Measuring Placebo Effect by Elimination and Investigating Mechanism of Action

Placebo Effect Clinical Trial

Official title:

Measuring Placebo Effect by Elimination and Investigating Its Mechanism of Action

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426010
• Other study ID #: RAC# 2051072
• Secondary ID: KACST:ARP-26-45
• Status: Completed
• Phase: N/A
• First received: January 23, 2007
• Last updated: December 11, 2011
• Start date: January 2007
• Est. completion date: February 2009

Study information

• Verified date: December 2011
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Research Advisory Council, KFSH & RCSaudi Arabia: King Abdulaziz City for Science & Technology (KACST)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Placebo Effect
• Placebo Mechanisms of Action

Intervention

Drug:
• caffeine/placebo
caffeine or placebo, either overt or covert

Locations

Country	Name	City	State
Saudi Arabia	Center for Clinical Studies & Empirical Ethics, KFSH & RC	Riyadh

Sponsors (2)

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

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	4 hours area under the curve (AUC) of peripheral systolic blood pressure		4 hours	No
Primary	4 hours area under the curve (AUC) of energy level measured by Visual Analogue Scales.		4 hours	No
Primary	4 hours area under the curve (AUC) of alertness level measured by Visual Analogue Scales.		4 hours	No
Primary	4 hours area under the curve (AUC) of nausea measured by Visual Analogue Scales.		4 hours	No
Secondary	Cmax of serum caffeine (in a subgroup)		4 hours	No
Secondary	Tmax of serum caffeine (in a subgroup)		4 hours	No
Secondary	t1/2 of serum caffeine (in a subgroup)		14 hours	No
Secondary	AUC of serum caffeine (in a subgroup)		14 hours	No