Status:
COMPLETED
Measuring Placebo Effect by Elimination and Investigating Mechanism of Action
Lead Sponsor:
King Faisal Specialist Hospital & Research Center
Collaborating Sponsors:
King AbdulAziz City for Science and Technology
Conditions:
Placebo Effect
Placebo Mechanisms of Action
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief 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 ...
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 f...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Males and nonpregnant females 18 and 40 years of age with at least high school education.
- Exclusion criteria:
- Include evidence of clinically relevant deviation from normal health (such that it may affect the endpoints, make the ingestion of caffeine dangerous, or affect the pharmacokinetics/pharmacodynamics of caffeine),
- Pregnancy,
- Poor venous access,
- Hypertension (more than 140/90),
- Heart disease,
- History of panic attacks,
- Average daily caffeine consumption of more than 300 or less than 100 mg,
- Smoking,
- Alcohol abuse,
- Taking any medication other than birth control bills (including over-the-counter drugs) within one week from starting the study,
- Hypersensitivity to caffeine or related compounds,
- Hemoglobin of less than 13 gm/L, and recent (one week) acute illness
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00426010
Start Date
January 1 2007
End Date
February 1 2009
Last Update
December 13 2011
Active Locations (1)
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1
Center for Clinical Studies & Empirical Ethics, KFSH & RC
Riyadh, Saudi Arabia, 11211