UMIN-CTR Clinical Trial

Basic information
Public title	A preliminary test to examine the efficacy and safety of web-based brief intervention (ALMIGHT brief) for high-risk drinkers
Acronym	A preliminary test to examine the efficacy and safety of web-based brief intervention (ALMIGHT brief) for high-risk drinkers
Scientific Title	A preliminary test to examine the efficacy and safety of web-based brief intervention (ALMIGHT brief) for high-risk drinkers
Scientific Title:Acronym	A preliminary test to examine the efficacy and safety of web-based brief intervention (ALMIGHT brief) for high-risk drinkers
Region	Japan

Condition
Condition	Heavy drinker
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the feasibility of ALMIGHT Brief and preliminarily consider the efficacy and safety of ALMIGHT Brief. ALMIGHT Brief is the 8-weeks-web-based brief counseling program based on cognitive-behavioral therapy for heavy drinkers to reduce the amounts of alcohol consumptions.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Change in HDD(Heavy Drinking Day) repeatedly measured by TLFB which is provided during baseline(one time/week, three times in total) and during intervention(one time/week, 8 times in total). HDD is calculated weekly. The calculation for HDD is that the number of days which the amount of alcohol consumption is higher than 61g per day in men, or 41g per day in women is divided by the number of days which the data of alcohol consumption is correctly obtained (not missed)and multiplied by 7. If the number of days which the data is correctly obtained (not missed)was less than 3 days per a week, all the datas of the week will be treated as missing datas.
Key secondary outcomes	- TAC(total alcohol consumption) repeatedly measured by TLFB which is provided during baseline(one time/week, three times in total) and during intervention(one time/week, 8 times in total) The calculation for TAC is similar to that for HDD. Also, a missing data is defined in Primary outcome section. - Change in quality of life(AQolS) and productivity(HPQ) after the 8-weeks-intervention compared with the baseline period. - TLFB at 12 weeks and 24 weeks after the intervention.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	A 3-week baseline is used as a control, and an 8-week web-based brief counseling to reduce the amount of alcohol consumption is used as an intervention.
Interventions/Control_2	A 3-week baseline is used as a control, and an 8-week web-based brief counseling and an application(ver.1) to reduce the amount of alcohol consumption is used as an intervention.
Interventions/Control_3	A 3-week baseline is used as a control, and an web-based brief counseling and an application(ver.2) to reduce the amount of alcohol consumption is used as a intervention.
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	1)Participants who speak Japanese and aged 20 and over 2) Participants with a high or very high DRL both at screening and at the start of the intervention. (DRL is assessed by the average daily alcohol intake. ) 3)Participants in employment 4)Participants who are able to receive online counseling via video call with a smartphone (5)Participants who can communicate with the clinical trial implementation staff (6)Participants who have a will to use the application for reducing alcohol consumption after receiving counseling via video call at a predetermined time and procedure (7)Participants who understand the purpose and content of this research and can give consents in writing to participate in the research voluntarily.
Key exclusion criteria	(1) Those whose Heavy Drinking Days (Heavy Drinking Day: HDD, 61 + g/day in men and 41 + g/day in women) Is less than 6 in the 4 weeks prior to the screening (2) Those who have five straight non-drinking days in the 4 weeks prior to the screening (3) Those who participated in an alcohol use disorder treatment or drinking reduction support program or self-help group in the four weeks prior to screening (4) Those who had received other structured psychotherapy in the four weeks prior to screening (5) Those with intellectual disability or dementia (DSM-5) (6) Those who used incompatible drugs in the 4 weeks prior to screening (7) Those with clinically serious and unstable complications. (8) Those who has had a history of alcohol withdrawal delirium or convulsive seizures due to alcohol withdrawal. (9) Those with a history of epilepsy or a history of seizures. (10) Those with significant rarefaction at the time of the screening or at the start of the intervention (11) Those who have been judged to be at serious suicide risk by the principal investigator or co-investigators (12) Those who drive vehicles with their main job, or who are engaged in hazardous occupations such as operating machinery or working at height (13) Those who participated in any clinical trial in the 4 weeks prior to the screening (14) Those who do not have a fixed address or telephone number (15) Those who do not routinely use a smartphone installed with iOS 13.0 or higher (16) Those who do not use the LINE messaging app on their smartphones (17) Those who has been judged to be not suitable for the subject of this this study by the principal investigator
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Ryuhei Middle name Last name So
Organization	CureApp, Inc.
Division name	Medical Division Regulatory Affairs Department
Zip code	103-0001
Address	12-5 Nihonbashi Kodenmacho YS Building 4F, Chuo-ku, Tokyo, Japan
TEL	03-6231-0183
Email	ryuhei.so@cureapp.jp

Public contact
Name of contact person	1st name Maki Middle name Last name Miyazaki
Organization	CureApp, Inc.
Division name	Medical Division Clinical Development Department
Zip code	103-0001
Address	12-5 Nihonbashi Kodenmacho YS Building 4F, Chuo-ku, Tokyo, Japan
TEL	03-6231-0183
Homepage URL
Email	maki.miyazaki@cureapp.jp

Sponsor
Institute	CureApp, Inc.
Institute
Department

Funding Source
Organization	CureApp, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Hospital Organization Kurihama medical and Addiction center
Address	5-3-1, Nobi, Yokosuka city, kanagawa prefecture, Japan
Tel	046-848-1550
Email	220-shomuhanchou@mail.hosp.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	株式会社CureApp

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 08 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	2020 Year 06 Month 01 Day
Date of IRB	2020 Year 06 Month 04 Day
Anticipated trial start date	2020 Year 06 Month 08 Day
Last follow-up date	2021 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 06 Month 05 Day
Last modified on	2022 Year 11 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046414