Measuring Placebo Effect by Elimination and Investigating Mechanism of Action

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: King Faisal Specialist Hospital & Research Center
• Collaborator: King AbdulAziz City for Science and Technology
• Treatments: Caffeine

Criteria

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