Measuring Placebo Effect by Elimination and Investigating Mechanism of Action - Full Text View

Purpose

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
Placebo Effect Placebo Mechanisms of Action	Drug: caffeine/placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Measuring Placebo Effect by Elimination and Investigating Its Mechanism of Action

Resource links provided by NLM:

MedlinePlus related topics: Caffeine

U.S. FDA Resources

Further study details as provided by King Faisal Specialist Hospital & Research Center:

Primary Outcome Measures:

4 hours area under the curve (AUC) of peripheral systolic blood pressure [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
4 hours area under the curve (AUC) of energy level measured by Visual Analogue Scales. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
4 hours area under the curve (AUC) of alertness level measured by Visual Analogue Scales. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
4 hours area under the curve (AUC) of nausea measured by Visual Analogue Scales. [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cmax of serum caffeine (in a subgroup) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Tmax of serum caffeine (in a subgroup) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
t1/2 of serum caffeine (in a subgroup) [ Time Frame: 14 hours ] [ Designated as safety issue: No ]
AUC of serum caffeine (in a subgroup) [ Time Frame: 14 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	January 2007
Study Completion Date:	February 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 overt then covert caffeine	Drug: caffeine/placebo caffeine or placebo, either overt or covert
Active Comparator: 2 covert then overt caffeine	Drug: caffeine/placebo caffeine or placebo, either overt or covert
Active Comparator: 3 overt then covert placebo	Drug: caffeine/placebo caffeine or placebo, either overt or covert
Active Comparator: 4 covert then overt placebo	Drug: caffeine/placebo caffeine or placebo, either overt or covert

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426010

Locations

Saudi Arabia
Center for Clinical Studies & Empirical Ethics, KFSH & RC
Riyadh, Saudi Arabia, 11211

Sponsors and Collaborators

King Faisal Specialist Hospital & Research Center

King AbdulAziz City for Science and Technology

Investigators

Principal Investigator:

Muhammad M Hammami, MD, PhD

KFSH & RC, Riyadh

More Information

No publications provided by King Faisal Specialist Hospital & Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hammami MM, Al-Gaai EA, Alvi S, Hammami MB. Interaction between drug and placebo effects: a cross-over balanced placebo design trial. Trials. 2010 Nov 19;11:110.

Responsible Party:	Muhammad Hammami, King faisal specialist hospital & research center
ClinicalTrials.gov Identifier:	NCT00426010 History of Changes
Other Study ID Numbers:	RAC# 2051072, KACST:ARP-26-45
Study First Received:	January 23, 2007
Last Updated:	December 11, 2011
Health Authority:	Saudi Arabia: Research Advisory Council, KFSH & RC Saudi Arabia: King Abdulaziz City for Science & Technology (KACST)

Keywords provided by King Faisal Specialist Hospital & Research Center:

Placebo effect
Caffeine
Systolic BP
VAS

Additional relevant MeSH terms:

Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Central Nervous System Agents
Therapeutic Uses

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ClinicalTrials.gov processed this record on May 19, 2013