UMIN-CTR Clinical Trial

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
Last 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
1st 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