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 |
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Health condition(s) or Problem(s) studied | Alcohol dependence |
Date of first enrollment | 06/02/2023 |
Target sample size | 260 |
Countries of recruitment | |
Study type | Interventional |
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 Outcome | Change in HDD from baseline to week 12 |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | We 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 criteria | We 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
Primary Sponsor | So Ryuhei |
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Secondary Sponsor | |
Source(s) of Monetary Support | Japan Agency for Medical Research and Development |
Secondary ID(s) |
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 |
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 |
alm-clin-reg@cureapp.jp | |
Affiliation | CureApp, Inc |