UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055131 |
|---|---|
| Receipt number | R000058686 |
| Scientific Title | A Study on Evaluation of Treatment Programs for Women with Substance Use Disorders |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2024/08/01 11:11:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study on Evaluation of Treatment Programs for Women with Substance Use Disorders
Acronym
A Study on Evaluation of Treatment Programs for Women with Substance Use Disorders
Scientific Title
A Study on Evaluation of Treatment Programs for Women with Substance Use Disorders
Scientific Title:Acronym
A Study on Evaluation of Treatment Programs for Women with Substance Use Disorders
Region
| Japan |
Condition
Condition
Substance Use Disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of treatment programs for women with substance use disorders.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Substance use in the last 30 days
Key secondary outcomes
PDS-5, Alexisomia scale score
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Implemented a treatment program for women with substance use disorders using a workbook.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Women continuing treatment for substance use disorders at the study site.
2) Subjects who have voluntarily consented after receiving an explanation regarding this research.
3) Persons who are 18 years of age or older at the time of obtaining consent.
Key exclusion criteria
1) Subjects with many missing or clearly false answers.
2) Others who are judged to be inappropriate by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Matsumoto |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health Department of Drug Dependence Research
Zip code
187-8553
Address
4-1- 1 Ogawahigashicho, Kodaira, Tokyo
TEL
042-346-1954
tmatsu@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Kondo |
Organization
National Center of Neurology and Psychiatry
Division name
National Institute of Mental Health Department of Drug Dependence Research
Zip code
187-8553
Address
4-1- 1 Ogawahigashicho, Kodaira, Tokyo
TEL
042-346-1954
Homepage URL
a-kondo@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Ethics Committee
Address
4-1- 1 Ogawahigashicho, Kodaira, Tokyo
Tel
042-341-2712
rinri-jimu@ncnp.go.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
| 2024 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 01 | Day |
Last modified on
| 2024 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058686
