Study identification

PURI

https://redirect.ema.europa.eu/resource/49889

EU PAS number

EUPAS11854

Study ID

49889

Official title and acronym

Use of Selincro® and impact on usual practice (USE-PACT)

DARWIN EU® study

No

Study countries

France

Study description

Selincro® (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.

Study status

Finalised
Research institution and networks

Institutions

Multiple centres: 180 centres are involved in the study

Contact details

Nicholas Moore

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Lundbeck France
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable