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CompletedNCT01052675Updated Sep 14, 2021

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

An observational study in Drug Abuse and Drug Dependence, sponsored by Nantes University Hospital. Completed at 10 sites in France. Per ClinicalTrials.gov, last updated 2021-09-14.

Sponsored by Nantes University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
3,180
Sex
All
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Study 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.

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Conditions studied

  • Drug Abuse
  • Drug Dependence

Keywords

  • Drug and substance problematic use, abuse or dependence
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In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's enrollment of 3,180 is above the median of 250 across 296 observational studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Pharmacodependent patients

Eligibility criteria

Inclusion Criteria:

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

Observational model
Other
Time perspective
Prospective
Enrollment
3,180 participants (actual)

Groups and cohorts

  • Pharmacodependance cases

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

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What researchers measure

Primary outcomes

  1. Psychometrics properties Evaluation of the new questionnaire centered on addiction to medicine .

    Time frame: At the beginning of the study

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Study locations

10 sites
  • 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
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References and documents

Publications

  • 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. PubMed 27302554 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01052675
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Jan 20, 2010
Start date
Jan 3, 2008
Primary completion
Jun 14, 2011
Completion
Sep 15, 2013
Last update
Sep 14, 2021

Study contacts

Jolliet Pascale, MD
study director · Nantes's University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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