An interventional study of Hydroxizine and Placebo in Placebo Effect and Placebo Drug Interaction, sponsored by King Faisal Specialist Hospital & Research Center. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by King Faisal Specialist Hospital & Research Center · Not applicable, Interventional, and Basic science
The total effect of a medication is the sum of its drug effect, placebo effect (meaning response of placebo), and their possible interaction. Current interpretation of the results of clinical trials (the gold standard in evidence based medicine) assumes no such interaction. Using a novel cross-over balanced placebo design and caffeine as a model drug, the investigators have recently shown that a negative interaction does exist; suggesting that the size of drug effect as currently measured by clinical trials may not be accurate. Due to the novelty of the findings and their important clinical practice and research implications, they need to be confirmed using another drug; and the size of drug effect measured using the novel design need to be directly compared to that measured using conventional clinical trial design. The results of the study are expected to further our understanding of a widely used medical intervention, i.e., placebo, and help assess the appropriateness of randomized clinical trials in determining the size of drug effect.
BACKGROUND:
The total effect of a medication is the sum of its drug effect, placebo effect (meaning response of placebo), and their possible interaction. Current interpretation of the results of clinical trials (the gold standard in evidence based medicine) assumes no such interaction. Using a novel cross-over balanced placebo design and caffeine as a model drug we have recently shown that a negative interaction does exist; suggesting that the size of drug effect as currently measured by clinical trials may not be accurate. Due to the novelty of the findings and their important clinical practice and research implications, they need to be confirmed using another drug; and the size of drug effect measured using the novel design need to be directly compared to that measured using conventional clinical trial design.
DESIGN:
A cross-over balanced placebo plus randomized placebo-controlled clinical trial design.
METHODS:
480 adults will be double-blindly randomized to three groups: first generation H-1 receptor antagonist- hydroxyzine (25 mg), placebo, or hydroxyzine+placebo group. The first two groups will receive the assigned intervention described by the investigators as hydroxyzine or placebo, in a randomized crossover design. The third group will receive hydroxyzine and placebo in a randomized double-blind placebo-controled crossover design. Group assignment will be concealed from volunteers and recruiters. Data collectors will be blinded to group assignment and intervention assignment. Volunteers will be partially deceived to the intervention assignment in the first two groups and blinded in the third group. The interventions to the third group will be also administered blindly. Serum hydroxyzine levels will be determined 3 hours post intervention from all volunteers to verify compliance and help maintain deception/blinding. The results of the study are expected to further our understanding of a widely used medical intervention, i.e., placebo, and help assess the appropriateness of randomized clinical trials in determining the size of drug effect.
King Faisal Specialist Hospital & Research Center is the lead sponsor of 98 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
This group will receive a first generation H-1 receptor antagonist, hydroxyzine (25 mg) twice on two days; on one day described by the investigator as hydroxyzine and on the other day described by the investigator as placebo, in a randomized balanced crossover design.
Drug: Hydroxizine
This group will receive a placebo twice on two days; on one day described by the investigator as hydroxyzine and on the other day described by the investigator as placebo, in a randomized balanced crossover design.
Other: Placebo
This group will receive hydroxyzine and placebo in a randomized double-blind placebo-controled crossover design.
Drug: hydroxyzine/placebo
25 mg orally, one time on two different days, 72 hours apart
Matching placebo once on two different days, 72 hours apart.
25 mg hydroxyzine or placebo once on two different days, 72 hours apart
Area-under-the-curve for drowsiness
Seven-hour-area-under-the-curve of drowsiness on 100 mm visual analog scales will be determined
Time frame: seven hours
Area-under-the-curve for dryness of the mouth
Seven-hour-area-under-the-curve of dryness of the mouth on 100 mm visual analog scales will be determined
Time frame: seven hours
Mean percent of time of reporting drowsiness on a dichotomous scale.
Mean percent of time of reporting drowsiness on a dichotomous scale will also be determined.
Time frame: seven hours
Mean percent of time of reporting dryness of mouth
Mean percent of time of reporting dryness of mouth on a dichotomous scale will also be determined.
Time frame: seven hours
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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King Faisal Specialist Hospital & Research Center