UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047526 |
|---|---|
| Receipt number | R000054191 |
| Scientific Title | A study of the nocebo effect of caffeine: differences in expression with and without explanation and interindividual variability factors. |
| Date of disclosure of the study information | 2022/04/19 |
| Last modified on | 2024/04/23 14:21:51 |
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Basic information
Public title
A study of the nocebo effect of caffeine: differences in expression with and without explanation and interindividual variability factors.
Acronym
A study of the nocebo effect of caffeine
Scientific Title
A study of the nocebo effect of caffeine: differences in expression with and without explanation and interindividual variability factors.
Scientific Title:Acronym
A study of the nocebo effect of caffeine
Region
| Japan |
Condition
Condition
Adverse effect
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Depending on how the drug is explained to the patient, the ease of manifestation of the nocebo effect can change and affect the occurrence of side effects. In this study, study subjects will be divided into two groups: one group will receive an explanation of the effects of caffeine (increased heart rate, palpitations, gastric discomfort, etc.) and the other group will not receive an explanation of caffeine and will drink coffee. The effects of providing explanations will be clarified and the nocebo effect will be examined.
Basic objectives2
Others
Basic objectives -Others
To measure changes in cerebral blood flow in the dorsolateral prefrontal cortex of the brain with respect to the perception of the nocebo effect. Furthermore, we will elucidate the inter-individual variability factors of the nocebo effect and examine the differences in the onset of the nocebo effect and the mechanism of its onset.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the subjective indicators of caffeine (subjective symptom questionnaire and state anxiety) in the different manifestations of the nocebo effect.
To compare palpitations and gastric discomfort (VAS) and STAI (state anxiety) as subjective measures before and after coffee consumption in the explained and unexplained groups.
Key secondary outcomes
To measure changes in cerebral blood flow in the dorsolateral prefrontal cortex of the brain with respect to the perception of the nocebo effect. Furthermore, we will elucidate the inter-individual variability factors of the nocebo effect and examine the differences in the onset of the nocebo effect and the mechanism of its onset.
The COMT gene polymorphism, 5-HTT gene polymorphism, CCK gene polymorphism differences and personality will be examined as interindividual variability factors for the nocebo effect.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Groups with and without explanation of caffeine side effects, etc.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
# Healthy adults aged 20-39
# Able to drink black coffee
# Able to maintain confidentiality of information related to this study.
Key exclusion criteria
# Persons who have a history of getting sick from caffeinated beverages.
# Persons taking drugs (xanthines, CNS stimulants, MAO inhibitors, cimetidine, etc.) that are listed as concomitant precautions in the caffeine package insert (caffeine anhydrous).
# Those taking mucoprotective or gastric acid secretion inhibitors (including medical and OTC drugs)
# Women who are pregnant or may become pregnant
# Smokers or non-smokers
#Those with a history of adverse drug reactions or allergies to medications (however, the decision to participate in the study will be made after consultation with a medical specialist).
# Other persons who are considered inappropriate to conduct this study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Tohru |
| Middle name | |
| Last name | AOMORI |
Organization
Keio University, Faculty of Pharmacy
Division name
Hosipital Pharmacy and Science
Zip code
105-8512
Address
1-5-30, Shibakoen, Minato-ku, Tokyo
TEL
03-5400-2486
aomori-th@pha.keio.ac.jp
Public contact
Name of contact person
| 1st name | Minae |
| Middle name | |
| Last name | Isawa |
Organization
Keio University, Faculty of Pharmacy
Division name
Hosipital Pharmacy and Science
Zip code
105-8512
Address
1-5-30, Shibakoen, Minato-ku, Tokyo
TEL
03-5400-2486
Homepage URL
isawa-mn@pha.keio.ac.jp
Sponsor or person
Institute
Keio University, Faculty of Pharmacy
Hosipital Pharmacy and Science
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research from Japan Society for the Promotion of Science (JSPS).
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University Faculty of Pharmacy Medical Ethics Board
Address
35 Shinano-machi, Shinjyuku-ku, Tokyo
Tel
03-5363-3503
med-rinri-jimu@adst.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
120
Results
A clinical trial of 120 patients was completed. The allocation of 60 patients to the explanation group and 60 patients to the non-explanation group was 1:1.
Results date posted
| 2024 | Year | 04 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy adults aged 20-39
Participant flow
Adverse events
Nothing of note.
Outcome measures
Subjective and Objective Evaluation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 04 | Month | 19 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054191
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| Registered date | File name |
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