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

September 13, 2021 updated by: Nantes University Hospital
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Hôpital Pellegrin
      • Caen, France, 14033
        • CHRU de Caen
      • Grenoble, France, 38043
        • CHU de Grenoble
      • Lyon, France, 69424
        • Centre Antipoison - Centre de Pharmacovigilance
      • Marseille, France, 13274
        • Hôpital Salvator
      • Montpellier, France, 34295
        • Hopital Lapeyronie
      • Nancy, France, 54035
        • CHU de Nancy
      • Nantes, France, 44093
        • CHU de Nantes
      • Paris, France, 75475
        • Hôpital Fernand Widal
      • Toulouse, France, 31073
        • Faculté de médecine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pharmacodependent patients

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psychometrics properties Evaluation of the new questionnaire centered on addiction to medicine .
Time Frame: At the beginning of the study
At the beginning of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2008

Primary Completion (Actual)

June 14, 2011

Study Completion (Actual)

September 15, 2013

Study Registration Dates

First Submitted

January 19, 2010

First Submitted That Met QC Criteria

January 19, 2010

First Posted (Estimate)

January 20, 2010

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD/07/10-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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