Interventional, Open-label Study of 18 mg Selincro® As-needed Use, in the Treatment of Patients With Alcohol Dependence in Primary Care
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 378
- 试验地点
- 48
- 主要终点
- Change in the number of Heavy Drinking Days (HDDs) (days/month)
研究概览
简要总结
To determine the reduction in alcohol consumption in patients with alcohol dependence treated with 18 mg Selincro® as-needed use, in conjunction with continuous psychosocial support in primary care
详细描述
635 patients are planned (total number of patients) with 475 patients treated with Selincro® (Cohort A) and 160 patients not treated with Selincro® (Cohort B) to determine the reduction in alcohol consumption in patients with alcohol dependence.
Cohort A will comprise patients who maintain a high drinking risk level (DRL, defined by World Health Organization (WHO) as >60g alcohol/day for a man or >40g alcohol/day for a woman), or above, in the period between the Screening and Inclusion Visits.
Cohort B will comprise patients who reduce their alcohol consumption in the period between the Screening and Inclusion visits, that is, patients who do not maintain at least a high DRL at the Inclusion Visit (and are therefore not eligible for treatment with nalmefene according to the SmPC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •The patient has alcohol dependence diagnosed according to ICD-
- •The patient has had a high DRL in the 4 weeks preceding the Screening Visit.
- •The patient is a man or woman, aged ≥18 years.
- •The patient provides a stable address and telephone number.
排除标准
- •The patient has one or more contraindications to the prescription of Selincro®:
- •hypersensitivity to the active substance or to any of the excipients
- •taking opioid analgesics
- •current or recent opioid addiction
- •acute symptoms of opioid withdrawal
- •recent use of opioids suspected
- •severe hepatic impairment (Child-Pugh classification)
- •severe renal impairment (eGFR <30 ml/min per 1.73 m2)
- •a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, or delirium tremens)
- •The patient has had <6 HDDs (defined by the European Medicines Agency as a day with an alcohol consumption >60g for men or >40g for women) in the 4 weeks preceding the Screening Visit.
- •The patient has physical alcohol withdrawal symptoms and requires immediate detoxification for which inpatient treatment is required.
- •The patient is currently participating or has recently (in the 4 weeks preceding the Screening Visit) participated in a treatment or support programme for alcohol-use disorders, including Alcohol Anonymous, detoxification treatment, and treatment of alcohol withdrawal symptoms, or the patient is already taking nalmefene or has taken nalmefene in the 6 months preceding the Screening Visit.
结局指标
主要结局
Change in the number of Heavy Drinking Days (HDDs) (days/month)
时间窗: Baseline to Month 3
Cohort A
次要结局
- Change in Total Alcohol Consumption (TAC) (g/day)(Baseline to Month 3)
- Drinking Risk Level response (RSDRL); defined as a downward shift in Drinking Risk Level (DRL); for patients with a very high DRL at baseline, a shift to medium DRL or below; for patients with a high DRL at baseline, a shift to low DRL or below(Baseline to Month 3)
- RLDRL response; defined as a downward shift in DRL to low DRL or below(Baseline to Month 3)
- Response defined as ≥70% reduction in TAC(Baseline to Month 3)
- Response defined as 0 to 4 HDDs (days/month)(Month 3)
- Change in Clinical Global Impression - Severity of Illness (CGI-S) score(Baseline to Week 12)
- Clinical Global Impression - Global Improvement (CGI-I)(Week 12)
- y-glutamyl transferase (y-GT)(Week 12)
- Alanine aminotransferase (ALT)(Week 12)
- Aspartate aminotransferase (AST)(Week 12)
- Change in 36-item Short-form Health Survey version 2 (SF-36) (only for patients in France and the United Kingdom)(Baseline to Week 12)