effects of ropinirole with placebo to see if the medication changes how confident people feel about their answers and how well their confidence matches their actual performance. The medication works by affecting a brain chemical called dopamine, and researchers want to know if changing dopamine levels makes people more overconfident or less able to tell when they have made mistakes.

The purpose of this study is to determine whether a single dose of ropinirole changes metacognitive performance in healthy adults and to understand how brain chemistry affects self-awareness and the ability to monitor one's own thinking. Participants will receive either ropinirole or placebo on different occasions, and they will complete cognitive tasks that test memory and thinking while rating how confident they are in their answers. The study will measure whether the medication makes people feel more or less confident compared to their actual performance and whether it affects their ability to distinguish correct answers from incorrect ones.

During the study, participants will undergo brain imaging using resting-state fMRI, which is a type of scan that shows how different parts of the brain communicate with each other when a person is not performing any specific task. The researchers will look at specific brain networks including the Default Mode Network and Salience Network to see if ropinirole changes the connections between brain regions. Each participant will take part in sessions where they receive either the medication or placebo, complete cognitive tests with confidence ratings, and have brain scans to examine how the drug affects both brain activity and the ability to judge one's own performance.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and preparation

    Your cognitive health will be assessed using a standard mental status examination to confirm eligibility.

    You will be required to abstain from alcohol and any psychotropic substances (substances that affect mental processes) for the entire duration of your participation in the study.

    You must not be taking any medical treatment at the time of participation.

  2. Step 2

    Pre-session preparation

    You will be required to fast for 3 hours before receiving the study medication or placebo. This means no food or drinks (except water) during this time.

    You should plan not to drive until midnight on the day of your session for safety reasons.

  3. Step 3

    Study medication administration

    You will receive either a single oral dose of ropinirole 1 mg (a tablet taken by mouth that affects dopamine in the brain) or a placebo (an inactive tablet with no medication).

    The medication or placebo will be given as a film-coated tablet to be swallowed.

    Neither you nor the study staff will know which treatment you are receiving during the session.

  4. Step 4

    Cognitive testing

    You will complete cognitive tasks that assess your memory and thinking abilities.

    One task will be a modified version of the Rey Auditory-Verbal Learning Test, which involves listening to and remembering words.

    After completing parts of the tasks, you will be asked to rate your confidence in how well you performed.

    These tests measure your ability to accurately judge your own performance, which is called metacognition.

  5. Step 5

    Brain imaging session

    You will undergo a resting-state functional MRI scan (a brain imaging technique that measures brain activity while you rest).

    During this scan, you will lie still in the MRI scanner without performing any specific tasks.

    The scan will measure how different regions of your brain communicate with each other, particularly in networks called the Default Mode Network and Salience Network.

  6. Step 6

    Post-session safety period

    You must continue to avoid driving until midnight on the day of your session.

    You should continue to abstain from alcohol and psychotropic substances throughout your participation in the study.

Who can join the trial?

10 criteria

  • You must be male
  • You must be a nonsmoker
  • You must be cognitively healthy, which means your thinking and memory abilities are normal. This will be checked using a simple test called Mini-Mental State Examination where you need to score 30 points
  • You must be between 20 and 35 years old
  • You must be able to understand and write in Italian
  • You must have completed more than 13 years of education
  • You must agree not to drink alcohol or take any psychotropic substances (substances that affect your mind or mood) for the entire time you are in the study
  • You must agree not to drive until midnight on the day you take part in the study session
  • You must not eat for 3 hours before taking the study drug or placebo (an inactive substance used for comparison)
  • You must not be taking any medical treatment

Who cannot join the trial?

15 criteria

  • Female participants - this study only includes male volunteers
  • Age outside the adult range - only adults can participate in this study
  • Any known allergy or sensitivity to ropinirole (the study medication) or any of its ingredients
  • Current use of medications that may interact with ropinirole, including other drugs that affect dopamine (a chemical messenger in the brain)
  • History of heart disease or problems with blood pressure, as ropinirole can affect heart function and blood pressure
  • History of mental health conditions such as severe depression, psychosis (losing touch with reality), or other psychiatric disorders
  • History of movement disorders such as Parkinson's disease or restless legs syndrome
  • Current or recent use of recreational drugs or history of substance abuse (problems with alcohol or drugs)
  • Liver or kidney disease, as these organs process and remove the medication from your body
  • History of fainting or sudden drops in blood pressure when standing up
  • Sleep disorders such as sudden sleep attacks or severe daytime sleepiness
  • Currently taking part in another research study or have participated in one within the last few months
  • Any serious medical condition that could make taking the study medication unsafe
  • Smoking or use of nicotine products, as these can affect dopamine levels in the brain
  • Inability to understand or follow the study instructions
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Investigated drugs

  • Ropinirole

    is a medication that acts as a dopamine agonist, which means it works by mimicking the effects of dopamine in the brain. Dopamine is a natural chemical messenger that plays a role in movement, mood, and cognitive functions. In this study, ropinirole is being used to see if it affects how well people can judge their own mental performance and confidence in their answers. The researchers want to understand whether increasing dopamine activity in the brain changes a person's ability to accurately assess whether they got something right or wrong.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active drug. It is used as a comparison to help researchers determine whether any effects observed in the study are actually due to the active medication or simply due to participants' expectations or other factors unrelated to the drug itself.

What is already known about the treatment

Ropinirole – Ropinirole is a medication that belongs to a class of drugs called dopamine agonists, which means it works by mimicking the action of dopamine, a natural chemical messenger in the brain that helps control movement and other important functions. It is typically taken by mouth as a tablet and is already approved for medical use, having been proven safe in humans. In this clinical trial, researchers are giving healthy volunteers a single 1 mg oral dose to study how it affects their ability to judge their own thinking accuracy (called metacognition) and how different brain regions communicate with each other at rest, rather than using it to treat a disease.

Investigated diseases

Anosognosia – Anosognosia is a condition in which a person is unaware of their own neurological or cognitive deficits. Individuals with this condition lack insight into their impairments and may deny or fail to recognize symptoms that are obvious to others. This unawareness is not due to denial or psychological defense mechanisms, but rather stems from damage to specific brain regions. The condition can affect the ability to accurately judge one's own performance and capabilities. Anosognosia commonly occurs following stroke, traumatic brain injury, or in progressive neurological conditions. The lack of self-awareness can significantly impact daily functioning and the person's ability to seek or accept help.
Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-520800-81-00Protocol codeUnaWireD-ROPEstimated enrolment20 patientsSponsorUniversita' Degli Studi Di Modena E Reggio Emilia

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