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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006347
Receipt No. 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

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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
Email 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
Email ogai-ys@igakuken.or.jp

Sponsor
Institute Tokyo Metropolitan Institute of Medical Science
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007529

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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