drugset / Trial / NCT01501747

The Placebo Effect May Involve Modulating Drug Bioavailability

NCT01501747

RandomizedCrossoverTriple-blind

Summary

The total effect of a medication is the sum of its drug effect, placebo effect (meaning response of placebo), and their interaction. Current interpretation of clinical trials (the gold standard of evidence-based-medicine) assumes no interaction, and the mechanism(s) underlying such interaction have not been fully explored. One possibility is that the placebo effect may modulate drug bioavailability. Using caffeine as a model drug, we have recently shown that the placebo effect of caffeine ingestion prolongs caffeine half life. Due to the novelty of this finding and its important clinical practice and clinical research implications, it needs to be confirmed in another set of subjects and extended to additional drugs. The results of the study are expected to further our understanding of the mechanism of action of a widely used medical intervention, i.e., placebo. The results will be important for both clinical practice and clinical research.

Timeline

Start
2012-02
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 500 mg Oral
Comparator CEPHALEXIN ANHYDROUS Small molecule 500 mg Oral
Comparator Caffeine Small molecule 300 mg Oral
Comparator Ibuprofen Small molecule 400 mg Oral

Indications

No indication recorded.