NCT00426010

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 at the pharmacokinetics level.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

December 13, 2011

Status Verified

December 1, 2011

Enrollment Period

2.1 years

First QC Date

January 23, 2007

Last Update Submit

December 11, 2011

Conditions

Placebo EffectPlacebo Mechanisms of Action

Keywords

Placebo effectCaffeineSystolic BPVAS

Outcome Measures

Primary Outcomes (4)

  • 4 hours area under the curve (AUC) of peripheral systolic blood pressure

    4 hours

  • 4 hours area under the curve (AUC) of energy level measured by Visual Analogue Scales.

    4 hours

  • 4 hours area under the curve (AUC) of alertness level measured by Visual Analogue Scales.

    4 hours

  • 4 hours area under the curve (AUC) of nausea measured by Visual Analogue Scales.

    4 hours

Secondary Outcomes (4)

  • Cmax of serum caffeine (in a subgroup)

    4 hours

  • Tmax of serum caffeine (in a subgroup)

    4 hours

  • t1/2 of serum caffeine (in a subgroup)

    14 hours

  • AUC of serum caffeine (in a subgroup)

    14 hours

Study Arms (4)

1

ACTIVE COMPARATOR

overt then covert caffeine

Drug: caffeine/placebo

2

ACTIVE COMPARATOR

covert then overt caffeine

Drug: caffeine/placebo

3

ACTIVE COMPARATOR

overt then covert placebo

Drug: caffeine/placebo

4

ACTIVE COMPARATOR

covert then overt placebo

Drug: caffeine/placebo

Interventions

caffeine/placeboDRUG

caffeine or placebo, either overt or covert

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Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and nonpregnant females 18 and 40 years of age with at least high school education.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Clinical Studies & Empirical Ethics, KFSH & RC

Riyadh, 11211, Saudi Arabia

Location

Related Publications (1)

  • 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.

    PMID: 21092089DERIVED

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Muhammad M Hammami, MD, PhD

    KFSH & RC, Riyadh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2007

First Posted

January 24, 2007

Study Start

January 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

December 13, 2011

Record last verified: 2011-12

Locations

SA(1)