The Placebo Effect May Involve Modulating Drug Bioavailability

NCT01501747 | Completed

• 1 other identifier: RAC2101105
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

The total effect of a medication is the sum of its drug effect, placebo effect (meaning response of placebo), and their interaction. Current interpretation of clinical trials (the gold standard of evidence-based-medicine) assumes no interaction, and the mechanism(s) underlying such interaction have not been fully explored. One possibility is that the placebo effect may modulate drug bioavailability. Using caffeine as a model drug, we have recently shown that the placebo effect of caffeine ingestion prolongs caffeine half life. Due to the novelty of this finding and its important clinical practice and clinical research implications, it needs to be confirmed in another set of subjects and extended to additional drugs. The results of the study are expected to further our understanding of the mechanism of action of a widely used medical intervention, i.e., placebo. The results will be important for both clinical practice and clinical research.

Conditions

Placebo Effect; Drug Half Life; Pharmacokinetics

Keywords

Placebo effect; drug half life; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Plasma half life

  The study has 4 sub-parts (one for eah of 4 drugs), each sub-part has a crossover design. The time frame to measure the outcome depends on the drug studied. For caffeine it is 24 hours, for paracetamol, it is 14 hours, for cephalexin, it is 6 hours, and for ibuprofen, it is 10 hours.

  24 hours

Secondary Outcomes (3)

• Area under the curve

  24 hours

• Tmax

  24 hours

• Cmax

  24 hours

Study Arms (2)

overt drug

ACTIVE COMPARATOR

The study has 4 sub-parts (one for each of 4 drugs), each sub-part has a crossover design. In this arm, the volunteer will be given one oral dose of 300 mg caffeine, 500 mg paracetamol, 500 mg cephalexin, or 400 mg ibuprofen and will be told that they are receiving such medication.

Drug: Caffeine, paracetamol, cephalexin, or ibuprofen

Placebo (Covert drug)

PLACEBO COMPARATOR

The study has 4 sub-parts (one for each of 4 drugs), each sub-part has a crossover design. In this arm, the volunteer will be given one oral dose of 300 mg caffeine, 500 mg paracetamol, 500 mg cephalexin, or 400 mg ibuprofen and will be told that they are receiving a placebo.

Drug: Placebo (caffeine, paracetamol, cephalexin, or ibuprofen)

Interventions

Caffeine, paracetamol, cephalexin, or ibuprofen DRUG

The study has 4 sub-parts (one for each of 4 drugs), each sub-part has a crossover design. In this arm, the volunteer will be given one oral dose of 300 mg caffeine, 500 mg paracetamol, 500 mg cephalexin, or 400 mg ibuprofen and will be told that they are receiving the active drug.

overt drug

Placebo (caffeine, paracetamol, cephalexin, or ibuprofen) DRUG

The study has 4 sub-parts (one for each of 4 drugs), each sub-part has a crossover design. In this arm, the volunteer will be given one oral dose of 300 mg caffeine, 500 mg paracetamol, 500 mg cephalexin, or 400 mg ibuprofen and will be told that they are receiving a placebo.

Placebo (Covert drug)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Having no evidence of clinically important deviation from normal health as indicated by medical history, vital signs, and clinical laboratory tests.
• Acceptance to abstain from taking any medication other than birth control pills (including over-the-counter drugs) for at least 1 week prior to, and during the study; and from smoking and taking alcohol or caffeine or related xanthenes-containing beverages or food for 48 hours before and throughout each study period.
• Having good peripheral venous access.
• For the caffeine study, habitual daily caffeine intake should be 100-300 mg.

You may not qualify if:

• Women should be non-pregnant and non-lactating. For menstruating women, the study will be conducted 5 to 19 days after the last menstrual period and a urine pregnancy test will be performed.
• Should not have history of hypersensitivity to the drug to be tested or to its related compounds.
• Body Mass Index (BMI) should be less than 35 kg/m2.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital & Research Center

Riyadh, 11211, Saudi Arabia

Location

Related Publications (1)

• Hammami MM, Yusuf A, Shire FS, Hussein R, Al-Swayeh R. Does the placebo effect modulate drug bioavailability? Randomized cross-over studies of three drugs. J Negat Results Biomed. 2017 May 23;16(1):10. doi: 10.1186/s12952-017-0075-2.

  PMID: 28535819 DERIVED

MeSH Terms

Interventions

Caffeine; Acetaminophen; Cephalexin; Ibuprofen

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cephalosporins; beta-Lactams; Lactams; Thiazines; Sulfur Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2011
• First Posted: December 29, 2011
• Study Start: February 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

SA (1)