The Effect of Ritalin (Methylphenidate Hydrochloride) on Pain and Auditory Sensitivity: an Exploratory Double-blind Randomized Controlled Trial on Healthy Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Experimental pain intensity measured on a visual analogue scale (0-100)
研究概览
简要总结
- To examine whether Ritalin has analgesic properties in healthy subjects.
- To examine if Ritalin analgesic effect is a pain specific phenomenon or a part of a broader, non-specific effect on high mental functions.
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 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male subjects between the ages of 20 to 40
- •Healthy subjects without known disease and without any chronic pain
- •Subjects without known cognitive problems, which can understand the research and its goals
- •Subjects who are not taking any medications
- •Subjects without hearing problems
- •Subjects without attention deficit disorder (ADHD) problems
排除标准
- •Subjects who are known to suffer from any disease or any chronic pain
- •Subjects taking psychotropic drugs (except Ritalin) or any analgesics
- •Subjects who have any contradictions for ritalin administration
- •subjects with suspected cognitive disability
研究组 & 干预措施
methylphenidate hydrochloride
The study will include two sessions which will be conducted at the same time of the day, one week apart from each other. Each session will last approximately 6 hours. In each session subjects will be exposed to baseline experimental pain models and auditory tests. Then they will receive either one MP SR 20 mg tablet or an identical looking placebo.
干预措施: methylphenidate hydrochloride (Drug)
Sugar pill
The study will include two sessions which will be conducted at the same time of the day, one week apart from each other. Each session will last approximately 6 hours. In each session subjects will be exposed to baseline experimental pain models and auditory tests. Then they will receive either one MP SR 20 mg tablet or an identical looking placebo.
干预措施: Sugar pill (placebo) (Drug)
结局指标
主要结局
Experimental pain intensity measured on a visual analogue scale (0-100)
时间窗: 4 hours
次要结局
- effect of Ritalin on auditory sensitivity, measured by the response to different auditory stimulations(4 hours)
- pain intensity (NPS 0-100) in response to thermal stimuli and the measures of the auditory tests.(4 hours)
研究者
Eisenberg Elon MD
Director, Pain research Unit
Rambam Health Care Campus