Home
Clinical Trials
NCT00426010

Measuring Placebo Effect by Elimination and Investigating Mechanism of Action

NCT ID: NCT00426010

Last Updated: 2011-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Placebo Effect Placebo Mechanisms of Action

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Placebo effect Caffeine Systolic BP VAS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

overt then covert caffeine

Group Type ACTIVE_COMPARATOR

caffeine/placebo

Intervention Type DRUG

caffeine or placebo, either overt or covert

2

covert then overt caffeine

Group Type ACTIVE_COMPARATOR

caffeine/placebo

Intervention Type DRUG

caffeine or placebo, either overt or covert

3

overt then covert placebo

Group Type ACTIVE_COMPARATOR

caffeine/placebo

Intervention Type DRUG

caffeine or placebo, either overt or covert

4

covert then overt placebo

Group Type ACTIVE_COMPARATOR

caffeine/placebo

Intervention Type DRUG

caffeine or placebo, either overt or covert

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

caffeine/placebo

caffeine or placebo, either overt or covert

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

King AbdulAziz City for Science and Technology

OTHER

Sponsor Role collaborator

King Faisal Specialist Hospital & Research Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

King faisal specialist hospital & research center

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Muhammad M Hammami, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

KFSH & RC, Riyadh

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Clinical Studies & Empirical Ethics, KFSH & RC

Riyadh, , Saudi Arabia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Saudi Arabia

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1186/1745-6215-11-110.

Reference Type DERIVED

PMID: 21092089 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KACST:ARP-26-45

Identifier Type: -

Identifier Source: secondary_id

RAC# 2051072

Identifier Type: -

Identifier Source: org_study_id