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Recruitment status Terminated
Unique ID issued by UMIN UMIN000011707
Receipt No. R000013689
Scientific Title Evaluation of small dose aripiprazole for the treatment of alcohol use disorders: a randomized, double-blind, placebo-controlled study.
Date of disclosure of the study information 2013/09/11
Last modified on 2015/03/14

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Basic information
Public title Evaluation of small dose aripiprazole for the treatment of alcohol use disorders: a randomized, double-blind, placebo-controlled study.
Acronym Evaluation of small dose aripiprazole for the treatment of alcohol use disorders: a randomized, double-blind, placebo-controlled study.
Scientific Title Evaluation of small dose aripiprazole for the treatment of alcohol use disorders: a randomized, double-blind, placebo-controlled study.
Scientific Title:Acronym Evaluation of small dose aripiprazole for the treatment of alcohol use disorders: a randomized, double-blind, placebo-controlled study.
Region
Japan

Condition
Condition Alcohol use disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy and safety of small dose of aripiprazole in the patients with alcohol use disorders.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Rate of change of carbohydrate-deficient transferrin (%CDT) in the 4week and the 12 week
Key secondary outcomes 1. Days abstinent from drinking
2. Drinks per day
3. Drinks per drinking day
4. The obsessive-compulsive drinking scale(OCDS)
5. Electroencephalography(Voluntary participation)

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 Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Aripiprazole was administered orally at 3mg once a day for 8weeks.
Interventions/Control_2 Placebo was administered orally once a day for 8 weeks.
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
20 years-old <=
Age-upper limit
64 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients with Alcohol use diorders by DSM-IV-TR
2. Patients with 15 or over in AUDIT(the Alcohol Use Disorders Identification Test)
3. Patients with experience that failed in abstinence from alcoholic drinks befere, and who continues drinking
4.Patients with 20-64 years of age at study entry
5. Written informed consent by patients
Key exclusion criteria 1. Comatose state
2. Influence of the central nerve inhibitor such as a barbituric acid derivative, the anesthetic
3. Current use of any other dopamine D2 agonist or antagonist
4. Current use of any other antialcoholic drug
5. Other current drug abuse or dependence
6. Use of epinephrine
7. Allergy or hypersensitivity to aripiprazole
8. Woman during pregnancy or shortly after childbirth
9. High suicidal risk
10. Uncontrollable diabetic
11. Decreased liver function (aminotransferase greater than 5 times normal) or cirrhosis more than Child C
12. Current major psychiatric disorder
13. Current dementia
Target sample size 36

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaomi Iyo
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-222-7171
Email iyom@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tasuku Hashimoto
Organization Chiba University Graduate School of Medicine
Division name Department of Psychiatry
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL 043-222-7171
Homepage URL
Email t-hashimoto@faculty.chiba-u.jp

Sponsor
Institute Department of Psychiatry, Chiba University Graduate School of 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 Chiba University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 G25015
Org. issuing International ID_1 IRB committee in Chiba University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 千葉大学医学部附属病院 Chiba University Hospital(千葉県, Chiba Pref)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 11 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 Terminated
Date of protocol fixation
2013 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 09 Month 17 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
2013 Year 09 Month 11 Day
Last modified on
2015 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013689


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