NCT06545929已完成2 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 2 Study to Evaluate Impact of Sunobinop (V117957) on Alcohol Craving in Subjects Diagnosed With Moderate to Severe Alcohol Use Disorder and Seeking Treatment
Knoa Pharma LLC2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Alcohol Urge Questionnaire (AUQ)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of sunobinop compared to placebo on alcohol craving in subjects with moderate to severe alcohol use disorder and these subjects are seeking treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Male and female age ≥18 years.
- •Diagnosis of moderate or severe alcohol use disorder.
- •Currently seeking treatment for alcohol use disorder.
- •Has 4 or more heavy drinking days (HDD) in each of the 4 weeks prior to baseline visit.
排除标准
- •Subjects that meet current DSM-5 criteria for moderate or severe substance use disorder other than alcohol and nicotine.
- •Other protocol-specific inclusion and exclusion criteria may apply.
研究组 & 干预措施
Sunobinop
Experimental
干预措施: Sunobinop (Drug)
Placebo to match sunobinop
Placebo Comparator
干预措施: Placebo to match sunobinop (Drug)
结局指标
主要结局
Alcohol Urge Questionnaire (AUQ)
时间窗: Day 14
The questionnaire consists of 8 items; each with 7-item scale in which 1= "strongly disagree" and 7 = "strongly agree".
次要结局
- Desire for Alcohol Visual Analog Scale (DFA-VAS)(Day 14)
研究者
研究点 (2)
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