Caffeine Withdrawal, Migraine
Conditions
Brief summary
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
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. .
Interventions
DRUGCaffeine
From the point of enrollment, patients will substitute their daily dietary caffeine with either placebo- or capsulated caffeine tablets (Recip®, 100mg).
Sponsors
King's College London
University Hospital of North Norway
Nordlandssykehuset HF
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Migraine days | 10 weeks | Reduction from baseline in monthly migraine days (withdrawal vs. caffeine) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Withdrawal symptoms and/or syndrome (according to criteria) | 2 first days after caffeine withdrawal(withdrawal vs. caffeine) | 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 |
| Migraine attacks | 10 weeks | Reduction from baseline in monthly migraine attacks (withdrawal vs. caffeine) |
| Sleep improvement | 10 weeks | Reduction from baseline in PSQI and measured by actigraphy (withdrawal vs. caffeine) |
| Quality of life | 10 weeks | Reduction from baseline in HIT-6 (withdrawal vs. caffeine) |
Countries
Norway
Outcome results
None listed