The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache
Condition: Episodic Migraine
MeSH terms: Migraine Disorders; Headache
Intervention: Maxalt; placebo pill; placebo pills
Intervention description: anti-migraine drug; placebo pills; placebo pills
Intervention MeSH terms: Rizatriptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Evidence-based medicine depends on distinguishing between pharmacological effects and placebo
      effects in randomized controlled trials (RCT). This proposal seeks to rigorously investigate
      fundamental questions concerning pharmacological effects, placebo effects and their
      interactions. Relief of symptoms of acute migraine will be the test condition for this
      scientific experiment because of migraine's evident clinical significance and the possibility
      of using participants as their own control during sequential acute migraine attacks. Our
      overall goal is to elucidate how the pharmacological effects of 100 mg rizatriptan (an
      FDA-proven effective medication for acute migraine) and the effects of placebo treatment can
      be modified by varied knowledge and/or expectation ("contextual") conditions. Such knowledge
      has the possibility to suggest potentially more efficient methodologies to test new
      medications that can be used to augment and enhance the apparatus of the RCT.

      General Aim: To elucidate and clarify what is a pharmacological effect and what is a placebo
      effect, how such effects vary in different knowledge/expectations contexts, and mutually
      constitute one another and interact.

      General Hypothesis: The measured pharmacological effect of an effective medication
      (rizatriptan) and the measured effect of placebo treatment are determined significantly by
      different knowledge/expectations contexts.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will be considered for this study if they suffer from classical or common
             migraine for at least 3 years.

          -  Candidates will recruited from the clinical case load of Dr. Zahid Bajwa and the
             headache and pain management center at BIDMC.

          -  Only patients older than 18 years of age,

          -  Able to communicate clearly in English,

          -  Able to give an informed consent will be considered as candidates.

          -  No limitation of gender or race is justified and thus, it is open to all patients
             fulfilling criteria for migraine type headache.

          -  Patients will be able to withdraw from the study at any time.

          -  They will be included in the study if they meet the criteria for migraine with or
             without aura (Headache-classification-committee-of-the-International-Headache-Society
             1988), if they had >4 migraine attacks each month for the previous year.

        Exclusion Criteria:

          -  Exclusion criteria will include cardiovascular or cerebrovascular disorders,

          -  Cardiac risk factors and liver disease,

          -  Uncontrolled hypertension,

          -  Peripheral and central nervous system disorders that affect sensory functions (such as
             sensory neuropathies and chronic pain),

          -  The use of opiates or other analgesic drugs for any reason, and the use of other
             prophylactic anti-migraine drugs.

          -  Any patient with active hepatitis or elevated liver enzymes (based on their BIDMC
             medical record) will be excluded as well.

          -  Employees who are under the direct supervision of the investigators will not
             participate in the study.