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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016384
Receipt No. 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 2020/04/21

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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
Institute Saitama Prefectural Psychiatric Hospital
Institute
Department

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 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 01 Month 30 Day
Last modified on
2020 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.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


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