The Effects of Caffeine Withdrawal on Migraine

Phase 3TerminatedNCT03022838

Nordlandssykehuset HF10 enrolled

Overview

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.

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. .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Migraine Caffeine Withdrawal

Interventions

CaffeineDRUG

From the point of enrollment, patients will substitute their daily dietary caffeine with either placebo- or capsulated caffeine tablets (Recip®, 100mg).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (3)

Nordland Hospital

Bodø, Norway

Departement of Neurology, NLSH HF

Bodø, Norway

Departement of Neurology

Tromsø, Norway

Outcomes

Primary Outcomes

Migraine days

Reduction from baseline in monthly migraine days (withdrawal vs. caffeine)

Time frame: 10 weeks

Secondary Outcomes

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

Time frame: 2 first days after caffeine withdrawal(withdrawal vs. caffeine)

Migraine attacks

Reduction from baseline in monthly migraine attacks (withdrawal vs. caffeine)

Time frame: 10 weeks

Sleep improvement

Reduction from baseline in PSQI and measured by actigraphy (withdrawal vs. caffeine)

Time frame: 10 weeks

Quality of life

Reduction from baseline in HIT-6 (withdrawal vs. caffeine)

Time frame: 10 weeks

Data from ClinicalTrials.gov

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