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Measuring Placebo Effect by Elimination and Investigating Mechanism of Action

2014-08-27 03:40:33 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Conditions

Placebo Effect

Intervention

caffeine/placebo

Location

Center for Clinical Studies & Empirical Ethics, KFSH & RC
Riyadh
Saudi Arabia
11211

Status

Recruiting

Source

King Faisal Specialist Hospital & Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:40:33-0400

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Medical and Biotech [MESH] Definitions

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.

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A plant genus of the family STERCULIACEAE. This is the source of the kola nut which contains CAFFEINE and is used in popular beverages.

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