UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006347 |
|---|---|
| Receipt number | R000007529 |
| Scientific Title | The prospective study of effect of ifenprodil on relapse prevention in patients with substance dependence |
| Date of disclosure of the study information | 2011/09/14 |
| Last modified on | 2015/05/01 17:36:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The prospective study of effect of ifenprodil on relapse prevention in patients with substance dependence
Acronym
The effect of ifenprodil on relapse prevention in patients with substance dependence
Scientific Title
The prospective study of effect of ifenprodil on relapse prevention in patients with substance dependence
Scientific Title:Acronym
The effect of ifenprodil on relapse prevention in patients with substance dependence
Region
| Japan |
Condition
Condition
Alcohol dependence
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of the medication with G-protein-activated inwardly rectifying potassium (GIRK) channel inhibitor (ifenprodil) on the relapse prevention in patients with alcohol dependence.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Slip: alcohol use during the past month
2) Level of alcohol drinking: frequency and amount of alcohol drinking
3) Dropout: dropout of treatment
4) Craving and relapse risk: assessment by self-rating questionnaire including VAS and Alcohol Relapse Risk Scale (ARRS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Prior administered group: patients administered control drug (vitamin C, product name: Cinal, 600mg/day) during 3 months after ifenprodil (product name: Cerocral, 60mg/day) during 3 months
Interventions/Control_2
Latter administered group: patients administered ifenprodil during 3 months after control drug during 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Outpatients diagnosed as alcohol dependence
2) Stabilized patients who can complete the questionnaire
3) Patients in abstinence within 2 years
4) Patients who can respond in Japanese
5) Patients suspected mild cognitive deficiency from the results of a test of cognitive functions (or existing brain image data)
Key exclusion criteria
1) Patients with noncompliance
2) Participants of other clinical trials
3) Patients with comorbid psychiatric disorder (e.g. schizophrenia) or serious physical diseases
4) Patients with considerably low motivation for treatment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazutaka Ikeda |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Addictive Substance Project
Zip code
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo 156-8506, Japan
TEL
03-6834-2390
ikeda-kz@igakuken.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasukazu Ogai |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Addictive Substance Project
Zip code
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo 156-8506, Japan
TEL
03-6834-2390
Homepage URL
ogai-ys@igakuken.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Institute of Medical Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Metropolitan Matsuzawa Hospital
Name of secondary funder(s)
Ministry of Health, Labour and Welfare
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
東京都立松沢病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2011 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 14 | Day |
Last modified on
| 2015 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007529
