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

JRCT ID: jRCT2032220560

Registered date:07/01/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Alcohol dependence
• Date of first enrollment: 06/02/2023
• Target sample size: 260
• 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• 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
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development