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
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
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
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
