UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011144 |
|---|---|
| Receipt number | 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 09:39:19 |
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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
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
higashiya@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University, Graduate School of MedicineDepartment of Nuclear Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012990
