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We propose to measure the effect of placebo by elimination as well as by a "balanced placebo" design, determine its interaction with active drug, and explore whether placebo exerts part of its effect at the pharmacokinetics level.
Placebos have been in use for centuries in medical practice. However, there is continued controversy regarding their effectiveness and mechanisms of action.
The results of the study are expected to further our understanding of a widely used medical intervention, i.e., placebo, and of how to maximize its potential beneficial effect. It will also help assess the appropriateness of measuring the placebo effect by elimination, which has important ethical implications in relation to the design of randomized clinical trials.
Comparison: caffeine vs placebo. Dependent variables:4 hours area under the curve (AUC) of pharmacodynamics endpoints as well as pharmacokinetics endpoints in a subgroup.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Center for Clinical Studies & Empirical Ethics, KFSH & RC
King Faisal Specialist Hospital & Research Center
Published on BioPortfolio: 2014-08-27T03:40:33-0400
Many patients with Parkinson's disease (PD) have sleep problems, including excessive sleepiness during the day. This is probably due to degeneration of sleep-regulating areas in the brain...
Objective: Assess the effect of caffeine in the following vestibular function tests: Cervical Vestibular Evoked Potential (cVEMP), Ocular Vestibular Evoked Potential(oVEMP) and Caloric Tes...
Investigate how manipulating the time between caffeine ingestion and exercise may alter exercise performance and cognition
Apnea of prematurity is a common condition that is usually treated with methylxanthines. Methylxanthines are adenosine receptor blockers that have powerful influences on the central nervou...
The purpose of this study is to evaluate the effect of rizatriptan, alone or combined with caffeine for treating acute attacks of migraine. Each subject will have 3 months to treat 3 acu...
Although Alpinia galanga has been reported to improve cognitive performance in animals, it has not been thoroughly studied for its potential psychostimulant effect in humans. A randomized, double-dumm...
The placebo effect is usually studied in clinical settings for decreasing negative symptoms such as pain, depression and anxiety. There is interest in exploring the placebo effect also outside the cli...
The purpose of this study was to determine whether caffeinated gum influenced performance in a battery of soccer-specific tests used in the assessment of performance in soccer players. In a double bli...
The aim of this study was to determine the effect of caffeine intake on overall basketball performance in experienced players. A double-blind, placebo-controlled, randomized experimental design was us...
Placebo-controlled trials are the gold standard measure of efficacy in the development of new treatments for depression. However, the large placebo effects associated with standard measures of subject...
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine's most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes SMOOTH MUSCLE, stimulates CARDIAC MUSCLE, stimulates DIURESIS, and appears to be useful in the treatment of some types of headache. Several cellular actions of caffeine have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide PHOSPHODIESTERASES, antagonism of ADENOSINE RECEPTORS, and modulation of intracellular calcium handling.
A synthetic PGE2 analog that has an inhibitory effect on gastric acid secretion, a mucoprotective effect, and a postprandial lowering effect on gastrin. It has been shown to be efficient and safe in the treatment of gastroduodenal ulcers.
A plant genus of the family STERCULIACEAE. This is the source of the kola nut which contains CAFFEINE and is used in popular beverages.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
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