UMIN-CTR Clinical Trial

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

Alcohol use disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Department of Psychiatry, Chiba University Graduate School of Medicine

Institute

Department

Personal name

Organization

Chiba University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

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

Date of disclosure of the study information

2013

Year

09

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2013

Year

09

Month

11

Day

Last modified on

2015

Year

03

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013689