We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Caffeine Withdrawal on Migraine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03022838
Recruitment Status : Recruiting
First Posted : January 18, 2017
Last Update Posted : March 1, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Migraine Caffeine Withdrawal Drug: Caffeine Phase 2 Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Caffeine Withdrawal on Migraine - a Randomized, Double-blind, Crossover Study
Actual Study Start Date : February 28, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Name: Recip
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 Name: Recip


Outcome Measures

Primary Outcome Measures :
  1. Migraine days [ Time Frame: 10 weeks ]
    Reduction from baseline in monthly migraine days (withdrawal vs. caffeine)


Secondary Outcome Measures :
  1. Withdrawal symptoms and/or syndrome (according to criteria) [ Time Frame: 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

  2. Migraine attacks [ Time Frame: 10 weeks ]
    Reduction from baseline in monthly migraine attacks (withdrawal vs. caffeine)

  3. Sleep improvement [ Time Frame: 10 weeks ]
    Reduction from baseline in PSQI and measured by actigraphy (withdrawal vs. caffeine)

  4. Quality of life [ Time Frame: 10 weeks ]
    Reduction from baseline in HIT-6 (withdrawal vs. caffeine)


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03022838


Contacts
Contact: Karl B Alstadhaug, MD, PhD 7553400 karl.bjornar.alstadhaug@nlsh.no
Contact: Hilde K Ofte, MD, PhD 7553400 hilde.karen.ofte@nlsh.no

Locations
Norway
Nordland Hospital Not yet recruiting
Bodø, Norway, 8011
Contact: Karl B Alstadhaug, MD, PhD    75534000    karl.bjornar.alstadhaug@nlsh.no   
Contact: Hilde K Ofte, MD, PhD    75534000    hilde.karen.ofte@nlsh.no   
Departement of Neurology, NLSH HF Recruiting
Bodø, Norway, 8092
Contact: Karl Alstadhaug, MD, PhD         
Principal Investigator: Karl Alstadhaug, MD, PhD         
Sponsors and Collaborators
Nordlandssykehuset HF
King's College London
Investigators
Study Director: Jan T Henriksen Department for research and patient safety, Nordland Hospital trust
More Information

Responsible Party: Nordlandssykehuset HF
ClinicalTrials.gov Identifier: NCT03022838     History of Changes
Other Study ID Numbers: 2015/1729REK
First Posted: January 18, 2017    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents