Pharmacokinetics Clinical Trial
Official title:
The Placebo Effect May Involve Modulating Drug Bioavailability
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.
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.
DESIGN: Balanced cross-over, single-dose, two-period, two-group deign comparing caffeine,
paracetamol, cephalexin, and ibuprofen described as such (overt) to the same medication
described as placebo (covert).
METHODS: 32, 50, 50, and 30 healthy adult volunteers will be enrolled in the caffeine (300
mg), paracetamol (500 mg), cephalexin (500 mg), and ibuprofen (400 mg) cross-over studies,
respectively. Volunteers will be partially deceived to the intervention assignment (i.e., in
the covert arm). Serum levels of each drug will be blindly determined by locally validated
HPLC assays. Plasma half life (primary outcome) as well as Cmax, Tmax, and AUC (secondary
outcomes) of each drug will be determined and analyzed by ANOVA.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
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