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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025637
Receipt No. R000029496
Scientific Title Information therapy using inaudible sounds for substance use disorders
Date of disclosure of the study information 2017/01/12
Last modified on 2019/05/14

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Basic information
Public title Information therapy using inaudible sounds for substance use disorders
Acronym Information therapy for substance use disorders
Scientific Title Information therapy using inaudible sounds for substance use disorders
Scientific Title:Acronym Information therapy for substance use disorders
Region
Japan

Condition
Condition Substance use disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of information therapy using inaudible sounds for substance use disorders.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Change from the baseline by the OCDS (Obsessive Compulsive Drinking Scale) scores after 8-week information therapy
Key secondary outcomes Change from the baseline by the following items
1.ACQ-SF-R (Alcohol Craving Questionnaire Short Form Revised) score
2.The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
3.AUDIT(The Alcohol Use Disorders Identification Test)
4.Medication

Following items in relation to safety
5. Attrition rate of any cause
6. All adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Exposure of inaudible sounds for 8 weeks during cognitive behavioral therapy sessions
Interventions/Control_2 Exposure of audible sounds for 8 weeks during cognitive behavioral therapy sessions
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
90 years-old >
Gender Male and Female
Key inclusion criteria -Patients who meet criteria of substance use disorders by DSM-5
-Inpatients/outpatients of the Kurihama Medical and Addiction Center
-Patients who completed detoxification therapy, in case they are inpatients
Key exclusion criteria -In case they have history of developmental disorder, bipolar disorder or schizophrenia.
-In case they are evaluated as insufficient for providing informed consent
-In case they are evaluated as not appropriate for enrolling in the study by attending physician.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Manabu
Middle name
Last name Honda
Organization National Center of Neurology and Psychiatry
Division name Department of Functional Brain Research, National Institute of Neuroscience
Zip code 187-8502
Address 4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8502, Japan
TEL 042-346-1718
Email honda@ncnp.go.jp

Public contact
Name of contact person
1st name Yuichi
Middle name
Last name Yamashita
Organization National Center of Neurology and Psychiatry
Division name Department of Functional Brain Research, National Institute of Neuroscience
Zip code 187-8502
Address 4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8502, Japan
TEL 042-346-1718
Homepage URL
Email yamay@ncnp.go.jp

Sponsor
Institute National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 Ogawa-Higashi, Kodaira, Tokyo 187-8502, Japan
Tel 048-462-1111
Email ml_rinrijimu@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
2017 Year 01 Month 12 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
2016 Year 09 Month 08 Day
Date of IRB
2016 Year 08 Month 26 Day
Anticipated trial start date
2017 Year 01 Month 12 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 12 Day
Last modified on
2019 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029496

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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