Pharmacological, Clinical and Statistical Assessment of a... | NCT01052675

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

NCT01052675

Sponsor

Nantes University Hospital

Status

Completed

Last Update Posted

Sep 14, 2021Actual

Enrollment

3,180Actual

Phase

Not provided

Conditions

Drug Abuse
Drug Dependence

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 3, 2008Actual

Primary Completion Date

Jun 14, 2011Actual

Completion Date

Sep 15, 2013Actual

First Submitted Date

Jan 19, 2010

First Submission Date that Met QC Criteria

Jan 19, 2010

First Posted Date

Jan 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2021

Last Update Posted Date

Sep 14, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pharmacodependance cases		Case report from one of the French CEIP for drug and substance problematic use, abuse or dependence except alcohol and tobacco.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pharmacodependent patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jolliet Pascale, MD	Nantes's University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Pellegrin		Bordeaux		33076	France
CHRU de Caen

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27302554	Derived	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.

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders