EUCTR2013-004688-30-DE进行中（未招募）不适用
Interventional, open-label study of 18 mg Selincro® as needed use, in the treatment of patients with alcohol dependence in primary care
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 379
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The patient has alcohol dependence diagnosed according to ICD-10.
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 374
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •The patient has one or more contraindications to the prescription of Selincro®:
- •a. hypersensitivity to the active substance or to any of the excipients,
- •b. taking opioid analgesics,
- •c. current or recent opioid addiction,
- •d. acute symptoms of opioid withdrawal,
- •e. recent use of opioids suspected,
- •f. severe hepatic impairment (Child-Pugh classification),
- •g. severe renal impairment (eGFR <30 ml/min per 1.73 m2),
- •h. 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.
研究者
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