Status: PlannedLast updated on: 08/08/2017
1. Study identification
EU PAS Register NumberEUPAS11854
Official titleUse of Selincro® and impact on usual practice
Study title acronymUSE-PACT
Study typeObservational study
Brief description of the studySelincro® (nalmefene) has obtained European market authorisation “for the reduction of alcohol consumption in adult patients with alcohol dependence who have a high drinking risk level, without physical withdrawal symptoms and who do not require immediate detoxification”. The French health authorities have requested an evaluation on real-life conditions of Selincro® use and its impact on morbidity. In response, a French prospective cohort including 1000 patients initiating Selincro® followed during 1 year using a random sample of general practitioners, psychiatrists, and physicians in specialised structures has been developed. The main objective is to evaluate the evolution of alcohol consumption at 1 year in patients initiating Selincro®. The secondaries are to describe prescribers characteristics; initial demographic, clinical, biological characteristics of patients; patient support, notably psychosocial, at start and during treatment; characteristics of Selincro® during the study period; the frequency of adverse effects during Selincro® treatment. Each participing physician should, during 4-month period, include in cohort all patients for whom he/she initiates Selincro® and fulfilling the eligibility criteria, and record in a non-inclusion register patients for whom Selincro® is initiated and not included in cohort. The physician will follow the patients with a clinical evaluation at 1, 3, 6, 9 and 12 months performed during usual follow-up consultations. In parallel, each patient will complete a self-administered questionnaire at the same points. Patients declared as lost-to-follow-up and, failing that, his/her general practitioner will be contacted in order to fill-out a “last known status questionnaire”. For patients who could not be reached, vital status will be investigated using the INSEE/INSERM centralised procedure defined by decree. The representativeness of the cohort will be evaluated by an analysis in a representative French health insurance database.
Was this study requested by a regulator?Yes: France
Is the study required by a Risk Management Plan (RMP)? Not applicable
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Professor
Last name Moore
First name Nicholas
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?435
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 signed01/07/2015
Start date of data collection01/09/2015
Start date of data analysis01/07/2017
Date of interim report, if expected
Date of final study report01/12/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesLundbeck France100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Blin
First name Patrick
Address line 1University of Bordeaux – Bâtiment du Tondu – Case 41 – 146 rue Léo Saignat
Address line 2 
Address line 3 
CityBordeaux 
Postcode 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Dr 
Last name Blin 
First name Patrick 
Address line 1University of Bordeaux – Bâtiment du Tondu – Case 41 – 146 rue Léo Saignat 
Address line 2 
Address line 3 
CityBordeaux 
Postcode 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code) 
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