The Effects of Caffeine Withdrawal on Migraine - a Randomized, Double-blind, Crossover Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Migraine days
研究概览
简要总结
Sporadic and chronic dietary consumption of caffeine has substantial biological effects on the nervous system. The effects on migraine are at large not known. In this study we want to assess the effects of caffeine withdrawal on migraine.
详细描述
The actions of caffeine as an antagonist of adenosine receptors have been extensively studied, and there is no doubt that both daily and sporadic dietary consumption of caffeine has substantial biological effects on the nervous system. The current opinion is that caffeine both can cure and trigger headaches. Caffeine is a component of many combination drugs marketed for the relief of headaches, but on the other hand it is strongly incriminated as a risk factor for developing chronic headache. Withdrawal may cause symptom constellations similar to the migraine syndrome. Further, caffeine consumption may affect sleep and alertness, possibly influencing the risk of migraine attacks. .
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •migraine present for at least 1 year and fulfilling diagnostic criteria (ICHD-3 beta)
- •=/> 3 migraine attacks per month
- •no migraine prophylaxis the last month
- •consumption =/> 300 mg and </= 800 mg caffeine per day the last month
- •signed consent
排除标准
- •suspicion of medication-overuse headache
- •pregnancy and breast feeding
- •serious co-morbidity or conditions requiring Medical treatment or caution
- •working night shift
- •use of drugs with moderate or major interactions with caffeine
研究组 & 干预措施
Caffeine
Caffeine tablets (Recip) 100 mg, 300-800 mg
干预措施: Caffeine (Drug)
Placebo
Placebo tablets
干预措施: Caffeine (Drug)
结局指标
主要结局
Migraine days
时间窗: 10 weeks
Reduction from baseline in monthly migraine days (withdrawal vs. caffeine)
次要结局
- Sleep improvement(10 weeks)
- Withdrawal symptoms and/or syndrome (according to criteria)(2 first days after caffeine withdrawal(withdrawal vs. caffeine))
- Migraine attacks(10 weeks)
- Quality of life(10 weeks)