Status: Finalised First registered on: 15/07/2015
Last updated on: 13/02/2019
1. Study identification
EU PAS Register NumberEUPAS10298
Official titlePregabalin abuse in France : a national cohort study
Study title acronym
Study typeObservational study
Brief description of the studyPregabalin is a psychoactive drug indicated in neuropathic pain, generalized anxiety disorder and partial epilepsy. It modifies neuronal activity, binding α2δ1 presynaptic voltage-dependent calcic channel receptor, which is responsible for its psychotropic action. Neuropsychiatric adverse drug reactions, such as euphoria, have been described. Pregabalin abuse has been suggested in a few toxicological studies, pharmacovigilance studies, and small surveys among opioid users or treated by opiate maintenance drugs. Despite signals of abuse in some European countries, no data suggest a potential for pregabalin abuse in France, and no study has ever compare pregabalin abuse to other drug used in the same indication. Searching a possible pregabalin abuse seems all the more relevant as its consumption increases in France and in Europe. This study aims to investigate pregabalin abuse and its frequency in the French general population, in comparison with other drugs used in similar indications and to determine the factors associated with pregabalin abuse.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsPharmacoepidemiology INSERM 1027
Department/Research groupPharmacoepidemiology research team
Organisation/affiliationUniversity of Toulouse 3 and INSERM 1027
Website/Homepagehttp://www.u1027.inserm.fr/
Details of (Primary) lead investigator
Title Dr
Last name Lapeyre-Mestre
First name Maryse
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/02/201502/02/2015
Start date of data collection06/04/201501/06/2015
Start date of data analysis04/05/201515/06/2015
Date of interim report, if expected
Date of final study report30/10/201524/12/2015
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherToulouse University Hospital100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Lapeyre-Mestre
First name Maryse
Address line 137 Allees Jules
Address line 2 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance
Phone number (incl. country code)33-561145960 
Alternative phone number33-561145606 
Fax number (incl. country code)33-561145928 
Email address maryse.lapeyre-mestre@univ-tlse3.fr
Public Enquiries
Title Dr 
Last name Lapeyre-Mestre 
First name Maryse 
Address line 137 Allees Jules 
Address line 2 
Address line 3 
CityToulouse 
Postcode31000 
CountryFrance 
Phone number (incl. country code)33-561145960 
Alternative phone number33-561145606 
Fax number (incl. country code)33-561145928 
Email address maryse.lapeyre-mestre@univ-tlse3.fr 
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