UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016384
Receipt number R000018925
Scientific Title A randomized controlled trial of a brief intervention for substance use disorder
Date of disclosure of the study information 2015/02/01
Last modified on 2021/08/20 10:52:48

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Basic information

Public title

A randomized controlled trial of a brief intervention for substance use disorder

Acronym

A randomized controlled trial of a brief intervention for substance use disorder

Scientific Title

A randomized controlled trial of a brief intervention for substance use disorder

Scientific Title:Acronym

A randomized controlled trial of a brief intervention for substance use disorder

Region

Japan


Condition

Condition

substance use disorder

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to evaluate the efficacy of a brief intervention for substance use disorder

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

abstinence rate

Key secondary outcomes

retention rate and drug use after discharge, change of scores beteween pre- and post-intervention on the self rating scales


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


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

intervention group recieve a 30-minutes brief intervention for substance use disorder

Interventions/Control_2

the control group receive a standard pamphlet about substance use disorder

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

Patients of substance use disoreder who are under inpatint treatment in psychiatric emergency ward of Saitama Prefectural Psychiatric 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

60


Research contact person

Name of lead principal investigator

1st name Yuzo
Middle name
Last name Aikawa

Organization

Saitama Prefectural Psychiatric Hospital

Division name

Psyciatry

Zip code

362-0806

Address

818-2, Komuro, Ina-machi, Saitama, 362-0806 Japan.

TEL

048-723-1111

Email

yuzoaikawa@yahoo.co.jp


Public contact

Name of contact person

1st name Yuzo
Middle name
Last name Aikawa

Organization

Saitama Prefectural Psychiatric Hospital

Division name

Psychiatry

Zip code

362-0806

Address

818-2, Komuro, Ina-machi, Saitama, 362-0806 Japan.

TEL

048-723-1111

Homepage URL


Email

yuzoaikawa@yahoo.co.jp


Sponsor or person

Institute

Saitama Prefectural Psychiatric Hospital

Institute

Department

Personal name



Funding Source

Organization

the Research Grant for Nervous and Mental Disorders

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

Saitama Prefectural Psychiatric Hospital

Address

818-2, Komuro, Ina-machi, Saitama, 362-0806 Japan.

Tel

048-723-1111

Email

yuzoaikawa@yahoo.co.jp


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

2015 Year 02 Month 01 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

2014 Year 01 Month 06 Day

Date of IRB

2015 Year 01 Month 06 Day

Anticipated trial start date

2015 Year 02 Month 02 Day

Last follow-up date

2020 Year 04 Month 30 Day

Date of closure to data entry

2020 Year 09 Month 30 Day

Date trial data considered complete

2020 Year 12 Month 31 Day

Date analysis concluded

2021 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 01 Month 30 Day

Last modified on

2021 Year 08 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018925


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name