UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051865 |
|---|---|
| Receipt number | R000059178 |
| Scientific Title | Effectiveness of memory recall intervention on drinking behavior and mental health among alcohol drinkers |
| Date of disclosure of the study information | 2023/08/09 |
| Last modified on | 2023/08/08 15:58:18 |
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Basic information
Public title
An experiment on memory recall by olfactory stimulation of alcoholic beverages
Acronym
An experiment on memory recall by olfactory stimulation of alcoholic beverages
Scientific Title
Effectiveness of memory recall intervention on drinking behavior and mental health among alcohol drinkers
Scientific Title:Acronym
Effectiveness of memory recall intervention on drinking behavior and mental health
Region
| Japan |
Condition
Condition
drinking behavior
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In recent years, there has been a great deal of research on olfaction and memory in the field of cognitive psychology, and it has been empirically demonstrated that olfactory stimulation affects memory, behavior after recall, and even mental health. In this study, we focus on this point and empirically examine the effects of memory recall induced by olfactory stimulation of alcohol on appropriate control of drinking behavior and mental health in alcohol drinkers and alcohol addicts. Based on these studies, we will integrate the perspectives of both cognitive psychology and clinical psychology to clarify how alcohol drinkers can establish a good relationship with alcohol.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
drinking behavior
Key secondary outcomes
characteristics and function of olfactory autobiographical memory, mood states, health-related quality of life, Well-being
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Presentation of alcoholic beverage odor stimuli and positive memory recall
Interventions/Control_2
Presentation of alcoholic beverage odor stimuli and negative memory recall
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
| 59 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Alcohol preference group (AUDIT 1 <= 7 points) and alcohol addiction group (AUDIT => 8 points)
Key exclusion criteria
-Those who are in the fragrance industry.
-Those who usually do not drink alcohol at all
-Those who do not have a good sense of smell.
-Those who smoke cigarettes and have not quit smoking cigarettes for six months.
-Those who cannot recall past events by smelling.
-Those who cannot type Japanese on their smartphones.
-Those who cannot use their own smartphone to participate in the experiment.
-Those who cannot pay the electricity and communication costs for the use of the smartphone in the survey.
-Those who are infected with a COVID-19
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Kohsuke |
| Middle name | |
| Last name | Yamamoto |
Organization
Osaka Sangyo University
Division name
Faculty of International Studies
Zip code
574-0013
Address
3-1-1 Nakagaito, Daito City, Osaka
TEL
072-875-3001
kyamamoto@int.osaka-sandai.ac.jp
Public contact
Name of contact person
| 1st name | Kohsuke |
| Middle name | |
| Last name | Yamamoto |
Organization
Osaka Sangyo University
Division name
Faculty of International Studies
Zip code
574-0013
Address
3-1-1 Nakagaito, Daito City, Osaka
TEL
072-875-3001
Homepage URL
kyamamoto@int.osaka-sandai.ac.jp
Sponsor or person
Institute
Osaka Sangyo University
Institute
Department
Personal name
Funding Source
Organization
The Osake No-Kagaku Foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokusho University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Sangyo University
Address
3-1-1 Nakagaito, Daito City, Osaka
Tel
072-875-3001
kyamamoto@int.osaka-sandai.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
| 2023 | Year | 08 | Month | 09 | 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 08 | Month | 08 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059178
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| Registered date | File name |
| Research case data | |
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