Pharmacological, Clinical and Statistical Assessment of a New Tool Available for Pharmacodependence Report Evaluation
1 other identifier
observational
3,180
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2008
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 3, 2008
CompletedFirst Submitted
Initial submission to the registry
January 19, 2010
CompletedFirst Posted
Study publicly available on registry
January 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2013
CompletedSeptember 14, 2021
September 1, 2021
3.4 years
January 19, 2010
September 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psychometrics properties Evaluation of the new questionnaire centered on addiction to medicine .
At the beginning of the study
Study Arms (1)
Pharmacodependance cases
Case report from one of the French CEIP for drug and substance problematic use, abuse or dependence except alcohol and tobacco.
Eligibility Criteria
Pharmacodependent patients
You may qualify if:
- case report from one of the French CEIP for drug and substance problematic use, abuse or dependence except alcohol and tobacco.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Hôpital Pellegrin
Bordeaux, 33076, France
CHRU de Caen
Caen, 14033, France
CHU de Grenoble
Grenoble, 38043, France
Centre Antipoison - Centre de Pharmacovigilance
Lyon, 69424, France
Hôpital Salvator
Marseille, 13274, France
Hôpital Lapeyronie
Montpellier, 34295, France
CHU de Nancy
Nancy, 54035, France
CHU de Nantes
Nantes, 44093, France
Hôpital Fernand Widal
Paris, 75475, France
Faculté de médecine
Toulouse, 31073, France
Related Publications (1)
Victorri-Vigneau C, Hardouin JB, Rousselet M, Gerardin M, Guerlais M, Guillou M, Bronnec M, Sebille V, Jolliet P; French Addictovigilance Network. Multicentre study for validation of the French addictovigilance network reports assessment tool. Br J Clin Pharmacol. 2016 Oct;82(4):1030-9. doi: 10.1111/bcp.13044. Epub 2016 Jul 28.
PMID: 27302554DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jolliet Pascale, MD
Nantes's University Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2010
First Posted
January 20, 2010
Study Start
January 3, 2008
Primary Completion
June 14, 2011
Study Completion
September 15, 2013
Last Updated
September 14, 2021
Record last verified: 2021-09