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Search / Trial NCT02492581

Use of Selincro and Impact on Usual Practice

Launched by UNIVERSITY OF BORDEAUX · Jul 3, 2015

Trial Information

Current as of May 06, 2025

Completed

Keywords

Selincro Cohort Real Life Total Alcohol Consumption Heavy Drinking Days Clinical Global Impression Severity Eq5 D A Qo Ls Sheehan Disability Scale

ClinConnect Summary

Selincro® (nalmefene) has obtained European market authorisation and is indicated "for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level, without physical withdrawal symptoms and who do not require immediate detoxification". The French health authorities (Haute Autorité de Santé, HAS, and Agence Nationale de Sécurité du Médicament et des produits de santé, ANSM) have requested an evaluation of the real-life conditions of use of Selincro and its impact on morbidity.

In response, USE-PACT has been developed : a cohort of patien...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adult patient (≥18 years) initiating Selincro
  • Patient accepting to participate
  • Patient without linguistic barrier, notably to read the information letter and to complete the self-administrated questionnaires
  • Patient not included in another study susceptible to modify patient care
  • Patient not under a guardianship
  • Exclusion Criteria:
  • Minor patient (≤18 years)
  • Patient refusing to participate
  • Patient with linguistic barrier
  • Patient included in another study susceptible to modify patient care
  • Patient under a guardianship

About University Of Bordeaux

The University of Bordeaux is a prestigious academic institution recognized for its commitment to advancing medical research and education. With a strong emphasis on innovation and interdisciplinary collaboration, the university actively sponsors clinical trials aimed at enhancing healthcare outcomes and contributing to scientific knowledge. Leveraging its state-of-the-art facilities and a network of expert researchers, the University of Bordeaux fosters an environment conducive to rigorous clinical investigation, ultimately striving to translate research findings into effective therapeutic solutions for patients.

Locations

Bordeaux, , France

Patients applied

0 patients applied

Trial Officials

Nicholas MOORE, Professor

Study Director

University of Bordeaux

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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