The Effects of Caffeine Withdrawal on Migraine

Phase 2

Terminated

• Conditions: Migraine; Caffeine Withdrawal
• Interventions: Drug: Caffeine

• Registration Number: NCT03022838
• Lead Sponsor: Nordlandssykehuset HF

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. .

Study Timeline

• Study First Submitted: 2016-12-29
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-18
• Study Start: 2017-02-28
• Status Verified: 2019-07
• Primary Completion: 2019-07-22
• Study Completion: 2019-07-22
• Last Update Submitted: 2019-07-22
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Caffeine	Caffeine	Caffeine tablets (Recip) 100 mg, 300-800 mg
Placebo	Caffeine	Placebo tablets

Primary Outcome Measures

Name	Time	Method
Migraine days	10 weeks	Reduction from baseline in monthly migraine days (withdrawal vs. caffeine)

Secondary Outcome Measures

Name	Time	Method
Sleep improvement	10 weeks	Reduction from baseline in PSQI and measured by actigraphy (withdrawal vs. caffeine)
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)
Quality of life	10 weeks	Reduction from baseline in HIT-6 (withdrawal vs. caffeine)

Trial Locations

Locations (3)

Departement of Neurology; 🇳🇴 Tromsø, Norway

Departement of Neurology, NLSH HF; 🇳🇴 Bodø, Norway

Nordland Hospital; 🇳🇴 Bodø, Norway