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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2032220560

Registered date:07/01/2023

A clinical trial of a therapeutic application ALM-003 for alcohol dependence

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedAlcohol dependence
Date of first enrollment06/02/2023
Target sample size260
Countries of recruitment
Study typeInterventional
Intervention(s)Intervention group: ALM-003 adjunct to treatment as usual for 24 weeks Control group: a simple drink diary app and psychoeducation material adjunct to treatment as usual (enhanced treatment as usual) for 24 weeks

Outcome(s)

Primary OutcomeChange in HDD from baseline to week 12
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaWe will include people who meet all the following criteria: 1) 20 years of age or older 2) diagnosed with alcohol dependence according to ICD-10 3) High or Very High Drinking Risk Level during screening period (from week -4 to week 0) 4) Can be treated on outpatient clinics 5) No serious social or family problems due to drinking 6) No life-threatening organ failures 7) CIWA-Ar score < 10 at week -4 and week 0 8) Agree to participate in the present study 9) Accustomed to use a smartphone with iOS 14.0 or higher or Android 10 or higher
Exclude criteriaWe will not include people who meet any of the following criteria: 1) < 6 heavy drinking days (HDD) during the screening period 2) 5 consecutive no drinking days during the screening period 3) Diagnosed with dementia or intellectual disability 4) Has participated in any structured treatment for alcohol dependence, structured programs for drinking moderation, or self-help groups during the 4 weeks prior to week -4 5) Concomitant use of medications for alcohol dependence during the 4 weeks prior to week -4 6) Has participated in any intervention study during the 4 weeks prior to week -4 7) Has participated in a preliminary study of the prior version of ALM-003 8) Judged to be at high risk of suicide by investigators or PHQ-9 item 9 (suicidal thoughts) is 1 or more at week -4 9) Female with pregnancy or expecting 10) No fixed address or telephone number 11) Judged to be inappropriate as a participant by investigators

Related Information

Contact

Public contact
Name Asuka Shishido
Address Kodenma-Cho YS building 4th floor 12-5, Nihonbashi Kodenma-Cho, Chuo-ku, Tokyo, Japan Tokyo Japan 103-0001
Telephone +81-3-6231-0183
E-mail alm-clin-reg@cureapp.jp
Affiliation CureApp, Inc
Scientific contact
Name Ryuhei So
Address Kodenma-Cho YS building 4th floor 12-5, Nihonbashi Kodenma-Cho, Chuo-ku, Tokyo, Japan Tokyo Japan 103-0001
Telephone +81-3-6231-0183
E-mail alm-clin-reg@cureapp.jp
Affiliation CureApp, Inc