Drug AbuseNCT01052675
Pharmacological, Clinical and Statistical Assessment of a New Tool Available for Pharmacodependence Report Evaluation
An observational study of Drug Abuse and Drug Dependence, run by Nantes University Hospital at 10 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Abuse, Drug Dependence
- How many people
- 3,180 participants
- Where
- 10 sitesFrance
- Study dates
- 3 Jan 2008to 15 Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pharmacodependent patients
Who may be able to join
- case report from one of the French CEIP for drug and substance problematic use, abuse or dependence except alcohol and tobacco.
Who cannot join
None listed.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Hôpital Pellegrin
Bordeaux, 33076
CHRU de Caen
Caen, 14033
CHU de Grenoble
Grenoble, 38043
Centre Antipoison - Centre de Pharmacovigilance
Lyon, 69424
Hôpital Salvator
Marseille, 13274
Hôpital Lapeyronie
Montpellier, 34295
CHU de Nancy
Nancy, 54035
CHU de Nantes
Nantes, 44093
Hôpital Fernand Widal
Paris, 75475
Faculté de médecine
Toulouse, 31073
About this study
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.
- Conditions
- Drug Abuse, Drug Dependence
- Keywords
- Drug and substance problematic use, abuse or dependence
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Psychometrics properties Evaluation of the new questionnaire centered on addiction to medicine .
Measured: At the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
- Study start3 Jan 2008
- Primary completion14 Jun 2011
- Study completion15 Sep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug AbuseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 3,180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jolliet Pascale, MD, Study director, Nantes's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052675
- Sponsor's protocol ID
- BRD/07/10-C
- Status last verified
- Sep 2021
- First submitted
- 19 Jan 2010
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological, Clinical and Statistical Assessment of a New Tool Available for Pharmacodependence Report Evaluation
- ClinicalTrials.gov ID
- NCT01052675
- Acronym / sponsor ID
- BRD/07/10-C
- Conditions
- Drug Abuse, Drug Dependence
- Keywords
- Drug and substance problematic use, abuse or dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,180 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 3 Jan 2008 (actual)
- Primary completion
- 14 Jun 2011 (actual)
- Study completion
- 15 Sep 2013 (actual)
- First posted
- 20 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacodependance cases | – | –Case report from one of the French CEIP for drug and substance problematic use, abuse or dependence except alcohol and tobacco. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pharmacodependent patients
Key inclusion criteria (1 listed)
- case report from one of the French CEIP for drug and substance problematic use, abuse or dependence except alcohol and tobacco.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychometrics properties Evaluation of the new questionnaire centered on addiction to medicine .
Time frame: At the beginning of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Derived from this study: PubMed 27302554Victorri-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jolliet Pascale, MD study director
Nantes's University Hospital
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Abuse and Drug Dependence, run by Nantes University Hospital at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometrics properties Evaluation of the new questionnaire centered on addiction to medicine . (time frame: At the beginning of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01052675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.