Effects of Nalmefene and Baclofen on Impulsivity in Subjects With Alcohol Use Disorder and Healthy Control Subjects: A Randomized, Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Change in "Stop-signal reaction time" in the Stop-Signal Task
研究概览
简要总结
Impulsivity is a central feature of addiction. Nalmefen is an authorized treatment for alcohol addiction. Baclofen has empathically been advocated to have some efficacy in this indication. The aim of the present study is to test the effect of Nalmefene and Baclofen on impulsivity.
Primary study objective: To examine the effect of Nalmefene and Baclofen on impulsivity (as measured by the Stop Signal Task) in subjects with alcohol use disorder and healthy control subjects.
Main secondary study objectives: To examine the effect of Nalmefene and Baclofen on risk taking (as measured by the Balloon Analogue Risk Task) and on the preference for small immediate rewards over large delayed rewards (as measured by the Delay Discounting Task). To compare subjects with alcohol use disorder and healthy control subjects on these tasks.
Primary study outcome: Stop-signal reaction time in the Stop-Signal Task Main secondary study outcomes: Equivalence point in the Delay-Discounting Task and Average number of pumps delivered in the Balloon Analogue Risk Task
Study Design: Randomized, placebo control, cross-over, single-dose
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
- Quadruple (Participant, Care Provider, 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
- 是
入选标准
- •30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20),
- •30 sex and age-matched healthy controls,
- •over 18, informed consent.
排除标准
- •opiate-treatment,
- •contra-indications for Nalmefene and/or Baclofen,
- •unstable psychiatric disorder,
- •pregnancy,
- •acute withdrawal syndrome.
研究组 & 干预措施
Alcohol Use Disorder
30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20) : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
干预措施: Baclofen (Drug)
Alcohol Use Disorder
30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20) : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
干预措施: Placebo Oral Capsule (Drug)
Alcohol Use Disorder
30 patients with DSM-5 Diagnosis of Alcohol Use Disorder, at least moderate (303.90/F10.20) : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
干预措施: Nalmefene (Drug)
Healthy Control
30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
干预措施: Nalmefene (Drug)
Healthy Control
30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
干预措施: Baclofen (Drug)
Healthy Control
30 sex and age-matched healthy controls : Nalmefene 18mg, Baclofen 10mg, Placebo Oral Capsule
干预措施: Placebo Oral Capsule (Drug)
结局指标
主要结局
Change in "Stop-signal reaction time" in the Stop-Signal Task
时间窗: 0 and 2 hours post-dose
Before-drug/after-drug difference of the stop-signal reaction time in the Stop Signal Task at Visit 2, Visit 3 and Visit 4.
次要结局
- Change in "Equivalence point" in the Delay-Discounting Task(0 and 2 hours post-dose)
- Change in "Average number of pumps" delivered in the Balloon Analogue Risk Task(0 and 2 hours post-dose)
研究者
Prof. Daniele Zullino
Prof.
University Hospital, Geneva