UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006280 |
|---|---|
| Receipt number | R000007401 |
| Scientific Title | The pilot randomized controlled trial of the Japanese Matrix Program for alcohol dependence syndrome |
| Date of disclosure of the study information | 2011/09/03 |
| Last modified on | 2012/10/24 12:48:52 |
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Basic information
Public title
The pilot randomized controlled trial of the Japanese Matrix Program for alcohol dependence syndrome
Acronym
The pilot randomized controlled trial of the Japanese Matrix Program for alcohol dependence syndrome (J-MAT study)
Scientific Title
The pilot randomized controlled trial of the Japanese Matrix Program for alcohol dependence syndrome
Scientific Title:Acronym
The pilot randomized controlled trial of the Japanese Matrix Program for alcohol dependence syndrome (J-MAT study)
Region
| Japan |
Condition
Condition
Alcohol dependence syndrome
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of the Japanese Matrix Program for alcohol dependence syndrome.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Abstinence rate
Key secondary outcomes
Drop-out rate, self-efficacy on abstinence, cognition on drinking, coping skills
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
The Japanese Matrix Program, which is the cognitive-behavioral (relapse prevention model) substance abuse treatment program is conducted for 3 months.
Interventions/Control_2
The standard educational treatment program is conducted for 3 months.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Alcohol dependent patients who are under inpatient treatment in Tokyo Metropolitan Matsuzawa Hospital and whose medical condition is stable enough to answer the questionnaires.
Key exclusion criteria
Those who are considered inadequate for the participation by a doctor.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nozomu Asukai |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Mental Health Promotion Project
Zip code
Address
2-1-6 Kamkitazawa, Setagaya-ku, Tokyo, 156-8506
TEL
03-5316-3100
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Harada |
Organization
Mejiro University
Division name
Faculty of Human Science
Zip code
Address
4-31-1 Nakaochiai, Shinjuku-ku, Tokyo, 161-8539
TEL
03-5996-3136
Homepage URL
t.harada@mejiro.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Medical Science
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
| 2011 | Year | 09 | Month | 03 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 13 | Day |
Date of closure to data entry
| 2013 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 03 | Day |
Last modified on
| 2012 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007401
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
