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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01052675
Other study ID # BRD/07/10-C
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 3, 2008
Est. completion date September 15, 2013

Study information

Verified date September 2021
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In France, the Afssaps is the body in charge of the evaluation of pharmacodependance. In order to fulfil its mission, the Afssaps has created a network of 11 Centres for Evaluation and Information on Pharmacodependance (CEIP), coordinated by the Drugs and Psychotropics Unit. Pharmacodependence notifications issued by professionals are collected by each Centre which evaluates them. Nantes' CEIP created an original tool to harmonize case reporting and make it possible to homogeneously evaluate the seriousness of pharmacodependence cases as each CEIP had his own way of analysing his cases. The aim of this study is to assess this tool.


Recruitment information / eligibility

Status Completed
Enrollment 3180
Est. completion date September 15, 2013
Est. primary completion date June 14, 2011
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - case report from one of the French CEIP for drug and substance problematic use, abuse or dependence except alcohol and tobacco.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hôpital Pellegrin Bordeaux
France CHRU de Caen Caen
France CHU de Grenoble Grenoble
France Centre Antipoison - Centre de Pharmacovigilance Lyon
France Hôpital Salvator Marseille
France Hôpital Lapeyronie Montpellier
France CHU de Nancy Nancy
France CHU de Nantes Nantes
France Hôpital Fernand Widal Paris
France Faculté de médecine Toulouse

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Psychometrics properties Evaluation of the new questionnaire centered on addiction to medicine . At the beginning of the study
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