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2025-520800-81-00Not yet recruitingPhase 2/3

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Sept 2026

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Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
20 (estimated)
First submitted
19 Aug 2025
Start date
Dec 2025
Lead sponsor
Universita' Degli Studi Di Modena E Reggio Emilia
EU CT number
2025-520800-81-00

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 20
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Controindication to MRI (e.g. claustrophobia, metallic implants or foreign bodies, pacemaker)

Other illness

  • Known allergy to ropinirole and to eccipients
  • 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
  • History of substance abuse

Lab values

  • 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

Other

  • On medical treatment at screening

Who the study is looking for

  • 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

Age in the registry: 18 years to 64 years · Sex: Male · Accepts healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Azienda Ospedaliero - Universitaria di ModenaModenaItalyNot yet recruiting

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