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Sponsors and Collaborators: |
King Faisal Specialist Hospital & Research Center King Abdulaziz City for Science & Technology (KACST) |
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Information provided by: | King Faisal Specialist Hospital & Research Center |
ClinicalTrials.gov Identifier: | NCT00426010 |
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.
Condition | Intervention |
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Placebo Effect Placebo Mechanisms of Action |
Drug: caffeine/placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Measuring Placebo Effect by Elimination and Investigating Its Mechanism of Action |
Estimated Enrollment: | 180 |
Study Start Date: | January 2007 |
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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
Contact: Muhammad M Hammami, MD, PhD | 966 1 4424527 | muhammad@kfshrc.edu.sa |
Saudi Arabia | |
Center for Clinical Studies & Empirical Ethics, KFSH & RC | Recruiting |
Riyadh, Saudi Arabia, 11211 | |
Principal Investigator: Muhammad M Hammami, MD, PhD |
Principal Investigator: | Muhammad M Hammami, MD, PhD | KFSH & RC, Riyadh |
Study ID Numbers: | RAC# 2051072, KACST:ARP-26-45 |
Study First Received: | January 23, 2007 |
Last Updated: | September 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00426010 |
Health Authority: | Saudi Arabia: Research Advisory Council, KFSH & RC; Saudi Arabia: King Abdulaziz City for Science & Technology (KACST) |
Placebo effect Caffeine Systolic BP VAS |
Caffeine citrate Caffeine |
Phosphodiesterase Inhibitors Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Central Nervous System Stimulants Enzyme Inhibitors Central Nervous System Agents Pharmacologic Actions |