jRCT2032220560CompletedNot Applicable
A multicenter randomized, open-label trial to assess the efficacy and safety of the digital therapeutics ALM-003 for alcohol dependence
CureApp, Inc0 sites260 target enrollmentStarted: February 6, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 260
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 20age old over to No limit (—)
- Sex
- All
Inclusion Criteria
- •We will include people who meet all the following criteria:
- •20 years of age or older
- •diagnosed with alcohol dependence according to ICD-10
- •High or Very High Drinking Risk Level during screening period (from week -4 to week 0)
- •Can be treated on outpatient clinics
- •No serious social or family problems due to drinking
- •No life-threatening organ failures
- •CIWA-Ar score < 10 at week -4 and week 0
- •Agree to participate in the present study
- •Accustomed to use a smartphone with iOS 14.0 or higher or Android 10 or higher
Exclusion Criteria
- •We will not include people who meet any of the following criteria:
- •< 6 heavy drinking days (HDD) during the screening period
- •5 consecutive no drinking days during the screening period
- •Diagnosed with dementia or intellectual disability
- •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
- •Concomitant use of medications for alcohol dependence during the 4 weeks prior to week -4
- •Has participated in any intervention study during the 4 weeks prior to week -4
- •Has participated in a preliminary study of the prior version of ALM-003
- •Judged to be at high risk of suicide by investigators or PHQ-9 item 9 (suicidal thoughts) is 1 or more at week -4
- •Female with pregnancy or expecting
- •No fixed address or telephone number
- •Judged to be inappropriate as a participant by investigators
Outcomes
Primary Outcomes
-
Change in HDD from baseline to week 12
Secondary Outcomes
No secondary outcomes reported
Investigators
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