NCT00426010

Measuring Placebo Effect by Elimination and Investigating Mechanism of Action

Measuring Placebo Effect by Elimination and Investigating Its Mechanism of Action

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Placebo Effect
• Placebo Mechanisms of Action

Interventions

Type	Name	Description
DRUG	caffeine/placebo	caffeine or placebo, either overt or covert

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-01-24
• Last updated: 2011-12-13

Locations

1 site across 1 country: Saudi Arabia