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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011144
Receipt No. R000012990
Scientific Title Examination about the change of the cerebral blood flow before and after the treatment of the abstinence supplement using the cerebral blood flow scintigraphy
Date of disclosure of the study information 2013/08/01
Last modified on 2016/07/25

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Basic information
Public title Examination about the change of the cerebral blood flow before and after the treatment of the abstinence supplement using the cerebral blood flow scintigraphy
Acronym Examination about the change of the cerebral blood flow for the treatment of the abstinence supplement
Scientific Title Examination about the change of the cerebral blood flow before and after the treatment of the abstinence supplement using the cerebral blood flow scintigraphy
Scientific Title:Acronym Examination about the change of the cerebral blood flow for the treatment of the abstinence supplement
Region
Japan

Condition
Condition Alcoholism
Classification by specialty
Medicine in general Psychiatry Radiology
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine a change of the cerebral blood flow before and after the treatmen of the abstinence supplement (Regtect) in cerebral blood flow scintigraphy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes In this study, we intend for the patients who consulted an alcohol dependence treatment outpatient.
We intend for the patients with the abstinence will.
We use Regtect as abstinence adjuvant medicine.
Treatment using Regtect is provided.
We conduct a cognitive function evaluation and foreign follow-up before and after treatment.
The cerebral blood flow scintigraphy is carried out in a hospital nuclear medicine laboratory attached to the Osaka City University School of Medicine.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We intend for the patients who consulted Kotani clinic for alcoholism.
They receive abstinence from alcoholic drinks treatment (including psycho-social therapy and rehabilitation such as the counseling), and we selects the patients who became the alcohol abstinence possible.
We give regtect in Kotani clinic subsequently.
We intend for the patients who secession from alcohol dependence is done and can continue abstinence from alcoholic drinks.
Key exclusion criteria The patients who drank again during abstinence from alcoholic drinks treatment. The patients who stopped going to hospital and treatment by oneself.
The patients who were not able to undergo cerebral blood flow scintigraphy.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeaki Higashiyama
Organization Osaka City University, Graduate School of Medicine
Division name Nuclear Medicine
Zip code
Address 1-4-3 Asahimachi Abeno-ku Osaka-city Osaka
TEL 06-6645-3885
Email higashiya@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeaki Higashiyama
Organization Osaka City University, Graduate School of Medicine
Division name Nuclear Medicine
Zip code
Address 1-4-3 Asahimachi Abeno-ku Osaka-city Osaka
TEL 06-6645-3885
Homepage URL
Email higashiya@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University, Graduate School of MedicineDepartment of Nuclear Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2015 Year 12 Month 01 Day
Date of closure to data entry
2016 Year 07 Month 28 Day
Date trial data considered complete
2016 Year 07 Month 28 Day
Date analysis concluded
2016 Year 09 Month 28 Day

Other
Other related information We compare the cerebral blood flow before and after the treatment of the abstinence in alcoholism.
We determine the association between alcoholism and intracerebral local blood flow change site.
The objective effect of treatment judgment, effect of treatment response prediction is enabled.
We evaluate an intracerebral blood flow change by Regtect.

Management information
Registered date
2013 Year 07 Month 08 Day
Last modified on
2016 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012990

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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