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Pharmacological, Clinical and Statistical Assessment of a New Tool Available for Pharmacodependence Report Evaluation

Sponsor
Nantes University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01052675
Collaborator
(none)
3,180
Enrollment
10
Locations
68.4
Actual Duration (Months)
318
Patients Per Site
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3180 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Pharmacological, Clinical and Statistical Assessment of a New Tool Available for Pharmacodependence Report Evaluation
    Actual Study Start Date :
    Jan 3, 2008
    Actual Primary Completion Date :
    Jun 14, 2011
    Actual Study Completion Date :
    Sep 15, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Pharmacodependance cases

    Case report from one of the French CEIP for drug and substance problematic use, abuse or dependence except alcohol and tobacco.

    Outcome Measures

    Primary Outcome Measures

    1. Psychometrics properties Evaluation of the new questionnaire centered on addiction to medicine . [At the beginning of the study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • case report from one of the French CEIP for drug and substance problematic use, abuse or dependence except alcohol and tobacco.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital Pellegrin Bordeaux France 33076
    2 CHRU de Caen Caen France 14033
    3 CHU de Grenoble Grenoble France 38043
    4 Centre Antipoison - Centre de Pharmacovigilance Lyon France 69424
    5 Hôpital Salvator Marseille France 13274
    6 Hôpital Lapeyronie Montpellier France 34295
    7 CHU de Nancy Nancy France 54035
    8 CHU de Nantes Nantes France 44093
    9 Hôpital Fernand Widal Paris France 75475
    10 Faculté de médecine Toulouse France 31073

    Sponsors and Collaborators

    • Nantes University Hospital

    Investigators

    • Study Director: Jolliet Pascale, MD, Nantes's University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nantes University Hospital
    ClinicalTrials.gov Identifier:
    NCT01052675
    Other Study ID Numbers:
    • BRD/07/10-C
    First Posted:
    Jan 20, 2010
    Last Update Posted:
    Sep 14, 2021
    Last Verified:
    Sep 1, 2021
    Keywords provided by Nantes University Hospital
    Drug and substance problematic use, abuse or dependence
    Additional relevant MeSH terms:
    Substance-Related Disorders

    Study Results

    No Results Posted as of Sep 14, 2021