The Effects of Caffeine Withdrawal on Migraine

Study Overview
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Brief Summary
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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.

Detailed Description
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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. .

Official Title
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The Effects of Caffeine Withdrawal on Migraine - a Randomized, Double-blind, Crossover Study

Conditions
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Migraine, Caffeine Withdrawal

Intervention / Treatment
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* Drug: Caffeine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caffeine<br>Caffeine tablets (Recip) 100 mg, 300-800 mg | Drug: Caffeine<br>* From the point of enrollment, patients will substitute their daily dietary caffeine with either placebo- or capsulated caffeine tablets (Recip®, 100mg).<br>* Other names: Recip;|
| Placebo Comparator: Placebo<br>Placebo tablets | Drug: Caffeine<br>* From the point of enrollment, patients will substitute their daily dietary caffeine with either placebo- or capsulated caffeine tablets (Recip®, 100mg).<br>* Other names: Recip;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migraine days | Reduction from baseline in monthly migraine days (withdrawal vs. caffeine) | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Withdrawal symptoms and/or syndrome (according to criteria) | If patients report withdrawal symptoms, these will be recorded and eventually diagnosed as either caffeine withdrawal symptoms or migraineous symptoms in accordance with international criteria | 2 first days after caffeine withdrawal(withdrawal vs. caffeine) | 
| Migraine attacks | Reduction from baseline in monthly migraine attacks (withdrawal vs. caffeine) | 10 weeks | 
| Sleep improvement | Reduction from baseline in PSQI and measured by actigraphy (withdrawal vs. caffeine) | 10 weeks | 
| Quality of life | Reduction from baseline in HIT-6 (withdrawal vs. caffeine) | 10 weeks |