The Effects of Caffeine Withdrawal on Migraine

Nordlandssykehuset HF

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Caffeine Withdrawal; Migraine

Treatments: Drug: Caffeine

Study type: Interventional

Funder types: Other

Identifiers

NCT03022838

2015/1729REK

Details and patient eligibility

About

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.

Full 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. .

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

Caffeine

Active Comparator group

Description:

Caffeine tablets (Recip) 100 mg, 300-800 mg

Treatment:

Drug: Caffeine

Placebo

Placebo Comparator group

Description:

Placebo tablets

Treatment:

Drug: Caffeine