The Effects of Caffeine Withdrawal on Migraine

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

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.

Study Overview

• Status: Terminated
• Conditions: Migraine; Caffeine Withdrawal
• Intervention / Treatment: Drug: Caffeine

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Norway
  • Bodø, Norway, 8092
    • Departement of Neurology, NLSH HF
  • Bodø, Norway, 8011
    • Nordland Hospital
  • Tromsø, Norway, 9037
    • Departement of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nordlandssykehuset HF
• Collaborators: King's College London; University Hospital of North Norway
• Investigators: Study Director: Jan T Henriksen, Department for research and patient safety, Nordland Hospital trust

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2017
• Primary Completion (Actual): July 22, 2019
• Study Completion (Actual): July 22, 2019

Study Registration Dates

• First Submitted: December 29, 2016
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 22, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: 2015/1729REK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No