Use of Selincro and Impact on Usual Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Relative change of Total Alcohol Consumption (TAC) between inclusion and end of follow-up at one year
研究概览
简要总结
USE-PACT is a cohort study of patients initiating Selincro® with one-year follow-up, performed using a random sample of prescribers. The aim of the study is to evaluate the use of Selincro in real-life and its impact on alcohol consumption at one year.
详细描述
Selincro® (nalmefene) has obtained European market authorisation and is indicated "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 (Haute Autorité de Santé, HAS, and Agence Nationale de Sécurité du Médicament et des produits de santé, ANSM) have requested an evaluation of the real-life conditions of use of Selincro and its impact on morbidity.
In response, USE-PACT has been developed : a cohort of patients initiating Selincro® with one-year follow-up.
The primary objective is to evaluate the change of alcohol consumption at one year in patients initiating Selincro® in usual practice.
The secondary objectives are :
- Describe prescriber characteristics,
- Describe the initial demographic, clinical, and biological characteristics of patients at the start of treatment,
- Describe patient support, notably psychosocial, at start of treatment and during treatment,
- Describe characteristics of Selincro® treatment during the study period,
- Describe the frequency of adverse effects during Selincro® treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient (≥18 years) initiating Selincro
- •Patient accepting to participate
- •Patient without linguistic barrier, notably to read the information letter and to complete the self-administrated questionnaires
- •Patient not included in another study susceptible to modify patient care
- •Patient not under a guardianship
排除标准
- •Minor patient (≤18 years)
- •Patient refusing to participate
- •Patient with linguistic barrier
- •Patient included in another study susceptible to modify patient care
- •Patient under a guardianship
结局指标
主要结局
Relative change of Total Alcohol Consumption (TAC) between inclusion and end of follow-up at one year
时间窗: One year
次要结局
- Relative and absolute change of Heavy Drinking Days (HDD) with respect to inclusion(at 1 month, 3 months, 6 months, 9 months and 12 months after inclusion)
- Relative and absolute change of TAC with respect to inclusion(at 1 month, 3 months, 6 months, 9 months and 12 months after inclusion)
- At least 70% reduction in TAC with respect to inclusion(at 1 month, 3 months, 6 months, 9 months and 12 months after inclusion)
- Change in the alcohol consumption risk level according to the WHO with respect to inclusion(at 1 month, 3 months, 6 months, 9 months and 12 months after inclusion)
研究者
Patrick BLIN
Doctor
University of Bordeaux