NCT01969617已完成1 期
Interventional, Randomized, Double-blind, Cross-over, Placebo-controlled Study to Investigate the Effects of Nalmefene After Single Dose on the Blood Oxygen Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Signal in the Ventral Striatum to Reward Responding in the Monetary Incentive Delay Task (MIDT), in Non-treatment Seeking Subjects With Alcohol Dependence Following Alcohol Challenge
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task
研究概览
简要总结
To contribute to the understanding of the underlying neurobiological mechanism behind the interaction of alcohol and nalmefene
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The subject has alcohol dependence, diagnosed according to DSM-IV-TR™.
排除标准
- •The subject is seeking treatment for alcohol dependence.
- •The subject has had <6 heavy drinking days (HDDs) in the 4 weeks prior to the Screening Visit.
- •The subject has had an average alcohol consumption below high risk levels (that is, 60 grams of alcohol/day for men) <4 weeks prior to the Screening Visit.
- •The subject has >5 consecutive abstinence days in the 4 weeks prior to the Screening Visit.
- •The subject has a Revised Clinical Institute Withdrawal Assessment of Alcohol Scale, (CIWA-Ar), score ≥
- •The subject is, in the opinion of the investigator, at significant risk of suicide or meets the exclusion criteria based on C-SSRS.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Nalmefene 18 mg, then placebo
Experimental
18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride
干预措施: Nalmefene 18 mg, then placebo (Drug)
Placebo, then Nalmefene 18 mg
Placebo Comparator
18 mg nalmefene corresponds to 20 mg nalmefene hydrochloride
干预措施: Placebo, then Nalmefene 18 mg (Drug)
结局指标
主要结局
Blood oxygen level dependent (BOLD) fMRI signal in the ventral striatum to reward responding using the monetary incentive delay task (MIDT) task
时间窗: Day 1
次要结局
- Safety(Up to Day 8 and a 10-day safety follow up)
- Risk of suicidality(Up to Day 8)
研究者
研究点 (1)
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