NCT02752503Unknown不适用
Open-label Trial on Therapeutic Effect and Tolerability of Nalmefene in Subjects With Alcohol Use Disorder and Comorbid Borderline Personality Disorder
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Days of excessive alcohol intake
研究概览
简要总结
The objective is to study the effectiveness of Nalmefene in decreasing alcohol intake in subjects with alcohol use disorder and comorbid BPD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alcohol use disorder according to DSM 5
- •Borderline personality disorder according to DSM 5
- •CGI-BPD > 3
- •Female have to use contraception
排除标准
- •Other axis I disorders
- •Severe organic disorder
- •Pregnancy or breastfeeding
- •Allergy to Nalmefene
- •Subjects with Opioids use disorder or in treatment with opioid agonists
研究组 & 干预措施
Nalmafene
Experimental
干预措施: Nalmefene (Drug)
结局指标
主要结局
Days of excessive alcohol intake
时间窗: 2 months
Excessive alcohol intake: \>60 g in males; \>40 g in females
Daily average intake (grams)
时间窗: 2 months
Daily average intake (grams)
次要结局
- Borderline symptoms on the Borderline Symptom List - 23 (BSL-23)(2 months)
- Global Impression of the Clinic on the Clinical Impression - BPD (GCI-BPD)(2 months)
研究者
研究点 (1)
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