UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054785 |
|---|---|
| Receipt number | R000062602 |
| Scientific Title | A longitudinal study for prescription and over-the-counter drug use disorder |
| Date of disclosure of the study information | 2024/06/27 |
| Last modified on | 2024/06/26 15:34:29 |
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Basic information
Public title
A longitudinal study for prescription and over-the-counter drug use disorder
Acronym
A longitudinal study for prescription and over-the-counter drug use disorder
Scientific Title
A longitudinal study for prescription and over-the-counter drug use disorder
Scientific Title:Acronym
A longitudinal study for prescription and OTC use disorder
Region
| Japan |
Condition
Condition
Prescription and over-the-counter drug use disorders
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Longitudinally acquire clinical characteristics of individuals with prescription and over-the-counter drug use disorders.
Basic objectives2
Others
Basic objectives -Others
Perform psychological evaluation for individuals with prescription and over-the-counter drug use disorders.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self efficacy Scale for Drug Dependence, SOCRATES-8D, UCLA Loneliness Scale. Beck Depression Inventory, Beck Anxiety Inventory, Difficulties in Emotion Regulation Scale, The 20-items Toronto Alexithymia Scale
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals diagnosed with prescription drug and/or over-the-counter drug use disorder who regularly visit NCNP hospital
Key exclusion criteria
In case that primary care physician concerns worsening of symptoms by participating in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kyoji |
| Middle name | |
| Last name | Okita |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Psychiatry
Zip code
187-8551
Address
4-1-1 Ogawa-higashi, Kodaira, Tokyo
TEL
042-341-2711
kokita@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Saito |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Psychiatry
Zip code
187-8551
Address
4-1-1 Ogawa-higashi, Kodaira, Tokyo
TEL
042-341-2711
Homepage URL
ysaito@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board at National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-higashi, Kodaira, Tokyo
Tel
042-341-2711
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 | 06 | Month | 27 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Longitudinal study for prescription and/or over-the-counter drug use disorders
Management information
Registered date
| 2024 | Year | 06 | Month | 26 | Day |
Last modified on
| 2024 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062602
