The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
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.