UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination about the change of the cerebral blood flow before and after the treatment of the abstinence supplement using the cerebral blood flow scintigraphy
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Shigeaki Higashiyama
Organization	Osaka City University, Graduate School of Medicine
Division name	Nuclear Medicine
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	Shigeaki Higashiyama
Organization	Osaka City University, Graduate School of Medicine
Division name	Nuclear Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000012990