Authorised Phase II and Phase III (Integrated) Healthy volunteers (mechanistic study evaluating the effect of a single oral dose of ropinirole 1 mg on metacognition and resting‑state functional brain connectivity. Product has MA and has been shown to be safe in humans)

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

EU CTIS ID: 2025-520800-81-00

What this study is testing

The primary objective is to determine whether a single oral dose of the dopamine agonist ropinirole modulates metacognitive performance in healthy adults. Metacognition refers to the ability to reflect on and accurately judge one’s own cognitive performance. By studying metacognition in healthy volunteers, we can probe how neuromodulation might enhance or impair self-monitoring abilities, providing insight relevant to disorders characterized by anosognosia or unawareness of neurological disturbances. Pharmacological studies in healthy people have only recently begun to demonstrate that metacognitive ability is indeed susceptible to drug manipulation. Notably, Hauser et al. (2017) provided the first evidence that a drug can selectively improve metacognitive performance: in a placebo-controlled trial, blocking noradrenergic β-receptors with propranolol significantly increased subjects’ metacognitive accuracy (measured as type-II ROC area) without improving basic task performance. We aim to extend this line of research by testing a dopaminergic agent’s impact on metacognitive abilities. In particular, we hypothesize that increasing dopaminergic tone will transiently alter an individual’s insight into their performance by inducing overconfidence. This hypothesis is supported by preliminary evidence that inducing a transient hyper-dopaminergic state in healthy people can change both brain network dynamics and one’s capacity to judge personal errors. Through a controlled pharmacological challenge, our study will assess whether a single oral dose of the dopamine-agonist ropinirole can measurably improve or impair metacognitive performance on cognitive tasks requiring self-evaluation of accuracy. More precisely, we will use metacognitive measures from experimental psychology (Fleming & Lau, 2014; Ernst et al, 2017) to test the hypothesis that, relative to placebo, a single dose of ropinirole given to healthy volunteers transiently increases metacognitive bias (i.e., the difference between confidence rating and actual performance) and decreases metacognitive relative accuracy (measured as metacognitive efficiency, i.e., the ratio between performance and metacognitive performance, and Goodman–Kruskal Gamma correlation, i.e., the ability to identify with higher confidence correct answers and with lower confidence errors), without affecting the level of the actual cognitive performance. In other words, the primary objective is to test if a single dose of ropinirole makes the subject over-confident about their cognitive performance and decreases how well that participant’s confidence in their answers discriminates correct responses from incorrect ones and predicts whether those answers are correct on a trial-by-trial basis. Demonstrating drug-induced changes in metacognition will contribute to clarify the neurotransmitter systems involved in self-awareness and point toward novel pro-metacognitive interventions for patients with anosognosia or impaired insight.

  • Phase II and Phase III (Integrated)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Male
  • Nonsmoker
  • Cognitively healthy (Mini-Mental State Examination, MMSE=30)
  • Age 20-35
  • Able to understand and write in Italian
  • Years of Education > 13 years

You likely can't join if

  • Known allergy to ropinirole and to eccipients
  • Controindication to MRI (e.g. claustrophobia, metallic implants or foreign bodies, pacemaker)
  • History of neurological or psychiatric conditions at screening visit or from past history
  • Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular or oncologic disease, or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results
  • Evidence of renal (creatinine clearance < 60 mL/min) or hepatic dysfunction (GOT/GPT > 31 U/L) on blood testing at screening or from past clinical history
  • History of substance abuse
See the full eligibility criteria
Who can join
  • Male
  • Nonsmoker
  • Cognitively healthy (Mini-Mental State Examination, MMSE=30)
  • Age 20-35
  • Able to understand and write in Italian
  • Years of Education > 13 years
  • Participants are required to ensure no alcohol or any psychotropic substance intake for all the duration of the study
  • Consent to refrain from driving until midnight in the day of the session
  • Required to fast 3 hours before drug/placebo administration
  • On no medical treatment
What rules you out
  • Known allergy to ropinirole and to eccipients
  • Controindication to MRI (e.g. claustrophobia, metallic implants or foreign bodies, pacemaker)
  • History of neurological or psychiatric conditions at screening visit or from past history
  • Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular or oncologic disease, or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results
  • Evidence of renal (creatinine clearance < 60 mL/min) or hepatic dysfunction (GOT/GPT > 31 U/L) on blood testing at screening or from past clinical history
  • History of substance abuse
  • On medical treatment at screening

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling male, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.